Prospective Evaluation of CyberKnife Stereotactic Radiosurgery for Low and Intermediate Risk Prostate Cancer: Emulating HDR Brachytherapy Dosimetry
Phase: NA
Conditions: Prostate Cancer, Prostatic Cancer, Prostatic Neoplasms, Prostate Neoplasms, Cancer of the Prostate
Sponsor: Accuray Incorporated

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PROSPECTIVE EVALUATION OF CYBERKNIFE STEREOTACTIC 
RADIOSURGERY FOR LOW AND INTERMEDIATE RISK PROSTATE 
CANCER: EMULATING HDR BRACHYTHERAPY DOSIMETRY 
PROTOCOL NUMBER: ACCP002.2
NCT00643617
STUDY CHAIRS 
Radiation Oncology Donald B. Fuller, MD 
Radiation Medical Group, Inc. 
2466 1st Ave. 
Physics/QA George Mardirossian Ph.D. 
□ 
□ 
San Diego, CA 92101 
(619) 230-0400
Urology 
John Naitoh, MD 
Coast Urology Medical Group, Inc. 
9850 Genesee Ave, Suite 440 
(858) 453-8914
Study Sponsor Accuray Incoiporated 
1310 Chesapeake Terrace 
Sunnyvale, CA 94089 
Telephone: (408) 716-4600 
FAX Number: (408) 716-4620 
Version Date: 
Western Cancer Center 
2466 1st Ave 
San Diego, CA 92101 
(619) 230-0400
November 30, 2012 
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_ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _
 
_ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _
5 2 
 
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: E M U L A TI N G H D R 
B R A C H Y T H E R A P Y D O SI M E T R Y 
 
 
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   
  
  
 
 
 

_ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _
 
_ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _
5 2 
 
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 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- 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  
 
 
 

_ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _
 
_ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _
5 2 
 
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  
  
  
  
  
  
 
 
 

_ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _
 
_ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _
5 2 
 
 
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: E M U L A TI N G H D R B R A C H Y T H E R A P Y D O SI M E T R Y 
 
 
S C H E M A 
 
  
 
 
 
  
Ris 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 8 G y              
A 2. Inter me di ate Risk : 
    
I   
& fi d ucial  
C T a n d  
( 9. 5 G y x 4) 
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 2a,      
R 
  
  
  
 
   
   Gleas o n = 7 & P S A  1 0, or  
   
 Gleas o n  6 & P S A > 1 0 &  2 0 
   
 
 
 
 
 
 
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 :  2 5 3 

_ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _
 
_ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _
5 2 
 
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 2a, 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 
 
 
_ _ _ _ _ _ _ ( 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)  
Is t here i m pla nte d har d w are near t he pl a n ni n g t ar get v ol u me 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 vesti 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? 
 
 
 
 
 

_ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _  
 
_ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _  
 
 
 
P a g e 7 of 5 2 
 
 
1.  B A C K G R O U N D 
1. 1.  D uri n g t he pr ostate-s pecific a nti ge n era, a n e ver-i ncr easi n g p erce nta ge of 
me n wit h pr ostatic 
a de n ocarci n o ma h a ve pr ese nte d wit h cli nicall y l ocalize d, i nter me diate Gleas o n gra d e, p ote ntiall y 
c ura ble disease.  C o n ve nti o nal treat me nt o pti o ns f or t hese patie nts i ncl u de la par osc o pi c or o pe n 
ra dical pr ostatect o m y, e xter nal bea m ra diati o n t hera p y, per m a ne nt s o urce i nterstitial brac h yt h era p y, 
a n d hi g h d ose r ate ( H D R) re m ote after l oa di n g br ac h yt her a p y, eit her as 
m o n ot hera p y, or i n 
c o m bi nati o n wit h e xter nal bea m ra di ot her a p y. 1 
 
1 . 2. Alt h o u g h eac h of t he treat me nt o pti o ns is p ote ntiall y c urati ve i n selecte d patie nts, eac h treat me nt 
o pti o n als o has dra w b ac ks. T he p ost- o p erati ve r ec o ver y peri o d ma y b e s u bsta ntial f oll o wi n g ra di cal 
pr ostatect o m y; t he peri o d of ur ol o gic s y m pt o ms ma y be pr otr acte d a n d occasi o nall y se v er e f oll o wi n g 
per ma ne nt s o ur ce br ac h yt her a p y; t he sc he d uli n g d urati o n is s u bsta ntial f or e xter nal bea m 
ra di ot hera p y a n d t he disc o mf ort of i n d w elli n g tra ns peri neal cat heters is si g nifi ca nt f or H D R 
brac h yt hera p y p atie nts.  A d diti o nall y, all l ocal treat me nts carr y a ris k of n e gati ve l o n g-ter m q u alit y of 
life c o nse q ue n ces, a n d o ccasi o nall y, s eri o us c o m plicati o ns. 
 
1. 3.  T he use of h y p ofracti o nate d C y ber K nife stere otactic t hera pe utic r a diati o n as a m o dalit y of tr eat me nt 
f or earl y-sta ge pr ostate ca ncer has als o bee n d escri be d.2 I n c o ntra disti ncti o n t o tra diti o nal e xter nal 
b ea m r a di ot hera p y, t his met h o d e ntails a t her a pe utic ra di ati o n pr ocess t hat uses a m ore pr ecise 
tar geti n g m et h o d ol o g y, all o wi n g a m or e f ocal treat me nt mar gi n ar o u n d t he pr ostate. T his m ore 
effecti vel y li mits t he v ol u me of a dj ace nt tiss ue recei vi n g hi g h d ose r a diati o n, w hic h i n t ur n all o ws t he 
deli ver y of a m u c h s h orter series of treat me nts, e m pl o yi n g a m uc h lar ger d ose of ra diati o n p er 
treat me nt. W he n s o a p plie d, t he ra diati o n bec o m es tiss ue a blati ve wit hi n t he hi g h d ose z o ne, a n d as 
s uc h, ma y be des cri be d as a f or m of r a di os ur ger y. 
 
1. 4.  Alt h o u g h ver y li mite d e x perie nce has bee n gai n e d t o date, t he ra di os ur gical a p pr oac h f or pr ostat e 
ca ncer carries wit h it a n u m ber of p ote ntial a d va nta ges, i ncl u di n g t he p ossi bilit y of l o wer m or bi dit y 
d ue t o t he ver y s mall tr eat me nt mar gi ns, m ore r a pi d rec o ver y fr o m si de effects d u e t o t he lac k of a 
s ur gical res ecti o n or i m pla nte d ra di oacti vit y, c o n ve nie nce of a o ne w ee k treat me nt c o urse, a n d lac k 
of tra ns peri n eal H D R cat heters wit h t heir atte n d a nt pai n a n d h os pital a d missi o n re q uire me nt. 
 
1. 5.  T he mai n tec h nical pr o ble m t hat pre ve nts t he a p plicati o n of ra di os ur ger y f or pr ostate ca ncer is t h at 
t he pr ostate m a y m o ve s u bsta ntiall y, b ot h bet w ee n fracti o ns (i nterfr acti o n m oti o n) a n d d uri n g t he 
treat me nt itself (i ntrafracti o n m oti o n), e ve n if ri gi d b o d y i m m o bilizati o n is a p plie d, d u e t o t he effect 
of or ga n m oti o n. 3, 4 T his pr ostate m oti o n effect necess aril y lea ds t o t he a p plicati o n of a l ar ger 
radi ot hera p y pla n ni n g tar get v ol u me t o c o m pe ns at e, effecti vel y re n d eri n g r a di os ur ger y i m p ossi ble b y 
tra diti o nal ra di ot hera p y or ra di os ur gical s yste ms. 
 
1. 6.  T he C y ber K nife  is a u ni q ue n o ni n vasi ve ra di os ur gical s yste m, ca p a ble of treati n g a n y part of t h e 
b o d y fr o m a n y of a p pr o xi matel y 1 6 0 0 diff ere nt t ar geti n g a n gl es, creati n g a hi g hl y c o nf or mal t hree-
di me nsi o nal ra di os ur gical treat me nt v ol u me, g ui d e d b y ort h o g o nal X-ra y- base d tar geti n g fee d bac k, 
a n d deli veri n g ra di ati o n b y a hi g hl y c olli mate d, r o b oticall y c o ntr olle d li near accelerat or. T he 
C y ber K nife  s yste m t ar gets i m pla nte d fi d ucial mar kers wit h s u b- milli meter i nitial set- u p acc urac y, 
a n d c o nti n u o usl y u p d ates t he pla n ni n g tar get v ol u me b y o btai ni n g m ulti ple i ntrafracti o nal ort h o g o n al 
X-ra y-i ma ges, pr o d uci n g a n a ut o mate d r o b otic a dj ust me nt after eac h X-ra y fee d bac k ste p, res ulti n g 
i n a real-ti me tar get v ol u me trac ki n g pr ocess t hat mai ntai ns milli meter acc urac y t hr o u g h o ut t h e 

_ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _  
 
_ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _  
 
 
 
P a g e 8 of 5 2 
 
 
radi os ur gical treat me nt. 5 T h us, t he 
C y ber K nife  d e vice all o ws a re pr o d uci ble 
met h o d of 
ra di os ur gical pr ostat e treat me nt.  
 
