Prospective Evaluation of CyberKnife Stereotactic Radiosurgery for Low and Intermediate Risk Prostate Cancer: Homogenous Dose Distribution
Phase: NA
Conditions: Prostate Cancer, Prostatic Cancer, Prostate Neoplasms, Prostatic Neoplasms, Cancer of the Prostate
Sponsor: Accuray Incorporated

A C C P 0 0 1. 4 
_ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _
5 7 
 P R O S P E C TI V E E V A L U A TI O N O F C Y B E R K NI F E S T E R E O T A C TI C 
R A DI O S U R G E R Y F O R L O W A N D I N T E R M E DI A T E RI S K 
P R O S T A T E C A N C E R: 
H O M O G E N O U S D O S E DI S T RI B U TI O N  
P R O T O C O L N U M B E R:  A C C P 0 0 1. 4 
Cli nic al Tri als. g o v I de ntifier: N C T 0 0 6 4 3 9 9 4
S T U D Y C H AI R S 
R a di ati o n O nc ol o g y  
R o bert Meier, M D 
P h ysics/ Q A  
Cristia n C otr utz, P h. D. 
S we dis h Ca ncer I nstit ute 
Seattle C y ber K nife Ce nt er 
5 5 0 1 7 t h A ve S uite A 1 0 
5 5 0 1 7 t h A ve S uite A 1 0 
Seattle, W A 9 8 1 2 2 
Seattle, W A 9 8 1 2 2 
( 2 0 6) 3 8 6- 6 7 0 7
( 2 0 6) 3 2 0- 7 1 3 0
Q u alit y of Lif e & 
Marti n Sa n da M D  
Utilities O utc o mes 
Bet h Isr ael D eac o n ess M e dical Ce nter 
3 3 0 Br o o kli ne A v e 
B ost o n M A 0 2 2 1 5 
SI T E C H AI R S 
Bet h Isr ael De ac o ness Ir vi n g Ka pla n, M. D. 
Bet h Isr ael H os pital 
3 3 0 Br o o kli ne A v e  
B ost o n, M A 0 2 2 1 5 
( 6 1 7) 6 6 7- 2 3 4 5
St u d y S p o ns or Acc ur a y I nc or p orat e d 
1 3 1 0 C hesa pea k e Terrace 
S u n n y vale, C A 9 4 0 8 9 
Tele p h o ne: ( 4 0 8) 7 1 6- 4 6 0 0 
F A X N u m ber:  ( 4 0 8) 7 1 6- 4 6 2 0 
Versi o n D ate:  
M a y 1 3, 2 0 1 3 

A C C P 0 0 1. 4 
_ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _
5 7 
 
 
 
 
Pr ot o c ol Si g n at ur e P a g e  
 
 
 
 
P R O S P E C TI V E E V A L U A TI O N O F C Y B E R K NI F E S T E R E O T A C TI C R A DI O S U R G E R Y F O R 
L O W A N D I N T E R M E DI A T E RI S K 
P R O S T A T E C A N C E R: H O M O G E N O U S D O S E DI S T RI B U TI O N 
 
 
I ha v e r e a d t hi s pr ot o c ol a n d a gr e e t o a d h er e t o t h e r e q uir e m e nt s. I will pr o vi d e c o pi e s of t hi s pr ot o c ol a n d 
all p erti n e nt i nf or m ati o n t o t h e st u d y p er s o n n el u n d er m y s u p er vi si o n. I will di s c u s s t hi s m at eri al wit h t h e m 
a n d e n s ur e t h e y ar e f ull y i nf or m e d r e g ar di n g t h e c o n d u ct of t h e st u d y a c c or di n g t o t h e pr ot o c ol a n d i n 
stri ct a c c or d a n c e wit h all a p pli c a bl e U. S. F o o d a n d Dr u g A d mi ni str ati o n ( “ F D A ” ) r e g ul ati o n s a n d g ui d eli n e s 
a p pli c a bl e t o t h e St u d y, i n cl u di n g wit h o ut li mit ati o n t h e r e g ul ati o n s s et f ort h i n P art s 5 0, 5 4, 5 6 a n d 8 1 2 of 
2 1 C. F. R., a n d all ot h er a p pli c a bl e f e d er al, st at e, or l o c al l a w s, g ui d eli n e s, r ul e s, a n d r e g ul ati o n s of a n y 
t y p e.  
 
 
 
_ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _  
Cli ni c al Sit e  
 
 
  
  
  
  
  
 
  
  
  
  
 
 
Si g n at ur e, Pri n ci p al I n v e sti g at or    
  
  
  
D at e 
 
 
  
  
  
  
  
 
  
  
 
Pri nt e d N a m e, Pri n ci p al I n v e sti g at or   
  
  
 
 
 

A C C P 0 0 1. 4 
_ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _
5 7 
 
C O N T A C T IN F O R M A TI O N  
 
 
S p o ns or C o nt acts:  
 
  
 
 
  
 
 
 
Vict or C he n. 
Direct or, Cli nical St u dies Ma na ge me nt 
Acc ura y I nc or p orate d 
1 3 1 5 C hesa pea ke T errace 
S u n n y vale, C A  9 4 0 8 9 
T el.  
  
4 0 8 2 0 3- 6 2 3 1 
Fa x  
  
4 0 8 7 8 9- 4 2 7 7 
E- mail  
vc he n @acc ura y.c o m  
 
P atric k M orse 
P r o gr a m M a n a ger, Cli nic al St u dies 
Acc ur a y I nc or p or ate d 
1 3 1 0 C hesa pea ke T errace 
S u n n y vale, C A  9 4 0 8 9 
T el.  
  
4 0 8 2 0 3- 0 8 1 1 
Fa x  
  
4 0 8 7 8 9- 4 2 7 7 
E- mail  
p m orse @acc ura y.c o m  
 
 
 
 
 

A C C P 0 0 1. 4 
_ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _
5 7 
 
I N DE X 
 
Sc he ma, Eli gi bilit y C hec klist 
 
1. 0  
Bac k gr o u n d 
 
2. 0  
O bjecti ves 
 
3. 0  
De vice 
 
4. 0  
Pretreat me nt E val u ati o n  
 
 
5. 0  
Patie nt Selecti o n & Eli gi bilit y 
 
6. 0  
Re gistrati o n Pr oce d ures 
 
7. 0  
Pat h ol o g y 
 
8. 0  
Treat me nt 
 
9. 0  
Patie nt Assess me nts & T o xicit y 
 
1 0. 0 
Data C ollecti o n 
 
1 1. 0 
Statistical C o nsi derati o ns 
 
1 2. 0 
Data Safet y a n d M o nit ori n g 
 
1 3. 0 
S o urce of S u bjects a n d R ecr uit me nt Pr oce d ures 
 
1 4. 0 
Ris k t o Be nefit Rati o 
 
1 5. 0 
C osts a n d Pa y me nts   
 
 
1 6. 0 
A p pe n dices 
  
  
  
  
  
  
  
  
  
 
  
A p pe n di x I: 
Patie nt c o nse nt 
  
A p pe n di x II: 
Perf or ma nce Stat us Scales 
  
A p pe n di x III: Sta gi n g 
  
A p pe n di x I V: Data c ollecti o n d oc u me nts 
  
A p pe n di x V: 
N CI c o m m o n t o xicit y criteria/ R T O G/ E O R T C 
A p pe n di x VI:  A U A, S F- 1 2, E PI C, S HI M, U S M D q uesti o n naires 
  
  
  
 
1 7. 0 
Refere n ces  
  
  
  
  
  
 
 
 

A C C P 0 0 1. 4 
_ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _
5 7 
 
 
P R O S P E C TI V E E V A L U A TI O N O F C Y B E R K NI F E S T E R E O T A C TI C 
R A D I O S U R G E R Y F O R L O W A N D I N T E R M E DI A T E RI S K 
P R O S T A T E C A N C E R: H O M O G E N O U S D O S E DI S T RI B U TI O N  
 
 
S C H E M A 
 
  
  
 
 
  
R is k Gr o u p 
S 
1. L o w Risk :  
  
R 
 
 
T  
C S T 1 b- T 2a 
  
  
E 
R  
Gleas o n ≤ 6 & P S A ≤ 1 0  
    
G  
Ultras o u n d  
Pla n ni n g  
3 6. 2 5 G y *              
A 2 . I nter me di ate Risk: 
   
I   
& fi d ucial  
C T a n d  
( 7. 2 5 G y x 5) 
T  
C S T 2 b 
    
S  
place me nt  
f use d M RI 
C y ber K nife 
I 
 
Gleas o n ≤ 6 & P S A ≤ 1 0  
    
T  
 
F  
  or  
 
E  
           
  
 
Y   
C S T 1 b- T 2 b,      
R 
  
  
  
 
   
   Gleas o n = 7 & P S A ≤ 1 0, or  
   
 Gleas o n ≤ 6 & P S A > 1 0 & ≤ 2 0 
  
 
 
 
 
* P rescri be d d ose t o P T V; pr ostate recei ves 8 G y x 5 
 
 
P A TI E N T P O P U L A TI O N (see secti o n 4. 0 f or c o m plete eli gi bilit y) 
Hist ol o gicall y-c o nfir me d, a de n ocarci n o ma of t he pr ostate 
Cli nical Sta ge T 1 b – T 2 b, N X- 0, M X- 0 
O ne of t he f oll o wi n g c o m bi nati o ns: 
- Gleas o n sc ore 2- 6 a n d P S A ≤ 2 0 
- Gleas o n sc ore 7 a n d P S A ≤ 1 0 
E C O G  Perf or ma n ce Stat us 0- 1 
N o pri or pr ostate ra diati o n or ot her defi niti ve t hera p y 
 
 
 
Re q uire d s a m ple size : 3 1 9 patie nts. 
 

A C C P 0 0 1. 4 
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5 7 
 
E LI GI BI LI T Y C H E C K LI S T 
 
_ _ _ _ _ _ _ ( Y)  
Is t here hist ol o gi call y pr o ve n pr ostate a d e n ocarci n o ma, bi o ps y wit hi n o ne year of  
e nroll me nt? 
 
_ _ _ _ _ _ _ ( 2- 6)  
W hat is t he Gleas o n Sc ore?  
 
_ _ _ _ _ _ _ ( T 1 b – T 2 b) W hat is t he cli nical T-sta ge? ( AJ C C 6 t h E diti o n) 
 
_ _ _ _ _ _ _ ( Y)  
Is t he p atie nt cli nical N x or N 0, a n d M x or M 0? 
 
_ _ _ _ _ _ _ ( 0- 2 0)  
W hat is t he patie nt’s P S A?   
 
_ _ _ _ _ _ _ ( L, I)  
D oes t he patie nt f all i nt o o ne of t hese ris k gr o u ps ( AJ C C 6 t h E diti o n): 
-  L o w: C S T 1 b- T 2a, Gleas o n 2- 6, P S A ≤ 1 0 
 
-  Inter me diat e: C S T 2 b, Gleas o n 2- 6, P S A ≤ 1 0, or 
 
   C S T 1b- T 2 b, a n d Gleas o n 2- 6, P S A ≤ 2 0 n g/ ml, or Gleas o n 7, P S A ≤ 1 0 n g/ ml 
 
_ _ _ _ _ _ _ ( Y)  
Is t he pr ostate v ol u me ≤ 1 00 cc? 
 
_ _ _ _ _ _ _ ( 0- 1)  
W hat is t he E C O G perf or ma nce stat us? 
 
_ _ _ _ _ _ _ ( N)  
Has t he patie nt u n der g o n e pr ostatect o m y or cr y ot hera p y of t h e pr ostate? 
 
_ _ _ _ _ _ _ ( N)  
Has t he patie nt ha d ra di ot hera p y t o t he pr ostate or l o wer pel vis? 
 
_ _ _ _ _ _ _ ( N)  
Has t he patie nt i m pla nte d har d ware near t hat w o ul d pr o hi bit a p pr o priate tr eat me nt 
pla n ni n g or tr eat me nt deli ver y, i n t he i n v esti gat or’s o pi ni o n? 
 
_ _ _ _ _ _ _ ( N)  
Has t he patie nt ha d c he m ot hera p y f or a mali g na nc y i n t he last 5 years? 
 
_ _ _ _ _ _ _ ( N)  
Has t he patie nt ha d a n i n vasi ve mali g n a nc y ( ot h er t ha n t his pr ostate ca ncer, or basal 
or  sq ua m o us s ki n ca ncers) i n t he last 5 years? 
 
_ _ _ _ _ _ _ ( N)  
Has t he patie nt’s a n dr o ge n f u ncti o n bee n a bl ate d d uri n g t he p ast 2 m o nt hs? See 
Sec ti o n 5. 1 2 
 
 
 
 

A C C P 0 0 1. 4 
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5 7 
 
1. 0  
B A C K G R O U N D 
1. 1  
Pr ostate ca ncer is t he m ost c o m m o n mali g na nc y i n me n; a n esti mate d 2 1 9, 0 0 0 cases will be 
dia g n ose d i n t he U nite d States i n 2 0 0 7 1. P S A scree ni n g h as le d t o earlier st a ge dia g n oses; i n 
1 9 9 8, 9 2 % of pr ostate ca ncers w ere dia g n os e d wit h cli nicall y or ga n- c o nfi n e d disease 2. 
Acc or di n g t o t he N CI C o nse ns us C o nfere n ce i n 1 9 8 8 3, a n d t he Pr ostate Ca ncer Pa nel of t he 
A me rica n Ur ol o gical Ass ociati o n i n 1 9 9 54, treat me nt o pti o ns t hat s h o ul d be disc usse d wit h 
each p atie nt i n t his cate g or y i ncl u d e ra di cal pr ostatect o m y, e xter nal bea m r a diati o n t hera p y 
( R T), i nterstitial brac h yt hera p y a n d watc hf ul waiti n g. 
1. 2  
First atte m pts t o treat or ga n-c o nfi n e d pr ostate ca n cer wit h r a di ot hera p y yiel de d p o or 
bi oc he mical diseas e fr ee o utc o mes, as i ns ufficie nt d oses wer e deli ver e d t o t he tar get. Si nce 
t he 1 9 8 0’s, c o nf or m al R T tec h ni q ues ha v e bee n d e vel o pe d w hic h re d uce d d ose t o t he 
s urr o u n di n g or ga ns, all o wi n g t he s afe d eli ver y of gr eater d oses t o t he pr ost ate. C o nf or mal 
R T has bee n ac hie ve d eit her t hr o u g h 3- di me nsi o n c o nf or mal e xter nal bea m R T, or t hr o u g h 
pr ostate brac h yt h er a p y. T hese tec h ni q u es ha ve yi el de d disease-fr ee o utc o mes si milar t o 
t h ose see n wit h ra dical pr ostatect o m y (see ta bl e 1), alt h o u g h n ot wit h o ut t o xicit y. 
1. 3  
M o der n e xter nal bea m ra di ot hera p y uses t hree- di me nsi o nal treat me nt pla n ni n g, deli veri n g 
R T t o t he pr ostate t hr o u g h t y picall y 5- 7 c o pla nar bea ms. Wit h i nte nsit y m o d ulate d 
ra di ot hera p y (I M R T), d ose is m o d ulate d t hr o u g h eac h of t h ese bea ms. D ue t o variati o ns i n 
patie nt p ositi o ni n g a n d i nter nal or ga n m oti o n, t he p ositi o n of t he pr ostate ca n n ot be 
acc ur atel y deter mi ne d usi n g e xteri or s ki n mar ks. Placi n g g ol d fi d ucials i n t he pr ostate, a n d 
i ma gi n g pri or t o treat me nt deli ver re d u ces tar geti n g err or, b ut t his t y pi call y d oes n ot 
acc o u nt f or m o ve me nt wit hi n a gi ve n treat me nt sessi o n. S uc h i ntrafracti o nal m o ve me nt ca n 
be s u bsta ntial: i n o ne st u d y 5 it was esti mate d at 2 m m, 6 m m, a n d 7 m m i n t he left-ri g ht, 
a nteri or- p osteri or, a n d cr a nial-ca u d al directi o ns, r es pecti vel y.  Ra diati o n o nc ol o gists 
acc o u nt f or t his u ncertai nt y b y a d di n g a m ar gi n t o t he i nte n de d tar get. E x pa n di n g ra di al 
di me nsi o ns t o create a “ pla n ni n g tar get v ol u me” ( P T V) i ncreas es t he v ol u me of s urr o u n di n g 
n or mal str uct ures i n t he hi g h d ose r e gi o n, p ote ntiall y i ncr easi n g t o xicit y. 
1. 4  
I n t he p ast deca de, tr a ns p eri neal ultras o u n d- g ui de d brac h yt hera p y has gai ne d p o p ularit y f or 
treati n g or ga n- c o nfi ne d pr ostate ca n cer. Br ac h yt hera p y all o ws t he deli ver y of c o nf or mal, 
hi g h- d ose ra di ot her a p y t o t he pr ostate, wit h a r a pi d d ose fall- off o utsi de of t he i m pla nte d 
re gi o n. Fa v ora ble l o n g-t er m o utc o mes usi n g per m a ne nt i o di ne- 1 2 5 (I- 1 2 5) a n d palla di u m-
1 0 3 ( P d- 1 0 3) i m pla nts ha ve bee n r e p orte d i n n u mer o us st u dies 6 7 8 9 1 0.  
1. 5  
H ig h- d os e rat e ( H D R) br ac h yt her a p y has bee n use d i n t he treat me nt of pr ostate ca n cer si nce 
t he 1 9 8 0’s1 1 1 2 1 3 1 4 1 5 1 6 1 7 1 8 1 9 2 0 2 1 2 2 2 3. Cat heters are pl ace d t e m p oraril y i n t he pr ostat e, 
a n d t he n l oa de d wit h a hi g h- d os e Iri di u m- 1 9 2 s o ur ce, deli veri n g a fe w fr acti o ns of ver y 
hi g h- d ose R T. I nitial pr ot oc ols e m pl o yi n g H D R c o m bi ne d c o n ve nti o nall y fr acti o nate d 
e xter nal bea m R T wit h a n H D R b o ost. M ore rece nt re p orts ha ve e m pl o ye d H D R as 
m o n ot hera p y 2 4 2 5 2 6 2 7 2 8 2 9. A dj usti n g f or pre-treat me nt ris k fact ors, t hes e st u dies yi el d 
b D F S o utc o mes at least as fa v ora ble t o t h ose s ee n wit h L D R br ac h yt her a p y or c o nf or mal 
d ose-escalate d R T or I M R T (see ta ble 1). I n dee d, a pr os pecti ve, n o n-ra n d o mize d st u d y 
fr o m Willia m Bea u m o nt H os pital3 0 c o m pari n g H D R m o n ot hera p y v ers us L D R 
bra c h yt hera p y ( P d- 1 0 3) s h o we d a s u peri or 5- year e ve nt-fr ee s ur vi v al  ( 9 8 % vs. 8 5 %, 
p = 0. 0 1) a n d a tre n d t o war ds i m pr o ve d fr ee d o m fr o m ca ncer fail ur e ( 9 8 % vs. 9 2 %, p = 0. 1) i n 
t he H D R c o h ort. T he s a me gr o u p s h o we d ac ute a n d late t o xicit y, p ote nc y, a n d Q O L 
f oll o wi n g H D R br ac h yt h era p y w as m ore f a v ora ble t ha n eit her L D R brac h yt hera p y or 
c o nf or mal e xter nal bea m R T 3 1 3 2. T he rate of i m p ote n ce t hree years f oll o wi n g H D R was 
1 6 % , c o m par e d t o 4 5 % f oll o wi n g L D R brac h yt h era p y. 

A C C P 0 0 1. 4 
_ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _
5 7 
 
 
T a b le 1. b D F S O utc o mes f or L o w- Ris k Pr ost at e C a ncer 
R x  
Details 
I nstit uti o n 
# pts 
Me dia n
f/ u yrs 
5- y r b D F S: Defi niti o n 
P h oe ni x 
A S T R O 
A ve ‡ 
H D R 
4 5- 5 0 G y + 2- 4 f x b o ost  
Seattle, Kiel, Bea u mt 3 3 
4 6  
5  
  
9 6 % 
9 2 % 
3 6 G y + 5. 5- 6 G y  x  4 b o ost  C A E n d oc urie 3 4  
7 0  
7. 2 5  
9 3 %  
9 0 % 
H D R 
M o n ot x: 6 – 7. 2 5 G y x 6  
C A E n d oc urie
3 5  
1 1 7#  
8  
  
9 6 % 
9 7 % 
M o n ot x: 9. 5 G y x 4  
Bea u m o nt
3 6 
9 5 †  
4. 2  
  
9 8 % 
L D R 
M o n ot x: 1 4 5 G y I 1 2 5  
R T O G 9 8 0 5
3 7 p hase II  
9 5  
5. 3  
9 9 %  
9 3 % 
8 8 % 
M o n ot x: I 1 2 5 & P d 1 0 3  
1 1 i nst meta-a nal ysis
3 8 
1 4 4 4  
5. 2 5  
8 6 %  
8 8 % 
E B 
I M R T: 7 0 G y, 2. 5 G y/f x  
Cle v Cli n3 9 h y p ofract  
3 6  
5. 5  
9 7 %  
9 7 %  
9 7 % 
I M R T: 8 1 G y, 1. 8 G y/f x  
M S K C C4 0 
2 0 3  
7  
9 2 %  
8 4 % 
8 3 % 
3 d R T/I M R T: > 7 2 G y  
9 i nstit meta-a nal ysis 4 1 
7 0  
5. 7  
  
7 9 % 
3 d R T/I M R T: 7 0- 7 6 G y  
9 i nstit meta-a nal ysis 4 2 
2 3 1  
6. 3  
9 4 %  
 
3 d C o nf or mal: 7 8 G y  
M D A ra n d d ose-esc 4 3  
3 2  
> 5  
9 3 %  
9 2 % 
pr ot o n bst t o 7 9. 2 G y  
M G H, L o m a Li n da 4 4 
1 1 6  
5. 5  
9 6 %  
8 0. 5 % 
  
I nstit uti o ns 
A ut h or 
# pts 
f/ u yrs 
Defi niti o n  
b D F S  
A ve ‡ 
R P 
Ba yl or 
H ull 4 5 
2 9 9  
3. 9  
P S A ≥0. 4  
9 2. 5 % 
9 4 % 
Cle v Cli nic & 
M S K Merc y 
K u pelia n 4 6 
5 2 4 *  
5. 5  
P S A≥0. 2 
9 2 % 
U ni v Pe n ns yl va nia  
D’ A mic o 4 7 
3 2 2  
5  
A S T R O  
8 8 % 
H o p ki ns 
Ha n 4 8 
8 9 9 *  
5. 9  
P S A≥0. 2  
9 8 % 
*N u m ber of p atie nts, b D F S esti mate d base d o n pr o p orti o ns wit hi n eac h ris k gr o u p. #7 5 % l o w ris k, 2 5 % 
i nter me diate; †I n cl u de d T 2 b i n l o w-ris k gr o u p. ‡W ei g hte d a ver a ge, usi n g A S T R O or state d defi niti o n. 
 
1. 6  
Ra diati o n o nc ol o gists fracti o nate R T d ose t o re d u ce t o xicit y t o s urr o u n di n g n or mal tiss ues. 
F or m ost ca n cers, b y d eli veri n g d os e o ver se veral wee ks, e q ui val e nt ca n cer- killi n g eff ect is 
ac hie ve d wit h re d uce d l o n g-ter m t o xicit y. T h e eff ect of d ose fracti o nati o n o n b ot h ca ncer 
a n d n or mal tiss ues ca n b e esti mate d usi n g t h e “li near- q u a dratic m o d el”. I n t his m o del, t he 
al p ha- beta rati o reflects t he res p o nse of n or mal tiss ues or ca n cers t o c ha n ges i n R T d ose per 
fracti o n. M ost ca n cers res p o n d t o R T as d o ra pi dl y- di vi di n g n or mal tiss ues (e. g., s ki n or 
m uc o us me m bra nes), a n d t h us ha ve hi g h α /β  rati os, i n t he 1 0- 1 2 G y ra n ge. Tiss ues wit h 
l o wer α /β  rati os are m or e se nsiti ve t o lar ge d ose p er fr acti o n (als o k n o w n as 
h y p ofracti o nat e d) R T. 
1. 7  
T he fa v or a ble c o ntr ol rat es o bser ve d wit h h y p ofracti o nate d R T le d ra di o bi ol o gists t o 
rec o nsi der α /β  rati o of pr ostate car ci n o ma. Se ver al resear c hers ha ve c o ncl u de d t hat pr ostate 
ca ncer has a n u n us uall y l o w α /β  rati o of a b o ut 1. 5 G y4 9 5 0 5 1 5 2 5 3. A n ot her a n al ysis5 4 
esti mate d t he α /β  rati o w as bet wee n 3. 1- 3. 9 G y; a m ore rece nt st u d y5 5 of 3 7 5 6 patie nts 
yi e l de d a rati o bet w ee n 2. 6 a n d 3. 7 G y. A l o w α /β  rati o is c o nsiste nt wit h ot her bi ol o gic 
pr o p erties of pr ostate ca n cer: a n u n us u all y l o n g t u m or d o u bli n g ti mes 5 6, a n d a ver y l o w 
pr o p orti o n of pr olifer ati n g cells 5 7. Alt h o u g h t he act ual α /β  rati o f or pr ost ate ca ncer is 
de ba te d, t he acce pte d r a n ge of 1 – 4 G y a p p ears t o be si milar t o, or s maller t ha n t he α /β  rati os 
f or late effects i n t he s urr o u n di n g n or mal tiss ues ( 3- 5 G y). T h us a t hera p e utic gai n c o ul d be 
ac hie ve d b y h y p ofracti o nati o n. I n d ee d, t his a p pr o ac h s h o ul d res ult i n e q ui vale nt or 
i m pr o ve d ca ncer c o ntr ol wit h re d uce d t o xicit y5 8 5 9 6 0. 

A C C P 0 0 1. 4 
_ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _
5 7 
 
1. 8  
I n 1 9 5 1, Lars Le ksell, a S we dis h ne ur os ur ge o n, first descri be d r a di os ur ger y: t he use of 
c o n ver gi n g bea ms of i o nizi n g ra diati o n t o n o n-s ur gicall y a blate i ntracra nial lesi o ns. He later 
de vel o pe d t he “ Ga m ma K nife”, w hic h f oc uses 2 0 1 c ol u m nate d C o- 6 0 bea ms at a si n gle 
is oce nter. A met al fra m e was fi x e d t o t he patie nt’s s k ull, pr o vi di n g b ot h a r efer e nce f or 
treat me nt, a n d a m ea ns t o ri gi dl y fi x t he s k ull. A n ot her met h o d of deli veri n g ster e otactic 
ra di ot hera p y us es m ulti ple is oce ntric arcs fr o m a li near acceler at or e q ui p pe d wit h a s mall 
c olli mat or; a gai n t he pati e nt ri gi dl y i m m o bilize d. 
1. 9  
I n t he 1 9 9 0s a n o vel de vi ce was d e vel o pe d at Sta nf or d U ni versit y f or d eli veri n g st ere otactic 
ra di os ur ger y wit h o ut t he nee d f or ri gi d i m m o bilizati o n. T his de vice, calle d “ C y ber K nife”, 
uses a li g ht w ei g ht x- ba n d li near accelerat or m o u nte d o n a n i n d ustrial r o b ot. T he s yst e m 
uses a pair of a m or p h o us silic o n detect ors t o gat her ort h o g o n al fl u or osc o pic i ma ges of t he 
patie nt. B o n y la n d mar ks or i m pla nte d fi d ucials near t he tar get ar e c o nti n u o usl y i ma ge d, a n d 
t he s yste m’s c o m p uter a ut o maticall y ma kes a dj ust me nts t o acc o u nt f or v ari ati o ns i n set- u p 
or patie nt m o ve me nt. T h e tar get ca n be tr eate d fr o m a b o ut 1 2 0 0 differe nt directi o ns, usi n g 
c o pla nar or n o n-c o pla n ar bea ms. T he C y ber K nife ca n treat static i ntra- a n d e xtra-cra nial 
sites wit h s u b- milli meter acc ur ac y. 
1. 1 0  T he C y b er K nif e s h o ul d be a n i deal d e vice f or treati n g pr ostate ca n cer b eca use 1) tar geti n g 
acc ur ac y f or static tar gets is e x celle nt, wit h a n err or of a b o ut 1 m m, 2) it ca n a dj ust f or i ntra-
fracti o nal or ga n m oti o n, re d uci n g t he v ol u me of t he tar get P T V a n d t h eref ore t he d ose t o 
s urr o u n di n g or ga ns, 3) b y usi n g o ver o n e- h u n dr e d n o n-c o n pla nar bea ms, t he d ose gra di e nt 
bet wee n t he pr ostate a n d s urr o u n di n g tiss ues ma y be s u peri or t o t hat ac hie v e d wit h 
c o n ve nti o nal li near accel erat ors, a n d 4) t he r a di o bi ol o g y of pr ostate ca n cer ma y f a v or lar ge 
d ose per fracti o ns. 
1. 1 1  T he feasi bilit y of C y b er K nife f or tr eati n g l ocalize d pr ostate ca ncer was first descri be d b y 
Ki n g at Sta nf or d U ni versit y 6 1. T heir p hase I pr ot o c ol deli vere d 3 6. 2 5 G y i n 5 fracti o ns of 
7. 2 5 G y.  I n a r ece nt re p ort 6 2 of ac ute a n d 1 8- m o nt h late t o xicit y i n 2 6 “l o w-ris k” patie nts, 
n o p atie nt e x perie nce d gr a de 3 or 4 ac ute or l ate t o xicit y, a n d o nl y o ne p atie nt e x perie nce d a 
gr a de 2 late m or bi dit y ( uret hral strict ur e). T o xicit y w as less t ha n t hat re p orte d i n M D 
A n ders o n’s e xter nal b ea m d ose escalati o n trial. Mea n P S A 1 8 m o nt hs after treat me nt was 
0. 2 2 n g/ ml. Na ples C o m m u nit y H os pital re p orte d 6 3 a series of m ore t ha n 7 0 l o w a n d 
i nter me diate ris k patie nts treate d wit h t he C y ber K nife. T he pr ostat e recei ve d 3 5 G y i n 5 
fracti o ns of 7 G y eac h; ac ute t o xicit y was mi ni mal. 
 
T a ble 2 : H y p of r acti o n ate d R T Sc he d ules           2 G y/f x E q ui vale nt D ose 
                   ( All d oses e x presse d i n G y)  
           Ass u mi n g α /β  rati o of: 
I nstit uti o n/ pr ot oc ol  
 D ose/f x   #f xs   T otal d ose 
1. 5 G y 3 G y 
1 0 G y 
Na ples C y b er K nif e  
   7  
      5   3 5  
  
8 5  
7 0   
4 9. 6 
Sta nf or d C y b er K nif e    7. 2 5       5   3 6. 2 5   
9 0. 6     7 4. 3  
5 2. 1 
Bea u m o nt H D R *  
   9. 5       4   3 8  
  
1 1 9. 4 9 5  
6 1. 8 
De ma nes H D R *  
   7. 2 5       6   4 3. 5   
1 0 8. 8 8 9. 2 
6 2. 5 
T his pr ot oc ol: G T V      8  
      5   4 0  
  
1 0 8. 6 8 8  
6 0 
R T O G 0 4 1 5 
    
   2. 5       2 8   7 0  
  
8 0  
7 7  
7 2. 9 
* D oes n ot acc o u nt f or heter o ge neit y i n H D R pla ns. 
 