1. 7.  T here ar e als o ra di o bi ol o gical data t hat s u g gest h y p ofracti o nate d r a di os ur gical treat me nt ma y b e 
a d va nta ge o us f or pr ostat e ca n cer, as c o nte m p orar y d ata s u g gest t he α /β  r ati o f or pr ostate ca n cer tiss ue 
ma y  be as l o w as 1. 5 G y.6 T hese val ues of α /β  are c o m para bl e t o, if n ot l o wer, t ha n late-r es p o n di n g 
n or mal tiss ues. 6 T his mea ns t hat i n a d diti o n t o ca usi n g eff ecti ve ca n cer cell ular a blati o n a n d tiss ue 
s pari n g d u e t o of its p h ysics attri b utes, a c o urse of h y p ofr acti o nat e d C y ber K nife  pr ostate 
ra di os ur ger y ma y als o cr eate a fa v ora ble t her a pe utic rati o b y virt ue of t he r a di o bi ol o gic se nsiti vit y of 
pr ostate ca n cer itself t o h y p ofr acti o nati o n, effecti vel y res ulti n g i n ra di o bi ol o gic t u m or d ose 
escalati o n. 6, 7 
 
1 . 8. Fr o m a d osi metr y sta n d p oi nt, C y ber K nife ® r a di os ur ger y a p p ears ca p a ble of pr o d uci n g a d ose 
distri b uti o n c o m para ble t o t hat create d b y pr ostate H D R brac h yt her a p y treat me nt, wit h o ut t he 
i n vasi ve tra ns peri neal cat heters. As s uc h, t h e C y ber K nife pr ostate ra di os ur ger y d ose fracti o nati o n 
sc he d ule pr escri be d i n t his st u d y is b ase d u p o n pri or p u blis he d pr ostate H D R brac h yt her a p y 
m o n ot hera p y e x perie n ce, w hic h s u g gests efficac y a n d saf et y, wit h a me di a n f oll o w- u p d ur ati o n of 3 5 
m o nt hs. 8 T he ra di os ur ger y v ol u me i n t his st u d y 
will be 
ma de t o rese m ble pr ostate 
H D R 
br ac h yt hera p y t hera p e utic v ol u me as cl osel y as p ossi ble, wit h si milar d ose li mitati o n o bjecti ves t o 
a djace nt tiss ues, i ncl u di n g t he r ect u m, bla d der a n d uret hra. 
 
1. 9.   Beca use of t he narr o w treat me nt mar gi n, a n d s h ar p fall off of ra di ati o n d ose be y o n d t he treat me nt 
mar gi n, it is o nl y a p pr o priate t o i ncl u de p atie nts wit h a hi g h li keli h o o d of l ocalize d diseas e f or 
C y ber K nife ® m o n ot hera p y. T h ese patie nts are r eas o na bl y i de ntifie d b y e x a mi nati o n of t he Parti n 
Ta bles 9, w hic h pre di ct t he pr o ba bilit y of pat h ol o gic disease e xte nsi o n be y o n d t he pr ostate, a n d als o 
b y  e x a mi nati o n of t he l o n g ter m res ults of per ma ne nt s o urce br ac h yt her a p y liter at ure1 0, 1 1, as 
p er ma ne nt s o urce br ac h yt her a p y pr o d uces a t hera pe utic 
mar gi n of si milar 
ma g nit u de t o t he 
t hera pe utic mar gi n pr o vi de d b y C y b er K nif e treat me nt as descri be d i n t his pr ot oc ol. T he l o n g-ter m 
brac h yt hera p y literat ur e descri bes bi oc he mical disease free s ur vi val rates e x cee di n g 8 0 % f or 
fa v ora bl e pr o g n osis a n d selecte d i nter me di ate pr o g n osis patie nts as des cri b e d i n t his pr ot oc ol. 1 0, 1 1  
 
1. 1 0.  
T he i ncl usi o n criteria a n d pla n ni n g tar get v ol u m e ( P T V) mar gi n s pecifi cati o ns i n t his pr ot oc ol 
are desi g ne d s u c h t hat t he ris k of disease e xte nsi o n be y o n d t he P T V will be less t ha n 5 % f or 
“fa v or a ble pr o g n osis” p atie nts ( Gleas o n sc or e < 6 a n d P S A < 1 0 n g/ ml) a n d less t ha n 1 0 % f or 
“i nter me diate pr o g n osis” patie nts ( Gleas o n sc ore 7 or P S A 1 0. 1 – 2 0 n g/ ml). Patie nts will be stratifie d 
acc or di n g t o t heir pr o g n ostic gr o u pi n g. 
 
1. 1 1.  
Pla n ni n g tar get v ol u me ( P T V) mar gi ns will be base d u p o n t he ris k a n d pr e dicte d ma g nit u de of 
e xtraca ps ular e xte nsi o n, as m ost rece ntl y re p orte d b y C ha o, K K, et al, d etaile d i n secti o ns 6. 1. 2 – 
6. 1. 4 of t his pr ot oc ol d o c u me nt. 1 2 Briefl y, f or classic “fa v ora ble” pr o g n osis patie nts ( P S A <1 0 n g/ ml, 
T-sta ge < = T 2 a a n d Gleas o n sc ore <  6), a ra dial mar gi n of 2 m m will be a d de d ar o u n d t he pr ostat e t o 
creat e t he pla n ni n g tar get v ol u me. T he ra dial m ar gi n will be i ncrease d t o 5 m m p oster olat erall y f or 
t he “i nter me di ate pr o g n osis” a n d p ositi ve p eri n e ural i n vasi o n cas es, t o acc o u nt f or t h eir i ncreas e d 
ris k a n d p ote ntial r a dial dista nce of e xtraca ps ular e xte nsi o n fr o m t he pr ost ate, w hic h t y picall y occ urs 
al o n g t he n e ur o vas c ular b u n dle. 1 2 Pr o xi mal se mi nal vesicle c o v era ge will be a d de d f or i nter me diate 
ris k patie nts or t h ose wit h pr ostate base i n v ol ve m e nt as detaile d i n secti o n 6. 1. 1 of t his d oc u me nt. I n 

_ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _
 
_ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _
5 2 
 
all cases, w her e t he o ut er s urface of t he rect u m a b uts t he p osteri or s urface of t he pr ostate, t h e P T V 
mar gi n i n t hat area will be re d uce d t o zer o. 
 
1. 1 2.  
As m ost patie nts wit h l o w a n d i nter me diate ris k pr ostate ca ncers s ur vi v e at least 1 0 years after 
i nter ve nti o n, t he m or bi dit y ass o ciate d wit h t hera p y f or earl y sta ge pr ostate ca ncer is a cr ucial f act or 
of patie nt o utc o me. Alt h o u g h tra diti o nal, p h ysici a n-re p orte d t o xicit y d ata are a us ef ul c o m p o ne nt f or 
e val uati n g treat me nt-r el ate d m or bi dit y, it has bee n s h o w n t hat patie nt-re p ort data (c ollecte d via 
sta n dar dize d q uesti o n naires) ar e m ore se nsiti ve t ha n p h ysicia n r e p orts t o t he f ull se verit y a n d br o a d 
ra n ge of t her a p y effects o n patie nt Healt h- Rel ate d Q ualit y of Life ( H R Q O L), partic ularl y a m o n g m e n 
wit h pr ostate ca n cer. 1 3 
 
1. 1 3.  
T he feasi bilit y of C y ber K nife f or tr eati n g l o calize d pr ostate ca n cer was first descri be d b y Ki n g 
at Sta nf or d U ni versit y. T heir p has e I pr ot oc ol d eli vere d 3 6. 2 5 G y i n 5 fr acti o ns of 7. 2 5 G y.  I n a rece nt 
re p ort 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 gra 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 gra de 2 lat e m or bi dit y ( uret hr al strict ur e). 
T o xicit y was less t ha n t hat re p orte d i n M D A n d ers o n’s e xter nal bea m d ose escal ati o n trial. Mea n 
P S A 1 8 m o nt hs after treat me nt was 0. 2 2 n g/ m 1 4. 
 
1. 1 4 . 
A n ot her p ote ntial be nefit of C y ber K nife r a di os ur ger y rel ati ve t o H D R brac h yt hera p y is better 
preser v ati o n of p ote nc y, e ve n if t he ra diati o n distri b uti o n is esse ntiall y i de ntical bet wee n t hese 
m o dalities. T his is s o beca use nee dle tra u ma has bee n i de ntifie d as a p ote ntiall y si g nifica nt 
c o ntri b ut or y f act or t o er ectile d ysf u n cti o n wit h brac h yt hera p y, i ncl u di n g H D R- base d m o n ot hera p y 
tec h ni q ue, pr es u ma bl y d ue t o direct p h ysical i nj ur y t o t h e ne ur o v asc ular b u n dle a n d/ or b ul b of t he 
pe nis, partic ularl y 
w he n greater t ha n 1 3 nee dle i nserti o ns ar e perf or me d. 1 5 B y c o m paris o n, 
C y b er K nife ra di os ur ger y is n o ni n vasi ve, a n d s o re m o ves t his partic ular erectile d ysf u ncti o n ris k 
fact or. 
 
1. 1 5.  
T o c o nfir m o ur h y p ot hesis t hat C y b er K nif e ra di os ur ger y 
ma y b e 
ma de t o rese m ble a 
“ n o ni n vasi ve H D R d osi metr y deli ver y s yste m,” i n a d diti o n t o si m pl y creati n g e q ui vale nt d osi metr y,  
it is necessar y t o s h o w cli nical e q ui vale nce b ot h i n ter ms of effi cac y a n d t o xicit y.  
 
T a ble 1. 5- Ye ar b D F S O utc o mes f or H D R- M o n ot her a p y f or Pr ost ate C a ncer 
H D R Details  
I nstit uti o n 
# pts 
Me dia n f/ u yrs 
P h oe ni x 
A S T R O 
6 – 7. 2 5 G y x 6 
C A E n d oc urie 1 8 
1 1 7  
3. 3  
  
9 7 % 
9. 5 G y x 4  
Bea u m o nt 1 9 
9 5  
4. 2  
  
9 8 % 
7. 5 G y x 6  
Te x as Tec h 2 0 
1 4 5  
5 
  
9 0 % 
6. 5 G y x 6  
Ga m ma W est – Fa v.  ( S L C) 2 1  
2 0 9  
1. 2  
9 6 % *  
9 9 % * 
Ga m ma W est – I nt. 2 1 
1 1 9  
1. 2  
8 9 % *  
8 9 % * 
6 G y x 8- 9  
Osa ka (J a pa n) 2 2 
1 1 1  
2. 2 5  
  
7 0 % † 
 
T ot als 
7 9 6  
2. 4  
  
9 0 % 
* 3 year r es ult; Pr ojecti n g c o nsta nt fail ure rate i n t his series t o 5 years yiel ds 9 8 % a n d 8 2 % A S T R O-
defi niti o n P S A D F S f or f a v ora ble a n d i nter me diat e ris k cases, res pecti vel y. † Pre d o mi na ntl y 
u nfa v ora bl e pr o g n osis cases i n t his series; 5 year l ocal c o ntr ol is 9 7 %. 
 

_ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _
 
_ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _
5 2 
 
Bas e d o n t h e data pr o vi d e d i n t he re p orts s u m mari ze d a b o ve, a n d a d di n g a P S A D F S de gra dati o n 
fact or t o t he G a m ma W est series t o c o m pe nsate f or t heir s h ort me dia n f oll o w- u p, t he a v era ge 
calc ulate d 5 year H D R m o n ot hera p y A S T R O- bas e d P S A D F S is 9 8 % f or fa v ora ble pr o g n osis, 8 2 % 
f or i nter me diate pr o g n osis a n d 5 9 % f or u nfa v or a ble pr o g n osis cases. T h er e are t o o f e w P h oe ni x-
base d P S A D F S res ults t o pr oject a mea ni n gf ul P h oe ni x- base d H D R m o n ot hera p y P S A D F S 
efficac y r es ult. 
It is a ntici pate d t hat t he case mi x i n t his st u d y will be a p pr o xi matel y 7 0 % l o w ris k/ 3 0 % 
i nter me diate pr o g n osis cases, lea di n g t o a pr e dict e d C y ber K nif e m o n ot her a p y 9 4 % 5 year P S A 
D F S rate, wit h a p ote ntial ra n ge of 8 2 % ( 0 % f a v or a ble or l o w ris k pr o g n osis cases accr u e d) t o 9 8 % 
( 1 0 0 % fa v ora ble cases accr ue d). If t he pr ot o c ol case mi x de viates fr o m t hese perce nta ges, t h e n t he 
pr ot oc ol D F S rat e re q uir e d t o s uccessf ull y test t he pri mar y efficac y h y p ot hesis detaile d i n Secti o n 
2. 0  ma y n ee d t o be a dj uste d acc or di n gl y. 
 
T a ble 2. T o xicit y re vie w f or H D R- M o n ot her a p y f or Pr ost at e C a ncer 
H D R Details  
I nstit uti o n 
# pts 
Me dia n f/ u  
> = G d 3 t o xicit y 
T otal ( %) 
GI ( %) 
G U ( %) 
6 – 7. 2 5 G y x 6  
C A E n d oc urie 1 8  
1 1 7  
3. 3 
3 
0  
3 
9. 5 G y x 4  
Bea u m o nt 1 9 
9 5  
4. 2 
8 
0  
8 
7. 5 G y x 6  
Te x as Tec h 2 0 
1 4 5  
5  
5 – 8 *  
1  
4 – 7 * 
6. 5 G y x 6 
Ga m ma W est ( S L C) 2 1  
3 2 8  
1. 2 
1 
0  
1 
6 G y  x 8- 9  
Osa ka (J a pa n) 2 2  
1 1 1  
2. 2 5  
7 
1  
6 
 
T ot als  
7 9 6  
2. 4 
6  
0 - 1  
5 
* 3 % ac ute a n d 4 % c hr o nic gr a de 3 G U t o xicit y – It is u nclear t o w hat d e gr ee ac ute a n d c hr o nic 
gr a de 3 G U t o xicit y p o p ulati o ns o verla p i n t his st u d y. 
 
D ue t o s h ort me dia n f oll o w- u p, t he i nci de nce of > = gra de 3 late t o xicit y is li kel y u n deresti mate d. W e pr oj ect t hat t he 
i nci de nce of late t o xicit y will i ncrease b y a p pr o xi matel y 5 0 % w he n all data reac h 5 years mat urit y, yiel di n g a pr oj ecte d 
c u m ulati ve 5 year H D R m o n ot hera p y gra de 3 t o xicit y  i nci de nce of 9 % ( 7- 8 % G U; 1- 2 % GI). I n t his st u d y, 
bi o c he mical disease-fr ee s ur vi val ( A S T R O a n d P h oe ni x defi niti o n), free d o m fr o m l ocal rec urre nce, 
free d o m fr o m dista nt rel a pse, cli nical disease-free s ur vi val, disease-s pecific s ur vi val a n d o verall 
s ur vi val 
will be rec or d e d. T he i nci de nce of gr a de 3 or hi g her t o xicit y a n d t he effect of 
C y ber K nife ® ra di os ur ger y o n bla d der, b o w el, a n d se x ual f u ncti o n will be f oll o we d a n d m o nit ore d 
usi n g sta n dar dize d, patie nt self-a d mi nistere d q u esti o n naires 1 6 a n d c o m pare d wit h res ults p u blis he d 
i n peer-r e vie w e d literat ur e f or ot her pr ostate ca ncer t hera p e utic m o dalities. 1 7  
 
2.  O B J E C TI V E S 
P RI M A R Y O B J E C TI V E S :  T he pri mar y st u d y g oal is t o d oc u me nt t he efficac y of t he 
C y ber K nife pr o ce d ure, w here efficac y is defi n e d b y bi oc h e mical Diseas e- Fr ee S ur vi val ( b D F S), 
usi n g P h oe ni x a n d A S T R O defi niti o ns, at 5 years. T his will be acc o m plis he d t hr o u g h testi n g t he 
pri mar y efficac y h y p ot heses detaile d i n Secti o ns 1. 1. 5 a n d 1 1. 2. A d diti o nall y, descri pti ve 
statistics will be pr o vi de d c o m pari n g t he C y ber K nife S R S b D F S rate t o p u blis he d H D R 
m o n ot hera p y b D F S rates re p orte d i n t he liter at ure.  A sec o n d pri mar y st u d y g oal is t o acc ur atel y 
meas ure t he rates of ac ut e a n d late gr a de 3- 5 gastr oi ntesti nal a n d ge nit o uri n ar y t o xicit y o bs er ve d 
d uri n g t he fi ve years f oll o wi n g C y ber K nife S R S f or pr ostate ca ncer.   

_ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _
 
_ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _
5 2 
 
 
S E C O N D A R Y O B J 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 ulati o n: Rates of l ocal 
fail ure, dista nt fail ur e, cli nical disease-free s ur vi val, disease-s pecific s ur vi v al, a n d o ver all s ur vi val; 
q ualit y of life ( Q O L) i n ge neric a n d or ga n-s pecifi c d o mai ns; w or k eff ort re q uire d i n treat me nt 
pla n ni n g a n d d eli 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.  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 cl eara 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 ster e ot actic ra di os ur ger y a n d pr ecisi o n ra di ot her a p y f or l esi o ns, t u m ors a n d 
c o n diti o ns of t he brai n, b ase of s k ull a n d cer vic o-t h oracic s pi ne, h ea d a n d n ec k usi n g t he C y b er K nif e. 
O n A u g ust 1 0, 2 0 0 1, A cc ura y, I nc. recei ve d 5 1 0( k) F D A cleara nce ( 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 ster e otactic r a 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 here i n t he b o d y w h e n ra diati o n tr eat m e nt is i n dicate d. 
 