1. 1 2  Calc ulati o n of E q ui vale nt D oses. I n t his pr ot oc ol, t he li near q ua dratic f or m ula is use d t o 
calc ulate e q ui vale nt d oses. T hree ass u m pti o ns ar e ma de: 1) s u blet hal da ma ge is c o m plet el y 
re pair e d bet wee n fr acti o ns, 2) n o re pair of s u blet hal da ma ge occ urs d uri n g a gi ve n fracti o n, 

A C C P 0 0 1. 4 
_ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _
5 7 
 
a n d 3) n o re p o p ul ati o n occ urs d uri n g t he tr eat me nt c o urse (i.e., t here is n o ti me fact or). 
E q ui vale nt d ose at a s pecifie d d ose/f x d, f or a n ass u me d α /β  rati o r, is e x presse d as E Q Dd 
(α /β =r ). 
1. 1 3  D o se Selecti o n. See ta ble 2 f or 2 G y/f x e q ui vale nt d oses. T he 5- year b D F S o utc o mes f or 
H D R series a n d f or h y p ofracti o nat e d E B R T are s u peri or t o t h ose re p orte d usi n g 
c o n ve nti o nall y fracti o nate d 3 D c o nf or mal or I M R T (see ta ble 1). T his s u g gests t hat a n 
E Q D 2 of 8 0 G y or m ore ma y b e re q uir e d t o ac hi e ve 5- year b D F S i n t he 9 6- 9 8 % ra n ge. At 
Sta nf or d a n d Na pl es C o m m u nit y H os pital, t o xicit y f oll o wi n g C y b er K nif e ( 7. 2 5 G y x 5 
fracti o ns, a n d 7 G y x 5 fracti o ns, res pecti vel y, b ot h calc ulate d 3- 5 m m fr o m t he pr ostate 
b or der) was mi ni mal. I n t he Na ples series, me dia n P S A o utc o mes o ne year after tr eat me nt 
was 1. 2 n g/ ml, s o me w hat gr eater t ha n t hat re p orte d i n brac h yt her a p y seri es, s u g gesti n g d ose 
escalati o n be y o n d 7 G y x 5 w o ul d be be neficial. T he Sta nf or d C K pr ot oc ol ga v e a n E Q 2 
7 4 . 3 t o 9 0. 6 G y (f or α /β  r ati os of 3 G y a n d 1. 5 G y, r es pecti vel y); P S A res p o nse was e x celle nt, 
falli n g t o a n a ver a ge of 0. 2 2 n g/ ml at 1 8 m o nt hs. T his pr ot oc ol t h us uses t he Sta nf or d d ose 
a n d P T V: 7. 2 5 G y x 5 fracti o ns prescri be d t o t he P T V, defi ne d as t he pr ostate e x pa n de d 
3 m m p osteri orl y, a n d 5 m m else w her e. T he r a pi d d ose gra die nt ac hie va bl e wit h C y ber K nife 
all o ws t he si m ulta ne o us deli ver y of a great er d ose t o t he pr ostate ( G T V). T o deli ver a B E D 
a p pr oac hi n g t hat prescri be d i n t he H D R m o n ot her a p y s eries, 8 G y x 5 is prescri be d t o t he 
pr ostate. T h us t he P T V r ecei ves a n E Q D 2 of 7 4. 3 G y (if α /β = 3) , or a n E Q D2 of 9 0. 6 G y 
(α /β = 1. 5 ). T h e pr ostate r ecei ves a n E Q D2 (α /β = 3) of 8 8 G y, or 1 0 8. 6 G y f or α /β = 1 . 5. 
 
2. 0  
O B J E C TI V E S 
P RI M A R Y O BJ E C TI V E S: T he pri mar y s afet y g o al of t his st u d y is t o esti mate, i n b ot h l o w-ris k 
a n d i nter me diate-ris k c o h orts, t he rates of ac ute a n d late gra de 3- 5 gastr oi nt esti nal a n d 
ge nit o uri nar y t o xicit y o bser ve d d uri n g t he fi ve years f oll o wi n g C y b er K nif e S R S f or pr ostate 
ca ncer. T he pri mar y efficac y g oal is t o d oc u me nt t he rate of bi oc he mical Disease- Fr ee S ur vi val 
( b D F S), P h oe ni x a n d A S T R O defi niti o ns, at 5 years. 
S E C O N D A R Y O BJ E C TI V E S: t o meas ure t he f oll o wi n g i n t he st u d y p o p ul ati o n: Rates of l ocal 
fail ure, dista nt fail ur e, disease-free s ur vi val, disease-s pecifi c s ur vi val, a n d o verall s ur vi val; q ualit y 
of life ( Q O L) i n ge neric a n d or ga n-s p ecific d o m ai ns; w or k eff ort re q uir e d i n treat me nt pla n ni n g 
a n d deli ver y of C y ber K nife S R S.   
 
Patie nts will be f oll o we d a n n uall y t o 1 0 years, t o c ollect a d diti o nal data f or descri pti ve a n al ysis. 
 
3. 0  
D E VI C E  
  
Acc ur a y, I nc. ( S u n n y v ale, C A), recei ve d F D A cleara nce i n J ul y 1 9 9 9 t o pr o vi de treat me nt pla n ni n g 
a n d i ma ge g ui de d stere otactic ra di os ur ger y a n d precisi o n ra di ot hera p y f or lesi o ns, t u m ors a n d 
c o n diti o ns of t he brai n, base of s k ull a n d cer vic o-t h oracic s pi ne, hea d a n d nec k usi n g t h e 
C y ber K nife. O n A u g ust 1 0, 2 0 0 1, Acc ura y, I nc. recei v e d 5 1 0( k) F D A cl eara n ce ( 5 1 0( k) n u m ber 
K 0 1 1 0 2 4) t o pr o vi de treat me nt pla n ni n g a n d i ma ge- g ui de d stere otactic ra di os ur ger y a n d precisi o n 
ra di ot hera p y f or lesi o ns, t u m ors, a n d c o n diti o ns a n y w h ere i n t he b o d y w h e n ra diati o n treat me nt is 
i n dicate d. 
 
4. 0  
P R E T R E A T M E N T  E V A L U A TI O N 
E val uati o ns Re q uire d f or Eli gi bilit y: 
4. 1  
C o m plete hist or y & p h ysical e x a mi nati o n 
4. 2  
Assess me nt of perf or ma n ce stat us 

A C C P 0 0 1. 4 
_ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _
5 7 
 
4. 3  
Pa t h ol o gic c o nfir mati o n of a de n ocar ci n o ma of t he pr ostate 
4. 4  
Ser u m P S A, < 9 0 da ys pri or t o re gistrati o n, or < 6 0 da ys pri or t o h or m o ne t hera p y, a n d 3 0 
or 9 0 da ys aft er disc o nti n ui n g fi nasteri de or d utast eri de, r es pecti vel y, See s ecti o n 5. 3. 
4. 5  
C B C, platelets, ser u m B U N a n d creati ni ne a n d t est oster o ne; ma y b e dr a w n after r e gistrati o n 
4. 6  
Ultras o u n d of pr ostate, or C T of pel vis or di gital r ectal e x a m ( D R E) 
4. 6. 1  T o deter mi ne pr ostat e size b y i ma gi n g: v ol u me = π / 6 x le n gt h x hei g ht x wi dt h; if 
v ol u me deter mi ne d b y D R E esti mate, m ust be c o nfir me d o n C T pla n ni n g; if 
v ol u me is > 1 0 0 cc t he n patie nt is i neli gi ble 
4. 6. 2  Meas ure me nt fr o m C T or ultras o u n d ≤ 6 m o nt hs pri or t o re gistrati o n or ≤ 1 4 da ys 
pri o r t o re gistrati o n if h or m o ne t hera p y is gi ve n; it patie nt ha d ta ke n fi n asteri de or 
d utasteri de, v ol u me deter mi ne d > 3 0 or > 9 0 da ys res pecti vel y after disc o nti n uati o n  
4. 7  
Patie nt s h o ul d be a ble t o c o m plete q uesti o n naires (see a p p e n di x VI); b aseli ne 
q uesti o n naires ma y be c o m plete d bef or e or after e nr oll me nt, b ut bef ore tr eat me nt. 
4. 7. 1  S F- 1 2 q uesti o n naire 
4. 7. 2  A U A q uesti o n naire 
4. 7. 3  E PI C- 2 6 q uesti o n nair e 
4. 7. 4  S HI M q uesti o n nair e 
4. 7. 5  Utilizati o n of Se x ual Me dicati o ns/ De vices q uesti o n naire 
 
5. 0  
P A TI E N T S E L E C TI O N & E LI GI BI LI T Y  
5. 1  
Hist ol o gicall y pr o ve n pr ostate a de n ocar ci n o ma 
5. 1. 1  Gleas o n sc or e 2- 7 (re vie we d b y refer e nce l a b, see als o secti o n 5. 4; if i nitial 
pat h ol o g y diff ers fr o m t hat of ref er e nce l a b, t he refere n ce la b’s i nter pr etati o n will 
be use d f or eli gi bilit y a n d ris k gr o u p assi g n m e nt (see als o secti o n 7. 2. 1) 
5. 1. 2  Bi o ps y wit hi n o ne year of date of r e gistrati o n 
5. 2  
Cli nical sta ge T 1 b- T 2 b, N 0- N x, M 0- M x ( AJ C C 6 t h E diti o n) 
5. 2. 1  T- sta ge a n d N-sta ge d eter mi ne d b y p h ysical e x a m a n d a vaila ble i ma gi n g st u dies 
( ultras o u n d, C T, a n d/ or M RI; see s ecti o n 4. 5) 
5. 2. 2  M-sta ge deter mi ne d b y p h ysical e x a m, C T or M RI. B o ne s ca n n ot r e q uire d u nless 
cli nical fi n di n gs s u g gest p ossi ble osse o us metastases. 
5. 3  
P S A ≤ 2 0 n g/ ml (see secti o n 5. 4; if pre-e nr oll me nt P S A was dra w n > 6 0 d a ys pri or t o 
C y ber K nife tr eat me nt, a n ot her P S A o btai ne d ≤ 6 0 da ys pri or t o treat me nt, will bec o me t he 
pre- treat me nt P S A a n d will deter mi ne eli gi bilit y a n d ris k gr o u p; pr e-tr eat m e nt P S A m ust be 
dra w n 3 0 or 9 0 d a ys after disc o nti n ui n g fi nasteri de or d utasteri de res pecti vel y) 
5. 4  
Patie nts bel o n gi n g i n o ne of t he f oll o wi n g ris k gr o u ps: 
5. 4. 1  L o w: C S T 1 b- T 2a a n d Gleas o n 2- 6 a n d P S A ≤ 1 0, or  
5. 4. 2  Inter me diate: C S T 2 b a n d Gleas o n 2- 6 a n d P S A ≤ 1 0, or C S T 1 b- T 2 b, a n d Gleas o n 
2- 6 a n d P S A ≤ 2 0 n g/ ml, or Gleas o n 7 a n d P S A ≤ 1 0 n g/ ml 
5. 5  
Pr o state v ol u me: ≤ 1 0 0 cc 
5. 5. 1  De ter mi ne d usi n g: v ol u me = π / 6 x le n gt h x hei g ht x wi dt h 
5. 5. 2  Me as ure me nt fr o m C T or ultras o u n d ≤ 6 m o nt hs pri or t o re gistrati o n. 
5. 6  
E C O G  perf or ma nce stat us 0- 1 
5. 7  
N o pri or pr ostatect o m y or cr y ot her a p y of t he pr ostate 
5. 8  
N o pri or ra di ot hera p y t o t he pr ostate or l o wer pel vis 
5. 9  
N o i m pla nte d har d ware or ot her materi al t hat w o ul d pr o hi bit a p pr o priate tr eat me nt pla n ni n g 
or treat me nt deli ver y, i n t he i n vesti gat or’s o pi ni o n. 
5. 1 0  N o c he m ot her a p y f or a mali g na n c y i n t he last 5 years. 

A C C P 0 0 1. 4 
_ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _
5 7 
 
5. 1 1  N o hist or y of a n i n vasi ve mali g na n c y ( ot her t h a n t his pr ostate ca ncer, or b asal or s q ua m o us 
s ki n ca ncers) i n t he last 5 years. 
5. 1 2  N o h or m o ne a blati o n f or t w o m o nt hs pri or t o e nr oll me nt, or d uri n g tr eat me nt.  T his 
i ncl u des L H R H a g o nists (e. g. le u pr oli de, g osereli n, tri pt oreli n), a nta g o nists (e. g. de gareli x), 
peri p her al bl oc kers ( e. g. fl uta mi de, bical uta mi de, nil uta mi de), estr o ge ns (e. g. D E S), 
bilateral orc hiect o m y a n d 5-al p ha r e d uctase i n hi bit ors (fi nesteri d e or d utasteri de). 
5. 1 3  C o m pleti o n of patie nt q uesti o n naires i n secti o n 4. 7. 
5. 1 4  C o nse nt si g ne d.  
  
 
 
6. 0  
R E GI S T R A TI O N P R O C E D U R E S 
6. 1  
P R E- R E GI S T R A TI O N R E Q UI R E M E N T S: Pri or t o e nr olli n g patie nts i nt o t he st u d y, 
facilities m ust c o m plete t he Facilit y Q uesti o n naire, t he Be nc h mar k ( Dr y R u n) Treat me nt 
Pla n (see secti o n 8. 3. 2. 1), a n d t he P h ysics Q A re q uire me nts s pecifie d bel o w. After re vie w 
b y t he Pri nci pal I n v esti gat or a n d P h ysics C hair c o nfir ms satisfact or y c o m pleti o n, sites are 
eli gi ble f or st u d y p artici p ati o n.  
6. 1. 1  P H Y SI C S Q U A LI T Y A S S U R A N C E s hall at a mi ni m u m i ncl u de: 
6. 1. 1. 1  A B S O L U T E D O SI M E T R Y: Eac h site m ust d oc u me nt C y ber K nife a bs ol ut e 
cali brati o n i n water acc or di n g t o A A P M T G 5 1. Site m ust als o d oc u me nt 
t hat, wit hi n t he last year, p h ot o n bea m o ut p ut has bee n verifie d b y t he 
Ra di ol o gical P h ysics Ce nter ( R P C), usi n g t heir T L D mi ni- p ha nt o m 
pr oce d ur e. 
6. 1. 1. 2  D AI L Y Q A: partici pati n g sites m ust pr o vi de d oc u me ntati o n t hat, f or t he 
pri or m o nt h, t he f oll o wi n g has b ee n perf or m e d dail y: 
6. 1. 1. 2. 1  At least 3 0 0 0 M Us deli vere d dail y f or mac hi ne w ar m- u p ( per 
Acc ur a y) 
6. 1. 1. 2. 2  Te m perat ur e a n d at m os p heric pr ess ure r ec or d e d, o ut p ut 
cali brati o n perf or me d, a n d ne w o ut p ut fact or rec or de d. 
6. 1. 1. 2. 3  P ositi o n of laser at perc h p ositi o n verifie d t o be wit hi n 1 m m of 
fl o or ref ere n ce p oi nt. 
6. 1. 1. 3  M O N T H L Y Q A: sites m ust pr o vi de d oc u me ntati o n t hat t he f oll o wi n g 
m o nt hl y Q A is bei n g perf or me d: 
6. 1. 1. 3. 1  Bea m o ut p ut i n p ha nt o m verifie d as +/- 1 % of s p ecifie d o ut p ut 
6. 1. 1. 3. 2  Bea m e ner g y c o nsta nc y verifie d b y i o n c h a m ber meas ure me nts 
at 1 0c m a n d 2 0c m i n p ha nt o m, usi n g 6 0 m m c olli mat or a n d 
8 0c m S A D. Rati o s h o ul d be wit hi n +/- 2 % of t he T P R 2 0, 1 0 rati o 
deter mi ne d fr o m T P R ta bles. 
6. 1. 1. 3. 3  Bea m s y m metr y meas ure d b y w ater sca n ni n g s yst e m or b y 
ra di o gra p hic ( X V) or gaf c hr o mic ( E B T or M D 5 5) fil m. Bea m 
s y m metr y s h o ul d n ot e x cee d +/- 2 % usi n g area met h o d. 
6. 1. 1. 3. 4  Fi d ucial trac ki n g e n d-t o- e n d tests usi n g ball- c u be p ha nt o m. 
Ma xi m u m trac ki n g ra dial err or s h o ul d be < 0. 9 5 m m, wit h left-
ri g ht, a nt- p ost, a n d i nf-s u p err ors n ot e x cee di n g 0. 8 m m. 
6. 1. 1. 3. 5  Las er – r a diati o n fiel d c o n gr u e nce m eas ur e d usi n g X V or E B T 
fil m i n p ha nt o m u n der sta n dar d c o n diti o ns ( S A D = 8 0c m, 5 m m 
b uil d- u p material a n d 6 0 m m c olli mat or), wit h laser ce nt er 
mar ke d b y a pi n. Dis place me nt, e val uate d usi n g i ma gi n g 
s oft ware or gra p h p a per, s h o ul d n ot e x cee d 1 m m. 

A C C P 0 0 1. 4 
_ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _
5 7 
 
6. 1. 1 . 4 Dail y a n d m o nt hl y Q A as descri be d a b o ve ma y b e rec or de d i n t he 
C y ber K nife R o b otic Ra di os ur ger y S yste m Q A L o g B o o k, or i n ot her 
d oc u me nts, a n d s h o ul d c o nti n ue t hr o u g h o ut t he e nr oll me nt peri o d. 
6. 2  
P A TI E N T R E GI S T R A TI O N: Patie nts ma y b e re gistere d o nl y after all eli gi bilit y criteria are 
met: see Eli gi bilit y C hec klist a b o ve, a n d I ncl usi o n Criteria a n d E x cl usi o n Criteria C R Fs 
( Case Re p ort F or ms). Aft er t he patie nt si g ns t he C o nse nt F or m t he patie nt is e nr olle d i n t he 
st u d y, a n d sc h e d ule d f or treat me nt. T he pr e-tr eat me nt C R Fs are t he n fille d o ut b y t he 
i n vesti gat or a n d/ or res ear c h assista nt. T his data is retai ne d i n t he patie nt’s c hart a n d i n 
researc h office. T h e date of re gistrati o n s hall be t h e date t he c o nse nt was si g ne d. Fi d ucials 
m ust be place d wit hi n 6 0 da ys, a n d t he first fracti o n of ra di os ur ger y m ust be a d mi nistere d 
wit hi n 9 0 da ys of re gistrati o ns. 
 
7. 0  
P A T H O L O G Y  
7. 1  
Pat h ol o g y E v al uati o n: Sli des/ bl oc ks fr o m t he pr e-treat me nt dia g n ostic pr ostatic bi o ps y will 
be re vie w e d t o c o nfir m t he dia g n osis a n d Gleas o n sc ore. Ot her hist o pat h ol o gic feat ures, 
i ncl u di n g e xte nt of t u m or i n t he bi o psies, t he n u m ber of bi o psies p ositi ve a n d peri ne ur al 
i n vasi o n, s hall be rec or de d. 
7. 2  
Ce ntral Re vie w: All c o nse nti n g patie nts m ust ha ve a c o m plete re prese nt ati ve set of bi o ps y 
sli des or tiss ue bl oc k s u b mitte d t o t he Ce ntral Pat h ol o g y La b orat or y i n or d er f or t h e cas e t o 
be e val uat e d f or ce ntral p at h ol o g y r e vie w.  T h e f oll o wi n g m ust be pr o vi de d: 
7. 2. 1  A c o m plete re pr ese ntati ve set of bi o ps y sli des or tiss ue bl oc k; if i nitial pat h ol o g y 
differs fr o m t hat of ref er e nce la b, t he r ef ere n ce la b’s i nter pretati o n will be use d f or 
eli gi bilit y a n d ris k gr o u p assi g n me nt 
7. 2. 2  A Pat h ol o g y r e p ort d oc u me nti n g t he s u b mitte d bl oc ks, c ore or sli des c o ntai n 
t u m or; t he re p ort m ust i ncl u de t he A cc ur a y pr ot oc ol n u m ber a n d t he p atie nt’s case 
n u m ber.  T he patie nt’s na me a n d/ or ot her i de ntif yi n g i nf or m ati o n s h o ul d be 
re m o ve d fr o m t he re p ort. 
7. 2. 3  S u b mit materials f or ce ntral re vie w t o B ost wic k La b orat or y; ot her ce ntral re vie w 
la b 
ma y 
b e 
use d if 
a p pr o ve d 
b y 
S p o ns or 
a n d 
Pri nci pal I n v esti gat or. 
 
8. 0  
T R E A T M E N T:  C Y B E R K NI F E R A DI O S U R G E R Y 
8. 1  
FI D U CI A L P L A C E M E N T: All patie nts will ha ve g ol d fi d ucial see ds m eas uri n g 3- 5 m m 
place d i n t he pr ostate pri or t o treat me nt pla n ni n g. At least f o ur fi d ucial see ds will be place d 
u n der tra nsr ectal ultras o u n d g ui da nce, usi n g eit her tra ns peri neal or tra nsrectal a p pr o ac h, 
wit h l ocal a n est hesia a n d/ or se d ati o n as r e q uire d. T he use of li n ke d fi d ucials are 
e nc o ura ge d, si nce t he y ma y mi grate less t ha n i n di vi d uall y place d fi d uci als. T he p h ysicia n 
will place see ds s uc h t hat t he y are visi ble ( a n d n ot s u peri m p ose d) o n C y b er K nif e 
ort h o g o n al i ma gi n g, are n ot c olli near, a n d i deall y are s e par ate d b y 2 c m or m ore. Fi d u cials 
will be place d as a n o ut patie nt pr oce d ur e; at least t hree see ds m ust be usa ble f or trac ki n g 
d uri n g tr eat me nt. If a n i nteri m a nal ysis s h o ws u nacce pta ble fi d ucial mi grati o n wit h a 
s pecific tec h ni q ue or t y p e of fi d ucial, f urt her use of t his tec h ni q ue or t y p e of fi d ucial ma y 
be pr o hi bite d b y t h e Pri nci pal I n vesti gat or. 
8. 2  
T R E A T M E N T P L A N NI N G I M A GI N G:  T he treat me nt pla n will be create d base d o n t he 
ris k gr o u p assi g n e d b y t h e ref ere n ce la b re vie w. 
8. 2. 1  T o all o w fi d ucial sta bilizati o n a n d res ol uti o n of s welli n g, pla n ni n g st u dies will be 
i ma ge d 
5- 1 0 
da ys after fi d ucial 
place me nt. 
Al p ha 
Cra dle 
or a si milar 
i m m o bilizati o n de vice will be use d as nee de d. T o a v oi d pr ostate dist orti o n, i n t he 

A C C P 0 0 1. 4 
_ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _
5 7 
 
pri mar y C T use d f or tr eat me nt pla n ni n g, n o i n d w elli n g cat h eter s hall be place d. If 
re q uire d t o vis ualize t he uret hra, a cat h eter ma y be place d f or t he sec o n dar y 
i ma gi n g st u d y o nl y. C T sca ns will be ta ke n f or treat me nt pla n ni n g.  C T slices will 
be 1 – 1. 5 m m, wit h 2 0 0- 3 0 0 slices ta ke n ce nt er e d a p pr o xi matel y at t he pr ostate.  
T he i ma gi n g sets will be d o w nl oa de d t o t h e C y b er K nife tr eat me nt pla n ni n g s yste m 
t o de vel o p t he ra di os ur ger y tr eat me nt pla n. 
8. 2. 2  If n ot 
me dicall y c o ntr ai n dicate d, all p atie nts 
will u n der g o 
M RI i ma gi n g t o 
deter mi ne t he a nat o mical b or ders of t he pr ostate, a n d if p ossi ble, t he uret hra. T his 
st u d y will be f use d t o t he treat me nt pla n ni n g C T. N o e n d orectal c oil all o w e d. 
8. 2. 3  U R E T H R A L I D E N TI FI C A TI O N: T o rec or d D V H data f or t he pr ost atic a n d 
me m bra n o us uret hra, vis ualizati o n of t hese str uct ures is rec o m me n de d, b ut n ot 
ma n dit or y. If t he ur et hr a ca n n ot be vis ualize d a n d c o nt o ure d, t he n t o i ns ure t he 
pr ostatic uret hr a meets t he d ose c o nstrai nt s pecifie d i n 8. 3. 4. 7, t he pr escri pti o n d ose 
of 3 6. 2 5 G y s h all be n o less t ha n 7 5 % of D m a x. T o i de ntif y t h e uret hra, t he 
f oll o wi n g ma y be e m pl o ye d: 
8. 2. 3. 1  M RI, if uret hr a ca n be i de ntifie d. T o verif y t hat t he M RI is ca p a ble of 
vis ualizi n g t he uret hr a, o n t he first 3 cases a n a d diti o nal sec o n d ary s ca n 
(eit her M RI or C T) s h all be perf or me d wit h a n i n d welli n g cat heter i n place. 
T his will be c orrelate d wit h t he M RI sca n perf or me d wit h o ut a cat heter; if 
t he uret hra ca n be r elia bl y i ma ge d, t he n s u bse q ue nt cat heter place me nt is 
n ot re q uire d. 
8. 2. 3. 2  A sec o n d ary C T or M RI sca n wit h a n i n d welli n g uret hral cat heter i n place.  
8. 2. 3. 3  Uret hr o gr a m 
wit h c o ntrast deli neati n g t he 
me m bra n o us a n d pr ostati c 
uret hra. 
8. 2. 4  Pri or t o treat me nt pla n ni n g i ma gi n g, t he p atie nt will f oll o w t he b o wel/ uri nar y 
pre par ati o n pr oce d ures use d f or treat me nt (see secti o n 8. 4. 2). 
8. 3  
C Y B E R K NI F E T R E A T M E N T P L A N NI N G: 
8. 3. 1  T R E A T M E N T 
P L A N NI N G 
P R O C E D U R E S: I n v erse 
pla n ni n g 
usi n g t he 
C y ber K nife pla n ni n g s yste m will be e m pl o ye d. T he treat me nt pla n use d f or eac h 
treat me nt will be base d o n a n a nal ysis of t he v ol u metric d ose i ncl u di n g d ose-
v ol u me hist o gra m ( D V H) a nal yses of t he P T V a n d critical n or mal str uct ur es.  T he 
h o m o ge n e o us C T m o del s hall be use d; a n y b ea ms i ntersecti n g a hi p pr ost hesis s hall 
be t ur ne d off. N u m ber of pat hs a n d bea ms use d f or eac h patie nt will var y a n d will 
be deter mi ne d b y t he selecte d i n di vi d ual treat me nt pla n. T o re d uce o verall 
treat me nt ti me a n d t otal m o nit or u nits, 1 5 0- 2 0 0 n o n-zer o bea ms ar e rec o m me n de d. 
N o m ore t ha n 2 5 0 bea ms s hall be e m pl o ye d.  T u ni n g str uct ures s hall be e m pl o ye d 
t o mi ni mize c o nf or malit y i n de x ( CI) a n d ne w c o mf or malit y i n de x ( n CI), prefera bl y 
yi el di n g val ues less t ha n 1. 2 0 a n d 1. 2 5, res pecti vel y. 
8. 3. 2  Q U A LI T Y A S S U R A N C E 
8. 3. 2. 1  B E N C H M A R K ( D R Y R U N) C A S E R E VI E W: all p ote ntial sites s h all 
recei v e, pri or t o patie nt e nr oll me nt, a n a n o n y m o us electr o nic patie nt data 
set. A treat me nt pla n s h all be de vel o pe d, a n d t h e pla n re vie w e d b y t he PI 
a n d P h ysi cs C hair; c o m pleti o n of a satisfact or y pla n is r e q uire d pri or t o 
patie nt e nr oll me nt. 
8. 3. 2. 2  FI R S T P A TI E N T P R E- T R E A T M E N T R E VI E W: t he treat me nt pla n of t he 
first patie nt e nr olle d at eac h site m ust be re vie we d pri or t o be gi n ni n g 
ra di os ur ger y. T he Pri nci pal I n vesti gat or ( PI) s h all be n otifie d at t he ti me of 