4.  P R E T R E A T M E N T  E V A L U A TI O N  
4. 1.  C o m plete hist or y a n d p h ysical e x a m 
4. 2.  D R E fi n di n gs 
4. 3.  Assess me nt of perf or ma n ce stat us 
4. 4.  Hist ol o gical e v al uati o n of pr ostate bi o ps y wit h assi g n me nt of Gleas o n sc or e 
4. 5.  E val uati o n of t he pel vic l y m p h n o des wit h C T or M RI is o pti o nal 
4. 6.  Ser u m P S A.  La b or at or y e val uati o n m ust be d o ne wit hi n 9 0 da ys pri or t o r e gistrati o n, or < 6 0 d a ys 
pri or t o h or m o ne t her a p y, a n d 3 0 or 9 0 da ys after disc o nti n ui n g fi nasteri d e or d utasteri de, 
res pecti vel y. 
4. 7.  C B C, platelets, ser u m B U N, cr eati ni ne  a n d test oster o ne; ma y be dra w n aft er re gistr ati o n 
4. 8.  Tra nsrectal ultras o u n d v ol u me st u d y of t he pr ost ate or a di gital rectal e x a m ( D R E) will be perf or me d 
pri or t o e nr oll me nt t o verif y t he pr ostate v ol u me.  T he pr ostate v ol u me ma y be o btai ne d b y ste p 
secti o n s u m mate d meas ure me nts at 5 m m i nter vals t hr o u g h t he e ntire gla n d (ste p pi n g met h o d) or t he 
b y t he le n gt h- wi dt h- hei g ht met h o d.  A n M RI- b as e d pr ostate v ol u me meas ure me nt will als o be 
acce pta ble (s p ecif y w hic h m o dalit y). 
4. 8. 1.  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 or t o 
re gistrati o n if h or m o ne t hera p y gi ve n; if p atie nt ha d ta ke n fi nast eri de or d utasteri de, v ol u me 
deter mi ne d > 3 0 or > 9 0 d a ys (res p ecti vel y) after disc o nti n uati o n. 
4. 9.  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 b e 
c o m plete d bef ore or after e nr oll me nt, b ut bef ore tr eat me nt) 
4. 9. 1.  S F- 1 2 q uesti o n naire 
4. 9. 2.  A U A q uesti o n naire 
4. 9. 3.  E PI C- 2 6 q uesti o n nair e 
4. 9. 4.  S HI M q uesti o n nair e 
4. 9. 5.  Utilizati o n of Se x ual Me dicati o ns/ De vices q uesti o n naire  
 
5.  P A TI E N T S E L E C TI O N & E LI GI BI LI T Y  
5. 1.   Patie nt m ust be  1 8 years of a ge. 
5. 2.  H ist ol o gicall y pr o ve n pr ostate a de n ocar ci n o ma 

_ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _
 
_ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _
5 2 
 
5. 2. 1 . Gleas o n sc or e 2- 7 (re vie we d b y refer e nce l a b) if i nitial pat h ol o g y differs fr o m t hat 
of ref ere n ce la b, ref ere 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 me nt 
5. 2. 2.  Bi o ps y wit hi n o ne year of date of r e gistrati o n 
5. 3.   
Cli nical sta ge T 1 b- T 2 b, N 0- N x, M 0- M x ( AJ C C 6t h E diti o n) 
5. 3 . 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. 3. 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. 4.  P S A  2 0 n g/ ml (if pre- e nr oll me nt P S A was dra w n > 6 0 da ys pr ior t o C y ber K nife treat 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 pr e-tr eat m e nt P S A, a n d will deter mi ne 
eli gi bilit y a n d ris k gr o u p; pre-treat me nt P S A m ust be dra w n 3 0 or 9 0 da ys after disc o nti n ui n g 
fi nasteri de or d ut asteri de res pecti vel y) 
5. 5.   
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. 5. 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. 5. 2 . I nter 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. 6.   
Pr ostate v ol u me meas ure me nt:  
5. 6. 1.  Deter mi ne d usi n g: v ol u me = / 6 x le n gt h x hei g ht x wi dt h 
5. 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 gi ve n; if p atie 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 (r es pecti vel y) after disc o nti n uati o n.  
5. 7.   
E C O G perf or ma nce stat us 0- 1 
5. 8.   
N o pri or pr ostatect o m y or cr y ot her a p y of t he pr ostate 
5. 9.   
N o pri or ra di ot hera p y t o t he pr ostate or l o wer pel vis 
5. 1 0.  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 tr eat me nt deli ver y, i n t he i n v esti gat or’s o pi ni o n. 
5. 1 1.  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. 
5. 1 2.  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 3.  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 os ereli n, tri pt oreli n) a n d a nta g o nists (e. g. de gareli x), peri p heral 
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 nasteri d e or d utasteri de). 
5. 1 4.  C o m pleti o n of patie nt q uesti o n naires i n secti o n 4. 7. 
5. 1 5.  C o nse nt si g ne d.  
 
6.  R E GI S T R A TI O N P R O C E D U R E S 
 
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, f acilities m ust 
c o m plete t he Facilit y Q u esti o n naire, t he Be n c 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 ysi cs Q A re q uire me nts s pecifie d bel o w. After re vi e 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 partici pati o n.  
6. 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: 

_ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _
 
_ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _
5 2 
 
6. 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 v erifie d b y t he R a di ol o gical P h ysics Ce nter ( R P C),. 
6. 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 me d dail y: 
6. 1. 2. 1. 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 ura y) 
6. 1. 2. 1. 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. 2. 1. 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 refere n ce 
 
p oi nt. 
6. 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 p erf or m e d: 
6. 1. 3. 1. 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. 3. 1. 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  t w o d e pt hs 
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 o ut p ut r ati o deter mi ne d fr o m T P R ta bles. 
6. 1. 3. 1. 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 gr a p hic ( X V) 
 
or gafc 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 ar ea met h o d. 
6. 1. 3. 1. 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. 3. 1. 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 nter mar ke d b y a pi n. Dis place me nt, e v al uate d usi n g 
 
i ma gi n g s oft ware or gra p h pa per, s h o ul d n ot e x cee d 1 m m. 
6. 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 yst e 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 be re gister e d o nl y after all eli gi bilit y criteri a are met: see 
Eli gi bilit y C hec klist a b o ve, a n d I n cl usi o n Criteria a n d E x cl usi o n Criteria C R Fs ( Case Re p ort F or ms). 
After t h e patie nt si g ns t he C o nse nt F or m t he p atie nt is e nr olle d i n t he st u d y, a n d s c he d ule d f or 
treat me nt. T he pre-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 researc h assista nt. 
T his data is retai ne d i n t he patie nt’s c h art a n d i n researc h office. T h e dat e of re gistrati o n s hall be t he 
date t he c o nse nt was si g ne d. Fi d u cials 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.  P A T H O L O G Y  
7. 1.  Pat h ol o g y E val u ati o n: Sli des/ bl oc ks fr o m t he pre-treat me nt dia g n ostic pr ostatic bi o ps y will be 
re vie we 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 gi c feat ures, i n cl 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 p atie nts m ust ha ve a c o m plete re pr ese ntati 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 der f or t he case t o be e val uate d f or 
ce ntral pat h ol o g y r e vie w. T he f oll o wi n g m ust be pr o vi de d: 

_ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _
 
_ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _
5 2 
 
7. 2. 1 . A c o m plete re pr ese ntati ve set of bi o ps y sli des ( 1 2 sli des) or tiss ue bl oc k. If i nitial 
pat h ol o g y diff ers fr o m t h at of refer e nce la 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 me nt 
7. 2. 2.  A Pat h ol o g y re 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 Acc ura y pr ot oc ol n u m ber a n d t he patie nt’s case n u m ber. T he 
patie nt’s na me a n d/ or ot h er i de ntif yi n g i nf or mati 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 ntr al re vie w la b m a y 
be  
use d  
if  
a p pr o ve d  
b y  
S p o ns or  
a n d  
Pri n ci pal  
I n vesti gat or . 
 