A C C P 0 0 1. 4 
_ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _
5 7 
 
e nroll me nt of t his first patie nt, a n d of t he pr o p ose d first treat me nt date, t o 
ass ure PI’s a v aila bilit y f or re vie w. After pla n ni n g is c o m plete, t he treati n g 
site will se n d via o ver ni g ht deli ver y t o t he PI sit e: 1) De-i de ntifie d c o p y of 
t he treat me nt pla n ni n g data sets (i ncl u di n g f us e d pri mar y a n d sec o n d ar y 
i ma gi n g st u dies, c o nt o ur sets, a n d is o d ose distri b uti o ns/ D V Hs), 2) C o pies 
of t he Pre-treat me nt Pla n ni n g Pre p ar ati o n f or m, C y b er K nif e Tr eat me nt 
Pla n ni n g f or m, a n d Tr eat me nt Pla n Q A f or m. T he Pri nci pal I n v esti gat or 
a n d P h ysics C hair s hall c o m plete r e vie w wit hi n 3 w or ki n g da ys of r ecei pt; 
treat me nt will o nl y b e gi n after a n y necessar y c orrecti o ns ar e i m ple me nte d 
a n d fi nal pla n is a p pr o ve d.  T he PI ma y re q uir e a d diti o nal pre-treat me nt 
re vie ws as nee d e d t o i ns ure q ualit y.  T hese ma y c o u nt t o war d t he re q uire d 
re vie ws s pecifice d i n 8. 3. 2. 3. 1 
8. 3. 2. 3  P O S T- T R E A T M E N T R E VI E W: T he PI site will als o re vie w treat me nt 
pla ns a n d treat me nt d eli ver y rec or ds f or a d diti o nal pr ot oc ol patie nts:  
8. 3. 2. 3. 1  T he T R E A T M E N T P L A N of t he FI R S T pr ot o c ol patie nt f or all 
partici pati n g ra diati o n o nc ol o gists, ur ol o gists, a n d p h ysi cists 
s hall be re vie we d, u nless t he practiti o ner alrea d y u n der we nt pre-
treat me nt re vie w per secti o n 8. 3. 2. 2. Als o, treat me nt pla ns a n d 
treat me nt deli ver y r ec or ds of T H R E E a d diti o nal R A N D O M L Y 
c h ose n cas es fr o m eac h site will be re vie we d. If warr a nte d b y 
t he o utc o mes of a b o v e Q A re vie ws, t he PI ma y r e q uest t hat 
a d diti o nal cases be s u b mitte d f or re vie w pri or t o f urt her patie nt 
treat me nts. 
8. 3. 2. 3. 2  F or patie nts c h ose n f or p ost-treat me nt re vi e w, t he st u d y M o nit or 
will n otif y t h e tr eati n g site n o s o o ner t ha n 1 da y, b ut n o lat er 
t ha n 7 da ys, after c o m pleti o n of treat me nt. Wit hi n o ne wee k, t h e 
treati n g site will deli ver t o t he PI site: 1) De-i de ntifie d c o p y of 
t he treat me nt pla n ni n g data sets (i ncl u di n g f us e d pri mar y a n d 
sec o n dar y 
i m a gi n g 
st u dies, 
c o nt o ur 
sets, 
a n d 
is o d ose 
distri b uti o ns/ D V Hs), 2) C o pies of t he Pre-tr eat me nt Pla n ni n g 
Pre parati o n f or m, C y b er K nife Treat me nt Pla n ni n g f or m, a n d 
Treat me nt Pla n Q A f or m, 3) C y ber K nife Tr eat me nt f or m, a n d 
scree n ca pt ur es d oc u me nti n g treat me nt d eli ver y f or all fracti o ns. 
T hese will be re vie w e d b y t he PI a n d P h ysics c hair wit hi n o ne 
wee k, wit h fee d bac k gi ve n t o t he s u b mitti n g site as nee de d. 
8. 3. 3  E V A L U A T E D S T R U C T U R E S: 
8. 3. 3. 1  G T V: T he Gr oss T u m or V ol u me ( G T V) s hall i ncl u de t he pr ostate; n o m ore 
t ha n 0. 5c m of t he i m me diatel y a djace nt S V s hall b e i ncl u de d. 
8. 3. 3. 2  C T V: T he Cli nical Treat me nt V ol u me ( C T V) s hall i ncl u de: 
8. 3. 3. 2. 1  L O W- RI S K P A TI E N T S: ( C S T 1 b- T 2a, P S A ≤ 1 0, Gleas o n 
sc ore ≤ 6). Pat h ol o gi c data fr o m 
Willia m Bea u m o nt H os pital 
s h o we d o nl y 1 % of l o w-ris k patie nts ha d se mi nal vesicle ( S V) 
i n v ol ve me nt6 4; t his eli mi nates t he nee d t o treat S Vs i n t his 
gr o u p. T h us t h e C T V s hall e q ual t he G T V. 
8. 3. 3. 2. 2  I N T E R M E DI A T E RI S K P A TI E N T S: T he Bea u m o nt st u d y als o 
s h o we d o nl y 2 % of “ hi g h-ris k” patie nts ( P S A > 1 0, Gleas o n > 6, 
a n d/ or C S > T 2a) ha d S V i n v ol ve me nt distal t o 2 c m fr o m t he 

A C C P 0 0 1. 4 
_ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _
5 7 
 
pr o state. T he i nter me diat e ris k gr o u p C T V s hall t heref ore b e t he 
G T V pl us t he pr o xi mal 2c m of S Vs. 
8. 3. 3. 3  P T V: T he pr escri pti o n d ose s hall be deli ver e d t o t he Pla n ni n g T u m or 
V ol u me ( P T V). 
W hile t he static t ar geti n g acc ur ac y of t he C y b er K nif e is 
a b o ut 1 m m 6 5, def or mati o n of t he pr ostate, a n d t ar get m o ve me nt o cc urri n g 
after i ma gi n g b ut bef ore d ose deli ver y c o ul d c o ntri b ute t o tar geti n g 
u ncertai nt y. Alt h o u g h t he c u m ulati ve tar geti n g u ncertai nt y h as n ot bee n 
acc ur atel y q u a ntifie d, t he 3- 5 m m G T V t o P T V e x pa nsi o n e m pl o ye d i n t he 
Sta nf or d series a p pears m ore t ha n a de q uate. Sta nf or d p hase I data s h o w e d 
safel y a n d earl y cli nical res p o nse rates are acce pt a ble wit h t his P T V.  T h us 
t he P T V s hall e q ual t h e C T V e x pa n de d 3 m m p osteri orl y, a n d 5 m m i n all 
ot her di me nsi o n. 
8. 3. 3. 4  Micr osc o pic e val uati o n of pr ost atect o m y s peci me ns 
ma y d e m o nstrate 
E X T R A C A P S U L A R E X T E N SI O N: 9 9 % of 
micr osc o pic e xtra pr ostatic 
disease s h o ul d be 
wit hi n 3- 5 m m of t he pr ostate 6 6. Si nce 7. 2 5 G y is 
pr escri be d 3- 5 m m o utsi de t he pr ostate, a d ose a de q u ate t o a d dress 
micr osc o pic diseas e ( > 6 G y x 5) will easil y b e deli vere d at 5 m m.  
8. 3. 3. 5  N O R M A L TI S S U E S: C O N T O U RI N G R E Q UI R E D: T he str uct ures liste d 
bel o w 
will be c o nt o ure d a n d e val uate d 
wit h 
D V H a nal ysis. 
B o wel 
peristalsis a n d bla d der filli n g c ha n ge t he size a n d l ocati o n of n or mal 
str uct ures. If t he C T a n d M RI ( or sec o n dar y C T) s h o w n or mal tiss ues i n 
differe nt l ocati o ns i m me diatel y a djace nt (i.e., wit hi n < 2c m) t he pr ostate, 
t he c o nt o ure d str uct ur e s hall be a lar ger c o m p osite of b ot h i ma ge s ets. Gri d 
size s h o ul d be s ufficie ntl y lar ge t o i ncl u de t he e ntire str uct ur e. 
8. 3. 3. 5. 1  R E C T U M: defi ne d as a s oli d str uct ure, i n cl u di n g t he l u me n a n d 
rectal w all, e xte n di n g fr o m t he le vel of t he is c hial t u ber osit y t o 
t he si g m oi d fle x ure. 
8. 3. 3. 5. 2  B L A D D E R, defi ne d as a s oli d str uct ure i ncl u di n g t he bla d der 
wall a n d l u me n. 
8. 3. 3. 5. 3  P E NI L E B U L B: t he p orti o n of t he b ul b o us s p o n gi os u m t hat lies 
i nferi or t o t he ur o ge nital dia p hra g m. 
8. 3. 3. 5. 4  SI G M OI D C O L O N O R O T H E R B O W E L l yi n g wit hi n 2 c m of 
t he P T V s h o ul d be c o nt o ure d. 
8. 3. 3. 5. 5  T E S T E S, bilateral, s hall be c o nt o ure d. 
8. 3. 3. 6  N O R M A L TI S S U E S: C O U N T O U RI N G R E Q UI R E D I F VI S U A LI Z E D: 
8. 3. 3. 6. 1  P R O S T A TI C 
U R E T H R A, 
defi ne d as t he l u me n- m uc osal 
i nterface, e xte n di n g fr o m bla d der nec k t o t he 
me m bra n o us 
uret hra. If visi ble o n pl a n ni n g st u dies, t his s hall be c o nt o ure d 
a n d e val uate d. If n ot visi ble, t he n c o nt o uri n g is n ot re q uire d, 
h o we ver t he prescri pti o n d ose ( 3 6. 2 5 G y) s h o ul d b e pres cri be d at 
7 5 % of D ma x or great er. 
8. 3. 3. 6. 2  M E M B R A N O U S U R E T H R A s hall be c o nt o ure d, if visi ble. 
8. 3. 3. 6. 3  N E U R O V A S C U L A R B U N D L E, if visi ble o n 
M RI or C T: 
s h o ul d be c o nt o ure d i n tra ns verse pla n es e xte n di n g fr o m t he 
pr ostatic a pe x t o t he base. 
8. 3. 4  D O S E S P E CI FI C A TI O N S: All s pecifie d d oses are f or t he e ntire tr eat me nt c o urse. 
8. 3. 4. 1  T he P R E S C RI P TI O N D O S E  of 3 6. 2 5 G y  s hall be t he d ose t o t he P T V : 

A C C P 0 0 1. 4 
_ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _
5 7 
 
8. 3. 4 . 1. 1 Per pr ot oc ol : 
V 3 6. 2 5 G y s h all be at least 9 5 %, a n d t he 
prescri be d d ose s hall be 6 5- 8 5 % of D ma x ( or 7 5- 8 5 % if uret hra 
n ot c o nt o ure d). 
8. 3. 4. 1. 2  Mi n or variati o ns: V 3 6. 2 5 G y < 9 5 %, b ut ≥ 9 0 %. Prescri be d d ose 
6 0- 6 5 % ( 7 2- 7 4 % if uret hra n ot c o nt o ure d), or 8 5- 9 0 % of D ma x 
8. 3. 4. 1. 3  Maj or variati o ns: V 3 6. 2 5 G y < 9 0 %; pr escri be d d ose < 6 0 % or 
> 9 0 % of D ma x ( < 7 2 % if uret hra n ot c o nt o ur e d). 
8. 3. 4. 2  A S E C O N D A R Y D O S E  of 4 0 G y  s hall be t he d ose t o t he G T V : 
8. 3. 4. 2. 1  Per pr ot oc ol : G T V V 4 0 G y s h all be at least 9 5 %. 
8. 3. 4. 2. 2  Mi n or variati o n: V 4 0 G y < 9 5 %, b ut ≥ 9 0 %. 
8. 3. 4 . 2. 3 Maj or variati o n: V 4 0 G y < 9 0 %. 
8. 3. 4. 2. 4  G T V + 1 m m s hall als o be c o nt o ure d f or D V H a nal ysis. 
 
 
8. 3. 4. 3  R E C T U M : Per Pr ot oc ol : V 3 6 G y < 1cc.  
F or t he H D R c o m p o ne nt of R T O G 0 3 2 1, t he rect u m V 7 5 % R x D ose 
c o nstrai nt was < 1 cc. Ass u mi n g a n α /β  r ati o of 3 G y f or late effects, t he 
E Q D 1 .8 is 3 0. 1 G y. A d di n g t he 4 5 G y of e xter nal bea m prescri b e d i n R T O G 
0 3 2 1 yiel ds 7 5. 1 G y, at 1. 8 G y/f x. T he 5-fracti o n e q ui vale nt d ose is 7. 1 2 G y x 
5 = 3 5. 6 G y ( α /β = 3). T h us, t he 5-fracti o n c o nstrai nt e q ui vale nt t o t hat  use d 
i n R T O G 0 3 2 1 w o ul d be V 3 5. 6 G y < 1cc 
Usi n g t he r ectal c o nstrai nt f or c o nf or m al e xter nal bea m R T of R T O G 0 1 2 6 
(see ta ble 3), a n d c o n v erti n g t o a 5 fracti o n e q ui v ale nt d ose (α /β = 3) yi el ds 
D 1 5 <  3 6. 4 G y. F or a rect al v ol u me of 5 0cc, t his is e q ui vale nt t o V 3 6. 4 G y < 
7. 5cc. T he H D R c o nstrai nt is m ore restricti ve t ha n t hat of R T O G 0 1 2 6, t h us 
t his pr ot oc ol a d o pts a c o nstrai nt cl ose t o t he f or m er: rect u m V 3 6 G y < 1cc. 
8. 3. 4. 3. 1  Mi n or variati o n: Rect u m V 3 6 G y ≥ 1 cc, b ut < 2 cc. 
8. 3. 4. 3 . 2 Maj or variati o n: Rect u m V 3 6 G y ≥ 2 cc 
8. 3. 4. 4  B L A D D E R : Per Pr ot oc ol : V 3 7 G y < 1 0cc . 
R T O G 0 3 2 1 pr o p ose d a bla d der c o nstr ai nt f or H D R deli ver y as: V 7 5 % R x 
d ose < 1 cc. Des pite t his restricti o n, f or a s m all gr o u p of U C S F H D R pla ns, 
t he aver a ge  bla d d er V 8 0 % R x D ose was 0. 7cc6 7. A n attai na ble H D R 
c o nstrai nt w o ul d be V 8 0 % R x d ose < 1cc. C o n verti n g t o E Q D 1. 8 usi n g α /β  
of 3  for late eff ects, a n d a d di n g t he 4 5 G y e xter nal bea m yi el ds a E Q D 1. 8  of 
7 8. 6 G y. T his is e q ui vale nt t o 3 6. 6 G y i n 5 fr acti o ns. Bea u m o nt ha d n o 
T a ble 3 . N or mal Tiss ue D ose C o nstrai nts f or R T O G 0 1 2 6, a n d t he B E Ds f or Ac ute a n d Late Eff ects 
 
R T O G 0 1 2 6 
C o nstrai nt  
Ac ute effects: α /β  = 1 0  
Lat e effects: α /β  = 3 
 
 
 
B E D  
5 f x e q ui v  
B E D  
5 f x e q ui v 
Bla d der  
D 1 5  
8 0 G y  
9 4. 4  
4 8. 7  
1 2 8  
3 7. 8 
D 2 5  
7 5 G y  
8 8. 5  
4 6. 6  
1 2 0  
3 6. 4 
D 5 0  
6 5 G y  
7 6. 7  
4 2. 3  
1 0 4  
3 3. 5 
Rect u m  
D 1 5  
7 5 G y  
8 8. 5  
4 6. 6  
1 2 0  
3 6. 4 
D 2 5  
7 0 G y  
8 2. 6  
4 4. 5  
1 1 2  
3 5. 0 
D 5 0  
6 0 G y  
7 0. 8  
4 0. 0  
9 6  
3 1. 9 
Pe nile b ul b  
me dia n  
5 2. 5 G y  
6 2. 0  
3 6. 4  
8 4  
2 9. 5 

A C C P 0 0 1. 4 
_ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _
5 7 
 
bla d der c o nstr ai nt f or H D R, a n d re p ort e d mi ni mal c hr o nic bla d der t o xicit y 
( m ost was uret hr al). Usi n g t he bla d d er c o nstr ai nt f or c o nf or mal e xter nal 
bea m R T of R T O G 0 1 2 6 (see ta ble 3), a n d c o n v erti n g t o a 5 fr acti o n 
e q ui vale nt d ose ( α /β = 3) yi el ds: D 1 5 < 3 7. 8 G y, or c o nser vati vel y esti mati n g  
total bla d der v ol u me at 1 0 0cc, V 3 7. 8 G y < 1 5cc. W hile t his 5 fracti o n d ose 
c o nstrai nt is si milar t o R T O G 0 3 2 1’s 5-fracti o n e q ui vale nt of 3 6. 6 G y, t he 
1 5cc v ol u me c o nstr ai nt is far m ore li beral. Si nce bla d der v ol u mes ver y 
s u bsta ntiall y, a n a bs ol ute v ol u me c o nstrai nt ma y b e pref era bl e t o a 
fracti o nal v ol u me c o nstrai nt, es peciall y wit h t he ra pi d d ose fall- off s ee n 
wit h C y ber K nife. F or t his pr ot oc ol, a n a p pr o xi mate a ver a ge of t he t w o 
R T O G E Q Ds ( 3 7 G y) is use d as t he bla d der d ose c o nstrai nt. A v ol u me 
c o nstrai nt of 1 0cc is a p pr o xi matel y mi d wa y b et wee n 1cc a n d 1 5cc. 
8. 3. 4. 4. 1  Mi n or variati o n: V 3 7 G y ≥ 1 0cc, b ut < 2 0cc. 
8. 3. 4 . 4. 2 Maj or variati o n: V 3 7 G y ≥ 2 0cc 
8. 3. 4. 5  P E NI L E B U L B : Per Pr ot oc ol : V 2 9. 5 G y < 5 0 % . 
Mac k R oac h
6 8 f o u n d a n i n creas e d i nci de n ce of i m p ote nce w h e n t he a v era ge 
d os e t o t he pe nile b ul b w as great er t ha n 5 2. 5 G y, c o n ve nti o nall y 
fracti o nat e d. T his is bi ol o gicall y e q ui vale nt t o 2 9. 5 G y i n 5 fracti o ns, usi n g 
a n α /β  rati o of 3 G y. Eff orts s h o ul d be ma de t o mi ni mize t he penile b ul b 
V 2 9. 5 G y t o si g nifica ntl y less t ha n 5 0 %.  
8. 3. 4. 5. 1  Mi n or variati o n: V 2 9. 5 G y ≥ 5 0 %, < 7 5 % 
8. 3. 4. 5 . 2 Maj or variati o n: V 2 9. 5 G y ≥ 7 5 % 
8. 3. 4. 6  S I G M OI D C O L O N A N D O T H E R B O W E L: e v al uate d if l yi n g wit hi n 2c m 
of t he P T V. N o m ore t ha n 1cc ma y r ecei v e t he 2 G y/f x e q ui vale nt of 5 4 G y; 
ass u mi n g a n α /β = 3, t he 5-fracti o n e q ui vale nt is 3 0 G y. T h us V 3 0 G y < 1c c. 
8 . 3. 4. 7 P R O S T A TI C U R E T H R A ( w he n vis ualize d): Per Pr ot oc ol : V 4 7 G y < 2 0 %. 
Bea u m o nt’s H D R pr ot oc ol 6 9 li mite d “a n y se g me nt of uret hra” t o 1 2 5 % of 
pr escri pti o n d ose, or 4 7. 5 G y. T his is e q ui vale nt t o 1 4 1. 3 G y at 2 G y/f x, 
ass u mi n g α /β  r ati o of 3 f or late effects. T h e 5-fracti o n e q ui val e nt d ose is 
5 2. 4 G y. R T O G 0 3 2 1 f or H D R deli ver y r e q uire d t he V 1 2 5 % R x d ose < 1cc. 
I n cl u di n g t he 4 5 G y of e xter nal bea m d eli vere d, t h e E Q D1. 8 = 1 1 8. 6 G y < 1 
cc; t he 5 fr acti o n e q ui val e nt is 4 6. 4 G y. Si nce meas ure d dia meters of 
uret hras will var y d e pe n di n g o n cat heter dia m eter or s u bjecti ve M RI 
i nter pretati o n, a D V H c o nstrai nt mi g ht best be e x presse d as a fr acti o n of t he 
t otal v ol u me. Si nce 5cc w o ul d be a ge n er o us esti mate f or a uret hr al v ol u me, 
2 0 % v ol u me c o nstrai nt ( yi el di n g 1cc, per R T O G 0 3 2 1) is c o nser vati vel y 
c h ose n. T he d os e c o nstrai nt of 4 7 G y is mi d wa y bet wee n t he Bea u m o nt a n d 
R T O G re q uire m e nts. 
8. 3. 4. 7. 1  Mi n or variati o n: V 4 7 G y ≥2 0 %, < 5 0 % 
8. 3. 4. 7 . 2 Maj or variati o n: V 4 7 G y ≥5 0 % 
8. 3. 4. 7 . 3 If t he uret hra is n ot vis ualize d, t he n t he pr escri pti o n ( P T V) d ose 
m ust be prescri be d at n o less t ha n 7 5 % of D ma x. 
8. 3. 4. 8  M E M B R A N O U S U R E T H R A ( w he n i de ntifie d) P er Pr ot oc ol:  D 5 0 < 3 7 G y 
Si nce uret hral strict ur es f oll o wi n g H D R ofte n i n v ol ve t he me m bra n o us 
p orti o n, t his will be c o nt o ure d w he n vis ualize d. D ma x a n d D 5 0 will be 
rec or d e d; kee p D 5 0 bel o w 3 7 G y. 
8. 3. 4. 8. 1  Mi n or variati o n: D 5 0 ≥ 3 7 G y, < 3 9 G y 

A C C P 0 0 1. 4 
_ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _
5 7 
 
8. 3. 4 . 8. 2 Maj or variati o n: D 5 0 ≥ 3 9 G y 
8. 3. 4 . 9 N E U R O V A S C U L A R B U N D L E: If i de ntifie d, atte m pt t o kee p (f or b ot h 
ri g ht a n d left si des) V 3 8 G y < 5 0 %. 
8. 3. 4. 9. 1  Mi n or variati o n: V 3 8 G y ≥ 5 0 %, < 7 5 %. 
8. 3. 4. 9 . 2 Maj or variati o n: V 3 8 G y ≥ 7 5 %. 
8. 3. 4. 1 0  
I n v esti gat ors s hall atte m pt t o kee p n or m al tiss ue d oses a n d 
prescri pti o n c o v era ge as cl ose t o “ p er pr ot oc ol” s p ecificati o ns as p ossi ble. If 
all t he a b o ve “ Per Pr ot oc ol” d ose- v ol u me criteria ca n n ot be met o n a gi ve n 
patie nt, t he n n or mal tiss ue c o nstrai nts a n d tar get pres cri pti o ns ma y be 
rela x e d t o t he “ mi n or variati o n” ra n ge as f oll o ws. O ne mi n or variati o n i n 
eit her t he pri mar y or s ec o n dar y d ose pres cri pti o n c o ver a ge (e. g. P T V 
V 3 6. 2 5 G y 9 0- 9 5 % or 
G T V 
V 4 0 G y 9 0- 9 5 %) is all o we d; t w o 
mi n or 
variati o ns or o ne maj or v ariati o n is all o we d o nl y wit h t he c o nse nt of t he site 
c hair. O ne a d diti o nal mi n or variati o n is all o we d f or c o nstr ai nts o n t he 
rect u m, bla d d er, pr ost atic uret hr a, p e nile b ul b, a n d f or t he P T V pr escri pti o n 
is o d ose (i.e. perce nt of D ma x). A d diti o nal mi n or variati o ns are all o we d f or 
t he ot her n or mal tiss ue str uct ures. T her e s hall be n o deli ber ate maj or 
variati o ns o n n or mal tiss ue c o nstrai nts. All variati o ns s hall be n ote d. 
8. 3. 4. 1 1  
T E S T E S ( bilateral) s hall be c o nt o ure d, a n d n o pri mar y b ea ms s hall 
tra ns verse t his str uct ur e.  T he D 5 0 will be rec or de d. 
8. 3. 5  W O R K E F F O R T: f or all i n v ol ve d disci pli nes (ra diati o n o nc ol o gist, ur ol o gist a n d 
p h ysicist), t he ti me s pe nt perf or mi n g t he vari o us as pects of treat me nt pla n ni n g will 
be rec or de d. 
8. 4  
C Y B E R K NI F E T R E A T M E N T D E LI V E R Y 
8. 4. 1  T he prescri be d P T V d ose of 3 6. 2 5 G y s hall be gi ve n i n 5 fracti o ns usi n g t h e 
C y ber K nife. 
8. 4. 2  B o wel/ bla d der pre p ar ati o n: patie nts will be a d vise d t o a d here t o a l o w- gas, l o w-
m otilit y diet, starti n g at l east o ne da y pri or t o treat me nt. A fleets e n e ma s hall be 
a d mi nistere d 1- 2 h o urs pri or t o treat me nt. If pr ostate m o ve me nt re m ai ns si g nifica nt 
des pite t hese meas ures, a s mall- dia meter rectal t u be ma y be place d d uri n g 
treat me nt t o ve nt gas. Patie nts s hall uri nate i m me diatel y pri or t o eac h treat me nt. 
8. 4. 3  Treat me nt s h o ul d b e c o m plete d wit h 1 1 d a ys; o verall tr eat me nt ti me s h o ul d be n o 
less t ha n 8 8 h o urs, wit h n o less t ha n 1 2 h o urs bet w ee n a n y t w o fracti o ns.  
8. 4. 4  At least t hree fi d uci als s h o ul d be i de ntifie d f or eac h tr eat me nt. If f e wer t ha n t hree 
fi d ucials ca n be trac k e d, t he n a d diti o nal fi d ucials will be place d, a n d t h e patie nt 
re pla n ne d. E ver y eff ort will be m a de t o treat usi n g r otati o nal c orrecti o ns. T he 
treat me nt s yste m will be set t o rec or d r otati o ns o n t he treat me nt pri nt o ut. O n a 
gi ve n treat me nt, if r otati o nal c orrecti o ns ar e n ot p ossi ble, treat me nt ma y c o nti n ue, 
wit h r otati o nal deltas rec or de d, as l o n g as t hes e re mai n bel o w 2 d e gr ees. F or 
s u bse q ue nt treat me nts, di et c ha n ges or a d diti o nal b o wel pre parati o ns will be ma de, 
a n d/ or rectal t u be place d, a n d treat me nt s hall be atte m pte d usi n g r otati o nal 
c orrecti o ns. If treat me nt pr ocee ds wit h o ut r otati o nal c orrecti o ns, t he t hera pist s hall 
i nf or m t he atte n di n g ra diati o n o nc ol o gist, a n d rec or d t h e d urati o n of treat me nt 
perf or me d wit h o ut r otati o ns. 
8. 4. 5  O n t he da y of t he C y ber K nife tr eat me nt, t he patie nt will be ta ke n i nt o t he 
C y ber K nife s yst e m treat me nt r o o m, set u p i n t heir r es pecti ve i m m o bilizati o n 
de vices a n d p ositi o ne d o n t he C y b er K nif e c o uc h.  X-ra ys will be ta ke n wit h t he 

A C C P 0 0 1. 4 
_ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _
5 7 
 
C y b er K nife s yste m t o e ns ure t hat t he t u m or is ali g ne d i n a ma n ner c o nsiste nt wit h 
t he p ositi o n i n w hic h t he treat me nt pla n C T i ma ge was t a ke n. I m a gi n g s h o ul d occ ur 
e ver y 1- 3 n o des, p er t he discreti o n of t he atte n di n g p h ysicia n. Fi d uci al l ocati o ns i n 
t he i ma ges will be e xtracte d a n d c o m pare d t o t he fi d ucial l ocati o ns i n t he C T sca ns 
t o esti mate tar get m o ve me nts. T he f oll o wi n g pla n ni n g a n d treat me nt i nf or mati o n 
s hall be rec or d e d f or e ver y pla n a n d fr acti o n deli vere d: set- u p ti me r e q uire d, 
n u m ber of n o des treate d, n u m ber of n o des treate d wit h r otati o nal c orrecti o ns, 
n u m ber of n o des i ma ge d, a n d t otal treat me nt ti me. T his data will be c ollecte d o nt o 
Case Re p ort F or ms. 
8. 4. 6  All pla n ne d n o des will be tr eate d w he n e ver p ossi ble. If tr eat me nt 
m ust be 
ter mi nate d pre mat ur el y o n fracti o ns 1- 4, c o m pe nsate as f oll o ws. If 2/ 3 or m ore of 
all n o n-zer o n o d es w ere treate d, t h e n t he u ntreate d n o des pl us t h e f ull n e xt fracti o n 
s h o ul d be tr eate d o n t he ne xt treat me nt da y (t his s h o ul d i ntr o d uce a n err or of < 5 % 
i n B E D deli vere d). If fe ver t ha n 2/ 3 of t he n o n-zer o n o des were treate d, t he n t he 
u ntreate d p orti o n of t his fracti o n ( o nl y) will be ma de u p f or o n t he f oll o wi n g d a y. 
T he s u bse q ue nt fracti o n s hall be deli vere d o n t h e ne xt treat me nt da y. If tr eat me nt 
m ust be ter mi nate d pr e mat urel y o n t he fift h fr acti o n, a n d 9 0 % of t he n o n-zer o 
n o des wer e treate d, t he n n o f urt her treat me nt s h all be gi ve n (t his s h o ul d i ntr o d uce 
a n err or of < 5 % f or t otal B E D d eli vere d). If fe v er t ha n 9 0 % of t he n o n-zer o n o des 
were tr eate d, t h e n t he deficit s hall be deli ver e d o n t he f oll o wi n g tr eat me nt da y. All 
s uc h variati o ns s hall be r ec or de d. 
8. 4. 7  W O R K E F F O R T: f or all me m ber of t he treat me nt tea m (t hera pist, p h ysicist, 
ra diati o n o nc ol o gist, a n d ur ol o gist), ti me s pe nt acti vel y i n v ol ve d wit h treat me nt 
s hall be rec or de d. Als o, r e q uire d o n-site s u per vis or y ti me will be r ec or d e d. 
 
9. 0  
P A TI E N T A S S E S S M E N T S A N D T O XI CI T Y  
Assess me nt 
Pr e-
e ntr y 
 
O n t x 
da y 5 
F oll o w- u p i nter val: m o nt hs p ost t hera p y  
Years p ost 
t hera p y 
1 
w k  
1  
3  
6 
1 2 
1 8 
2 4 (e ver y 6 m o u p t o 5 
years) 
6- 1 0 
Hist or y 
X  
  
  
X 
X 
X 
X  
X 
X b  
 
P h ysical e xa m ( D R E) 
X  
  
  
  
X 
X 
X  
X 
X b  
 
E C O G P erf or ma nce Scale  
X  
  
  
  
X 
X 
X  
X 
X b  
 
Pr ostate Bi o ps y & Gleas o n 
sc orea 
X  
  
  
  
  
  
  
 
X 
 
P S A 
X  
  
  
  
X 
X 
X  
X 
X b  
X 
Pr ostate v ol u me assess me nt  
X  
  
  
  
  
  
  
 
 
 
C B C, platelets 
X  
  
  
  
  
  
  
 
 
 
B U N, creati ni ne 
X  
  
  
  
  
  
  
 
 
 
T est oster o ne 
X  
  
  
X 
X 
X 
X  
X 
X c 
X c 
T o xicit y e val uati o n 
X  
X  
X  
X 
X 
X 
X  
X 
X b  
X 
A U A sc ore 
X  
X  
X  
X 
X 
X 
X  
X 
X * 
X 
S F- 1 2 
X  
  
  
X  
  
X 
X  
 
X * 
 
E PI C- 2 6 Q uesti o n naire  
X  
  
  
X  
  
X 
X  
 
X * 
X 
S HI M Q uesti o n naire 
X  
  
  
X  
  
X 
X  
 
X * 
X 
Utilizati o n of Se x ual 
R x/ De vices 
X  
  
  
X  
  
X 
X  
 
X * 
 
a. Ce ntral re vi e w of p at h ol o g y; bi o ps y rec o m me n de d at 2 yrs, & re q uir e d at ti me of fail ure  
 

A C C P 0 0 1. 4 
_ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _
5 7 
 
b. C o nti n ue e ver y 6  m o nt hs t hr o u g h t o year 5 
c. Test oster o ne l e vels will be m o nit ore d u ntil t he 2 4 m o nt h f oll o w- u p visit a n d will be 
o pti o nall y meas ur e d at f oll o w- u p visits o ut t o 1 0 years.   
* C o nti n ue e ver y 1 2 m o nt hs t hr o u g h year 5; . 
 
 
9. 1  
E V A L U A TI O N D U RI N G T R E A T M E N T & F O L L O WI N G T R E A T M E N T 
9. 1. 1  P R E- E N T R Y A S S E S S M E N T: see secti o n 4. 7. 
9. 1. 2  Stere otactic r a di os ur ger y is a n o ut patie nt pr oce d ur e.  Patie nt ma na ge me nt 
i m me diatel y after t he pr o ce d ure will f oll o w r o uti ne patie nt care g ui deli nes as 
deter mi ne d b y t he p h ysicia n.  S u bjects will be pr o vi de d i nstr ucti o ns o n w h o t o call 
wit h s pecific c o ntact i nf or mati o n, i n t he e ve nt t he y e x perie n ce a n y u nt o w ar d eff ects 
f oll o wi n g treat me nt.  I n t he e ve nt a s u bject e x peri e nces a n y u nt o war d eff ects 
f oll o wi n g C y ber K nife treat me nt, i nf or mati o n s pecific t o t he patie nt’s c o n diti o n a n d 
s y m pt o ms, treat me nt i nter ve nti o n re q uire d, a n d h os pital sta y a n d c o urse will be 
rec or d e d f or p ur p oses of cli nical e val uati o n. 
9. 1. 3  A C U T E A S S E S S M E N T: Patie nts will ha ve t o xicit y e v al uati o n a n d A U A s c ore o n 
t he last da y of treat me nt. 
9. 1. 4  A S S E S S M E N T S F O L L O WI N G T R E A T M E N T: at o ne wee k after treat me nt, 
(all o we d wi n d o w: +/- 3 d a ys), t o xicit y a n d A U A s c ore will be e v al uate d. At 1 
m o nt h ( +/- 7 da ys) f oll o wi n g treat me nt, patie nts will be assesse d f or ac ute t o xicit y, 
a n d will fill o ut A U A f or m, S F- 1 2, E PI C- 2 6, S HI M a n d Utilizati o n of Se x ual 
R x/ De vices. At 3, 6, 1 2, 1 8, a n d 2 4 m o nt h ( +/- 2 w ks) i nter vals ( a n d e ver y 6 
m o nt hs t hereafter, t hr o u g h year 5, patie nts will be see n a n d e v al uate d, i ncl u di n g a 
hist or y, p h ysical e x a m, E C O G perf or m a nce st at us, P S A, t o xicit y e v al uati o n, a n d 
A U A sc or e. I n a d diti o n, at 6 m o nt hs, 1 2 m o nt hs a n d a n n uall y t h ereafter, t h e S F- 1 2, 
E PI C- 2 6, S HI M a n d Utilizati o n of Se x ual Me dicati o ns/ De vices will be 
a d mi nistere d. After t he 5 year f oll o w- u p patie nts will be see n yearl y t hr o u g h year 
1 0 (all o we d wi n d o w: +/- 1 m o nt h) a n d t he f oll o wi n g will be perf or me d: P S A, 
t o xicit y e val u ati o n, a n d t he f oll o wi n g q u esti o n naires will be a d mi nistere d: E PI C -
2 6; A U A; S HI M.  E x a mi nati o n a n d st u dies ma y b e d o ne at o utsi de f acilit y.  A 
ser u m t otal test oster o ne will be meas ure d at m o nt h 1 a n d e ver y P S A t hr o u g h year 
2.  
9. 1. 5  P R O S T A T E BI O P S Y will be perf or me d at ti me of bi oc he mical or l o cal cli nical 
fail ure, a n d is e n c o ur a ge d at 2 years f oll o wi n g tr eat me nt a n d at ti me of dista nt 
fail ure. 
9. 1. 6  B O N E S C A N will be perf or me d at t he ti me of bi o c he mical f ail ure, or w h e n t he 
patie nt de vel o ps si g ns of s y m pt o ms s u g gesti n g metastatic disease. 
9. 2  
C RI T E RI A F O R T O XI CI T Y 
9. 2. 1  A C U T E A N D L A T E T O XI CI T Y  
9. 2. 2  Ac ute si de effects ( < = 9 0 da ys of treat me nt start) will be assesse d usi n g t he N CI 
C o m m o n T o xicit y Criteri a versi o n 3. 0 ( see a p p e n di x V).  
9. 3  
Q U A LI T Y O F LI F E A S S E S S M E N T S 
9. 3. 1  S F- 1 2: T he S H O R T F O R M- 1 2 Healt h S ur ve y m eas ures ge neri c healt h stat us 
rele va nt acr oss diff ere nt a ge, diseas e, a n d treat me nt gr o u ps. It pr o vi d es a 
c o m pre he nsi ve, ps yc h o metricall y s o u n d assess me nt of healt h stat us fr o m t he 

A C C P 0 0 1. 4 
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5 7 
 
pat ie nt's p oi nt of vie w b y sc ori n g res p o nses t o sta n dar d q uesti o ns. T he S F- 1 2 is 
self-a d mi nistere d, a n d ca n us uall y be c o m plete d i n less t ha n 3 mi n utes wit h o ut 
assista nce. 
9. 3. 2  E X P A N D E D P R O S T A T E C A N C E R I N D E X C O M P O SI T E ( E PI C)- 2 6: is a 
vali date d c o m pre h e nsi ve i nstr u me nt de vel o pe d t o assess patie nt f u ncti o n a n d 
b ot her after pr ostate ca ncer treat me nt. It was de v el o pe d b y a n e x pert pa nel of 
ur ol o gical o nc ol o gists, ra diati o n o nc ol o gists (i ncl u di n g t h ose wit h brac h yt h era p y 
e x pertise), s ur ve y r esearc hers, a n d pr ostat e ca n cer n urses, t o a d dress s y m pt o ms 
relate d t o r a dical pr ostatect o m y, e xter nal bea m ra di ot hera p y, pr ostate 
brac h yt hera p y, a n d h or m o nal s y m pt o ms. See a p p e n di x VI.  
9. 3. 3  A M E RI C A N U R O L O GI C A L A S S O CI A TI O N ( A U A) S Y M P T O M I N D E X: Als o 
k n o w n as t he I nter nati o nal Pr ostate S y m pt o m Sc ore (I P S S), t his wi del y use d i n de x 
assesses uri nar y s y m pt o m b ot her. See a p pe n di x VI. 
9. 3. 4  S E X U A L H E A L T H I N V E N T O R Y F O R M E N ( S HI M): is a wi del y use d, 
i nter nati o nall y v ali date d a n d se nsiti ve i nstr u me nt f or assessi n g erectile 
d ysf u n cti o n 7 0. 
9. 3 . 5 U TI LI Z A TI O N O F S E X U A L M E DI C A TI O N S/ D E VI S E S: pr o vi des c o nte xt f or 
i nter preti n g t he se x ual d o mai n sc ore of t he E PI C q uesti o n naire. 
9. 4  
C RI T E RI A F O R DI S E A S E C O N T R O L: i nter vals will be meas ure d fr o m e nr oll me nt date. 
9. 4. 1  BI O C H E MI CI A L DI S E A S E- F R E E S U R VI V A L ( b D F S): is meas ur e d as ti me t o 
P S A fail ure. W hile earlier re p orts of pr ostate ca ncer patie nts treate d wit h 
ra di ot hera p y h a ve use d t he A S T R O c o nse ns us defi niti o n ( A C D) of P S A fail ure, 
rece nt st u dies7 1,7 2,7 3 ha ve s u g geste d t h e “ na dir + 2” d efi niti o n is a m ore se nsiti ve a n d 
s pecific defi niti o n of bi oc he mical f ail ure. I n d ee d, a rece nt e x pert pa nel met i n 
P h oe ni x 7 4 a n d de vel o pe d a c o nse ns us rec o m me n dati o n usi n g t he later d efi niti o n. S o 
t hat c o m paris o ns ca n b e ma de wit h earlier literat ure, b ot h defi niti o ns s hall be use d: 
9. 4. 1. 1  P h oe ni x defi niti o n: fail ure occ urs w he n t he P S A is ≥ 2 n g/ ml m ore t ha n t he 
l o west P S A meas ure me nt bef ore t he c urr e nt o ne, wit h n o bac k dati n g. 
A d mi nistrati o n of sal va ge t hera p y ( h or m o nes, s ur ger y, etc …) will be 
c o nsi dere d f ail ure. 
9. 4. 1. 2  Strict A S T R O C o nse ns us Defi niti o n ( A C D): fail ur e is defi ne d as t hr ee 
c o nsec uti ve rises i n p ost-treat me nt P S A, meas ure d at t he s pecifie d f oll o w-
u p i nter vals. If t hree c o ns ec uti ve P S A rises occ ur d uri n g t he first 2 years 
after tr eat me nt, f oll o we d b y a n o n- h or m o nal i n d uce d P S A decli ne, t his will 
n ot be c o nsi dere d a fail ur e. A d mi nistrati o n of sal va ge t her a p y ( h or m o nes, 
s ur ger y, etc …) will be c o nsi dere d fail ur e. Fail ure date is t he mi d p oi nt 
bet wee n t he d ates of t he l ast n o n-risi n g P S A a n d t he first P S A rise. 
9. 4. 2  C RI T E RI A F O R L O C A L F AI L U R E: cli nical e vi de nce of l o cal pr o gr essi o n or 
rec urre nce. Cli nical fail ure i ncl u des a p al pa ble a b n or malit y t hat has i ncrease d i n 
size, fail ure of re gressi o n of a pal pa ble a b n or malit y b y 2 years after tr eat me nt, or 
re de vel o p me nt of a pr ost ate a b n or malit y aft er c o m plete res p o nse. Patie nts wit h a 
pr ostate a b n or malit y c o m pati ble wit h l ocal rec urre nce, or a P S A f ail ure s hall 
u n der g o a pr ost ate bi o ps y. Hist ol o gic criteria f or l ocal fail ur e is a p ositi ve pr ostate 
bi o ps y m ore t ha n 2 years after tr eat me nt. Patie nts wit h a n or mal e x a m a n d n o 
e vi de nce of P S A fail ure s hall be c o nsi der e d c o ntr olle d l ocall y. Patie nts wit h 
cli nical fail ure a n d n o bi o ps y are c o nsi d ere d l ocal fail ures. If a patie nt is l o call y 

A C C P 0 0 1. 4 
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5 7 
 
c o ntr olle d at t he ti me of orc hiect o m y or a n dr o ge n a blati o n, he is ce ns or e d a n d 
c o nsi dere d “ n ot e val ua bl e” f or f urt her l o cal c o ntr ol.   
9. 4. 3  C RI T E RI A F O R N O N L O C A L F AI L U R E 
9. 4. 3. 1  DI S T A N T F AI L U R E (i n cl u des re gi o nal f ail ure): d oc u me nte d if cli nical, 
b o ne sca n, C T or ot her i ma gi n g st u d y s h o ws met astatic disease. 
Bi oc he mical fail ure wit h a ne gati ve pr ost ate bi o ps y s hall be c o nsi dere d 
dista nt o nl y fail ure. Bi o ps y of met astatic site re q uire d if ra di o gra p hic or 
cli nical fi n di n gs are e q ui v ocal. T y pe of m etastatic fail ure ( dista nt a n d/ or 
re gi o nal) s hall be rec or de d if k n o w n. Pr ostate bi o ps y r ec o m me n de d at t his 
ti me. 
9. 4. 3. 2  DI S E A S E- F R E E S U R VI V A L: f or a n y m eas ur e of disease, i ncl u di n g P E, 
P S A, b o ne sca n, C T/ M RI a n d bi o ps y, or deat h. 
9. 4. 3. 3  DI S E A S E- S P E CI FI C S U R VI V A L: f or a n y of t h e f oll o wi n g: 
9. 4. 3. 3. 1  Deat h d ue t o pr ostat e ca n cer. 
9. 4. 3. 3. 2  Deat h d ue t o ot her ca us es, wit h acti ve mali g n a n c y ( defi n e d b y 
cli nical or bi oc he mical e vi de nce of pr o gressi o n). If a patie nt 
s uffer e d a pre vi o us rela pse, b ut has i nacti ve disease, t his is n ot 
c o nsi dere d a disease-s pecific deat h. 
9. 4. 3. 3. 3  Deat h d ue t o c o m plicati o ns of treat me nt. 
9. 4. 3. 4  O V E R A L L S U R VI V A L: f or deat h fr o m a n y ca use 
 
1 0. 0  D A T A C O L L E C TI O N 
See a p pe n di x I V f or Cas e Re p ort F or ms & patie nt q uesti o n naires. 
 
1 1. 0  S T A TI S TI C A L C O N SI D E R A TI O N S 
1 1. 1  O V E R VI E W: T his st u d y’s pri mar y g oal is t o deter mi ne t he rate of ac ut e a n d late gra de 3- 5 
gastr oi ntesti nal a n d ge nit o uri nar y t o xicit y f oll o wi n g C y ber K nife tr eat me nt, a n d t o esti mate 
efficac y, meas ure d as 5- year b D F S. Per R T O G/ E C O G, ac ute t o xicit y will b e defi ne d as 
occ urri n g wit hi n 9 0 da ys of c o m pleti n g tr eat me nt. Lat e t o xicit y will be d efi ne d as t o xicit y 
occ urri n g m or e t ha n 9 0 d a ys after treat me nt. It is gra de d bas e d o n C o m m o n Ter mi n ol o g y 
Criteria f or A d v erse E v e nts ( C T C A E) v 3. 0.(see a p pe n di x V). 
1 1. 2  S A M P L E SI Z E: 
1 1. 2. 1  P RI M A R Y S A F E T Y O BJ E C TI V E: T h e st u d y is d esi g ne d t o test t he n ull 
h y p ot hesis t hat t he ac ute a n d late GI/ G U t o xicit y r ate 5 years f oll o wi n g treat me nt is 
gr eater t ha n 1 0 % vers us t he alter nati ve h y p ot h esis t hat t he t o xicit y rat e is less t ha n 
or e q ual t o 1 0 %. T he s a m ple size is deter mi ne d s uc h t hat t here is 9 0 % pr o ba bilit y, 
or p o wer, of i de ntif yi n g e x cessi ve t o xicit y if t he tr ue t o xicit y rate is 2 0 % at t he 
o ne-si de d 5 % si g nifica n ce le vel. 1 0 1 patie nts m ust t he n be accr ue d a n d f oll o we d 
f or 5 years, ass u mi n g n o patie nts e x cl u de d or l ost t o f oll o w- u p. Si nce t he tr eat me nt 
v ol u me f or i nter me diate ris k patie nts is lar ger t ha n f or l o w-ris k patie nts, t h e st u d y 
will be p o were d t o ass ess t o xicit y f or b ot h s u b gr o u ps. A d diti o nal e nr oll me nt f or 
i neli gi ble patie nts, or l ost t o f oll o w- u p: Si nce perf or mi n g ce ntral r e vie w of 
pat h ol o g y pri or t o e nr oll me nt is i m practical, s o me patie nts will be u p gra d e d, a n d 
t h us ma de i neli gi ble. I n R T O G 7 7- 0 6, ce ntr al re vie w u p gra de d a b o ut 8 % of 
Gleas o n 2- 6 patie nts t o Gleas o n 7- 1 0 7 5. If we ass u m e a si milar rate of u p gra di n g, 
a n d a ntici pate 8 % a d diti o nal i neli gi ble/lac k- of- d ata cases, s a m ple size m ust be 

A C C P 0 0 1. 4 
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5 7 
 
i ncreas e d b y 1/( 0. 9 2 * 0. 9 2) = 1 1 9. 3 3. T h us 1 2 0 patie nts are re q uire d t o esta blis h 
acce pta ble t o xicit y f or eac h ris k c o h ort. 
1 1. 2. 2  P RI M A R Y E F FI C A C Y 
O BJ E C TI V E: F or t he l o w-ris k c o h ort, t he st u d y is 
p o were d t o c o m pare 5- year b D F S rates o bser v e d wit h C y ber K nife t o 5- year b D F S 
rates re p orte d wit h d ose- escalate d e xter nal b ea m R T. I n Bea u m o nt’s m o n ot hera p y 
H D R series treati n g L R patie nts, 5- yr A S T R O b D F S was 9 8 %; i n De ma nes’ series 
of  7 5 % L R a n d 2 5 % I R, t his was 9 6 %. W e w o ul d e x pect P h oe ni x o utc o mes t o be 
sli g htl y hi g her t ha n A S T R O o utc o mes at 5 years. Si nce C K deli vers d os es si milar 
t o H D R m o n ot hera p y, a c o nser vati ve esti mate of t he s uccess rate f or C K is 9 7. 5 % 
f or L R patie nts. I n L R patie nts, pr os pecti ve st u dies fr o m 
Me m orial Sl oa n 
Ketteri n g 7 6 ( 2 0 3 patie nts, 8 1 G y) a n d 
M D 
A n ders o n7 7 ( 3 2 patie nts, 7 8 G y) 
de m o nstrate d 5- yr b D F S ( P h oe ni x defi niti o n) of 9 2 % a n d 9 3 %, res p ecti vel y. 
T ha mes’ 9-i nstit uti o n re vie w of 2 3 1 d ose-escalate d ( 7 0- 7 6 G y) L R patie nts re p orte d 
9 4 % 5- yr P h oe ni x b D F S. T h us, a n o bj ecti ve p erf or ma nce criteria ( O P C) f or l o w-
ris k patie nts treate d wit h d ose-escal ate d e xter nal bea m R T is 9 3 % 5- yr b D F S. 
Ass u mi n g t he C K s uccess rate is 9 7. 5 %, t o test s u peri orit y of C K a gai nst t his O P C 
wit h 8 0 % p o wer at t he 1-si de d 5 % si g nifica n ce le vel will re q uire 1 5 0 patie nts. 
I n creasi n g t he sa m ple si ze b y 1/( 0. 9 2 * 0. 9 2) f or i neli gi ble/lac k- of- d ata cas es yiel ds 
1 7 7. 2 2; t he re q uire d sa m ple size f or l o w-ris k patie nts is 1 7 8 patie nts. 
1 1. 2. 3  T O T A L A N D R E L A TI V E E N R O L L M E N T O F RI S K G R O U P S: Per secti o ns 
1 1. 2. 1 – 1 1. 2. 2, e nr oll me nt of 1 7 8 l o w-ris k patie nts are r e q uire d t o c o m par e t he 5-
year b D F S r ate o bser v e d wit h C y b er K nif e t o t he 5- year O P C r ate, a n d 1 2 0 
i nter me diate ris k patie nts are re q uire d t o esta blis h acce pt a ble t o xicit y f or eac h ris k 
c o h ort. Ca P S U R E data s h o we d a r ati o of l o w t o i nter me diate ris k patie nts, usi n g 
D’ A mic o’s defi niti o n 7 8, of 4 6. 8 %: 3 7. 2 %. T his C K pr ot oc ol e x cl u des i nter me diate 
risk patie nts wit h b ot h P S A 1 0- 2 0 n g/ ml a n d Gleas o n 7 hist ol o g y. Base d o n 
pr o p orti o ns of patie nts i n t hese s u b gr o u ps re p ort e d i n Parti n’s 7 9 st u d y, t his w o ul d 
e x cl u de 1 2 % of i nter me diate ris k patie nts. C o m bi ni n g t hese pr o p orti o ns, we w o ul d 
e x pect a rati o of l o w t o i nter me diate ris k patie nts of 1. 4 3 : 1. T h us we w o ul d e x pect 
1 7 2 l o w-ris k patie nts e nr olle d b y t he ti me 1 2 0 i nter me diate ris k patie nts h a ve bee n 
e nr olle d. Eac h c o h ort will be cl ose d t o accr ual o nce re q uisite e nr oll me nt is 
ac hie ve d: 1 7 8 l o w-ris k patie nts, a n d 1 2 0 i nter me diate ris k ( 2 9 8 t otal patie nts) 
1 1. 2. 4  A C C R U A L R A T E: t he i nitial t hree m o nt hs w hile i nstit uti o ns are o btai ni n g I R B 
a p pr o val, t heref ore w e d o n ot e x pect t o meet t he tar gete d m o nt hl y accr ual rate u ntil 
after t he first t hree m o nt hs.  T he esti mate d accr ual rate is 2. 5 patie nts p er st u d y site 
per m o nt h.  E x pectati o ns of 1 0 treati n g st u d y sites ass u me a n accr ual p eri o d of 
a p pr o xi matel y 1 1 m o nt hs, or 1 4 m o nt h t otal 
1 1. 2. 5  I N T E RI M A DJ U S T E M E N T I N E N R O L L M E N T: I nteri m a nal ysis of t he first 2 0 0 
e nr olle d patie nts s h o we d t hat 1 3 were act uall y i neli gi ble beca use t he y wer e ta ki n g 
fi nasteri de or d ut asteri de. E nr oll me nt will t h us be i ncreas e d b y 1 3 patie nts. 
E x cl usi o n of patie nts o n 5-al p ha r e d uctase i n hi bit ors is clarifie d i n secti o n 5. 1 2. W e 
rec o g nize t hat L H R H a g o nist/a nta g o nist (e. g. le u pr oli de, g os ereli n, tri pt or eli n, 
de gareli x), h or m o ne ( e. g. D E S), or peri p heral bl oc ker (e. g. fl uta mi de, bical uta mi de, 
nil uta mi de) a d mi nistrati o n gi ve n m or e t ha n t w o m o nt hs bef ore e nr oll me nt ma y 
i m pact efficac y.  T h us sa m ple size (secti o n 1 1. 2) will be i ncreas e d t o i ns ure 
e nr oll me nt is s ufficie nt t o ac hie ve st u d y o bjecti ves f or t he s u b gr o u p of p atie nts 
naï ve t o s uc h t her a p y. I nt eri m a nal ysis of t he first 2 0 0 e nr olle d patie nts s h o we d 

A C C P 0 0 1. 4 
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P a g e 2 5 of 5 7 
 
 
f our ha d r ecei v e d L H R H a g o nists or p eri p her al h or m o ne bl oc kers. W e c o ul d e x pect 
f o ur m ore s uc h p atie nts t o be e nr olle d t hr o u g h c o m pleti o n of t he st u d y. T h us 
e nr oll me nt s h o ul d be i ncrease d b y a n a d diti o nal ei g ht patie nts, or 2 1 p atie nts t otal. 
A p pl yi n g t he pr o p orti o n of l o w t o i nter me diate ris k patie nts descri be d i n secti o n 
1 1. 2. 3, t otal e nr oll me nt will be i ncreas e d t o 1 2 9 i nter me diate-ris k, a n d 1 9 0 l o w-ris k 
( 3 1 9 patie nt t otal). If s u bse q ue nt i nteri m e val uati o ns s h o w t he esti mate d pr o p orti o n 
of i neli gi ble/lac k- of- d ata cases is i nacc urat e, re q uire d e nr oll me nt will be 
acc or di n gl y a dj uste d. 
1 1. 3  I N T E RI M A N A L YI S F O R F U TI LI T Y 
W he n at least 5 0 % of t he L o w Ris k s u bjects ha v e reac h e d t he 3 year ti me p oi nt, a n i nteri m 
a nal ysis will be p erf or m e d f or t he pri mar y effi cac y h y p ot hesis t o deter mi n e if it is f utile t o 
c o nti n ue wit h st u d y f oll o w- u p t hr o u g h 5 years.  T he pri mar y efficac y st u d y o bjecti ve is t o 
esta blis h wit h 9 5 % c o nfi de nce t hat t he 5 year b D F S rate is > 9 3 % (t he O P C).  F or t he 
i nteri m a nal ysis t he 3 year b D F S rat e will be use d al o n g wit h t he sa m e O P C of 9 3 % .   
 
1 1. 3 1. Met h o d ol o g y: 
T he deter mi nati o n of 3 year b D F S will be ma de f or all s u bjects wit h s ufficie nt data 
t hr o u g h 3 years. N e xt, t he pr o ba bilit y of meeti n g t he effi cac y o bj ect at 3 years will 
be deter mi ne d usi n g si m ulati o n.  Res ults f or t he s u bjects w/ o s ufficie nt dat a 
t hr o u g h 3 years will be si m ulate d usi n g a bi n o mial distri b uti o n. T he ass u me d 
pr o ba bilit y of s uccess (i. e. b D F S) will be set at t he rate t hat w as o bser v e d f or t he 
s u bjects w/ 3 year d ata.  T he si m ulati o n will be r u n 1, 0 0 0 ti mes res ulti n g i n 1, 0 0 0 
c o m plete datasets.  T h e l o wer c o nfi de nce i nter val li mit f or 3 year b D F S r at e will be 
calc ulate d, usi n g t he Wils o n met h o d, f or eac h dat aset, a n d pr o b a bilit y of s uccess 
will be t he pr o p orti o n of datasets w her e t he l o wer c o nfi de nce li mit is bel o w 9 3 %. 
 
1 1. 3. 2. R ule: 
If t he pr o ba bilit y of ha vi n g a s u ccessf ul st u d y is l ess t ha n f o u n d t o be less t ha n 
 2 0 % t he n it will be c o nsi dere d f utile t o c o nti n ue with f oll o w- u p t hr o u g h 5 years.   
1 1. 4  S T A TI S TI C A L M E T H O D S 
1 1. 4. 1  P RI M A R Y E N P OI N T S  
1 1. 4. 1. 1  
S A F E T Y:  T he u p p er li mit of a o ne-si de d 9 5 % c o nfi de nce i nter val 
f or t he e x pecte d pr o p orti o n of patie nts e x perie nci n g a Seri o us A d vers e 
E ve nt ( S A E) is esti mate d b y U, w h er e 
)
(2
)
1(
4
)
2
(
2
0 5
.0
2
0 5
.0
0 5
.0
2
0 5
.0
Z
n
p
p n
Z
Z
Z
n p
U
+
−
+
+
+
=
 
He re “ p” is t he o bser ve d pr o p orti o n of patie nts e x perie nci n g a n S A E . T h e 
C y ber K nife i nter v e nti o n will be c o nsi dere d t o be s afe if t his st u d y’s res ult 
verifies t hat U is n ot a b o ve 2 0 % 8 0. 
1 1 . 4. 1. 2 
E F FI C A C Y:  T he l o wer  li mit of a o ne-si de d 9 5 % c o nfi de nce 
i nter val f or t he e x pecte d pr o p orti o n of patie nts e x perie nci n g bi oc h e mical 
disease-free s ur vi val ( b D F S) is esti mate d b y L, w here 
)
(2
)
1(
4
)
2
(
2
0 5
.0
2
0 5
.0
0 5
.0
2
0 5
.0
Z
n
p
p n
Z
Z
Z
n p
L
+
−
+
−
+
=
 
He re “ p” is t he o bser ve d pr o p orti o n of patie nts e x perie nci n g b D F S i n eit her 

A C C P 0 0 1. 4 
_ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _
5 7 
 
ar m of t he trial . T h e C y b er K nife i nter ve nti o n will be c o nsi der e d t o be 
effecti ve if t his st u d y’s res ult verifies t hat L is n ot bel o w 9 3 %. 
1 1. 4. 2  S E C O N D A R Y E N D P OI N T S  
1 1. 4. 2. 1  
Q U A LI T Y O F LI F E A S S E S S M E N T S: T he S F- 1 2 sc ores, A U A 
sc ore, E PI C- 2 6 sc ores ar e use d t o q ua ntif y q ualit y of life ( Q o L) at baseli ne 
a n d re peate dl y d uri n g t he p ost treat me nt peri o d ( s ee Secti o n 9. 0). W e will 
use t he ge neralize d esti mati n g e q u ati o n ( G E E) m et h o d t o pr o vi de vali d 
i nfere n ces. T his met h o d was ori gi nate d t o ma ke i nfere n ce a b o ut a ver a ge 
be ha vi o ur, w h ere t he d e p e n de nt varia bl e  de pe n ds n ot o nl y o n t he 
“e x pla nat or y” varia ble (ti me meas ure d i n m o nt hs) b ut als o o n t he 
c orrel ati o n of a patie nt’s re peat e d meas ur e me nts. T he G E E a p pr oac h fits t he 
m o del t o t he o bser ve d data as cl osel y as p ossi ble, wei g hti n g eac h p atie nts’ 
“cl uster” of meas ur e me nts o ver ti me i n versel y t o its varia nce – c o varia nce 
matri x. Wit h t his met h o d, n o i m p utati o ns are re q uire d a n d all data rec or de d 
is use i n t he a nal ysis. Ot h er i m p orta nt feat ures of G E E are t h at n o 
distri b uti o nal ass u m pti o ns f or t he de pe n de nt vari a ble are re q uire d t o us e t he 
met h o d a n d i n m ost cases vali d i nfere nces ar e pr o vi de d e ve n w h e n t he 
c orrel ati o n str uct ure is miss-s pecifie d. F or eac h sc ore, we will use G E E t o 
fit a m o del t o patie nts’ l o n git u di nal c o urs e of r e peate d val ues. W e 
h y p ot hesize t hat i m me diatel y f oll o wi n g tr eat me nt, t he G U & GI s u bsecti o ns 
of t he E PI C- 2 6 a n d t he A U A will de m o nstrate a w orse ni n g of G U a n d GI 
f u ncti o n, b ut t his will ret ur n t o n or mal wit h ti me. W e f urt her h y p ot hesize 
t hat t he se x ual f u ncti o n s u bset of t he E PI C- 2 6 will s h o w gr a d ual w orse ni n g 
f u ncti o n relati ve t o bas eli ne o ver t he fi ve- year f oll o w- u p peri o d. T h ese 
Q O L o utc o mes will be c o m pare d t o t h ose re p orte d i n ot her pr os pecti ve 
st u dies usi n g t he sa me i nstr u me nts, i ncl u di n g R T O G 0 2 3 2 a n d 0 4 1 5  
1 1. 4. 2. 2  
A D V E R S E E V E N T S: All a d verse e ve nts will be r ec or de d o n t h e 
case r e p ort f or ms. F or b ot h ac ute ( < = 9 0 da ys of tr eat me nt start ) a n d l ate 
( > 9 0 da ys of tr eat me nt st art), t he fre q ue n c y a n d pr o p orti o n of eac h t y p e of 
a d verse e ve nt will be pr ese nte d i n ta b ular f or m, o n b ot h a per- p atie nt a n d a 
per-e v e nt basis. 
1 1. 4. 2. 3  
S U R VI V A L O U T C O M E S:  “ S ur vi val” a nal yses will be perf or me d 
f or t he o utc o mes defi ne d i n Secti o n 9. 4. T hese i ncl u de L o cal a n d Dista nt 
t u m or C o ntr ol, Disease-free s ur vi val f or meas ures liste d i n Secti o n 9. 4. 3. 2, 
Disease-s p ecific s ur vi val f or meas ur es i ncl u di n g t h ose liste d i n Secti o n 
9. 4. 3. 3, a n d O ver-all s ur vi val f or deat h fr o m a n y ca use. Peri o dicall y o v er 
t he e xte n de d f oll o w- u p p eri o d, Ka pla n- Meier “s ur vi val” c ur ves will be 
calc ulate d (e x a m ples: at 6 m o nt hs, yearl y, 5 years, at e n d of patie nt f oll o w-
u p). Fr o m t he K a pla n- M eier c ur ve, des cri pti ve statistics will be calc ulate d 
i ncl u di n g esti mates of s ur vi val rates a n d m ea n a n d q uartile s ur vi val ti mes. 
1 1. 4. 2. 4  
W O R K E F F O R T:  At eac h site a n d f or eac h patie nt, ti me s pe nt 
acti vel y i n v ol ve d wit h pla n ni n g a n d treat me nt s h all be rec or d e d f or all 
me m ber of t he tr eat me nt tea m (t her a pist, p h ysicist, ra diati o n o nc ol o gist, a n d 
ur ol o gist). T he re q uir e d o n-site s u per vis or y ti me will als o be rec or d e d. 
A vera ge ti mes will be rec or de d. Ti me s pe nt b y tea m me m bers will be 
c o m pare d a n d c orrelate d wit h ot her o utc o mes (e. g. e x perie nce le v el of tea m 
me m ber, patie nt e nr oll me nt, treat me nt pla n ni n g/ d eli ver y Q A o utc o mes, 

A C C P 0 0 1. 4 
_ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _
5 7 
 
t o xicit y, b D F S a n d Q O L o utc o mes. 
 
1 2. 0  D A T A S A F E T Y A N D M O NI T O RI N G 
1 2. 1  Cli nical i nf or mati o n fr o m t he s u bjects will be rec or de d o nt o Case Re p ort F or ms a n d 
s u bse q ue ntl y tr a nsferre d i nt o a c o m p uter data b ase i n a sec ur e file at a re p ut a ble Cli nical 
Researc h Or ga nizati o n t hat is e x perie nce d a n d o p erates i n acc or da n ce wit h t he a p plica ble 
re g ulat or y a n d HI P A A g ui deli nes. 
1 2. 2  Acc ur a y’s cli nical m o nit or will peri o dicall y a nal yze data a n d i nitial o utc o mes fr o m S R S 
treat me nt i n or der t o m o nit or f or a n y i nf or mati o n of cli nical c o ncer n.  A d diti o nall y, as 
warr a nte d, saf et y i nf or m ati o n will be s u b mitte d b y o ne of t he lea d site’s i n vesti gat ors 
a n d/ or Acc ura y’s cli nical m o nit or t o Acc ura y’s m e dical m o nit or.  
1 2. 3  I N D E P E N D E N T D A T A S A F E T Y M O NI T O RI N G B O A R D: A n i n de pe n d e nt Data Saf et y 
M o nit ori n g B o ar d ( D S M B) will act as a n a d vis or y b oar d t o m o nit or patie nt safet y a n d 
e val uate t he efficac y of C y ber K nife Ster e otactic Ra di os ur ger y f or treati n g l o w a n d 
i nter me diate ris k pr ostate ca ncer.  T he D S M B will c o n d uct a n i n de p e n de nt o bjecti ve re vie w 
of t he data t o ma xi mize t he be nefit t o t he trial partici pa nts. T he D S M B will c o nsist of 3 
cli nicia ns w h o ar e e x perts i n or re pres e ntati ves of t he fiel ds of ra di ati o n o nc ol o g y, 
stere otactic ra di os ur ger y, ur ol o g y, cli nical trial met h o d ol o g y, a n d bi ostatistics.  
Me m bers hi p will c o nsist of pers o ns c o m pletel y i n de pe n de nt of t he i n v esti gat ors w h o ha ve 
n o fi na ncial, scie ntific or c o nflict of i nterest wit h t he trial.  Meeti n gs of t he D S M B will be 
hel d 4 ti mes a year, wit h o ne a n n ual meeti n g ta ki n g place f ace t o face a n d t he re mai ni n g 
meeti n gs occ urri n g via t elec o nfere nce.  T he first b oar d meeti n g will meet pri or t o i nitiati o n 
of t he st u d y t o disc uss t h e pr ot oc ol a n d est a blis h g ui deli nes t o m o nit or t he st u d y.  T he 
re mai ni n g q u arterl y m eeti n gs will be c o n d uct e d via telec o nf er e nce.  T h e D S M B will 
m o nit or a n d e val uate all a d verse e ve nts of all gr a d es t o esta blis h relati o ns hi p t o t he st u d y 
pr oce d ur es.  Base d o n t h e re vie w of t o xicities s u m mar y t he b o ar d will ma ke 
rec o m me n dati o ns t o eit h er c o nti n ue, m o dif y or ter mi nate t he st u d y.  After eac h meeti n g t he 
b oar d will pr o vi de t he PI a n d Acc ura y wit h a writte n re p ort c o ncer ni n g fi n di n gs f or t h e trial 
as a w h ole r elate d t o c u m ulati ve t o xicities o bser ve d a n d a n y rel e va nt r ec o m me n dati o ns 
relate d t o c o nti n ui n g, c ha n gi n g, or ter mi nati n g t he trial. I nf or mati o n o n c u m ulati ve 
t o xicities a n d rele va nt r ec o m me n dati o ns will als o be pr o vi de d b y A cc ur a y t o t he rest of t he 
partici pati n g sites t o be s hare d wit h t heir I R Bs. 
1 2. 4  A d verse E v e nts: A n u na ntici pate d a d vers e effect is defi ne d b y t he F D A as a n y s eri o us 
a d verse eff ect o n healt h or safet y or a n y life-t hr eate ni n g pr o ble m or deat h ca use d b y, or 
ass ociate d wit h, a d e vice, if t hat effect, pr o ble m, or deat h was n ot pre vi o usl y i de ntifie d i n 
nat ure, se v erit y, or de gr ee of i nci de nce i n t he pr ot oc ol (i ncl u di n g a s u p ple me ntar y pla n), or 
a n y ot h er u na ntici pat e d s eri o us pr o ble m wit h a de vice t hat relat es t o t he ri g hts, safet y, or 
welfar e of s u bjects. S h o ul d a n y u n a ntici pate d a d v erse de vi ce effects occ ur d uri n g t he c o urse 
of t he st u d y, t he cli nical m o nit or will e ns ure t hat t he y are d o c u me nte d b y t he i n vesti gat or 
a n d re p ort e d t o t he s p o ns or a n d t he r e vie wi n g I nstit uti o nal Re vie w B oar d (I R B) as s o o n as 
p ossi ble, b ut n o later t ha n te n w or ki n g da ys after t he i n vesti gat or first lear ns of t he eff ect(s).  
T he re p ort re gar di n g a n y u na ntici pate d a d v erse d e vice effect als o will be pr o vi de d t o all 
ot her I R Bs f or t he sites at w hic h t his cli nical e val uati o n is bei n g c o n d u cte d. T he cli nical 
m o nit or, o n be half of t he s p o ns or, will w or k wit h o ne of t he lea d site’s i n vesti gat ors a n d 
Acc ur a y’s me dical m o nit or t o c o n d uct a n e v al uati o n of s uc h effects. F oll o wi n g t his 
e val uati o n, if t he deter mi nati o n is ma de t hat a n u n a ntici pate d a d verse effect prese nts a n 
u nreas o na bl e ris k t o s u bjects, t he cli nical e v al uati o n will be pa use d, if dee me d a p pr o priat e 

A C C P 0 0 1. 4 
_ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _
5 7 
 
(t o e na ble f urt her i n vesti gati o n) or ter mi nate d as s o o n as p ossi ble. Ter mi nati o n s hall occ ur 
n o later t ha n fi ve w or ki n g da ys after t h e s p o ns or ma kes t he deter mi nati o n a n d n o later t ha n 
1 5 w or ki n g d a ys aft er t he s p o ns or recei ves n otice of t he u na ntici pate d a d verse de vice effect.   
I n t he e ve nt of t er mi nati o n, I R B a p pr o v al will be o btai ne d pri or t o res u mi n g t he cli nical 
e val uati o n. 
1 2. 5  Bel o w are criteria f or earl y ter mi nati o n of eit her ar m of t he trial s h o ul d a n e x cessi ve 
n u m ber of patie nts e x perie nce a Seri o us A d vers e E ve nt ( S A E). T his de pe n ds u p o n t he 
n u m ber s o far e nr olle d a n d a criteri o n t hat i de ntifi es t o o hi g h a rate. T h e st o p pi n g criteria 
differ after 4 8, 9 6 a n d 1 2 0 patie nts ha ve bee n e nr olle d i n b ot h gr o u ps wit h a d diti o nal 
a p plicati o ns w he n u p t o 1 4 4 a n d 1 7 8 ha ve b ee n e nr olle d i n t he l o w-ris k gr o u p . C o nsiste nt 
wit h Secti o n 1 1. 2. 1, we defi ne a n o bs er ve d S A E rate of 2 0 % as t o o hi g h T h e statistical 
re q uire me nt is t hat f or u p t o “ m” patie nts e nr olle d, t he n u m ber of o bser ve d S A Es m ust be 
fe w e n o u g h s o t hat t here is a 9 5 % c ha n ce t hat t he “tr ue” rate d o es n ot e x cee d 2 0 %. 
  
 
 
 
 
 
 
 
 
 
1 2. 6  Re g ulat or y Re p orti n g: A n y r e p orts re gar di n g safet y iss ues a n d p ot e ntial saf et y iss ues will 
als o be pr o vi de d t o Acc ura y’s Re g ulat or y Aff airs De part me nt.  S uc h r e p orts will be 
e val uate d a n d re p orte d t o t he F D A a n d all a p plica ble re g ulat or y a ge ncies, as dee me d 
re q uire d. 
 
1 3. 0  S O U R C E O F S U B J E C T S A N D R E C R UI T M E N T P R O C E D U R E S 
1 3. 1 S o urce of S u bjects: 
T he s u bjects will be male patie nt wit h l o w a n d i nter me diate ris k or ga n-c o nfi ne d pr ostate 
ca ncer.  T he raci al, ge n d er a n d et h nic c haracteristics of t he pr o p ose d s u bject p o p ulati o n will 
reflect t he de m o gra p hi cs of t he res pecti ve cli nical e val uati o n site’s s urr o u n di n g ar ea a n d/ or 
patie nt p o p ulati o n.  Eac h site will atte m pt t o recr uit s u bjects i n res pecti ve pr o p orti o n t o t he 
site’s res pecti ve d e m o gra p hics.  N o e x cl usi o n criteria s hall be base d o n race or et h nicit y.  
S u bjects will be i de ntifie d a n d recr uite d fr o m o ut p atie nt facilities affiliate d wit h sites 
selecte d t o partici pate i n t his cli nical st u d y.  I n a d diti o n, s u bjects ma y be r ecr uite d b y 
referrals t o t he cli nical st u d y sites.  I n t he e ve nt a d vertise me nt is use d f or r ecr uit me nt, a n y 
s uc h a d vertise me nt will r e q uire a p pr o val b y t he r es pecti ve site’s I R B pri or t o use. 
1 3. 2 Recr uit me nt Pr oce d ur es: 
After e v al uati o n b y a ur ol o gist a n d a r a diati o n o nc ol o gist, patie nts wit h l o w a n d 
i nter me diate ris k or ga n-c o nfi ne d pr ostate ca ncer will be offer e d C y b er K nife treat me nt.  
After t he d ecisi o n is ma de b y b ot h t he p atie nt a n d his p h ysicia n(s) t o pr ocee d wit h 
C y ber K nife tr eat me nt, t h e y will be scree ne d f or i n cl usi o n i n t he cli nical e val uati o n.  Details 
of t he e val uati o n will be disc usse d wit h t he patie nt, wit h a m ple ti me gi ve n f or q uesti o ns.  If 
t he y c h o ose t o partici p ate, t he patie nts will be as k e d t o si g n a n I nf or me d C o nse nt F or m. 
1 3. 3 Patie nt C o nfi de ntialit y: 
Seri o us A d verse E ve nt ( S A E) St o p pi n g Criteri a 
P artici p a nts t o 
be e nr olle d: 2 9 8  
( 1 7 8 l o w-ris k, 
1 2 0 i nter m-ris k)  
I n de pe n de ntl y f or b ot h l o w- a n d i nter m-ris k ar ms, st o p a n ar m if 
t he n u m ber of gr a de 3- 5 eff ects f or t h at ar m e q u als or e xcee ds: 
E nr oll me nt 1- 4 8: 6 S A Es 
E nr oll me nt 1- 9 6: 1 4 S A Es 
E nr oll me nt 1- 1 2 0: 1 8 S A Es 
E nr oll me nt 1- 1 4 4: 2 2 S A Es 
E nr oll me nt 1- 1 7 8: 2 8 S A Es 

A C C P 0 0 1. 4 
_ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _
5 7 
 
I n the atte m pt t o mai ntai n patie nt c o nfi de ntialit y f or all patie nts i n v ol ve d i n t his cli nical 
e val uati o n, patie nt i de ntifier i nf or mati o n will be r estricte d t o eac h res p ecti ve cli nical site.  
S u bject-s pecific i de ntificati o n re q uire d t o c o n d u ct t his e val uati o n (f or c o m m u nicati o n 
p ur p oses bet wee n t he s p o ns or a n d sites) will be r estricte d t o t he n u m ber assi g ne d t o t hat 
s u bject at t he ti me of re gistrati o n.  
 
 
 
 
 
1 4. 0  RI S K T O B E N E FI T R A TI O 
 
1 4. 1 T he deter mi nati o n of e ntr y i nt o t he cli nical e val uati o n will be ma de i n de pe n de nt of t he 
decisi o n t o treat wit h ster e otactic r a di os ur ger y.  T he ur ol o gist, r a diati o n o nc ol o gist a n d/ or 
me dical tea m perf or mi n g t he pr oce d ure will disc uss t he p ote ntial ris ks ass ociate d wit h 
stere otactic ra di os ur ger y a n d t he p ote ntial be nefits of c o ntr ol of diseas e pr o gr essi o n, des pite 
t he li mite d cli nical e x perie nce. 
 
1 4. 2 Ris ks: 
Ris k classificati o ns assi g ne d bel o w ar e bas e d o n c urre ntl y a vaila ble literat ure o n treati n g 
pr ostate ca n cer wit h ra di ati o n t hera p y i n a ma n n er c o m para ble t o t he ra di os ur ger y pla n n e d 
f or t his pr ot oc ol.  T he pr ot oc ol f or t his cli nical e v al uati o n was desi g ne d t o ass ure t hat t he 
be nefits a n d k n o wle d ge c ollecte d f or stere otactic r a di os ur ger y of m ali g n a nt pr ostate t u m ors 
o ut wei g h t he p ot e ntial ris ks t o t he s u bjects. 
 
Ris ks t o patie nts i n t his st u d y i ncl u de all t h ose ris ks c urre ntl y ass o ciate d wit h fi d ucial 
place me nt as w ell as t he ris ks of l ocalizi n g a n d deli veri n g r a diati o n t o t he pr ostate 
e n vir o n me nt.  T he safet y of t he C y b er K nif e s yst e m i n treati n g i ntracra ni al t u m ors has bee n 
well d oc u me nte d.  Ris ks of t he pr oce d ure f or t his cli nical st u d y al o n g wit h t he met h o ds t o 
mi ni mize t he ris k are des cri be d bel o w.  T h e ra di ati o n ris ks prese nte d are cate g orize d 
acc or di n g t o versi o n 2. 0 of t he Nati o nal Ca ncer I nstit ute’s C o m m o n T o xicit y Criteria.  
Li kel y effects ar e liste d as t h ose si de eff ects w hic h occ ur i n m ore t h a n 2 0 % of patie nts.  
Less li kel y effects occ ur i n 2 0 % or less of patie nts treate d.  Rar e b ut seri o us effects occ ur i n 
less t ha n 3 % of patie nts. 
 
1 4. 3 Ris ks Ass ociate d wit h E xter nal Ra diati o n T hera p y: 
All patie nts treate d u n der t his pr ot oc ol will be pr o vi de d wit h s pecific i nstr u cti o ns a n d 
c o ntact i nf or mati o n, i n t he e ve nt a n y p atie nt de vel o ps si de effects.  Ma n y of t hese si de 
effects g o a wa y s h ortl y after ra di ati o n t hera p y is st o p pe d, b ut i n s o me cases si de effects ca n 
be l o n g-l asti n g or p er ma ne nt.  T he f oll o wi n g i ncl u des ris ks ass ociate d wit h e xter nal bea m 
ra diati o n t hera p y t o t he pr ostate a n d s urr o u n di n g p el vis. 
 
Te m p or ary f ati g ue ( Likely):  self-li mite d si de eff ect. 
 
Te m p or ary fre q ue nt or l o ose st o ols (likel y):  see n otes 1 & 3. Diet c h a n ges or i m m o di u m 
will be prescri be d if necessar y. 
 

A C C P 0 0 1. 4 
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5 7 
 
Te m p or ary uri n ary fre q u e ncy, irrit ati o n, or re d uce d stre a m ( Likely):  see n otes 1, 2, 3. Al p ha 
bl oc ker will be pr escri be d if necessar y. 
 
Te m p or ary re d ness, t a n ni n g, or h air l oss of ski n i n t he tre at me nt are a (less likely):  see n ote 
1. T o pical pre p arati o ns will be prescri be d, if n ecessar y. 
 
Per m a ne nt uri n ary “ b ot her ”, e. g. nee d t o uri n ate ur ge ntly or fre q ue ntly (less likely):  see 
n otes 1, 2, 3. C hr o nic al p ha bl oc ker, or ot her me dical t hera p y ma y b e re q uir e d. 
 
Per m a ne nt b o wel “ b ot her ”, e. g. nee d t o m ove b o wels ur ge ntly or fre q ue ntly (l ess likely):  
see n otes 1, 2, 3. A d diti o n of “ b ul k” ( e. g. Meta m ucil) t o diet, or i m m o di u m,  ma y b e 
re q uire d. 
 
Rect al blee di n g (r are, b ut seri o us):  s ee n otes 1, 2, 3. H y dr oc ortis o ne s u p p osit ories or e ne mas 
ma y b e re q uir e d; bl o o d tra nsf usi o ns, t o pical a ntic o a g ul a nts, c oa g ulati o n, or h y p o baric 
o x y ge n tr eat me nts ma y b e necessar y. 
 
Uri n ary o bstr ucti o n w hic h c o ul d re q uire c at heter pl ace me nt (like likely):  s ee n otes 2, 3. 
F ole y, i nter mitte nt strai g ht cat heterizati o n, or s u pr a p u bic cat h eter ma y b e r e q uire d.  
 
Uret hr al sc arri n g, w hic h c o ul d i m p air uri ne stre a m, a n d c o ul d re q uire s ur gery t o re p air 
( Less likel y, b ut seri o us): see n otes 2, 3. C yst os c o p y, tra ns- uret hr a i ncisi o n, a n d/ or dialati o n 
ma y b e re q uir e d. 
 
Le ak a ge of s m all a m o u nts of uri ne, w hic h c o ul d re q uire we ari n g p a ds i n u n der we ar (less 
likely): see n otes 2, 3. 
 
I n a bility t o c o ntr ol uri ne, w hic h c o ul d re q uire a c at heter, pe nile cl a m p, or s ur gery t o re p air 
(r ar e, b ut seri o us): see n otes 2, 3. 
 
Uri n ary blee di n g (r are, b ut seri o us):  s ee n otes 1, 2, 3: c yst osc o p y or electr oc oa g ul ati o n ma y 
be re q uir e d. 
 
Pr ost ate, bl a d der, uret hr a, or rect al p ai n (r ar e):  s ee n otes 1, 2, 3. Ma y re q uire treat me nt 
wit h a nti bi otics, s ur ger y (eit her o pe n or c yst osc o pic), a nal gesi cs, or ot her me dicati o ns 
place d i n t he bla d d er, ur et hra, or rect u m. 
 
I m p ote nce ( L ess likely, b ut seri o us): s ee n otes 1, 2. Ma y re q uire treat me nt will me dicati o ns 
(e. g. Via gr a, M use, et c …), ot her er ectile ai ds ( e. g. pe nile p u m p), or s ur ger y. 
 
Re d ucti o n i n ej ac ul ate v ol u me (likely), w hic h c o ul d re d uce fertility:  u na v oi da ble, si nce t he 
tar get i ncl u des str uct ur es w hic h c o ntri b ute t o se m e n. 
 
P ai n wit h ej ac ul ati o n, or c h a n ge i n t he se ns ati o n of or g as m (less likely) : see n ote 2, 3. Ma y 
re q uire a nal gesics. 
 

A C C P 0 0 1. 4 
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P a g e 3 1 of 5 7 
 
 
Rec t al or uret hr al ulcer ati o n, or fist ul a, w hic h c o ul d res ult i n c ol ost o my a n d/ or ile ost o my 
(r ar e, b ut seri o us): see n otes 1, 2, 3. C o ul d als o re q uire a nti bi otics, s u pra p u bic or f ole y 
cat heter, li q ui d diet, h y p o baric o x y ge n tr eat me nts, me dicati o ns or ot her s ur geries.  
 
N ote 1: beca us e t he C y ber K nife treats t he pr ostate wit h o ver 1 0 0 bea ms c o mi n g fr o m ma n y 
directi o ns, ra diati o n d ose is c o nce ntrat e d o n t he pr ostate. C o m pare d wit h ot her e xter nal 
bea m ra diati o n de vi ces, l ess ra diati o n d ose is gi ve n t o t he s urr o u n di n g n or mal tiss ues, s uc h 
as t he rect u m a n d bla d der. I n a d diti o n, t hr o u g h o ut treat me nt, C y b er K nif e fr e q ue ntl y i ma ges 
t he pr ostate a n d c orr ects f or m o ve me nt of t he p atie nt or t he pr ostate. T his all o ws p h ysicia ns 
t o treat a s maller r e gi o n ar o u n d t he pr ostate, c o m p are d t o ot her ra diati o n de vices. T his 
mi ni mizes ra diati o n e x p os ure t o s urr o u n di n g n or m al str uct ures. T he d esi g n c haracteristics 
of t he C y b er K nif e t h us i ntri nsicall y mi ni mizes t he ris k f or si de effects or a d verse effects. 
N ote 2: t he ra diati o n t olera nce of t he n or mal tiss u es s urr o u n di n g t he tar get has bee n 
caref ull y c o nsi der e d, a n d li kel y acce pta bl e t olera n ces ha ve b ee n calc ulat e d. T hese n or mal 
tiss ue c o nstrai nts are liste d i n secti o n 8. 3. 2. D V H a nal ys es will be perf or m e d as s pecifi e d, 
t o i ns ure a d her e nce t o t h ese c o nstrai nts, t h us mi ni mizi n g ris k. 
N ote 3: t he lar ge d os e per fracti o n deli vere d wit h C y ber K nife ta k es a d va nt a ge of t he l o w 
α /β  rati o of pr ostate ca ncer rel ati ve t o t he s urr o u n di n g nor mal str uct ures. T he 
h y p ofracti o nati o n sc h e me t his re d uces t he ris k of si de effects or a d v erse effects. 
 
1 4. 4 Ris ks Ass ociate d wit h Fi d ucial Place me nt: 
I nfecti o n (r are):  I n t he e ve nt t hat a patie nt e x peri e nces i nf ecti o n as a res ult of fi d ucial 
place me nt, a nti o bi otic treat me nt will be prescri b e d. 
 
1 4. 5 
Mi ni mizati o n of Ris k: 
Stri n ge nt i ncl usi o n/e x cl usi o n criteria ha v e bee n i n c or p orat e d i nt o t his pr ot oc ol t o ass ure t hat 
a n y s u bject w h o ma y be at i ncreas e d ris k fr o m a n a d verse e ve nt is n ot e nr olle d i nt o t his 
cli nical st u d y.  S u bjects will be o bser ve d p ost pr o ce d ure t o ass ure t hat a n y ac ute a d v erse 
effects ar e detecte d i n a ti mel y ma n ner s o t hat pr o per me dical tr eat me nt ca n be i nitiate d.  
S u bjects als o will be pr o vi de d wit h i nstr ucti o ns as t o w h o m t o c o ntact al o n g wit h c o ntact 
tele p h o ne n u m bers, i n t h e e ve nt t he y e x perie nce a n y c o m plicati o ns. 
 
1 4. 6 P ote ntial Be nefits: 
Alt h o u g h pr e vi o usl y c o nfi ne d t o i ntracr a nial treat me nt, S R S is gai ni n g rec o g niti o n i n t he 
me dical c o m m u nit y as a n alter nati ve t o e xter nal b ea m ra diati o n t her a p y i n ot her parts of t he 
b o d y.  Us e of t he C y ber K nife s yste m ma y pr o vi d e t he f oll o wi n g b e nefits: 
 
•  Mi ni mall y i n vasi v e pr oce d ure perf or m e d o n a n o ut- patie nt basis 
•  Le n gt h e n i nter val t o t u m or pr o gressi o n 
•  I m pr o v e d s ur vi val 
•  Decr ease d ge nit o uri nar y, rectal a n d gastr oi ntesti nal t o xicities c o m pare d wit h 
c o n ve nti o nal ra diati o n t h era p y a n d ra dical pr ostat ect o m y 
•  Decr ease d t o xicities t o se x ual f u ncti o n c o m pare d t o ot her t y p es of r a diati o n t hera p y 
a n d ra dical pr ostatect o m y 
 
1 4. 7 Earl y Ter mi nati o n: 

A C C P 0 0 1. 4 
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5 7 
 
S u b jects ma y wit h dr a w or be disc o nti n ue d b y t he i n vesti gat or fr o m t he cli ni cal e val u ati o n at 
a n y ti me, h o w e ver, t h e y ma y b e re q u este d t o c o nti n ue wit h t heir f oll o w- u p P S A tests a n d 
e x a ms fi ve years f oll o wi n g t heir last S R S treat me nt. 
 
1 5  
C O S T S A N D P A Y M E N T S 
1 5. 1  Researc h St u d y C osts: 
Scree ni n g a n d cli nical assess me nt of t he patie nt pri or t o t he pr oce d ur e will be n o differ e nt 
t ha n w hat t y pi call y occ urs pri or t o c o n ve nti o nal ra diati o n t hera p y.  T her ef ore, a patie nt’s 
i ns ura nce will be bille d f or all tests a n d i ma gi n g ass ociate d wit h t his e val uati o n.  T he c ost 
of t he pr oce d ure itself will be bille d t o t he patie nt’s i ns ura nce c o m p a n y u n d er a n 
a p pr o priate c o de.  T his will i ncl u de all o perati ve a n d h os pital- base d c har ges.  F oll o w- u p 
assess me nt als o is n o diff ere nt t ha n w h at t y picall y occ urs f oll o wi n g a c o n ve nti o nal 
ra di ot hera p y a n d treat me nt f or t his p o p ulati o n of patie nts.  T heref ore, t he patie nt’s 
i ns ura nce will be bille d f or all tests a n d i ma gi n g ass ociate d wit h t he f oll o w- u p visits. 
 
1 5. 2  Researc h St u d y Pa y me nts: 
T here will be n o fi n a ncial rei m b urse me nt t o t he patie nt f or partici pati o n i n t his e val uati o n.  
S o me data ma na ge m e nt, salar y s u p p ort a n d s u p pli es will be pr o vi de d b y A cc ura y I nc., 
S u n n y vale, C A ( pr oject s p o ns or). 
 
 

A C C P 0 0 1. 4 
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5 7 
 
1 6  
A P P E N DI C E S                                                                                                                                                          
A p pe n di x I: S a m ple P atie nt C o nse nt F or m 
 
I nf or me d C o nse nt 
Pr os pecti ve E v al u ati o n of C y ber K nif e Stere ot a ctic R a di os ur ger y f or L o w a n d I nter me di ate Ris k 
Pr ost ate C a ncer: H o m o ge n o us D ose Distri b uti o n 
 
Date:  _ _ _ _ / _ _ _ _ / _ _ _ _ 
 
M M  
D D  
Y Y  
Ar e y o u partici pati n g i n a n y ot h er r esearc h st u dies?    _ _ _ _ _ yes 
  _ _ _ _ _ n o 
 
W h y h a ve I bee n as ke d t o t a ke p art i n t his rese arc h st u d y ? 
Y o u are i n vite d t o partici pate i n a cli nical e v al uati o n of a hi g hl y f oc use d ra diati o n treat me nt t o pr ostate 
t u m ors usi n g t he C y b er K nife ® s yste m ( ma n ufact ure d b y Acc ura y I nc or p or ate d, S u n n y v ale).  T h e p ur p ose 
of t his e val uati o n is t o l o o k at t he eff ect t his treat me nt will ha ve o n t he t u m or a n d y o ur q ualit y of life at 
vari o us ti meli nes f or 1 0 years after y o ur treat me nt.  If y o u d eci de t o p artici pate i n t his e val uati o n, y o u will 
nee d t o meet a n u m b er of re q uire me nts bef ore y o ur d oct ors deter mi ne t hat t his treat me nt is a p pr o priate f or 
y o u. 
 
W h o is c o n d ucti n g t he st u d y ? 
 
[ P L E A S E A D D I N S TI T UI O N H E R E] 
 
W h y is t his rese arc h st u d y bei n g d o ne ? 
T he p ur p ose of t his st u d y is t o deter mi ne t he effects of C y ber K nife ra di os ur ger y i n patie nts wit h pr ostate 
ca ncer.  T he C y ber K nife s yste m is a ne w t y p e of r a diati o n mac hi ne t hat uses a s pecial s yste m t o precisel y 
f oc us lar ge d os es of x-ra ys o n t he t u m or.  T he d e vice is desi g n e d t o c o nce ntrate lar ge d oses of r a di ati o n 
o nt o t he t u m or s o t hat i nj ur y fr o m ra di ati o n t o t he near b y n or m al tiss ue will be mi ni mal.  T he p ur p ose of 
t his e val uati o n is t o see if t his treat me nt will hel p patie nts wit h y o ur c o n diti o n a n d t o e val uate t he effect of 
t his treat me nt o n y o ur q u alit y of life o v er ti me. 
 
 
 
 
 
 

A C C P 0 0 1. 4 
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5 7 
 
T he C y b er K nif e s yst e m pre vi o usl y h as bee n us e d i n t he l u n g, brai n, h ea d a n d nec k as w ell as ot her areas 
of t he b o d y.  T he r es ults of treati n g t u m ors i n t he brai n ar e si milar t o a n o p erati o n i n w hic h t he t u m or is 
re m o ve d.  T he C y ber K nife s yste m has mar k et cleara nce fr o m t he U. S. F o o d a n d Dr u g A d mi nistrati o n t o 
treat t u m ors, lesi o ns a n d c o n diti o ns a n y w h ere i n t he b o d y w he n r a diati o n t hera p y is re q uire d. W hile t he 
de vice is n o l o n ger classifie d as “i n vesti gati o nal”, t he best treat me nt d ose a n d ti mes still are bei n g 
e val uate d.   
 
T he feasi bilit y of C y b er K nife f or tr eati n g l ocalize d pr ostate ca ncer was first descri be d b y t he gr o u p at 
Sta nf or d U ni versit y.  T he y r e p orte d t hat t he pr ostate t u m or mar ker “ pr ostat e s pecific a nti ge n” ( P S A) 
decrease d r a pi dl y i n 2 6 l o w ris k pr ostate ca ncer p atie nts treate d wit h t he C y b er K nife wit h a me dia n 
f oll o w- u p ti me of 1 8 m o nt hs. Fe wer si de effects were o bs er ve d c o m par e d t o c o n ve nti o nal e xter nal bea m 
ra diati o n.  I n a sec o n d st u d y, a gr o u p fr o m t he K orea Ca n cer Ce nt er, Se o ul, K orea, e x pl ore d t he 
a d va nta ges of C y b er K nif e ra di os ur ger y as a mi ni mall y i n vasi ve tr eat me nt o pti o n f or patie nts wit h pr ostate 
ca ncer.  T he y d e m o nstrat e d t hat t he C y b er K nif e w as eff ecti ve f or t he treat me nt of t u m ors i n t he pr ostate 
a n d i m pr o ve d t he q ualit y of life f or p atie nts b y mi ni mizi n g t he treat me nt si de eff ects a n d s h orte ni n g t he 
o verall treat me nt ti mes.  Rece ntl y, Na ples C o m m u nit y H os pital re p ort e d a series of m ore t ha n 7 0 l o w a n d 
i nter me diate ris k pr ostate ca ncer patie nts treate d wit h t he C y b er K nif e. T he y re p orte d a si g nifi ca nt 
decrease i n P S A val ues o ne year f oll o wi n g C y ber K nife treat me nt wit h mi ni mal ac ute t o xicities. 
 
H o w m a n y pe o ple will t a ke p art i n t he st u d y ? 
A p pr o xi matel y 3 1 9 p atie nts will be e nr olle d i n t his cli nical e val uati o n. 
 
W h at will h a p pe n if I t a ke p art i n t his rese arc h st u d y ? 
Pri or t o e ntra nce o n t his st u d y y o u will ha ve ha d y o ur pr ostate s pecific a nti ge n ( P S A) a n d test oster o ne 
c hec k e d a n d y o ur pr ostate bi o psie d wit hi n t he last 1 2 m o nt hs.  T he res ults of t he bi o ps y s h o w e d t hat y o u 
ha ve pr ostate ca n cer.  I n a d diti o n, y o u will ha ve a di gital rectal e x a m ( D R E) t o deter mi ne if t he ca ncer 
ca n be f elt.  Base d o n t he res ults of t hese tests a n d e x a mi nati o n it has bee n deter mi ne d t hat y o ur pr ost ate 
ca ncer is i n a n earl y sta ge a n d has n ot li kel y s prea d o utsi de t he pr ostate or a n y w her e else i n y o ur b o d y.  If 
y o u a gree t o b e i n t his st u d y, y o u will be as k e d t o rea d a n d si g n t his c o nse nt f or m bef or e ha vi n g a n y 
pr oce d ur e t hat is re q uir e d f or y o ur partici pati o n i n t his cli nical e val uati o n.   
 
Pre p ar ati o n f or Cy ber K nife tre at me nt t o t he pr ost ate:  
Y o u will be as ke d t o c o m plete s o me s h ort q uesti o n naires bef ore y o ur C y b er K nife tr eat me nt.  T h ese 
q uesti o n naires will as k y o u m ulti ple c h oice q uesti o ns a b o ut y o ur b o wel, bl a d der a n d s e x ual f u ncti o n.  
T he y will als o as k y o u s o me ge ner al q uesti o ns a b o ut y o ur m o o d, acti vit y a n d e ner g y le v els, a n d ge n eral 
healt h. 
 
Y o u will als o ha ve a p h ysical e x a mi nati o n a n d a pr oce d ur e t o place 4 s mall g ol d see ds i nt o t he pr ostate.  
T his pr oce d ur e is c o m m o nl y d o ne i n patie nts r ecei vi n g sta n dar d e xter nal bea m ra diati o n f or pr ostate 
ca ncer a n d is n ot a n e x peri me ntal pr oce d ure.  T h ese g ol d mar kers will be use d t o deter mi ne t he l ocati o n 
of t he pr ostate d uri n g t he C y ber K nife tr eat me nt.  A n ultras o u n d pr o be is pl ace d i nt o t he r ect u m a n d 
nee dles c o ntai ni n g t he g ol d see ds are g ui de d i nt o t he pr ostate a n d t h e n t he s ee ds ar e de p osite d.  Y o u will 
nee d t o clea n o ut y o ur rect u m a n d ta ke a nti bi otics t he da y of t he see d place me nt. 
 
Wit hi n 5- 1 0 da ys after place me nt of t h e g ol d see ds, y o u will be as k e d t o ret ur n t o t he h os pital t o ha ve a 
pla n ni n g C T sca n of t he pel vis.  T his is a re g ul ar C T sca n a n d is sta n dar d pr oce d ur e f or p atie nts recei vi n g 
e xter nal bea m irra di ati o n.  T he i ma ges o btai ne d d uri n g t he s ca n will be use d t o pla n t he C y ber K nife 

A C C P 0 0 1. 4 
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5 7 
 
treat me nts.  Y o u will als o ha ve a n M RI sca n of t h e pel vis, u nless me dicall y c o ntr ai n dicate d (f or e x a m ple 
if y o u ha ve a p ace m a ker) w hic h will be use d f or tr eat me nt pla n ni n g p ur p os es.  Y o u ma y be as ke d t o 
u n der g o a sec o n d sca n wit h a uret hral cat heter i n place. 
 
Cy ber K nife tre at me nt t o t he pr ost ate:  
T he C y b er K nif e treat me nt will us uall y b e starte d a fe w d a ys after t he C T s ca n of t he p el vis.  Y o ur c o urse 
of ra diati o n will c o nsist of fi ve se parate C y be K nif e treat me nts us uall y deli vere d o ver 5 c o ns ec uti ve wee k 
da ys ( ma xi m u m 1 1 da ys), wit h n o less t ha n 1 2 h o urs bet wee n a n y t w o fr acti o ns.  Eac h treat me nt sessi o n 
will ta ke a p pr o xi matel y 1. 5- 2. 5 h o urs.  Y o u will lie o n t he treat me nt ta ble a n d breat h e n or mall y w hile y o u 
recei v e y o ur r a diati o n treat me nt. 
 
H o w l o n g will I be i n t he st u d y ? 
T he treat me nt part of t he st u d y will last 5- 1 1 da ys.  O n t he last da y of treat me nt a n urse will as k y o u 
q uesti o ns a b o ut p ossi ble si de effects. After y o ur C y b er K nife tr eat me nt y o u will nee d f oll o w- u p visits t o 
deter mi ne h o w effecti ve was t he treat me nt a n d if y o u are ha vi n g a n y treat me nt relate d si de effects.  At 1- 2 
wee ks after tr eat me nt is c o m plete d, a res ear c h n urs e will call y o u a n d disc uss h o w y o u are d oi n g. At 1 
m o nt h after c o m pleti o n of t he C y b er K nif e treat me nt, y o u will be as ke d t o r et ur n t o t he h os pital f or a 
f oll o w- u p e x a mi nati o n t o c hec k f or a n y si de eff ects a n d a bl o o d test t o meas ure y o ur test oster o n e le vel.  
Y o u will als o be as ke d t o c o m plete t he sa me q u esti o n naires y o u c o m plete d pri or t o C y ber K nife tr eat me nt.  
T hese q uesti o n nair es will as k a b o ut y o ur b o wel, bl a d der a n d s e x ual f u ncti o ni n g, as w ell as m o o d, acti vit y 
a n d e ner g y l e vels, a n d ge neral healt h.. 
 
At 3 a n d 6 m o nt hs after c o m pleti o n of t he C y ber K nife treat me nt, y o u will b e as ke d t o r et ur n t o y o ur 
p h ysicia n f or a n e x a mi nati o n a n d a bl o o d test t o meas ure y o ur P S A le vel.  T his is t he sta n dar d pr oce d ure 
f or f oll o w- u p visits a n d will occ ur e ver y 6 m o nt hs t hereaft er f or 5 years, t he n yearl y f or a n a d diti o nal 5 
years. 
Test oster o ne le v els will be m o nit ore d u ntil t he 2 4 m o nt h f oll o w- u p visit a n d will be o pti o nall y meas ure d 
at f oll o w- u p visits o ut t o 1 0 years.   
At t hese visits, y o u als o will be as ke d t o c o m plete q uesti o n naires a b o ut y o ur b o wel, bla d der a n d se x ual 
f u ncti o ni n g a n d y o ur q ualit y of life. 
 
If it is s us pecte d t hat y o ur t u m or is gr o wi n g or if t here are c o ncer ns a b o ut disease pr o gr essi o n o n y o ur 
P S A e x a ms, a pr ostate nee dle bi o ps y of t he t u m or ma y b e perf or me d. T w o years after C y ber K nife 
treat me nt, y o u ma y be as ke d t o ha ve a pr ostate bi o ps y. 
 
C a n I st o p bei n g i n t he st u d y ? 
Y o u ma y d eci de t o st o p a n d wit h dra w fr o m t he st u d y at a n y ti me. 
 
W h at si de eff ects or ris ks c a n I e x pect f r o m bei n g i n t he st u d y ? 
Y o u ma y h a ve si de eff ects w hile o n t his st u d y.  M ost of t hese ar e liste d her e, b ut t here ma y b e ot her si de 
effects t hat we ca n n ot pr e dict.  Si de eff ects will var y fr o m pers o n t o pers o n.  E ver y o ne ta ki n g p art i n t he 
st u d y will be caref ull y w atc he d f or a n y si de effects.  H o we ver, d o ct ors d o n ot k n o w all t he si de eff ects 
t hat ma y h a p pe n.  Si de effects ma y be mil d or ver y seri o us.  Y o ur healt h care tea m ma y gi ve y o u 
me dicati o ns t o hel p lesse n s o me of t he si de effects.  Ma n y si de eff ects g o a wa y s o o n after y o ur r a diati o n 
t hera p y.  I n s o me cases, si de eff ects ma y be v er y s eri o us, l o n g-lasti n g, or m a y n e ver g o a wa y.  Y o u 
s h o ul d tal k wit h y o ur st u d y d oct or a b o ut a n y si de effects t hat y o u m a y ha v e w hile ta ki n g part i n t he st u d y  

A C C P 0 0 1. 4 
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5 7 
 
T he a d mi nistrati o n of ra diati o n itself is pai nless a n d t he o nl y disc o mf ort is e x pecte d t o be fr o m y o ur 
ha vi n g t o lie ver y still d uri n g t he tr eat me nt. 
 
T he bi o ps y a n d place me nt of t he g ol d mar kers m a y ca use s o m e disc o mf ort as t hese pr oce d ures re q uire t he 
use of s mall nee dles i nserte d i nt o t he pr ostate.  Disc o mf ort fr o m t hese pr oce d ures will be mi ni mize d b y 
t he use of l ocal n u m bi n g me dicati o ns (a nest hetics) a n d y o u m a y recei ve i ntr a ve n o us i njecti o n of s mall 
d oses of me dicati o ns t o ma ke y o u dr o ws y (s e dati ves).  It is li kel y t hat a patie nt u n der g oi n g t his pr o ce d ure 
ma y e x perie nce disc o mf ort fr o m place m e nt of t he nee dles a n d mi n or blee di n g beca use of i nj ur y t o s mall 
bl o o d vessels i n t he pat h of t he nee dle.  T he maj orit y of cases d o n ot re q uir e treat me nt a n d t h e blee di n g 
res ol ves s p o nta ne o usl y.  Ot her p ossi ble si de effects w hic h are rar e i ncl u de i nfecti o n re q uiri n g a nti bi otic 
treat me nt a n d si g nifica nt blee di n g re q uiri n g tra nsf usi o n a n d/ or s ur ger y. 
 
P ossi ble si de effects f oll o wi n g C y ber K nife tr eat me nt i ncl u de irritati o n of t he bla d der or uret hr a (t he t u be 
t hat carri es uri ne o ut of t he bla d der t hr o u g h t h e pe nis). T his ma y lea d t o te m p orar y s y m pt o ms i ncl u di n g a 
re d uce d str ea m of uri ne, b ur ni n g wit h uri nati o n, h a vi n g t o uri nat e m ore fre q ue ntl y, ha vi n g t o get t o t he 
bat hr o o m q uic kl y t o uri n ate a n d/ or getti n g u p m or e at ni g ht t o uri nat e.  Ot h er p ossi ble si de effects i n cl u de 
irritati o n t o t he rect u m w hic h ma y l ea d t o te m p orar y s y m pt o ms i ncl u di n g a n i ncreas e i n fre q u e nc y of 
st o ols, l o ose st o ols a n d/ or m ore gas wit h b o w el m o ve me nts.  S o me patie nts ha ve te m p or y mil d fati g ue, 
a n d s o me ma y de vel o p te m p orar y or per ma ne nt i m p ote nce (i na bilit y t o h a ve erecti o ns) or per ma ne nt 
acci de nt al lea ka ge of s m all a m o u nts of uri ne. Ot h er si de effects w hic h ar e less li kel y i ncl u de te m p orar y 
hair l oss, re d ness or t a n ni n g of s ki n i n t he treat me nt area, p er ma n e nt uri nar y ur ge nc y, per ma ne nt uri nar y 
fre q ue n c y, nee d t o m o ve b o wels ur ge ntl y or fre q u e ntl y, a n d rect al or uri nar y blee di n g.  Rarel y, s o me 
patie nts ma y e x perie nce t he i na bilit y t o c o ntr ol uri ne w hic h c o ul d r e q uire a cat heter.  E xtre mel y r are 
c o m plicati o ns i ncl u de rectal ulcer ati o n or fist ula w hic h c o ul d re q uir e a c ol ost o m y a n d/ or ur et hral 
ulcerati o n or fist ula w hi c h c o ul d res ult i n ile ost o m y.  If t he p ossi bilit y of si de eff ects ma ke y o u t o o 
u nc o mf orta ble, y o u are e nc o ura ge d t o c o ntact t he st u d y d oct or as s o o n as p ossi ble. 
 
Are t here be nefits t o t a ki n g p art i n t he st u d y ? 
 
C y ber K nife tr eat me nt t o t he pr ostate is d o ne wit h t he deli ver y of lar ge d oses of hi g hl y f o c use d r a diati o n 
i nstea d of t he m ore c o n v e nti o nal a p pr oac h w hic h is d o ne wit h l o w d oses of ra diati o n gi v e n dail y o ver 
se ve n t o ni ne wee ks.  T h e t hree i m p orta nt p ossi bl e be nefits t o C y b er K nif e t hera p y are t hat t he hi g her 
d oses of ra diati o n ma y b e: 1) m ore da m a gi n g t o t he t u m or a n d, t her ef or e, le n gt h e n t he ti me t o t u m or 
pr o gressi o n 2) ha v e a gr eater c h a nce of pr ol o n gi n g y o ur lif e, 2) less da ma gi n g t o s urr o u n di n g tiss ue 
3) m ore c o n v e nie nt t ha n treat me nts bei n g gi ve n d ail y o ver se ve n t o ni ne w ee ks 4) a mi ni mall y i n vasi ve 
pr oce d ur e perf or me d o n a n o ut- patie nt basis. 
 
T he i nf or mati o n w hic h is o btai ne d fr o m t his cli nical e val uati o n will be use d t o see h o w hel pf ul t his 
treat me nt is t o patie nts wit h pr ostate ca ncer a n d t o l o o k at t he eff ect t his treat me nt has o n y o ur q ualit y of 
life o ver ti me.  T his i nf or mati o n als o ma y be h el pf ul t o ot hers wit h y o ur c o n diti o n. 
 
W E C A N N O T A N D D O N O T G U A R A N T E E O R P R O MI S E T H A T Y O U WI L L R E C EI V E A N Y 
B E N E FI T S F R O M T HI S C LI NI C A L E V A L U A TI O N. 
 
Y o u will be t ol d if a n y n e w i nf or mati o n is lear n e d w hic h ma y affect y o ur c o n diti o n or i nfl ue nce y o ur 
willi n g ness t o c o nti n ue p artici pati o n i n t his e val uati o n. 

A C C P 0 0 1. 4 
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P a g e 3 7 of 5 7 
 
 
W h ile partici pati n g i n t his cli nical e val uati o n, y o u s h o ul d n ot ta ke part i n a n y ot her resear c h pr oject 
wit h o ut a p pr o val fr o m all of t he i n vesti gat ors.  T his is t o pr otect y o u fr o m p ossi ble i nj ur y res ulti n g fr o m 
s uc h t hi n gs as e xtra bl o o d dra wi n g, e xtra x-ra ys, i nteracti o n of r esearc h dr u gs, or si milar hazar ds. 
  
W h at ot her o pti o ns are t here ? 
T here are alter nati ves t o C y ber K nife r a diati o n f or treat me nt of y o ur earl y st a ge ca ncer.  T hese i n cl u de: 
•  W atc hf ul waiti n g: T his is a pr o gra m of cl ose f oll o w- u p dela yi n g defi niti ve treat me nt of y o ur 
ca ncer. 
•  S ur ger y: T his is t he s ur gi cal re m o val of t he pr ostat e. 
•  Brac h yt her a p y:  T his is t he place m e nt of a r a di oacti ve s o urce i nt o t he pr ostate. 
•  E xter nal Bea m Ra diati o n:  T his is t he use of a mac hi ne t o deli ver ra di ati o n t o t he pr ostate. 
•  H or m o nal T her a p y:  T he use of h or m o nes t o l o wer or bl oc k t he male h or m o ne test oster o ne, t o 
s u p press pr ostate ca ncer gr o wt h. 
•  Cr y ot her a p y: T his is freezi n g t he pr ostate. 
 
T hese o pti o ns ma y or ma y n ot be a p pr o priat e f or y o u.  Y o u s h o ul d disc uss t he m wit h y o ur p h ysici a ns 
pri or t o y o ur a gr ee me nt t o partici pate i n t his e x peri me ntal treat me nt f or earl y sta ge pr ostate ca ncer. 
 
P a y me nt 
Y o u will recei ve n o p a y me nt f or y o ur partici pati o n i n t his st u d y. 
T he st u d y d o ct ors will n ot be pai d f or y o ur p artici pati o n i n t his st u d y. 
 
W h at are t he c osts of t a ki n g p art i n t he st u d y ? 
T here is n o c ost f or parti ci pati n g i n t his e val uati o n.  Y o u or y o ur i ns ura n ce c o m pa n y will be res p o nsi ble 
f or t he e ntire c ost of treat me nt a n d s u bse q ue nt e v al uati o n.  Y o ur d oct or will disc uss t hese wit h y o u. 
 
W h at are m y ri g hts if I t a ke p art i n t his st u d y ? 
Partici pati o n i n t his st u d y is e ntirel y v ol u ntar y.  Y o u are free t o wit h dra w y o ur c o nse nt t o partici pate i n 
t his treat me nt pr o gra m at a n y ti me wit h o ut prej u di ce t o y o u or y o ur me di cal care.  Ref usal t o partici pate 
will i n v ol ve n o pe nalt y or l oss of be nefits.  Y o u ar e free t o see k car e fr o m a p h ysicia n of y o ur c h oice at 
a n y ti me.  If y o u d o n ot ta ke part i n or wit h dra w fr o m t his cli nical e val uati o n, y o u will c o nti n ue t o r ecei ve 
care. 
 
T he decisi o n ma y be m a de t o ta ke s u bjects o ut of t his cli nical e val uati o n d ue t o u na ntici pate d 
circ u msta nces.  S o me p ossi ble reas o ns f or wit h dra wi n g a s u bject fr o m t he e val uati o n ar e: 
 
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fail ure t o f oll o w i nstr ucti o ns 
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t he i n vesti gat or d eci des t hat c o nti n uati o n c o ul d be har mf ul t o y o u 
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y o u nee d treat me nt n ot all o we d i n t his cli nical e val uati o n 
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t he e val uati o n is ca n cele d 
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ot her a d mi nistrati ve reas o n 
 
 W h o c a n a ns w er m y q uesti o ns a b o ut t he st u d y ? 
If y o u ha ve a n y q uesti o ns, y o u will be e x pecte d t o as k t he m of t he d oct or a n d/ or his st u d y c o or di nat or.  If 
y o u ha v e a n y a d diti o nal q uesti o ns later, please c o ntact: 
[ P L E A S E A D D I N S TI T U TI O N S P E CI FI C I N F O R M A TI O N H E R E] 

A C C P 0 0 1. 4 
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5 7 
 
 
W h a t h a p pe ns if I a m i nj ure d bec a use I t o o k p art i n t his st u d y ? 
All f or ms of me dical dia g n osis a n d tr eat me nt – w het her r o uti ne or e x peri me ntal – i n v ol ve s o me ris k of 
i nj ur y.  I n s pite of all preca uti o ns, y o u mi g ht de vel o p me dical c o m plicati o ns fr o m partici pati n g i n t his 
e val uati o n.  If s uc h c o m plicati o ns occ ur, t he d o ct ors will assist y o u i n o btai ni n g a p pr o priate me di cal 
treat me nt b ut t his e val uati o n d oes n ot pr o vi de fi na ncial assista nce f or a d diti o nal me dical or ot her c osts.  
T here will be n o p a y m e nt f or treat me nt of pre- e xisti n g c o n diti o ns or f or a n y treat me nt of c o n diti o ns 
arisi n g after t h e e val uati o n.  N o f u n ds ha ve b ee n s et asi de t o c o m pe nsat e y o u f or wa ges ass ociat e d f or l ost 
ti me at y o ur w or k place.  
 
Si g n at ures 
 
I h a ve bee n gi ve n a c o p y of t his f or m.  I ha ve rea d t he c o nse nt f or m or it has bee n rea d t o me.  T his 
i nf or mati o n was e x plai ne d t o me a n d m y q u esti o ns were a ns wer e d. 
 
I a gree t o ta ke p art i n t his researc h st u d y. 
 
 
 
 
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Date 
  
  
Patie nt’s Si g nat ure 
  
  
Pri nte d Na me 
 
 
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Date 
  
            Si g nat ure of pers o n c o n d ucti n g   
Pri nte d Na me 
  
  
  
  
t he i nf or me d c o nse nt dis c ussi o n 
 
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Date 
  
  
I n v esti gat or’s Si g n at ure  
  
Pri nte d Na me 
 
I n t he e ve nt t hat a n i nter preter is nee de d: 
 
I h a ve acc uratel y a n d c o m pletel y r ea d t he f ore g oi n g d oc u m e nt t o: _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ 
   ( patie nt or le gal r e pr ese ntati ve’s na me) 
 
i n _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _t he patie nt’s ( or le gal re pr ese ntati ve’s) pri mar y la n g u a ge.       (I de ntif y 
la n g u a ge use d) 
 
He/ S he u n derst a n ds all ter mi n ol o g y/ c o n diti o ns, ac k n o wle d ges his/ her a gr ee me nt b y si g ni n g t he d o c u me nt 
i n m y pres e nce. 
 
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Si g nat ure of I nter preter  
  
  
  
Date 

A C C P 0 0 1. 4 
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P a g e 3 9 of 5 7 
 
 
A U T H O RI Z A TI O N F O R U S E O F P R O T E C T E D H E A L T H I N F O R M A TI O N F O R 
R E S E A R C H P U R P O S E S 
 
 
U S E A N D DI S C L O S U R E O F Y O U R P R O T E C T E D H E A L T H I N F O R M A TI O N  
 
Pr otecte d Healt h I nf or mati o n is a n y pers o n al healt h i nf or mati o n t hr o u g h w hic h y o u ca n be i d e ntifie d. A 
decisi o n t o partici pate i n t his resear c h mea ns t hat y o u a gree t o t he us e of y o ur healt h i nf or mati o n f or t he 
p ur p oses e x plai ne d i n t his c o nse nt f or m.  B y si g ni n g t his f or m, y o u are a ut h orizi n g t he use a n d discl os ure 
of y o ur healt h i nf or m ati o n c ollecte d i n c o n n ecti o n wit h y o ur p artici pati o n i n t his resear c h st u d y. Y o ur 
i nf or mati o n will o nl y be use d i n acc or da nce wit h t he pr o visi o ns of t his c o nse nt f or m a n d a p plica ble l a w. 
 
Y o ur healt h i nf or mati o n relate d t o t his st u d y, i ncl u di n g, bl o o d a n d ot her tiss ue sa m ples a n d r elate d 
rec or ds, p h ysical e x a mi nati o ns, past me dical hist or y, x-ra ys, C T sca ns, c o ns ulti n g s pecialist’s re p orts, 
o perati ve r e p orts, a n d p at h ol o g y re p orts ma y be us e d or discl ose d i n c o n necti o n wit h t his researc h st u d y. 
St u d y rec or ds t hat i de ntif y y o u will be ke pt c o nfi d e ntial as re q uir e d b y la w. E x ce pt w he n re q uire d b y la w, 
y o u will n ot be i de ntifie d b y na m e, S ocial Sec urit y #, a d dress, p h o ne #, or a n y ot h er direct pers o n al 
i de ntifier i n st u d y r ec or ds discl ose d o utsi de of t he [ E N T E R N A M E O F H O S PI T A L/ R E S E A R C H 
F A CI LI T Y]. F or rec or ds discl ose d o utsi de of [, y o u will be assi g ne d a u ni q ue c o de n u m ber. T he k e y t o 
t he c o de will be ke pt i n a l oc ke d file i n t he offi ce of t he Pri nci pal I n vesti gat or, [ E N T E R N A M E O F 
P RI N CI P L E I N V E S TI G A T O R]. 
 
Re prese ntati ves of t h e f oll o wi n g gr o u ps are a ut h orize d t o use a n d/ or discl ose y o ur healt h i nf or m ati o n i n 
c o n necti o n wit h t his researc h st u d y:  
      
•  T he pri nci pal i n vesti gat or, [ E N T E R N A M E O F P RI NI C P L E I N V E S TI G A T O R] a n d ot her 
researc hers i n v ol ve d i n t he e val uati o n  
•  T he [ E N T E R N A M E O F H O S PI T A L/ R E S E A R C H F A CI LI T Y]  I nstit uti o nal Re vie w B o ar d,  
•  T he resear c h n urse, cli nical res ear c h ass ociat e, a n d pr oject c o or di n at or 
 
T he parties liste d i n t he prece di n g p ara gra p h ma y discl ose y o ur healt h i nf or mati o n t o t he f oll o wi n g 
pers o ns a n d or ga nizati o ns f or t heir use i n c o n n ecti o n wit h t his researc h st u d y: 
     T he Office of H u m a n Researc h Pr ot ecti o ns i n t he U. S.  
     De part me nt Of Healt h a n d H u ma n Ser vices 
     T he U. S. F o o d a n d Dr u g A d mi nistrati o n 
     Acc ur a y, t he ve n d or f or C y ber K nife 
 
 
 

A C C P 0 0 1. 4 
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5 7 
 
E X P I R A TI O N D A T E O R E V E N T F O R T H E R E T E N TI O N O F R E C O R D S  
 
Y o ur a ut h orizati o n f or t h e use a n d/ or discl os ur e of y o ur h ealt h i nf or mati o n e x pires o ne year after t his 
m ulti-ce nter res ear c h pr oject is c o m plete d (s u bject f oll o w- u p peri o d after tr eat me nt will be  1 0 years). At 
t hat ti me eit her t he res ear c h i nf or mati o n n ot alrea d y i n y o ur me dical rec or d will be destr o ye d or 
i nf or mati o n i de ntif yi n g y o u will be re m o ve d fr o m s uc h st u d y r es ults at [ E N T E R N A M E O F 
H O S PI T A L/ R E S E A R C H C E N T E R].  A n y res earc h i nf or mati o n i n y o ur me dical rec or d will be ke pt 
i n defi nitel y. 
 
V O L U N T A R Y P A R TI CI P A TI O N 
 
Y o ur partici pati o n is v ol u ntar y a n d y o u ma y c h o ose n ot t o partici pate i n t his researc h st u d y or wit h dra w 
y o ur c o nse nt or a ut h orizati o n f or t he use a n d discl os ure of y o ur h ealt h i nf or mati o n at a n y ti me. Y o ur 
c h oice will n ot at a n y ti me aff ect t he c o m mit me nt of y o ur healt h care pr o vi ders t o a d mi nister care a n d 
t here will be n o pe n alt y or l oss of be nefits t o w hic h y o u are ot her wise e ntitle d. If y o u deci de t o e n d y o ur 
partici pati o n i n t he st u d y, please n otif y t he r esearc her(s) i n writi n g. 
 
If y o u ha ve q u esti o ns or c o ncer ns re gar di n g y o ur pri vac y a n d t he us e of y o ur pers o nal healt h i nf or m ati o n, 
please c o ntact t he Pri vac y Officer, at 4 5 9- 2 7 4 2.  
 
  
  
  
  
  
  
  
  
  
  
  
 
 
Si g nat ure ( S u bject) 
  
  
  
     
  
  
Date 
 
  
  
  
  
  
  
  
  
  
  
  
 
 
Si g nat ure ( par e nt/le gal g uar dia n/c o nser vat or)   
  
  
Date 
  
  
     
  
 
  
  
  
  
  
  
  
  
  
  
  
 
 
If si g n e d b y ot her t ha n p atie nt, i n dicate rel ati o ns hi p   
  
  
 
 
  
  
  
  
  
  
  
  
  
  
  
 
 
Wit ness  
  
  
  
  
  
  
  
Date 
 
 
 
 
  
 
 
 

A C C P 0 0 1. 4 
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5 7 
 
C A L I F O R NI A E X P E RI M E N T A L S U B J E C T’ S BI L L O F RI G H T S 
 
Calif or nia la w r e q uires t hat a n y pers o n as ke d t o ta ke part as a s u bject i n r esearc h i n v ol vi n g a me di cal 
e x p eri me nt, or a n y pers o n as ke d t o c o nse nt t o s uc h partici pati o n o n be half of a n ot her, is e ntitle d t o 
recei v e t he f oll o wi n g list of ri g hts writte n i n a la n g ua ge i n w hic h t he p ers o n is fl ue nt.  T his list i ncl u des 
t he ri g ht t o: 
 
1.  Be i nf or m e d of t he n at ur e a n d p ur p ose of t he e x peri me nt. 
2.  Be gi ve n a n e x pla nati o n of t he pr oce d ure t o be f oll o we d i n t he me dical e x peri me nt a n d a n y dr u g 
or de vice t o be utilize d.    
 
3.  Be gi ve n a descri pti o n of a n y atte n da nt disc o mf orts a n d ris ks reas o n a bl y t o be e x pecte d fr o m t he 
e x peri me nt.   
4.  Be gi ve n a n e x pla nati o n of a n y be nefits t o t he s u bject reas o n a bl y t o be e x pecte d fr o m t he 
e x peri me nt, if a p plica ble. 
5.  Be gi ve n a discl os ure of a n y a p pr o pri ate alter n ati ve pr oce d ures, dr u gs, or de vices t hat mi g ht b e 
a d va nta ge o us t o t he s u bj ect, a n d t heir relati ve ris ks a n d be nefits.   
6.  Be i nf or m e d of t he a ve n u es of me dical tr eat me nt, if a n y, a vaila bl e t o t he s u bject after t he 
e x peri me nt if c o m plicati o ns s h o ul d arise.   
7.  Be gi ve n a n o p p ort u nit y t o as k a n y q uesti o ns c o ncer ni n g t h e e x peri me nt or t he pr oce d ures 
i n v ol ve d. 
8.  Be i nstr ucte d t h at c o nse nt t o partici pate i n t he me dical e x peri me nt ma y b e wit h dra w n at a n y ti me 
a n d t he s u bject ma y disc o nti n ue partici pati o n i n t he me dical e x peri me nt wit h o ut prej u dice. 
9.  Be gi ve n a c o p y of t h e si g ne d a n d date d writte n c o nse nt f or m. 
1 0.  Be gi ve n t he o p p ort u nit y t o deci de t o c o nse nt or n ot t o c o nse nt t o a me dical e x peri me nt wit h o ut 
t he i nter ve nti o n of a n y ele me nt of f or ce, fra u d, deceit, d uress, c o erci o n, or u n d ue i nfl ue nce o n t h e 
s u bject’s decisi o n. 
 
F or q uesti o ns a b o ut patie nt ri g hts, c o ntact t he C hair ma n of t he I nstit uti o nal Re vie w B o ar d at [ E N T E R 
N A M E O F H O S PI T A L/ R E S E A R C H C E N T E R] at [ E N T E R C O N T A C T T E L E P H O N E N U M B E R].   
 
I h a ve car ef ull y rea d t he i nf or mati o n c o ntai ne d a b o ve a n d I u n d ersta n d f ull y m y ri g hts as a p ote ntial 
s u bject i n a me dical e x peri me nt i n v ol vi n g pe o ple as s u bjects.  
 
  
  
  
  
  
  
 
  
  
  
  
 
 
Si g nat ure ( patie nt)  
  
  
  
  
  
Date 
 
  
  
  
  
  
  
 
  
  
  
  
 
 
Si g nat ure ( par e nt/le gal g uar dia n/c o nser vat or)  
  
Date 
 
  
  
  
  
  
  
 
  
 
If si g n e d b y ot her t ha n p atie nt, i n dicate rel ati o ns hi p  
 
  
  
  
  
  
  
 
  
  
  
  
 
 
Wit ness  
  
  
  
  
  
  
Date 
 
  
  
 
A p pe n di x II: Perf or m a nce St at us Sc ales 
E C O G P E R F O R M A N C E S C A L E 
0 F ull y acti ve, a ble t o carr y o n all pre disease acti vities wit h o ut restricti o n ( K ar n ofsky 9 0- 1 0 0). 

A C C P 0 0 1. 4 
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5 7 
 
1 Restricte d i n p h ysicall y stre n u o us acti vit y b ut a m b ulat or y a n d a ble t o carr y o ut w or k of a li g ht or se de ntar y nat ure. F or 
e xa m ple, li g ht h o use w or k, office w or k ( K ar n ofsky 7 0- 8 0). 
2 A m b ulat or y a n d ca pa ble of all self-care b ut u na ble t o carr y o ut a n y w or k acti vities. U p a n d a b o ut m ore t ha n 5 0 % of wa ki n g 
h o urs ( K ar n ofsky 5 0- 6 0). 
3 Ca pa ble of o nl y li mite d self-care, c o nfi ne d t o be d or c hair 5 0 % or m ore of wa ki n g h o urs ( K ar n ofsky 3 0- 4 0). 
4 C o m pletel y disa ble d. Ca n n ot carr y o n a n y self-care. T otall y c o nfi ne d t o be d or c hair ( K ar n ofsky 1 0- 2 0). 
 
A p p e n di x III: A J C C S T A GI N G S Y S T E M, 6 T H  E DI TI O N, P R O S T A T E 
Pri m ary T u m or, Cli nic al ( T)  
T X Pri mar y t u m or ca n n ot be assesse d  
T 0 N o e vi de nce of pri mar y t u m or  
T 1 Cli nicall y i na p pare nt t u m or n ot pal pa ble or visi ble b y i ma gi n g  
   T 1a T u m or i nci de ntal hist ol o gic fi n di n g i n 5 % or less of tiss ue resecte d  
   T 1 b T u m or i nci de ntal hist ol o gic fi n di n g i n m ore t ha n 5 % of tiss ue resecte d  
   T 1c T u m or i de ntifie d b y nee dle bi o ps y (e. g., bec a use of elev ate d P S A)  
T 2 T u m or c o nfi ne d wit h pr ostate *  
   T 2a T u m or i n v ol ves less t ha n ½ of o ne l o be  
   T 2 b T u m ors i n v ol ves greater t ha n ½ of o ne l o be b ut < 2 l o bes  
   T 2c T u m or i n v ol ves b ot h l o bes  
T 3 T u m or e xte n ds t hr o u g h pr ostate ca ps ule * *  
   T 3a E xtraca ps ular e xte nsi o n ( u nil ater al or bil ater al)  
(s) 
 
 
 !
"
  
#$
%
$
$
 &
%
'
* N ote: T u m or f o u n d i n o ne or b ot h l o bes b y nee dle bi o ps y, b ut n ot pal pa ble or relia bl y visi ble b y i ma gi n g, is classifie d as T 1c  
* * N ote: I n vasi o n i nt o t he pr ostatic a pe x or i nt o ( b ut n ot bey o n d) t he pr ostatic ca ps ule is n ot classifie d as T 3, b ut as T 2. 
 
Re gi o n al Ly m p h N o des ( N)  
Cli nical   
N X Re gi o nal l y m p h n o des ca n n ot be assesse d  
 
N 0 N o re gi o nal l y m p h n o de metastasis  
 
N 1 Metastasis i n re gi o nal l y m p h n o de or n o des  
P at h ol o gic  
p N X Re gi o nal n o des n ot sa m ple d 
 
p N 0 N o p ositi ve re gi o nal n o d es  
 
p N 1 Metastases i n re gi o nal n o de(s)  
 
Dist a nt Met ast asis ( M) *  
M X  Prese nce of dista nt metast asis ca n n ot be assesse d ( n ot e val uate d b y a n y m o dalit y)  
M 0 N o dista nt metastasis  
M 1 Dista nt metastasis  
  M 1a N o nre gi o nal l y m p h n o d e(s)  
  M 1 b B o ne(s)  
  M 1c Ot her site(s) wit h or wit h o ut b o ne disease 
* N ote: W he n m ore t ha n o ne site of metastasis is prese nt, t he m ost a d va nce d cate g or y is use d; p M 1c is m ost a d va nce d.  
 
A p pe n di x I V:   D at a C ollecti o n D oc u me nts 
Ref er t o: htt p://e ve nta. ki ka me dical.c o m/acc ur a y- pr ostate/ 
 
A p pe n di x V: N CI C o m m o n t o xicit y criteri a/ R T O G/ E O R T C: 
Refer t o: htt p://cte p.ca ncer. g o v/f or ms/ C T C A E v 3. p df 
 
A p pe n di x VI:  A U A, S F- 1 2, E PI C, S HI M, U S M D Q uesti o n naires: 

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5 7 
 
A me ric a n Ur ol o gic al Ass oci ati o n ( A U A) s y m pt o m i n de x: was de vele o p e d t o hel p me n deter mi ne h o w 
b ot hers o me t heir uri nar y s y m pt o ms ar e a n d t o c h ec k t he effecti ve n ess of treat me nt. 8 1 T his q uesti o n naire 
ha s als o bee n a d o pte d w orl d wi de a n d is k n o w n as t he I nter n ati o nal Pr ostate S y m pt o m Sc ore (I P S S). It is 
s o meti mes see n wit h a Q ualit y of Lif e Scale at t he e n d of t he q uesti o n nair e.  
 
 
N a m e: _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _                                  T o d a y’ s d at e: _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ 
 
( Circle o ne n u m ber o n e ac h li ne) 
Al m ost 
ne ver 
Less 
t h a n    
1 ti me 
i n 5 
Less 
t h a n 
h alf t he 
ti me 
A b o ut 
h alf t he 
ti me 
M ore 
t h a n 
h alf t he 
ti me 
Al m ost 
al w a ys 
O ver t he past m o nt h or s o, h o w ofte n 
ha ve y o u ha d a se nsati o n of n ot 
e m pt yi n g y o ur bla d d er c o m pletel y after 
y o u fi nis he d uri nati n g? 
0  
1  
2  
3  
4  
5 
O ver t he past m o nt h or s o, h o w ofte n 
ha ve y o u ha d t o uri nat e a gai n less t ha n 
t w o h o urs after y o u fi nis he d uri nati n g? 
0  
1  
2  
3  
4  
5 
O ver t he past m o nt h or s o, h o w ofte n 
ha ve y o u f o u n d y o u st o p pe d a n d starte d 
a gai n se veral ti mes w he n y o u uri n ate d? 
0  
1  
2  
3  
4  
5 
O ver t he past m o nt h or s o, h o w ofte n 
ha ve y o u f o u n d it diffic ult t o p ost p o ne 
uri nati o n? 
0  
1  
2  
3  
4  
5 
O ver t he past m o nt h or s o, h o w ofte n 
ha ve y o u ha d a wea k uri nar y strea m? 
0  
1  
2  
3  
4  
5 
O ver t he past m o nt h or s o, h o w ofte n 
ha ve y o u ha d t o p us h or strai n t o be gi n 
uri nati o n? 
0  
1  
2  
3  
4  
5 
 
N o ne 
1 ti me 
2 ti mes 
3 ti mes 
4 ti mes 
5 or 
m o re 
ti mes 
O ver t he past m o nt h, h o w ma n y ti mes 
di d y o u m ost t y picall y get u p t o uri nate 
fr o m t he ti me y o u we nt t o be d at ni g ht 
u ntil t he ti me y o u g ot u p i n t he m or ni n g?  
0  
1  
2  
3  
4  
5 
 
Q u alit y of Lif e: If y o u w er e t o s p e n d t h e r e st of y o ur lif e wit h y o ur uri n ar y c o n diti o n j u st t h e w a y it i s n o w, h o w 
w o ul d y o u f e el a b o ut t h at ?    D eli g ht e d, Pl e a s e d, M o stl y s ati sfi e d, Mi x e d, M o stl y di s s ati sfi e d, U n h a p p y, T erri bl e 

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5 7 
 
S F- 1 2 ( S h ort F o r m) 
 
1. I n ge ner al, w o ul d y o u sa y y o ur healt h is e x celle nt, ver y g o o d, g o o d, fair, or p o or?  E x celle nt ...   Ver y 
G o o d ...    G o o d ...     Fair ...     P o or ...   
 
T he f oll o wi n g ite ms are a b o ut acti vities y o u mi g ht d o d uri n g a t y pical da y. D oes y o ur healt h n o w li mit 
y o u i n t hese acti vities? If s o, h o w m uc h?  
 
2) First, m o der ate acti vities s uc h as m o vi n g a ta ble, p us hi n g a v ac u u m clea n er, b o wli n g or pla yi n g g olf. 
D o es y o ur healt h n o w li mit y o u a l ot, li mit y o u a little, or n ot li mit y o u at all.   Li mite d a l ot ...    Li mite d 
a little ...   N ot li mite d at all ... 
 
3. Cli m bi n g se veral fli g hts of stairs. D oes y o ur healt h n o w li mit y o u a l ot, li mit y o u a little, or n ot li mit 
y o u  at all? Li mite d a l ot ...  Li mite d a little ...  N ot li mite d at all ... 
 
4. D uri n g t h e past f o ur w ee ks, ha ve y o u acc o m plis he d less t ha n y o u w o ul d li ke as a r es ult of y o ur 
p h ysical h ealt h?   N o ...     Yes ...   
 
5. D uri n g t h e past f o ur w ee ks, were y o u li mite d i n t he ki n d of w or k or ot her re g ular acti vities y o u d o as a 
res ult of y o ur p h ysical healt h?   N o ...    Yes ...    
 
6. D uri n g t h e past f o ur w ee ks, ha ve y o u acc o m plis he d less t ha n y o u w o ul d li ke t o as a res ult of a n y 
e m oti o nal pr o ble ms, s uc h as feeli n g de presse d or a n xi o us? N o ...  Yes ... 
 
7. D uri n g t h e past f o ur w ee ks, di d y o u n ot d o w or k or ot her re g ular acti vities as caref ull y as us u al as a 
res ult of a n y e m oti o nal pr o ble ms s uc h as f eeli n g d e presse d or a n xi o us?  N o ...   Yes ... 
 
8. D uri n g t h e past f o ur w ee ks, h o w m uc h di d pai n i nterfer e wit h y o ur n or m al w or k, i ncl u di n g b ot h w or k 
o utsi de t he h o me a n d h o use w or k? Di d it i nterfere n ot at all, sli g htl y, m o deratel y, q uite a bit, or e xtre mel y?  
N ot at all ...  Sli g htl y ...   M o deratel y ...    Q uite a bit ...   E xtre mel y ...   
 
T hese q uesti o ns ar e a b o ut h o w y o u f eel a n d h o w t hi n gs ha v e bee n wit h y o u d uri n g t he p ast 4 wee ks. F or 
eac h q u esti o n, please gi v e t he o ne a ns wer t hat c o mes cl osest t o t he wa y y o u ha ve bee n feeli n g. 
 
9. H o w m uc h ti me d uri n g t he p ast 4 wee ks h a ve y o u felt cal m a n d peacef ul ?  All of t he ti me ...   M ost of 
t he ti me ...  A g o o d bit of t he ti me ...  S o me of t he ti me ...   A little of t he ti me ...    N o ne of t he ti me ... 
 
1 0. H o w m uc h of t he ti me d uri n g t h e past 4 wee ks di d y o u ha v e a l ot of e n er g y? All of t he ti me ...  M ost 
of t he ti me ...  A g o o d bit of t he ti me ...   S o me of t he ti me ...   A little of t he ti me ...   N o ne of t he ti me ... 
 
1 1. H o w m uc h ti me d uri n g t he p ast 4 wee ks h a ve y o u f elt d o w n? All of t he ti me ...   M ost of t he ti me ...   
A g o o d bit of t he ti me ...    S o me of t he ti me ...   A little of t he ti me ...  N o ne of t he ti me ... 
 
1 2 D uri n g t h e past 4 wee ks, h o w m uc h of t he ti me has y o ur p h ysical healt h or e m oti o nal pr o ble ms 
i nterfer e d wit h y o ur s oci al acti vities li ke visiti n g wit h frie n ds, relati ves etc? All of t he ti me ...   M ost of 
t he ti me ...    S o me of t he ti me ...   A little of t he ti me ...    N o ne of t he ti me ... 

A C C P 0 0 1. 4 
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5 7 
 
 

A C C P 0 0 1. 4 
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5 7 
 
 

A C C P 0 0 1. 4 
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5 7 
 
 
 

A C C P 0 0 1. 4 
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5 7 
 
 

A C C P 0 0 1. 4 
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5 7 
 
S E X U A L H E A L T H I N V E N T O R Y F O R M E N ( S HI M) 
 
P A TI E N T N A M E: _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _        T O D A Y’ S D A T E: _ _ _ _ _ _ _ _ _ _ _ _ _ _  
 
P A TI E N T I N S T R U C TI O N S  
S e x u al h e alt h i s a n i m p ort a nt p art of a n i n di vi d u al' s o v er all p h y si c al a n d e m oti o n al w ell- b ei n g. Er e ctil e d y sf u n cti o n, 
al s o k n o w n a s i m p ot e n c e, i s o n e t y p e of v er y c o m m o n m e di c al c o n diti o n aff e cti n g s e x u al h e alt h. F ort u n at el y, t h er e 
ar e m a n y diff er e nt tr e at m e nt o pti o n s f or er e ctil e d y sf u n cti o n. T hi s q u e sti o n n air e i s d e si g n e d t o h el p y o u a n d y o ur 
d o ct or i d e ntif y if y o u m a y b e e x p eri e n ci n g er e ctil e d y sf u n cti o n. If y o u ar e, y o u m a y c h o o s e t o di s c u s s tr e at m e nt 
o pti o n s wit h y o ur d o ct or.  
 
E a c h q u e sti o n h a s s e v er al p o s si bl e r e s p o n s e s. Cir cl e t h e n u m b er of t h e r e s p o n s e t h at b e s t d e s cri b e s y o ur o w n 
sit u ati o n. Pl e a s e b e s ur e t h at y o u s el e ct o n e a n d o nl y o n e r e s p o n s e f or e a c h q u e sti o n .  
 
O V E R T H E P A S T 6 M O N T H S :  
 
1 . H o w d o y o u r at e 
y o ur c o nfi d e n c e 
t h at y o u c o ul d g et 
a n d k e e p a n 
er e cti o n ?  
 
V E R Y L O W 
L O W  
M O D E R A T E  
H I G H  
V E R Y H I G H  
 
1  
2  
3  
4  
5  
2. W h e n y o u h a d 
er e cti o n s wit h 
s e x u al sti m ul ati o n, 
h o w oft e n w er e 
y o ur er e cti o n s h ar d 
e n o u g h f or 
p e n etr ati o n 
( e nt eri n g y o ur 
p art n er) ?  
N O S E X U A L 
A C TI VI T Y  
A L M O S T 
N E V E R O R 
N E V E R  
A F E W T I M E S 
(M U C H L E S S 
T H A N H A L F 
T H E TI M E )  
S O M E TI M E S 
(A B O U T H A L F 
T H E  TI M E)  
M O S T T I M E S 
(M U C H M O R E 
T H A N , H A L F 
T H E  TI M E)  
A L M O S T 
A L W A Y S O R 
A L W A Y S  
0  
1  
2  
3  
4  
5  
3. D uri n g s e x u al 
i nt er c o ur s e, h o w 
oft e n w er e y o u a bl e 
t o m ai nt ai n y o ur 
er e cti o n aft er y o u 
h a d p e n etr at e d 
( e nt er e d) y o ur 
p art n er ?  
D I D N O T 
A T T E M P T 
IN T E R C O U R S E  
A L M O S T 
N E V E R O R 
N E V E R  
A F E W T I M E S 
(M U C H L E S S 
T H A N H A L F 
T H E TI M E )  
S O M E TI M E S 
(A B O U T H A L F 
T H E  TI M E)  
M O S T T I M E S 
(M U C H M O R E 
T H A N , H A L F 
T H E  TI M E)  
A L M O S T 
A L W A Y S O R 
A L W A Y S  
0  
1  
2  
3  
4  
5  
4. D uri n g s e x u al 
i nt er c o ur s e, h o w 
diffi c ult w a s it t o 
m ai nt ai n y o ur 
er e cti o n t o 
c o m pl eti o n of 
i nt er c o ur s e ?  
D I D N O T 
A T T E M P T 
IN T E R C O U R S E  
E X T R E M E L Y 
D I F FI C U L T  
V E R Y 
D I F FI C U L T  
D I F FI C U L T  
S LI G H T L Y 
D I F FI C U L T  
N O T 
D I F FI C U L T  
0  
1  
2  
3  
4  
5  
5. W h e n y o u 
att e m pt e d s e x u al 
i nt er c o ur s e, h o w 
oft e n w a s it 
s ati sf a ct or y f or 
y o u ?  
D I D N O T 
A T T E M P T 
IN T E R C O U R S E  
A L M O S T 
N E V E R O R 
N E V E R  
A F E W T I M E S 
(M U C H L E S S 
T H A N H A L F 
T H E TI M E )  
S O M E TI M E S 
(A B O U T H A L F 
T H E  TI M E)  
M O S T T I M E S 
(M U C H M O R E 
T H A N , H A L F 
T H E  TI M E)  
A L M O S T 
A L W A Y S O R 
A L W A Y S  
0  
1  
2  
3  
4  
5  
 
A d d t h e n u m b er s c orr e s p o n di n g t o q u e sti o n s 1- 5 .  
 
  
 
T O T A L:     _ _ _ _ _ _ _ _ _ _ _ 
 
T h e S e x u al H e alt h I n v e nt or y f or M e n f urt h er cl a s sifi e s E D s e v erit y wit h t h e f oll o wi n g br e a k p oi nt s:  
1- 7 S e v er e E D 8- 1 1 M o d er at e E D 1 2- 1 6 Mil d t o M o d er at e E D 1 7- 2 1 Mil d E D  
 

A C C P 0 0 1. 4 
_ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _
5 7 
 
U TI LI Z A TI O N O F S E X U A L M E DI C A TI O N S/ D E VI C E S 
 
T hi s q u e sti o n n air e i s d e si g n e d t o a s s e s s t h e u s e of er e ctil e ai d s a m o n g p ati e nt s tr e at e d 
f or pr o st at e c a n c er. T o h el p u s g et t h e m o st a c c ur at e m e a s ur e m e nt, pl e a s e a n s w er all 
q u e sti o n s h o n e stl y a n d c o m pl et el y. Y o u m a y r ef u s e t o a n s w er a n y q u e sti o n s f or a n y 
r e a s o n. All i nf or m ati o n c o nt ai n e d wit hi n t hi s s ur v e y will r e m ai n stri ctl y c o nfi d e nti al. 
T h a n k y o u f or p arti ci p ati n g a n d f or h el pi n g u s i m pr o v e t h e q u alit y of c ar e f or pr o st at e 
c a n c er p ati e nt s. 
 
T O D A Y’ S D A T E ( pl e a s e e nt er d at a w h e n s ur v e y c o m pl et e d) M o nt h _ _ _ _ _ _ _ _  D a y _ _ _ _ _ _ _ _ _ Y e ar _ _ _ _ _ _ _ _ _ _ 
 
T h e f oll o wi n g q u e sti o n s r el at e t o a n y tr e at m e nt s y o u m a y h a v e r e c ei v e d t o a s si st wit h y o ur er e cti o n s. 
1 D O Y O U H A V E A P E NI L E P R O S T H E SI S ? 
  1 N o 
  2 Y e s ( S ki p Q u e sti o n s 2- 4) 
2 H A V E Y O U U S E D A N Y M E DI C A TI O N S O R D E VI C E S T O AI D O R I M P R O V E E R E C TI O N S ? 
  1 N o ( S ki p Q u e sti o n 3, a n s w er Q u e sti o n 4) 
  2 Y e s 
3 F O R E A C H O F T H E F O L L O WI N G M E DI CI N E S O R D E VI C E S, P L E A S E I N DI C A T E W H E T H E R O R N O T Y O U H A V E T RI E D 
I T O R C U R R E N T L Y U S E I T T O I M P R O V E Y O U R E R E C TI O N S ( B Y CI R C LI N G Y O U R R E S P O N S E): 
  A VI A G R A O R O T H E R PI L L ( N A M E PI L L I F N O T VI A G R A): _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ 
     1 H a v e N O T tri e d it 
     2 Tri e d it, b ut w a s N O T H E L P F U L 
     3 It H E L P E D, b ut I a m N O T u si n g it N O W 
     4 It H E L P E D, a n d I u s e it S O M E TI M E S 
     5 It H E L P E D, a n d I u s e it A L W A Y S 
  B M U S E (I N T R A- U R E T H R A L A L P R O S T A DI L S U P P O SI T O R Y) 
     1 H a v e N O T tri e d it 
     2 Tri e d it, b ut w a s N O T H E L P F U L 
     3 It H E L P E D, b ut I a m N O T u si n g it N O W 
     4 It H E L P E D, a n d I u s e it S O M E TI M E S 
     5 It H E L P E D, a n d I u s e it A L W A Y S 
  C P E NI L E I N J E C TI O N T H E R A P Y ( S U C H A S C A V E R J E C T) 
     1 H a v e N O T tri e d it 
     2 Tri e d it, b ut w a s N O T H E L P F U L 
     3 It H E L P E D, b ut I a m N O T u si n g it N O W 
     4 It H E L P E D, a n d I u s e it S O M E TI M E S 
     5 It H E L P E D, a n d I u s e it A L W A Y S 
  D V A C U U M E R E C TI O N D E VI C E ( S U C H A S E R E C T- AI D) 
     1 H a v e N O T tri e d it 
     2 Tri e d it, b ut w a s N O T H E L P F U L 
     3 It H E L P E D, b ut I a m N O T u si n g it N O W 
     4 It H E L P E D, a n d I u s e it S O M E TI M E S 
     5 It H E L P E D, a n d I u s e it A L W A Y S 
  E O T H E R ( N A M E M E DI C A TI O N/ D E VI C E I F N O T LI S T E D) _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ 
     1 H a v e N O T tri e d it 
     2 Tri e d it, b ut w a s N O T H E L P F U L 
     3 It H E L P E D, b ut I a m N O T u si n g it N O W 
     4 It H E L P E D, a n d I u s e it S O M E TI M E S 
     5 It H E L P E D, a n d I u s e it A L W A Y S 
4 H O W W O U L D Y O U D E S C RI B E T H E U S U A L Q U A LI T Y O F Y O U R E R E C TI O N S WI T H O U T T H E A S SI S T A N C E O F 
M E DI CI N E S O R D E VI C E S D U RI N G T H E L A S T 4 W E E K S ? 
     1 N o n e at all 
     2 N ot fir m e n o u g h f or a n y s e x u al a cti vit y 
     3 Fir m e n o u g h f or m a st ur b ati o n a n d f or e pl a y o nl y 
     4 Fir m e n o u g h f or i nt er c o ur s e 
 
P ati e nt' s si g n at ur e _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _  
(U tili z ati o n of S e x u al M e di c ati o n s/ D e vi c e s, c o urt e s y of M S a n d a, D Mill er, a n d J W ei) 

A C C P 0 0 1. 4 
_ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _
5 7 
 
                                                 
1 7    R E F E R E N C E S 
 
1 J e mal A, M urra y T, Sie gel R et al. Ca ncer Statistics, 2 0 0 7.  C A Ca ncer J Cli n.  2 0 0 5; 5 7( 1): 4 3- 6 6. 
 
2 Pa q uette E L, S u n L, Pa q uette L R, et al: I m pr o ve d pr ostate ca n cer-s pecific s ur vi val a n d ot her disease 
par a meters: I m pact of pr ostate s pecific a nti ge n testi n g. Ur ol o g y 6 0: 7 5 6- 7 5 9, 2 0 0 2 
 
3 Mi d dlet o n R G, T h o m ps o n I M, A ust e nfiel d M S, et al. Pr ostate ca n cer cli nical g ui d eli nes pa nel s u m mar y 
rep ort o n t he ma n a ge me nt of cli nicall y l ocalize d pr ostate ca n cer. J Ur ol. 1 9 9 5; 1 5 4: 2 1 4 4- 2 1 4 8.  
 
4 1 4. Mi d dlet o n R G, T h o m ps o n I M, A uste nfel d M S, et al: Pr ostate ca ncer cli nical g ui deli nes pa n el 
s u mmar y re p ort o n t he m a na ge me nt of cli nicall y l ocalize d pr ostate ca n cer. J Ur ol 1 5 4: 2 1 4 4- 2 1 4 8, 1 9 9 5. 
 
5 Mela nc o n A., d e Cre v oisier R, K u ba n D, Lee A, C he u n g R, Z ha n g L, O’ D a niel J, M o ha n R., C o x J., 
D o n g L. A nal ysis of I ntr a- Fracti o nal V ariati o ns of A nat o m y D uri n g Pr ostate I M R T Treat me nt. IJ R O B P 
6 3( S 1): S 5 6 2. 
 
6 Blas k o , J., Gri m m, P., S yl vester J., Ba di oza ma ni, K., H oa k, D., Ca v a ha g h, W. Palla di u m- 1 0 3 
bra c h yt hera p y f or pr ostat e car ci n o ma. I nter nati o nal J o ur nal of Ra diati o n O nc ol o g y, Bi ol o g y, P h ysics 
2 0 0 0. 4 6( 4): p 8 3 9- 8 5 0. 
 
7 Gri m m, P. D., Blas k o, J. C., S yl v ester, J. E., Meier, R. M. Ca va na g h, W.: 1 0- year bi o c he mical ( pr ostate-
s pecific a nti ge n) c o ntr ol of pr ostate ca ncer wit h ( 1 2 5)I brac h yt h er a p y. I nt J Ra diat O nc ol Bi ol P h ys, 5 1: 
3 1, 2 0 0 1 
 
8 St o ne N N, St oc k R G, U n ger P. I nter me diat e ter m bi oc he mical-free pr o gressi o n a n d l ocal c o ntr ol 
f oll o wi n g 1 2 5I brac h yt hera p y f or pr ostate ca ncer. J Ur ol o g y 1 7 3: 8 0 3- 8 0 7 
 
9 P otters L. M or ge nster n C. Cal u gar u E. Fear n P. J assal A. Presser J. M ulle n E. 1 2- year o utc o mes 
f oll o wi n g per ma ne nt pr ostate brac h yt h era p y i n patie nts wit h cli nicall y l ocalize d pr ostate ca ncer.  J o ur nal 
of Ur ol o g y. 1 7 3( 5): 1 5 6 2- 6, 2 0 0 5  
 
1 0 I m pact of s u p ple me ntal e xter nal bea m ra di ot hera p y a n d/ or a n dr o ge n de pri vati o n t hera p y o n 
bi o c he mical o utc o me aft er per m a ne nt pr ostate brac h yt h era p y. M erric k G S, B utler W M, W all ner K E, 
Gal breat h R W, Li ef J H, Alle n Z, A da m o vic h E. I nter nati o nal J o ur nal of Ra diati o n O nc ol o g y, Bi ol o g y, 
P h ysics - J a n uar y 2 0 0 5 ( V ol. 6 1, Iss u e 1, Pa ges 3 2- 4 3) 
 
1 1 B or g he d e, G., H e deli n, H., H ol mä n g, S., et al., Irra diati o n of l ocalize d pr ostatic car ci n o ma wit h 
ac om bi nati o n of hi g h d os e rate iri di u m- 1 9 2 br ac h yt hera p y a n d e xter nal bea m ra di ot hera p y wit h t hree 
tar get defi niti o ns a n d d os e le vels i nsi de t he pr ostat e gl a n d. Ra di ot hera p y a n d O nc ol o g y, 1 9 9 7. 4 4( 3): 
p. 2 4 5- 5 0. 
 
1 2 Di n ges, S., D e ger, S., K os wi g, S., et al., Hi g h- d ose rate i nterstitial wit h e xter nal bea m irra diati o n f or 
l ocalize d pr ostate ca n cer--res ults of a pr os p ecti ve trial. Ra di ot hera p y a n d O nc ol o g y, 1 9 9 8. 4 8( 2): p. 1 9 7-
2 0 2. 
 

A C C P 0 0 1. 4 
_ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _
5 7 
 
                                                                                                                                                                            
1 3 Marti nez, A., G o nzalez, J., Str o m ber g, J., et al., C o nf or mal pr ostate br ac h yt hera p y: i nitial e x perie nce of 
a p hase I/II d ose- escal ati n g trial. I nt er nati o nal J o ur nal of Ra diati o n O nc ol o g y, Bi ol o g y, P h ysics, 1 9 9 5. 
3 3( 5): p. 1 0 1 9- 2 7. 
 
1 4 Marti nez, A. A., Kesti n, L. L., Str o m ber g, J. S., et al., I nt eri m re p ort of i ma ge- g ui de d c o nf or mal hi g h-
d o se rate br ac h yt hera p y f or patie nts wit h u nfa v or a ble pr ostate ca ncer: T he Willia m Bea u m o nt P hase II 
d ose escal ati n g trial. I nter nati o nal J o ur nal of Ra diati o n O nc ol o g y Bi ol o g y P h ysics, 2 0 0 0. 4 7( 2): p. 3 4 3-
3 5 2. 
 
1 5 Marti nez, A. A., Pata ki, I., E d m u n ds o n, G., et al., P hase II pr os p ecti ve st u d y of t he us e of c o nf or mal 
hi g h d ose-rate brac h yt h er a p y as m o n ot hera p y f or t he treat me nt of fa v or a ble sta ge pr ostate ca ncer: A 
feasi bilit y r e p ort. I nter nati o nal J o ur nal of Ra diati o n O nc ol o g y Bi ol o g y P h ysics, 2 0 0 1. 4 9( 1): p. 6 1- 6 9. 
 
1 6 Mate, T. P., G ottes ma n, J. E., Hatt o n, J., et al., Hi g h d ose-rate afterl oa di n g 1 9 2Iri di u m pr ostate 
br ac h yt hera p y: feasi bilit y r e p ort. I nter nati o nal J o ur nal of Ra diati o n O nc ol o g y, Bi ol o g y, P h ysics, 
1 9 9 8. 4 1( 3): p. 5 2 5- 3 3. 
 
1 7 Di n ges, S., L oe ni n g, S. A., a n d B u d ac h, V., [ C o m bi ne d iri di u m 1 9 2 afterl oa di n g t her a p y of pr ost ate 
carci n o ma]. Sc h weizeris c he R u n dsc ha u f ur Me di zi n Pra xis, 1 9 9 7. 8 6( 4 8): p. 1 9 0 8- 1 1. 
 
1 8 Kesti n, L. L., M arti nez, A. A., Str o m ber g, J. S., et al., Matc he d- p air a n al ysis of c o nf or mal hi g h- d os e-rate 
bra c h yt hera p y b o ost vers us e xter nal- bea m r a diati o n t hera p y al o ne f or l ocall y a d v a nce d pr ostate ca ncer. 
J o ur nal of Cli nical O nc ol o g y, 2 0 0 0. 1 8( 1 5): p. 2 8 6 9- 2 8 8 0. 
 
1 9 K o vács, G., G alalae, R., L oc h, T., et al., Pr ostate preser v ati o n b y c o m bi ne d e xter nal bea m a n d H D R 
bra c h yt hera p y i n n o dal n e gati ve pr ostate ca ncer. Stra hle nt her a pie u n d O n k ol o gie, 1 9 9 9. 1 7 5 S u p pl 2( 1 1): 
p. 8 7- 8. 
 
2 0 K o vacs, G., Wirt h, B., Berter ma n n, H., et al., Pr ostate Preser v ati o n b y C o m bi ne d E xter nal Bea m a n d 
H D R  Br ac h yt her a p y at N o dal Ne gati ve Pr ostate C a ncer Patie nts - A n I nter me diate A nal ysis After T e n 
Years E x perie n ce. I nt. J. Ra diati o n O nc ol o g y Bi ol. P h ys., 1 9 9 6. 3 6( 1 S u p ple): p. 1 9 8. 
 
2 1 Str o m ber g, J. S., Marti nez, A. A., H or witz, E. M., et al., C o nf or mal hi g h d os e rate iri di u m- 1 9 2 b o ost 
bra c h yt hera p y i n l ocall y a d va nce d pr ostate ca ncer: s u peri or pr ostate-s p ecifi c a nti ge n res p o ns e c o m p are d 
wit h e xter nal bea m treat me nt [see c o m me nts]. Ca ncer J o ur nal fr o m Scie ntific A merica n, 1 9 9 7. 3( 6): p. 
3 4 6- 5 2. 
 
2 2 Galalae, R. M., K o v acs, G., Sc h ultze, J., et al., L o n g-ter m o utc o me after electi ve irr a diati o n of t he p el vic 
l y mp hatics a n d l ocal d os e escal ati o n usi n g hi g h- d ose-rate brac h yt h era p y f or l ocall y a d va n ce d pr ostate 
ca ncer. I nter nati o nal J o ur nal of Ra diati o n O nc ol o g y, Bi ol o g y, P h ysics, 2 0 0 2. 5 2: p. 8 1- 9 0. 
 
2 3 Str o m ber g, J., Marti nez, A., G o nzalez, J., et al., Ultras o u n d- g ui de d hi g h d ose rate c o nf or mal 
bra c h yt hera p y b o ost i n pr ostate ca n cer: tr eat me nt descri pti o n a n d preli mi nar y res ults of a p h ase I/II 
cli nical trial. I nter n ati o nal J o ur nal of Ra diati o n O nc ol o g y, Bi ol o g y, P h ysics, 1 9 9 5. 3 3( 1): p. 1 6 1- 7 1. 
 

A C C P 0 0 1. 4 
_ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _
5 7 
 
                                                                                                                                                                            
2 4 Marti nez A A, Pata ki I, E d m u n ds o n G, Se bastia n E, Bra b bi ns D, G ustafs o n G. P hase II r etr os pecti ve 
st ud y of t he us e of c o nf or mal hi g h- d os e-r ate br ac h yt her a p y as m o n ot her a p y f or t he treat me nt of fa v ora ble 
sta ge pr ostate ca ncer: a f easi bilit y re p ort. I nt J Ra diat O nc ol Bi ol P h ys 2 0 0 1 J a n 1; 4 9( 1): 6 1 
 
2 5 Grills I S, Marti nez A A, H olla n der M, H ua n g R, G ol d ma n K, C he n P Y, G ustafs o n G S. Hi g h d os e r ate 
br ac h yt hera p y as pr ostate ca ncer m o n ot her a p y re d uces t o xicit y c o m par e d t o l o w d ose rate p alla di u m 
see ds. J Ur ol 2 0 0 4 Mar; 1 7 1( 3): 1 0 9 8- 1 0 4. 
 
2 6 Marti n T, Baltas D, K ur e k R, R o d di ger S, K o nt o va M, A na g n ost o p o ul os G, Da n ne n b er g T, B u hlei er T, 
S h azi kis G, T u n n U, Za m b o gl u N. 3- D c o nf or m al H D R brac h yt hera p y as m o n ot hera p y f or l ocalize d 
pr ostate ca n cer: a pil ot st u d y. Stra hle nt her O n k ol 2 0 0 4 A pr; 1 8 0( 4): 2 2 5- 3 2. 
 
2 7 G hileza n M, Var gas C, G ustafs o n G, B oi k e T, C ha o K, Kesti n L, Grills I, Se bastia n E, Marti nez A. 
Si m ilar 5- year Cli nical O utc o me f or Hi g h D os e Rate ( H D R) a n d L o w D os e Rate ( L D R) Br ac h yt her a p y 
( B T) f or Earl y Pr ostate Ca ncer Patie nts. I nt er nati o nal J o ur nal of Ra diati o n O nc ol o g y, Bi ol o g y, P h ysics - 1 
Oct o ber 2 0 0 5 ( V ol. 6 3, Iss ue ( S u p ple me nt 1), Pa ge S 3 7) 
 
2 8 I nterstitial Hi g h D os e Rate ( H D R) Br ac h yt hera p y f or Earl y Sta ge Pr ostat e Ca ncer. Mar k R, 
Val la b ha n G, A ki ns R, A n ders o n P, Nair M, Ne u ma n n T, W hite D, G urle y S. I nter n ati o nal J o ur nal of 
Ra diati o n O nc ol o g y, Bi ol o g y, P h ysi cs - 1 Oct o b er 2 0 0 5 ( V ol. 6 3, Iss ue ( S u p ple me nt 1), Pa ge S 3 0 4) 
 
2 9 Hi g h D os e Rate M o n ot h era p y f or Pr ostate Ca ncer. Sc h o ur L, De ma n es DJ, Altieri G A, Bra n dt D, 
Bar n a ba M, S k o olisari ya p or n P. I nter nati o nal J o ur nal of Ra diati o n O nc ol o g y, Bi ol o g y, P h ysics - 1 
Oct o ber 2 0 0 5 ( V ol. 6 3, Iss ue ( S u p ple me nt 1), Pa ge S 3 1 5) 
 
3 0 G hileza n M, Var gas C, G ustafs o n G, B oi k e T, C ha o K, Kesti n L, Grills I, Se bastia n E, Marti nez A. 
Si m ilar 5- year Cli nical O utc o me f or Hi g h D os e Rate ( H D R) a n d L o w D os e Rate ( L D R) Br ac h yt her a p y 
( B T) f or Earl y Pr ostate Ca ncer Patie nts. I nt er nati o nal J o ur nal of Ra diati o n O nc ol o g y, Bi ol o g y, P h ysics - 1 
Oct o ber 2 0 0 5 ( V ol. 6 3, Iss ue ( S u p ple me nt 1), Pa ge S 3 7) 
 
3 1 Grills I S, Marti nez A A, H olla n der M, H ua n g R, G ol d ma n K, C he n P Y, G ustafs o n G S. Hi g h d os e r ate 
bra c h yt hera p y as pr ostate ca ncer m o n ot her a p y re d uces t o xicit y c o m par e d t o l o w d ose rate p alla di u m 
see ds. J Ur ol 2 0 0 4 Mar; 1 7 1( 3): 1 0 9 8- 1 0 4. 
 
3 2 A Q ualit y of Life ( Q O L) Assess me nt of Pr ostate Ca ncer Patie nts U n der g oi n g Diff ere nt Ra di ati o n 
Trea t me nt m o dalities. Sa p ut o K, Isler K, W allace M, Balas u br a ma nia m M, Marti nez A. I nter nati o nal 
J o ur nal of Ra diati o n O nc ol o g y, Bi ol o g y, P h ysics - 1 Oct o ber 2 0 0 5 ( V ol. 6 3, Iss u e ( S u p ple me nt 1), P a ge 
S 4 4 6) 
 
3 3 Galalae R M, Marti nez A, Mate T, Mitc hell C, E d m u n ds o n G, N uer n ber g N, E ula u S, G ustafs o n G, 
Gri b ble M, K o vacs G. L o n g-ter m o utc o me b y ris k fact ors usi n g c o nf or mal hi g h- d ose-rate brac h yt h era p y 
( H D R- B T) b o ost wit h or wit h o ut ne oa dj u va nt a n dr o ge n s u p pressi o n f or l ocalize d pr ostate ca ncer. 
I nter nati o nal J o ur nal of Ra diati o n O nc ol o g y, Bi ol o g y, P h ysi cs. 2 0 0 5 5 8( 4) 1 0 4 8- 1 0 5 5. 
 

A C C P 0 0 1. 4 
_ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _
5 7 
 
                                                                                                                                                                            
3 4 De ma nes DJ, R o dri g uez R R, Sc h o ur L, Bra n dt D, Altieri G. Hi g h- d ose-rat e i nte nsit y- m o d ulate d 
bra c h yt hera p y wit h e xter nal bea m ra di ot hera p y f or pr ostate ca ncer: Calif or nia E n d oc urit her a p y’s 1 0- year 
res ults. I nt er nati o nal J o ur nal of Ra diati o n O nc ol o g y, Bi ol o g y, P h ysics.  2 0 0 5 6 1( 5) 1 3 0 6- 1 3 1 6. 
 
3 5 Hi g h D os e Rate M o n ot h era p y f or Pr ostate Ca ncer. Sc h o ur L, De ma n es DJ, Altieri G A, Bra n dt D, 
Ba rn a ba M, S k o olisari ya p or n P. I nter nati o nal J o ur nal of Ra diati o n O nc ol o g y, Bi ol o g y, P h ysics - 1 
Oct o ber 2 0 0 5 ( V ol. 6 3, Iss ue ( S u p ple me nt 1), Pa ge S 3 1 5) 
 
3 6 G hileza n M, Var gas C, G ustafs o n G, B oi k e T, C ha o K, Kesti n L, Grills I, Se bastia n E, Marti nez A. 
Si m ilar 5- year Cli nical O utc o me f or Hi g h D os e Rate ( H D R) a n d L o w D os e Rate ( L D R) Br ac h yt her a p y 
( B T) f or Earl y Pr ostate Ca ncer Patie nts. I nt er nati o nal J o ur nal of Ra diati o n O nc ol o g y, Bi ol o g y, P h ysics - 1 
Oct o ber 2 0 0 5 ( V ol. 6 3, Iss ue ( S u p ple me nt 1), Pa ge S 3 7) 
 
3 7 La wt o n C A, De Sil via M, Lee R W, G o melia L, Gri g n o n D, Gilli n M, M ort o n G, Pisa ns k y T, Sa n dler H. 
Res ults of a p hase II trial of tra nsrectal ultras o u n d- g ui de d p er ma n e nt ra di o acti ve i n m pla ntati o n of t he 
pr ostate f or d efi niti ve ma na ge me nt of l ocalize d a de n ocar ci n o ma of t he pr ostate ( R T O G 9 8- 0 5). 
I nter nati o nal J o ur nal of Ra diati o n O nc ol o g y, Bi ol o g y, P h ysi cs. 2 0 0 7 6 7( 1) 3 9- 4 7. 
 
3 8 Zel efs k y MJ, K u ba n D A et al. M ulti-i nstit uti o nal a nal ysis of l o n g-ter m o ut c o me f or sta ges T 1- T 2 
pr o state ca n cer treate d wit h per ma ne nt see d i m pla ntati o n. I nter nati o nal J o ur nal of Ra diati o n O nc ol o g y, 
Bi ol o g y, P h ysics.  2 0 0 7 6 7( 2) 3 2 7- 3 3 3. 
 
3 9 K u pelia n P A, T ha k kar, V V, K h u ntia D, Re d d y C, Klei n E, Ma ha de v a n A. H y p ofracti o ne d i nte nsite-
m o d ulate d ra di ot her a p y ( 7 0 G y at 2. 5 G y per fracti o n) f or l ocalize d pr ostate ca ncer: l o n g-ter m o utc o mes. 
I nter nati o nal J o ur nal of Ra diati o n O nc ol o g y, Bi ol o g y, P h ysi cs. 2 0 0 5 6 3( 5) 1 4 6 3- 6 8 
 
4 0 Zel efs k y MJ, C ha n H et al. L o n g-ter m o utc o me of hi g h d ose i nte nsit y m o d ulate d ra diati o n t her a p y f or 
pa tie nts wit h cli nicall y l o calize d pr ostate ca n cer. J Ur ol, 1 7 6, 1 4 1 5- 1 4 1 9, 2 0 0 6. 
 
4 1 K u pelia n P, K u ba n D et al. I m pr o ve d bi oc h e mical rela pse-free s ur vi val wit h i ncrease d e xter nal 
ra diati o n d oses i n patie nts wit h l ocalize d pr ostate ca ncer: t he c o m bi ne d e x perie nce of ni ne i nstit uti o ns i n 
patie nts treate d i n 1 9 9 4 a n d 1 9 9 5.  I nt. J Ra diati o n O nc ol o g y Bi ol P h ys., 6 1( 2), 4 1 5- 4 1 9, 2 0 0 5. 
 
4 2 T ha mes H D, K u b a n D A et al. I ncr easi n g E xter nal Bea m D ose f or T 1- T 2 Pr ostate Ca ncer: Eff ect o n 
Ris k Gr o u ps. IJ R O B P 6 5( 4): 9 7 5- 9 8 1, 2 0 0 6. 
 
4 3 C he u n g R, T uc k er S L et al. D ose- Res p o nse C har acteristics of L o w- a n d I nter me diate- Ris k Pr ostat e 
Ca n cer Treat e d wit h E xter nal Bea m Ra di ot hera p y. IJ R O B P 6 1( 4): 9 9 3- 1 0 0 2, 2 0 0 5. 
 
4 4 Ziet ma n A L, De Sel vi o M L et al. C o m paris o n of C o n ve nti o nal- D ose vs Hi g h- D ose C o nf or ma Ra di ati o n 
T her a p y i n Cli nicall y L o calize d A de n ocarci n o ma of t he Pr ostate. J A M A 2 9 4( 1 0), 1 2 3 3- 1 2 3 9, 2 0 0 5. 
 
4 5 H ull, G. W., Ra b ba ni, F., A b bas, F., W heel er, T. M., Katta n, M. W. a n d Scar di n o, P. T.: Ca ncer c o ntr ol 
wit h ra dical pr ostatect o m y al o n e i n 1, 0 0 0 c o nsec uti ve patie nts. J Ur ol, 1 6 7: 5 2 8, 2 0 0 2 
 
4 6 K u pelia n P A, P otters L, K h u ntia D, Ciez ki J P, Re d d y C A, Re ut her A M, Carls o n T P, Klei n E A. Ra dical 
pr o statect o m y, e xter nal b ea m ra di ot hera p y < 7 2 G y, e xter nal bea m ra di ot hera p y ≥7 2 G y, per ma ne nt see d 

A C C P 0 0 1. 4 
_ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _
5 7 
 
                                                                                                                                                                            
i m pla ntati o n, or c o m bi ne d see ds/e xter nal bea m r a di ot hera p y f or sta ge T 1 – T 2 pr ostate ca n cer. IJ R O B P 
5 8( 1): 2 5- 3 3, 2 0 0 4. 
 
4 7 D’ A mic o A V, W hitti n gt o n R, Mal k o wicz S B, et al: Bi oc he mical o utc o me after r a dical pr ostatect o m y, 
e xter nal bea m ra diati o n t hera p y, or i nterstitial ra diati o n t hera p y f or cli nicall y l ocalize d pr ostate ca n cer. 
J A M A 2 8 0: 9 6 9- 9 7 4, 1 9 9 8. 
 
4 8 Ha n M, Parti n A, Za h ur a k M, Pia nta d osi S, E pstei n J, W als h P. Bi oc he mical ( pr ostate s p ecific a nti ge n) 
recurre nce pr o b a bilit y f oll o wi n g ra dical pr ostatect o m y f or cli nicall y l ocalize d pr ostate ca ncer. J o ur nal of 
Ur ol o g y 1 6 9: 5 1 7- 5 2 3 
 
4 9 Bre n n er, D. a n d Hall, E., Fracti o nati o n a n d pr otracti o n f or ra di ot hera p y of pr ostate carci n o ma. 
I nter nati o nal J o ur nal of Ra diati o n O nc ol o g y Bi ol o g y P h ysics, 1 9 9 9. 4 3( 5): p. 1 0 9 5- 1 1 0 1. 
 
5 0 Ki n g, C. R. a n d F o wler, J. F., A si m ple a nal ytic deri vati o n s u g gests t hat pr ostate ca ncer al p ha/ beta r ati o 
is lo w. [ C o m me nt I n: I nt J Ra diat O nc ol Bi ol P h ys. 2 0 0 1 Se p 1; 5 1( 1): 1- 3 UI: 2 1 4 0 7 9 4 0]. I nter n ati o nal 
J o ur nal of Ra diati o n O nc ol o g y, Bi ol o g y, P h ysics, 2 0 0 1. 5 1( 1): p. 2 1 3- 4 
 
5 1 F o wler, J., C ha p pell, R., a n d Ritter, M., Is al p ha/ beta f or pr ost ate t u m ors r eall y l o w? I nter nati o nal 
J o ur nal of Ra diati o n O nc ol o g y, Bi ol o g y, P h ysics, 2 0 0 1. 5 0( 4): p. 1 0 2 1- 3 1. 
 
5 2 Bre n n er, D., M arti nez, A. A., E d m u n ds o n, G., et al., Direct e vi d e nce t h at pr ostate t u m ors s h o w hi g h 
se nsiti vit y t o fracti o nati o n (l o w a/ b rati o), si milar t o late-res p o n di n g n or mal tiss ue. I nter n ati o nal J o ur nal 
of Ra diati o n O nc ol o g y, Bi ol o g y, P h ysics, 2 0 0 2. 5 2( 1): p. 6- 1 3. 
 
5 3 F o wler J F, Ritter M A, C ha p pell RJ, Bre n ner DJ W hat h y p ofr acti o nate d pr ot oc ols s h o ul d be teste d or 
pr o state ca n cer? I nt. J. Ra diati o n O nc ol o g y Bi ol. P h ys., V ol. 5 6, N o. 4, p p. 1 0 9 3 – 1 1 0 
 
5 4 Kal H B, Va n G elle k o m M P R. I nt. J. Ra diati o n O nc ol o g y Bi ol. P h ys., V ol. 5 7, N o. 4, p p. 1 1 1 6 – 1 1 2 1, 
( 2 00 3)  
 
5 5 Willia ms S G, Ta yl or J M G et al. Esti mati o n of t he a/ b Rati o of Pr ostate Ca ncer Usi n g a M ulti vari ate 
A na l ysis of t h e I n di vi d ual Fracti o n Size Data of 3 7 5 6 Patie nts. I nt J Ra diat O nc ol Bi ol P h ys. 6 6( 3) S 1 0. 
 
5 6 Lee, W. R., Ha n ks, G. E., C or n, B. W., et al. O bs er vati o ns of Pretr eat me nt Pr ostate-s pecific A nti ge n 
D o u bli n g Ti me i n 1 0 7 Patie nts Referre d f or D efi niti ve Ra di ot hera p y. I nt. J. Ra diat. O nc ol. Bi ol. P h ys. 3 1, 
2 1- 2 4 ( 1 9 9 5). 
 
5 7 Ha uster ma ns, K. M. G., H ofla n d, I., V a n P o p pel, H., et al. Cell Ki netic Meas ure me nts i n Pr ostate 
Ca n cer. I nt. J. Ra diat. O nc ol. Bi ol. 
P h ys. 3 7, 1 0 6 7- 1 0 7 0 ( 1 9 9 7). 
 
5 8 D' S o uza, W. D. a n d T ha mes, H. D., Is t he al p h a/ beta rati o f or pr ostate ca ncer l o w? [ C o m me nt O n: I nt J 
Ra d iat O nc ol Bi ol P h ys. 2 0 0 1 Se p 1; 5 1( 1): 2 1 3- 4 UI: 2 1 4 0 7 9 6 8]. I nter n ati o nal J o ur nal of Ra diati o n 
O nc ol o g y, Bi ol o g y, P h ysics, 2 0 0 1. 5 1( 1): p. 1- 3. 
 

A C C P 0 0 1. 4 
_ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _
5 7 
 
                                                                                                                                                                            
5 9 D uc hes ne, G. M. a n d Pet ers, L.J., W hat is t he al p ha/ beta rati o f or pr ostate ca ncer? Rati o nale f or 
h y p ofracti o nat e d hi g h- d ose-rate brac h yt h era p y [ e dit orial]. I nt er nati o nal J o ur nal of Ra diati o n O nc ol o g y, 
Bi ol o g y, P h ysics, 1 9 9 9. 4 4( 4): p. 7 4 7- 8. 
 
6 0 F o wler, J. F., C ha p pell, R.J., a n d Ritter, M. A., T he pr os pects f or ne w tr eat me nts f or pr ostate ca ncer. 
I nter nati o nal J o ur nal of Ra diati o n O nc ol o g y, Bi ol o g y, P h ysi cs, 2 0 0 2. 5 2: p. 3- 5 
 
6 1 Ki n g C R, Le h ma n n J, A dler J R, Hai J.  C y b er K nife ra di ot hera p y f or l ocali ze d pr ostate ca n cer: 
Ra ti o nale a n d tec h nical f easii bilt y.   Tec h Ca n Res Treat:  2 0 0 3; 2: 2 5- 2 9. 
 
6 2 Hara W, Patel T, Pa wlic ki C, C ortr uz C, Presti J, Ki n g C. H y p ofracti o nate d Stere otactic Ra di ot her a p y 
f or Pr ostate Ca ncer: Earl y Res ults. I nt J Ra d O nc ol Bi ol P h ys. 6 3( 3), S 3 2 4. 
 
6 3 Frie dla n d J. Re p orte d at t he C y ber k nife Us ers’ M eeti n g, M arc h 8, 2 0 0 6, C hica g o, I L 
 
6 4 Kesti n L L, G ol dstei n N S, Vici ni F A et al, Tr eat me nt Of Pr ostate Ca ncer Wit h Ra di ot hera p y: S h o ul d 
T he E n tire Se mi nal Vesi cles Be I ncl u de d I n T he Cli nical Tar get V ol u me? I nt J Ra d O nc ol Bi ol P h ys 5 4 
( 3): 6 8 6- 6 9 7, 2 0 0 2 
 
6 5 C ha n g, S. D., Mai n, W., Marti n, D. P., Gi b bs, I. C., Heil br u n, M. P. : A n a nal ysis of t he acc urac y of t he 
C y b er K nife: a r o b otic fr a meless stere otactic ra di os ur gical s yste m. Ne ur os ur gery,  5 2( 1): 1 4 0- 6; disc ussi o n 
1 4 6- 7, 2 0 0 3. 
 
6 6 Da vis, Pisa n ks y, Wils o n et at. T he r a dial dista nce of e xtra- pr ostatic e xte nsi o n of pr ostate carci n o ma: 
i m plicati o ns f or pr ostate brac h yt hera p y. C a ncer  1 9 9 9; 8 5: 2 6 3 0- 2 6 3 7. 
 
6 7 H ua n g K. Re p orte d at t he 5t h A n n ual C y b er K nif e Users’ Meeti n g, J a n uar y 2 6 , 2 0 0 6. Carls ba d, C A 
 
6 8 R oac h M, Wi nter K, Mic hals ki J M, C o x J D, P ur d y J A, B osc h W, Li n X, S hi ple y W S. Pe nile b ul b d ose 
a nd  i m p ote nce after t hr ee- di me nsi o nal c o nf or mal r a di ot hera p y f or pr ostate ca ncer o n R T O G 9 4 0 6: 
Fi n di n gs fr o m a pr os p ecti ve, m ulti-i nstit uti o nal, p hase I/II d os e-es calati o n st u d y. I nter nati o nal J o ur nal of 
Ra diati o n O nc ol o g y, Bi ol o g y, P h ysi cs 6 0( 5): 1 3 5 1- 1 3 5 6. 
 
6 9 Marti nez A A, Pata ki I, E d m u n ds o n G, Se bastia n E, Bra b bi ns D, G ustafs o n G. P hase II r etr os pecti ve 
st ud y of t he us e of c o nf or mal hi g h- d os e-r ate br ac h yt her a p y as m o n ot her a p y f or t he treat me nt of fa v ora ble 
sta ge pr ostate ca ncer: a f easi bilit y re p ort. I nt J Ra diat O nc ol Bi ol P h ys 2 0 0 1 J a n 1; 4 9( 1): 6 1 
 
7 0 R ose n R C, Ca p pelleri J C, et al. De vel o p me nt a n d e val uati o n of a n a bri d ge d, 5-ite m versi o n of t he 
I nter nati o nal I n d e x of Erectile F u n cti o n (II E F- 5) as a dia g n ostic t o ol f or er ectile d ysf u ncti o n. I nt J I m p ot 
Res 1 9 9 9; 1 1: 3 1 9- 2 6. 
 
7 1T ha mes et al, I nt J Ra diat O nc ol Bi ol P h ys 5 7: 9 2 9, 2 0 0 3 
 
7 2 K u ba n D, T ha m es H, Le v y L et al. Fail ur e defi niti o n- de pe n de nt diff er e nces i n o utc o me f oll o wi n g 
ra diati o n f or l ocalize d pr ostate ca ncer: ca n o n size fit all? I nt J Ra d O nc ol Bi ol P h ys 6 1( 2): 4 0 9- 4 1 4. 
 

A C C P 0 0 1. 4 
_ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _
5 7 
 
                                                                                                                                                                            
7 3 K u ba n D, Le v y L, P otters L et al C o m paris o n of Bi oc he mical Fail ur e Defi niti o ns f or Per ma ne nt 
Pr o state Br ac h yt her a p y. I nt J Ra d O nc ol Bi ol P h ys. 1 Oct o ber 2 0 0 5 ( V ol. 6 3, Iss u e ( S u p ple me nt 1), Pa ge 
S 3 3) 
 
7 4 R oac h M, Ha n ks G, T h a mes H et al. Defi ni n g bi o c he mical f ail ure f oll o wi n g r a di ot hera p y wit h or 
wit h o ut h or m o nal t hera p y i n me n wit h cli nicall y l ocalize d pr ostate ca n cer: rec o m me n dati o ns of t he 
R T O G- A S T R O P h oe ni x c o nse ns us c o nf ere n ce. I nt J Ra d O nc ol Bi ol P h ys. 6 5( 4): 9 6 5- 9 7 4. 
  
7 5 La wt o n C et al, R T O G 9 8- 0 5: A P hase II Trial of Tra nsrectal Ultras o u n d G ui de d Per ma ne nt 
Ra d i oacti ve I m pla ntati o n of t he Pr ostate f or Defi niti ve Ma na ge me nt of L o calize d A de n ocar ci n o ma of t he 
Pr ostate; htt p:// w w w.rt o g. or g/ me m bers/ pr ot oc ols/ 9 8- 0 5/ 9 8- 0 5. p df , secti o n 1 3. 1 3. 2. 
 
7 6 Zel efs k y MJ, C ha n H et al. L o n g-ter m o utc o me of hi g h d ose i nte nsit y m o d ulate d ra diati o n t her a p y f or 
pat ie nts wit h cli nicall y l o calize d pr ostate ca n cer. J Ur ol, 1 7 6, 1 4 1 5- 1 4 1 9, 2 0 0 6. 
 
7 7 C he u n g R, T uc k er S L et al. D ose- Res p o nse C har acteristics of L o w- a n d I nter me diate- Ris k Pr ostat e 
Ca n cer Treat e d wit h E xter nal Bea m Ra di ot hera p y. IJ R O B P 6 1( 4): 9 9 3- 1 0 0 2, 2 0 0 5. 
 
7 8 D’ A mic o A V, W hitti n gt o n R, Mal k o wicz S B, et al: Bi oc he mical o utc o me after r a dical pr ostatect o m y, 
e xter nal bea m ra diati o n t hera p y, or i nterstitial ra diati o n t hera p y f or cli nicall y l ocalize d pr ostate ca n cer. 
J A M A 2 8 0: 9 6 9- 9 7 4, 1 9 9 8. 
 
7 9 Parti n A S u b o n g E et al. C o m bi nati o n of Pr ostate- S pecific A nti ge n, Cli nical Sta ge, a n d Gleas o n Sc ore 
t o Pre dict Pat h ol o gical Sta ge of L o calize d Pr ostate Ca ncer: A M ulti-i nstit uti o nal U p date. J A M A 1 9 9 7; 
2 7 7( 1 8): 1 4 4 5- 1 4 5 1 
 
8 0 A gresti, A.a n d C o ull, B. A p pr o xi mate is better t ha n ‘e x act’ f or i nter v al esti mati o n of bi n o mial 
pr o p orti o ns . T he A meric a n St atistici a n , 1 9 9 8. 5 2 ( 2): p. 1 1 9- 1 2 6. 
 
8 1 Barr y MJ, et al. ( 1 9 9 2). T he A merica n Ur ol o gical Ass ociati o n s y m pt o m i n de x f or be ni g n pr ostatic 
h y p er plasia. J o ur nal of Ur ol o g y, 1 4 8: 1 5 4 9 – 1 5 5 7