8.  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 s ee 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. A mi ni m u m of t hree fi d ucial see ds will be place d u n der 
tra nsrect al ultras o u n d g ui da nce, usi n g eit her tra ns peri neal or tr a nsrectal a p pr oac h, 
wit h l ocal 
a nest hesia a n d/ or se d ati o n as re q uire d. T he use of li n ke d fi d ucials are e n c o ura ge d, si nce t he y m a y 
mi grate less t ha n i n di vi d uall y place d fi d u cials. T he p h ysicia n will place see ds s u c 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 ber K nife ort h o g o nal i ma gi n g, are n ot c olli near, a n d i deall y ar e 
se parat e d b y 2 c m or m ore.  Fi d ucials will be place d as a n o ut patie nt pr oce d ure.  L ocal a n est hestic 
i njecti o n, oral or i ntra ve n o us se dati n g 
me dicati o n, oral or i ntra v e n o us pai n 
me dicati o n a n d 
pr o p h ylactic a nti bi otics ma y be gi ve n at t he discr eti o n of t he i n vesti gat or t o ma xi mize t he safet y a n d 
c o mf ort of fi d uci al place me nt.  At least t hree s ee ds m ust be usa ble f or tr ac ki n g d uri n g treat 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 pe 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 b e pr o hi bite d b y t he 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 ne d b y t h e refer e nce 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 
> = 7 da ys aft er 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 d e d.  
8. 2. 2.  C T sca ns will be t a ke n f or treat me nt pl a n ni n g.  C T slices will be 1 – 1. 5 m m, wit h 2 5 0- 5 1 2 
slices ta ke n ce nter e d at t he pr ostate.  T he i ma gi n g s ets will be d o w nl oa d e d t o t he C y b er K nif e 
treat me nt pla n ni n g s yst e m t o de vel o p t he ra di os ur ger y treat me nt pla n. 
8. 2. 3.  If n ot me dicall y c o ntrai n dicate d, all patie 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 h e pr ostate. 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 orect al c oil all o we d. 
8. 2. 4.  U R E T H R A L I D E N TI FI C A TI O N: 
8. 2. 4. 1. T he pla n ni n g C T a n d M RI sca ns will be d o ne wit h a F ole y cat heter i n place t o defi ne 
t he c o urse of t he uret hra t hr o u g h t he C T V.  T o i m pr o ve c o mf ort a n d mi ni mize 
i nc o n ve nie nce t o t he patie nt, if p ossi ble, C T a n d M RI pla n ni n g st u dies will be d o ne 
c o nsec uti vel y. T he s mall est p ossi ble F ole y cat h eter will be use d. 
8. 2. 5.  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 p ar ati o n 
pr oce d ur es 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 verse 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 tr eat me nt pla n use d f or eac h treat me nt will be base d 
o n a n a n al ysis of t he v ol u metric d ose i n cl 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 ures.  A n y b ea ms e nteri n g t hr o u g h a hi p pr ost hesis o n t heir 
wa y t o t h e pla n ni n g tar get v ol u me s hall b e t ur n e d off. N u m ber of pat hs a n d bea ms us e d f or 

_ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _
 
_ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _
5 2 
 
each 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.  A 
pri orit y will be pl ace d o n re d u ci n g o verall treat me nt ti me, n u m ber of n o n-zer o bea ms a n d 
t otal m o nit or u nits wit h o ut c o m pr o misi n g t he d osi metric li mits liste d i n secti o n 8. 3. 4.  All 
pla ns ar e e x pecte d t o re q uire n o m or e t ha n 2 h o urs per tr eat me nt, n o m ore t ha n 3 0 0 n o n-zer o 
bea ms a n d n o m ore t h a n 9 5, 0 0 0 m o nit or u nits f or all fracti o ns.  
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 hall recei ve, pri or t o 
patie nt e nr oll me nt, a n a n o n y m o us electr o ni c patie nt data set. A treat me nt pla n s hall be 
de vel o pe d, a n d t he pla n re vie we d b y t h e PI a n d P h ysics C hair; c o m pleti o n of a 
satisfact or y pla n is r e q uir e 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 r e vie w e d pri or t o b e gi n ni n g ra di os ur ger y. T he Pri nci pal 
I n v esti gat or ( PI) s h all be n otifie d at t he ti me of e nr oll me nt of t his first patie nt, a n d of 
t he pr o p ose d first tr eat m e nt date, t o ass ure PI’s a vaila bilit y f or r e vie w. After pla n ni n g 
is c o m plete, t he treati n g site will re vie w t he tr eat me nt pla n wit h t he PI a n d P h ysics 
C hair, eit her r e m otel y t hr o u g h a we b cast or si milar tec h ni q ue or via o ver ni g ht deli ver y 
of d oc u me nts t o t he PI site.  T he treat me nt pla n ni n g data i ncl u d es t he f use d pri mar y 
a n d sec o n dar 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, as well as 
t he pre-treat me nt pla n ni n g pr e par ati o n f or m, C y ber K nife tr eat me nt pla n ni n g f or m a n d 
treat me nt pla n Q A f or m. If t he treat me nt pla n d ata are s e nt via o ver ni g ht mail, t he 
Pri nci pal I n v esti gat or a n d P h ysi cs C hair s hall c o m plete re vie w wit hi n 3 w or ki n g da ys 
of recei pt; treat me nt will o nl y be gi n after a n y n ecessar y c orrecti o ns are i m ple me nte d 
a n d fi nal pla n is a p pr o v e d. 
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 deli ver y rec or ds f or a d diti o nal pr ot oc ol patie nts:  
8. 3. 2. 4. T he T R E A T M E N T P L A N S of u p t o t he first T H R E E pr ot oc ol patie nts 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 ysicists ma y be re vi e we d, at t he 
discreti o n of t he Pri nci pal I n vesti gat or a n d P h ysics C hair. Als o, treat me nt pla ns a n d 
treat me nt deli ver y rec or ds of T H R E E a d diti o nal R A N D O M L Y c h os e n cases fr o m eac h 
site will be re vie w e d. If warr a nte d b y t he o ut c o mes of a b o ve Q A re vi e ws, t he PI m a y 
re q uest t hat a d diti o nal cases be s u b mitte d f or re vi e w pri or t o f urt h er patie nt treat me nts. 
8. 3. 2. 4. 1.  F or patie nts c h os e n f or p ost-treat me nt re vie w, t he st u d y M o nit or will n otif y t he 
treati n g site n o s o o n er t ha n 1 d a y, b ut n o l ater t ha n 7 da ys, after c o m pl eti o n of 
treat me nt. 
Wit hi n o ne w ee k, t he 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 tr eat me nt pla n ni n g data s ets (i ncl u di n g f use d pri mar y a n d 
sec o n dar 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 parati o n f or m, C y ber K nife Treat me nt 
Pla n ni n g f or m, a n d Tr eat 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 ures d o c u me nti n g treat me nt deli ver y f or all fr acti o ns. T h ese will be 
re vie we d b y t h e PI a n d P h ysics c h air 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. C T V: T he Cli nical Treat me nt V ol u me ( C T V) 
8. 3. 3. 1. 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 or e  6): T he 
C T V i s t he pre-re gistere d 
M RI d efi ne d pr ost ate v ol u me, u nless 
M RI- b ase d 
i ma gi n g is me di call y c o ntrai n dicate d or j u d ge d i nacc ur ate b y t he i n vesti gat or (see 

_ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _
 
_ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _
5 2 
 
secti o n 8. 3. 3. 1. 2.), i n w hic h cas e t he C T ma y b e use d t o defi ne t h e C T V. 
A d diti o nall y, at t he discreti o n of t he i n vesti gat or, s o me or all of t he a djace nt 
se mi nal vesicle v ol u me ma y b e i ncl u de d i n t he C T V f or a n y of t he f oll o wi n g 
reas o ns: pr ostate b ase i n v ol ve me nt b y a n y criteria, peri ne ural i n vasi o n, or 
e q ui v ocal M RI e vi de nce of se mi nal vesicle i n vasi o n i n a patie nt wit h n o ot her 
cli nical or p at h ol o gical e vi de nce f or se mi nal vesi cle i n vasi o n. I n t he e ve nt t hat t he 
pla n ni n g M RI re v eals e vi de nce f or dir ect e xtraca ps ular i n vasi o n ( Sta ge T 3a) or 
se mi nal vesicle i n vasi o n ( Sta ge T 3 b) t hat t h e i n vesti gat or belie v es t o be a tr u e 
p ositi ve res ult, t he p atie nt will be wit h dra w n fr o m t he pr ot oc ol a n d tr eat e d b y a n 
alter nate met h o d off pr ot oc ol. 
8. 3. 3. 1. 2.  I N T E R M E DI A T E RI S K P A TI E N T S: ( P S A > 1 0, Gleas o n = 7, or C S  T 2 b) I n 
a d diti o n t o t he a b o ve, t he C T V will als o i ncl u d e n ot less t ha n 1. 0 c m of se mi nal 
vesicle tiss ue v ol u me a djace nt t o t he pr ostate v ol u me.  M RI visi ble fi d ucials, if 
a vaila ble, ar e e nc o ur a ge d f or o pti mal pr ostate v ol u me c o-re gistrati o n.  If M RI a n d 
C T pla n ni n g is d o ne, a n d i ma ge c o-r e gistrati o n is acc ur ate wit hi n 2 m m i n t he 
o pi ni o n of t he i n vesti gat or, t he M RI will be use d as t he C T V r efere nce i ma gi n g 
m o dalit y.  If C T a n d M RI are b ot h d o ne f or pla n ni n g p ur p oses, b ut i n t he o pi ni o n 
of t he i n vesti gat or t he c o-re gistrati o n of t hes e m o dalities is n ot acc urat e wit hi n 2 
m m ( T he m ost c o m m o n ca use of t his will li kel y be differi n g de grees of rectal 
c o nte nts bet wee n t h e st u dies), C T will be use d as t he C T V ref ere n ce i ma gi n g 
m o dalit y. T he i n vesti gat or will als o h a ve t h e discreti o n t o r e peat t he pla n ni n g M RI 
or C T.  T he i n vesti gat or will s pecif y w het her C T or M RI is t he C T V defi ni n g 
m o dalit y. I n t he e ve nt t hat t he pla n ni n g 
M RI re v eals e vi de n ce f or direct 
e xtraca ps ular i n vasi o n ( Sta ge T 3a) or se mi nal vesicle i n vasi o n ( Sta ge T 3 b) t hat t he 
i n vesti gat or b elie ves t o b e a tr u e p ositi ve r es ult, t he patie nt will be wit h dra w n fr o m 
t he pr ot oc ol a n d treate d b y a n alter nat e met h o d off pr ot oc ol. 
8. 3. 3. 2. P T V: T he prescri 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).  
8. 3. 3. 2. 1.  L O W RI S K P A TI E N T S ( P S A < 1 0 n g/ ml, T 2a, Gleas o n Sc ore  6):  T he P T V 
is an e nlar ge me nt of t he C T V.  T he C T V s h o ul d be e x pa n de d t o i ncl u de a 2 m m 
mar gi n at t he pr o xi mal, distal, a nteri or, later al a n d p osteri or as pects of t he C T V.  
P osteri orl y, w h ere t he C T V a b uts t he rect u m, t here will be n o mar gi n. 
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 ( P S A 1 0. 1 – 2 0 n g/ ml or Gleas o n Sc ore 7 
or T 2 b): T he P T V s h o ul d be e x pa n de d t o i ncl u d e a 2 m m mar gi n at t he pr o xi mal, 
distal, a nteri or, later al a n d p osteri or as p ects of t he C T V.  A p osteri or-later al 
mar gi n e x pa nsi o n of 5 m m will be a d de d o n t he si de of t he p ositi ve bi o ps y a n d o n 
t he si de of pal pa ble t u m or.  I n ot her w or ds, a n i nter me diate-ris k p atie nt will ha ve a 
u nilateral or bilater al C T V
 P T V p osteri or-later al mar gi n e x pa nsi o n of 5 m m.  If 
t he si de of t he p ositi ve bi o ps y is u n k n o w n, or if it c o nflicts wit h t he cli nical T-
sta ge fi n di n gs, t he p osteri or-lateral mar gi n e x pa nsi o n of 5 m m will be d o ne 
bilaterall y.  P osteri orl y, w here t he C T V a b uts t he rect u m, t her e will be n o mar gi n. 
8. 3. 3. 2. 3.  P E RI N E U R A L I N V A SI O N:  Re gar dless of pr o g n ostic s u bset, a p ost eri or-
lateral mar gi n e x pa nsi o n of 5 m m will be a d de d o n t he si de of t he p ositi ve bi o ps y.  
If t he si de of t he p ositi ve bi o ps y is u n k n o w n, or if it c o nflicts wit h t he cli nical T-
sta ge fi n di n gs, t he p osteri or-lateral mar gi n e x pa nsi o n of 5 m m will be d o ne 
bilaterall y.  P osteri orl y, w here t he C T V a b uts t he rect u m, t her e will be n o mar gi n. 
 

_ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _
 
_ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _
5 2 
 
8. 3. 3 . 3. 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 u ct 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 ur es. If t he C T a n d M RI s h o w n or mal 
tiss ues i n differe nt l ocati o ns i m me diatel y a dj ace nt (i.e., wit hi n < 2c m) t h e pr ostate, t he 
c o nt o ure d str u ct ure s h all be a lar ger c o m p osite of b ot h i ma ge sets. Gri d si ze s h o ul d be 
s ufficie ntl y l ar ge t o i ncl u de t he e ntire str u ct ure. 
8. 3. 3. 3. 1.  R E C T U M: defi ne d as t he visi ble o uter rectal wall, e xte n di n g fr o m 1. 5 c m  
 
s u peri or t o 1. 5 c m i nferi or t o P T V.  
8. 3. 3. 3. 2.  R E C T A L M U C O S A: Defi ne d as a 3. 0 m m c o ntr acti o n of t he rect u m v ol u me. 
8. 3. 3. 3. 3.  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 w all a n d l u me n. 
8. 3. 3. 3. 4.  U R E T H R A: T o be defi ne d b y F ole y cat heter o n pla n ni n g C T.  A p pr o val b y t he 
 
Ur ol o gist or Ra diati o n O nc ol o gist is re q uir e d. 
8. 3. 3. 3. 5.  P E NI L E B U L B: Will be defi ne d o nl y if i ma ge c o-re gistere d M RI is use d i n t he 
 
pla n ni n g pr o cess.  T he pe nile b ul b is defi ne d as 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. 3. 6.  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. 3. 3. 7.  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. 3. 8.  T E S T E S, bilateral s hall be c o nt o ure d. 
 
8. 3. 4.  D O S E S P E CI FI C A TI O N S: All s pecifie d d oses ar e f or t he e ntire treat me nt c o urse.  All 
v ol u me perce nta ges ar e r o u n de d t o t he near est te nt h of a perce nt f or c o nsiste nc y, i.e. a 
v ol u me of 0. 0 2 % s hall be rec or de d as 0. 0 %. 
 
8. 3. 4. 1. T he P R E S C RI P TI O N D O S E  of 3 8 G y  deli ver e d i n 4 fr acti o ns of 9. 5 G y p er fracti o n 
will be deli vere d i n  7 da ys, wit h > 9 5 % of t he P T V e nc o m passe d wit hi n t he 
p rescri pti o n is o d ose v ol u me. 
8. 3. 4. 2. R E C T U M O U T E R W A L L : 
8. 3. 4. 2. 1.  Defi ne d as t h e visi ble o uter rectal wall, e xte n di n g fr o m 1. 5c m. s u peri or t o 
 
1. 5c m i nferi or t o P T V. Ma xi m u m d ose ( Dma x ): 1 0 0 % of pres cri be d ( 3 8 G y) 
8. 3. 4 . 2. 2. Mi n or variati o n: 1 0 0. 1 – 1 1 0 % of t he pr escri be d d ose ( 4 1. 8 G y). 
8. 3. 4. 2. 3.  Maj or variati o n: > 4 1. 8 G y 
8. 3. 4. 3. R E C T A L M U C O S A:  
8. 3. 4. 3. 1.  Defi ne d as a 3. 0 m m c o ntracti o n of t he Rect u m o uter wall v ol u me. Ma xi m u m 
d ose ( D ma x ):  7 5 % of pres cri be d ( 2 8. 5 G y) 
8. 3. 4 . 3. 2. Mi n or variati o n: D ma x > 7 5 – 9 0 % of pres cri be d d ose ( 3 4. 2 G y) 
8. 3. 4. 3. 3.  Maj or variati o n: D ma x > 3 4. 2 G y 
8. 3. 4. 4. B L A D D E R :  
8. 3. 4. 4. 1.  D ma x: 1 2 0 % of prescri b e d d ose.  Hi g hest 1 0 % ( D 1 0):  1 1 0 % of prescri b e d 
 
dos e. 
8. 3. 4. 5. U R E T H R A : T o be defi ne d by F oley c at heter o n pl a n ni n g C T  
8. 3. 4. 5. 1.  Ma xi m u m d ose: 1 2 0 % of prescri be d d os e; Hi g hest 1 0 % ( D
1 0): <1 1 0 % of 
 
prescri be d d os e; Hi g hest 5 0 % ( D5 0): < 1 0 5 % of pr escri be d d ose 
8. 3. 4. 6. SI G M OI D C O L O N A N D O T H E R B O W E L: 

_ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _
 
_ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _
5 2 
 
8. 3. 4 . 6. 1. Si g m oi d c ol o n o uter wall a n d ot her b o w el o uter w all wit hi n 2 c m of P T V: 
D ma x < 7 5 % of prescri b e d ( 2 8. 5 G y) 
8. 3. 4. 6. 2.  Mi n or variati o n: D ma x > 7 5 – 9 0 % of pres cri be d d ose ( 3 4. 2 G y) 
8. 3. 4. 6. 3.  Maj or variati o n: D ma x > 3 4. 2 G y 
8. 3. 4. 7. N E U R O V A S C U L A R B U N D L E : Ur ol o gist or r a diati o n o nc ol o gist c o nt o ur a p pr o v al 
re q uire d.  D9 0, D5 0, D1 0, Dma x , V1 0 0 a n d V5 0 will be carrie d f or p ossi ble d osi metr y-
m o rbi dit y c orrel ati o n b ut n o s pecific d osi metr y c o nstr ai nt 
will be a p plie d – 
ne ur o vasc ul ar b u n dle a n at o m y will be defi ne d o nl y if i ma ge c o-r e gistere d M RI is use d 
i n t he pla n ni n g pr ocess.  If it is t he o pi ni o n of t he ur ol o gist t hat t he ne ur o vasc ul ar 
b u n dle is n ot well vis ualize d o n M RI, t his will be i n dicate d o n t he re p orti n g C R Fs a n d 
t he ne ur o vas c ular b u n dle d osi metr y para meters will n ot be re p orte d f or t hat patie nt. 
8. 3. 4. 8. P E NI L E B U L B :  Ur ol o gist or ra diati o n o nc ol o gist c o nt o ur a p pr o val re q uire d.  D9 0, 
D 5 0, D1 0, Dma x , V1 0 0 a n d V5 0 will be carrie d f or p ossi ble d osi metr y- m or bi dit y c orrelati o n 
b u t n o s pecific d osi metr y c o nstrai nt will be a p plie d. 
8. 3. 4. 9. T E S T E S ( bilateral) s h all be c o nt o ur e d, a n d n o pri mar y b ea ms s hall tra vers e t his 
str uct ure. T he D 5 0 will be rec or de d. 
8. 3. 4. 1 0.   C O N F O R M A LI T Y I N D E X F O R N O R M A L TI S S U E S :  T he rati o of t he 
prescri pti o n is o d ose v ol u me t o t he P T V will be > 1. 0 a n d < 1. 5.  Mi n or variati o n:  <  0. 9 9 
or > 1. 5 1 – 2. 0  
8. 3. 4. 1 1.  D O S E I N H O M O G E N EI T Y F O R N O R M A L TI S S U E S: T he P T V v ol u me 
recei vi n g at least 1 5 0 % of prescri pti o n d ose ( 5 7 G y) will be > 1 %, wit h o ut a s pecific 
ma xi m u m li mitati o n, pr o vi de d ot her n or mal tiss ue d osi metr y c o nstr ai nts ar e met. T his 
tra nslates t o a pr escri pti o n is o d ose li ne t hat d oes n ot e x cee d 6 6 %. M ore t y picall y, it is 
e x pecte d t hat t he prescri pti o n is o d ose li ne will be i n t he ra n ge of 5 0- 5 9 % f or patie nts i n 
t his pr ot oc ol. 
 
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 v ari o us as pects of treat me nt pla n ni n g will be 
rec or d e 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 8 G y s hall be gi ve n i n 4 fracti o ns usi n g t he C y b er K nife. 
8. 4. 2.  B o wel/ bla d der pre p ar ati o n:  
8. 4. 2. 1.  T he rect u m will be e m ptie d of its c o nte nts b y use of o ne or m or e Fleets e n e mas pri or 
t o t he pla n ni n g C T a n d M RI sca ns. 
8. 4. 2. 2. T here will be n o fl ui d i nt a ke b y t he patie nt wit hi n 4 h o urs pri or t o a pla n ni n g st u d y.  If 
t he patie nt ta kes a di ur etic, t hat me dicati o n will n ot be ta ke n t hat da y u ntil after t he 
pla n ni n g st u d y(s) h a ve b ee n c o m plete d.  T h e bla d der will be drai n e d c o m pletel y 
t hr o u g h t he us e of a F ole y cat heter a n d t he n r efille d wit h 1 0 0cc of sterile w ater pri or t o 
t he pla n ni n g C T a n d pri or t o t he pla n ni n g M RI sca ns.  If C T a n d M RI sca ns are d o ne 
c o nsec uti vel y, t he bla d d er will be drai ne d b et wee n t hese st u dies a n d refille d wit h 1 0 0 cc 
of sterile water i m me diatel y pri or t o t he sec o n d st u d y. 
8. 4. 2. 3. T he pla n ni n g C T a n d M RI sca ns will be d o ne wit h a F ole y cat heter i n place t o defi ne 
t he c o urse of t h e uret hr a t hr o u g h t he C T V.  T o i m pr o ve c o mf ort a n d mi ni mize 
i nc o n ve nie nce t o t he patie nt, if p ossi ble, t he C T a n d M RI pla n ni n g st u dies will be d o ne 
c o nsec uti vel y. 

_ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _
 
_ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _
5 2 
 
8. 4. 3 . Treat me nt s h o ul d be c o m plete d wit hi n 7 da ys.  
8. 4. 4.  At least t hree fi d ucials s h o ul d be i de ntifie d f or eac h treat 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 ma de t o tr eat usi n g r otati o nal c orrecti o ns. T he tr eat me nt s yste m will be s et 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 are 
n ot p ossi ble, treat me nt m a y c o nti n ue, wit h r otati o nal deltas r ec or d e d, as l o n g as t hese re mai n 
bel o w 2 de grees. F or s u bse q ue nt treat me nts, diet 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 r ectal 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 di ati 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 d a y of t he C y b er K nife treat me nt, t he p atie nt will be ta k e n i nt o t he C y b er K nif e 
s yste m treat me nt r o o m, set u p i n t heir res p ecti ve i m m o bilizati o n de vices a n d p ositi o ne d o n 
t he C y ber K nife c o u c h.  X-ra ys will be ta ke n wit h t he C y ber 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 m a 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. T ar get m o ve me nt is e x pecte d t o re q uire i ma gi n g 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, a n d i n n o sit uati o n s h o ul d i ma gi n g occ ur less fr e q ue ntl y 
t ha n e ver y 5 n o des. Fi d ucial 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 h e f oll o wi n g pla n ni n g a n d 
treat me nt i nf or mati o n s h all be rec or de d f or e ver y pla n a n d fracti o n deli vere d: set- u p ti me 
re 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 tr eat 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 treate d w he ne ver p ossi ble. If treat me nt m ust be ter mi nate d 
pre mat urel y o n fracti o ns 1- 3, c o m p e nsate as f oll o ws. If 2/ 3 or m or e of all n o n-zer o n o des 
were treat e d, t he n t h e u ntreate d n o des pl us t he f ull ne xt fracti o n s h o ul d be treate d o n t he n e 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 wer t ha n 2/ 3 of 
t he n o n-zer o n o des wer e treate d, t h e 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 h e s u bse q u e nt fr acti o n s hall b e deli vere d o n t he n e xt 
treat me nt da y. If treat me nt m ust be ter mi nate d pr e mat urel y o n t he f o urt h fracti o n, a n d 9 0 % 
of t he n o n-zer o n o des were treate d, t he n n o f urt her tr eat me nt s hall b e 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 deli ver e d). If f e wer t ha n 9 0 % of t he n o n-zer o n o des 
were tr eate d, t he n t he d eficit s hall be deli vere d o n t he f oll o wi n g treat me nt da y. All s uc h 
variati o ns s hall be rec or d e 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 d e d. 
Als o re q uire d o n-site s u p er vis or y ti me will be rec or de d. 
 
 
 
9.  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 4 
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 

_ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _
 
_ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _
5 2 
 
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  
  
  
  
  
  
  
  
  
 
T est oster o ne 
X  
  
  
  
X  
X  
X  
X  
X  
 
C B C, platelets 
X  
  
  
  
  
  
  
  
  
 
B U N, creati ni ne 
X  
  
  
  
  
  
  
  
  
 
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  
 
b. C o nti n ue e ver y 6 m o nt hs t hr o u g h year 5 
* . 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 oce d ure will f oll o w r o uti ne patie nt car e g ui d eli 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 nce a n y u nt o war d effects f oll o wi n g treat me nt.  I n t he e ve nt a s u bject 
e x perie nces a n y u nt o w ar d effects f oll o wi n g C y ber K nife treat me nt, i nf or m ati 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 uir e d, a n d h os pital sta y a n d 
c o urse will be r ec or d e d f or p ur p oses of cli nical e v al 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 tre at me nt (all o we d 
wi n d o w: +/- 3 d ays) , t o xicit y a n d A U A sc ore will be e val uat e d. At 1 m o nt h ( +/- 7 d ays) 
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 wks)  i nter v als (a n d e ver y 6 m o nt hs t hereaft er, t hr o u g h year 5), p atie nts will be see n 
a n d e val uat e d, i ncl u di n g a hist or y, p h ysical e x a m, E C O G perf or ma nce stat us, P S A, t o xicit y 
e val uati o n, a n d A U A sc ore. 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 her eaft er, t he 
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 v al uati o n, a n d t he f oll o wi n g 
q uesti 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 

_ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _
 
_ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _
5 2 
 
be d o ne at o utsi de f acilit y. A s er u m t otal test oster o ne will be meas ur e d at baseli ne a n d wit h 
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 nd  is e nc o ur a ge d at 2 ye ars f oll o wi n g treat 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. 1. 7.  A xial I m a gi n g ( C T or M RI) of t he a b d o me n a n d pel vis will be perf or me d at t he ti me of 
bi oc he mical fail ur e, or w he n t he patie nt de v el 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 Criteria v ersi 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, disease, a n d tr eat me nt gr o u ps. It pr o vi d es a c o m pr e he nsi ve, 
ps yc h o m etricall y s o u n d assess me nt of healt h stat us fr o m t he patie 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 he 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 ost ate 
ca ncer treat me nt. It was de vel 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 hera p y e x pertise), s ur ve y res ear c hers, a n d pr ostat e 
ca ncer n urses, t o a d dress s y m pt o ms relate d t o r a di cal pr ostatect o m y, e xter nal bea m 
ra di ot hera p y, pr ostate br ac h yt her a p y, a n d h or m o n al 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 n ati 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 p e 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 
vali date d a n d se nsiti ve i nstr u me nt f or assessi n g er ectile d ysf u ncti o n 1. 
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 ha v e use d 
t he A S T R O c o nse ns us d efi niti o n ( A C D) of P S A f ail ure, rece nt st u dies2,3,4 ha ve s u g geste d 
t he “ na dir + 2 ” defi niti o n is a m ore se nsiti ve a n d s p ecific defi niti o n of bi oc he mical fail ure. 
I n d ee d, a rece nt e x pert p a nel met i n P h oe ni x5 a n d de vel o pe d a c o nse ns us r ec o m me n dati o n 
usi n g t he later defi niti o n. S o t hat c o m paris o ns ca n be ma de wit h earlier literat ure, b ot h 
defi niti o ns s hall be use d:  

_ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _
 
_ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _
5 2 
 
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 her a p y ( h or m o n es, s ur ger y, etc …) will b e c o nsi der e d fail ur e. 
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 p ecifie d f oll o w- u p i nter vals. If t hree 
c o nsec 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 f ail ure. A d mi nistrati o n of 
sal va ge t her a p y ( h or m o n es, s ur ger y, etc …) will b e c o nsi der e d fail ur e. Fail ure date is t he 
mi d p oi nt bet wee n t he dat es of t he last 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 ocal pr o gr essi o n or rec urr e n ce: Cli nical fail ure i ncl u d es a pal pa ble 
a b n or malit y t hat h as i ncr ease d i n size, fail ure of r e gressi o n of a p al pa ble a b n or malit y b y 2 
years after tr eat me nt, or r e de vel o p me nt of a pr ostate a b n or malit y after 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 fail 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 aft er 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 dere 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 dere d l ocal fail ur es. If a patie nt is l ocall y c o ntr olle d at t he ti me of orc hiect o m y or 
a n dr o ge n a bl ati o n, he is ce ns ore d a n d c o nsi dere d “ n ot e val ua ble” f or f urt h er l ocal 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 metast atic disease. Bi oc h e mical fail ur e wit h a 
ne gati ve pr ostate bi o ps y s hall be c o nsi dere d dista nt o nl y fail ur e. Bi o ps y of metastatic 
site re q uire d if r a di o gra p hic or cli nical fi n di n gs ar e e q ui v ocal. T y p e of met astatic 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 d eat 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 uses, wit h acti ve mali g n a nc y ( d efi ne d b y cli nical or 
bi oc he mical e vi de n ce of pr o gressi o n). If a p atie nt s uffer e d a pre vi o us r ela pse, b ut 
has i nacti ve diseas e, t his is n ot c o nsi dere d a disease-s pecifi c 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.  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. 
 

_ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _  
 
_ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _  
 
 
 
P a g e 2 3 of 5 2 
 
 
1 1 . 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 he st u dy’s pri m ary g o als are t o deter mi ne Cy ber K nife m o n ot her a py effic acy a n d t o 
ev al u ate t he i nci de n ce of gr a de 3 or hi g her t oxicity as st ate d i n Secti o n 2. 0. Per R T O G/ E C O G, ac ute 
t oxicity will be defi ne d as occ urri n g wit hi n 9 0 d ays fr o m c o m pleti o n of tre at me nt. L ate t oxicity will 
be defi ne d as occ urri n g m ore t h a n 9 0 d ays fr o m c o m pleti o n of tre at me nt. It is gr a de d b ase d u p o n 
C o m m o n Ter mi n ol o gy Criteri a f or A dverse Eve nts ( C T C A E), v 3. 0., a n d R T O G/ E C O G defi niti o ns 
(s ee a p pe n di x 5). 
1 1. 2.  I N T E RI M A N A L Y SI S: A n i nteri m a n alysis w as perf or me d. T he res ults bel o w are b ase d o n a n 
over all o ne-si de d al p h a of 0. 0 5 a n d usi n g t he O’ Brie n- Fle mi n g s pe n di n gf u ncti o n, a n d were 
c alc ul ate d usi n g n Teri m ( St atistic al S ol uti o ns Lt d). T he i nteri m a n alysis is b ase d o n 4, 5 1 2 m o nt hs of 
f oll o w- u p, o ut of a t ot al p ossi ble of 1 5, 6 0 0 m o nt hs ( 6 0 m o nt hs * 2 6 0 S u bjects).  H e nce t he i nteri m 
a n alysis is perf or me d wit h a p pr oxi m ately 2 9 % of t he t ot al d at a p ossi ble f or t he fi n al a n alysis. T he 
fi n al al p h a m ust n o w be 0. 0 4 9 9 9. If t he Z-sc ore at t he i nteri m a n alysis excee ds 3. 4 5 7 0 1, t he n t he tri al 
c o ul d be st o p pe d. If t h Z-sc ore d oes n’t excee d 3. 4 5 7 0 1, t he n t he tri al will c o nti n ue t hr o u g h t he 
pri m ary assess me nt peri o d of 5 ye ars, w here t he P-v al ue f or s uccess is at m ost . 0 4 9 9 9 9 1.  
 
L o o k 1 
Fi nal A nal ysis- L o o k 2 
pr o p orti o n of i nf or mati o n  
0. 2 9 
1. 0 
Z- Sc ore B o u dar y 
3. 4 5 7 0 1 
1. 6 4 5 7 5 
N o mi nal Al p ha 
0. 0 0 0 2 7 
0. 0 4 9 9 9 1 
I n cre m e ntal Al p ha 
0. 0 0 0 2 7 
0. 0 5 
 
1 1. 3.   S A M P L E SI Z E: 
Pri mar y Efficac y E n d p oi nt a n d H y p ot h esis:  5- Year Bi o c he mical  Disease- Free   S ur vi val( b D F S) 
A m o n g C y ber K nife Treate d Patie nts     
 
              
b D F S is t he pri mar y efficac y o utc o me f or t he st u d y.  T he pr o p orti o n of pati e nts disease-free 
wit hi n 5 years of t he i nitial pr oce d ure is t he r ate of i nterest.  T he n ull a n d alter nati ve h y p ot heses 
are as f oll o ws:  
 
%
9 0
:0
<
π
H
 
%
9 0
:1
≥
π
H
 
 
π  
is t he e x pecte d pr o p orti o n of C y ber K nife tr eate d patients

 b D F S at 5 years.  T he C y ber K nife 
pr o ce d ur e is c o nsi der e d t o be eff ecti ve if t his st u d y’s res ult verifies t hat t he l o wer li mit of t he o ne-
si de d 9 5 % c o nfi de n ce i nt er val f or π is n ot bel o w 9 0 %. 
Statistical Sa m ple Size Deri vati o n 
 
Pri m ar y Effic ac y O bjecti ve 
W e calc ulate t he C y ber K nife Treat me nt Gr o u p sa m ple size, N, re q uire d t o test t he n ull h y p ot hesis 
t hat t he rate i n t he Tr eat me nt Gr o u p is less t ha n 9 0 %, a gai nst t he o ne-si d e d alter nati ve h y p ot hesis 
t hat t he rate is at least 9 0 %.. 
 
W e c h ose N lar ge e n o u g h t o test t he n ull h y p ot h esis a gai nst t he alter nati ve h y p ot hesis wit h p o wer 
e q ual t o 8 0 % at t he o ne-si de d 5 % si g nifica nce le v el.  

_ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _  
 
_ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _  
 
 
 
P a g e 2 4 of 5 2 
 
 
 
Le t Zu de n ote t he u p per u-t h perce ntile of t he sta n dar d n or mal distri b uti o n. He nce Z. 0 5 = 1. 6 4 5 
co rres p o n di n g t o t he o ne-si de d 5 % le vel of si g nifica nce a n d Z. 2 0 = 0. 8 4 c orres p o n ds t o 8 0 % 
p o wer. T he n t h e sa m ple size is deter mi ne d b y F or m ula 1: 
 
[
]
[ 
]
2
0
1
2
0
0
1
1
)
1(
)
1(
π
π
π
π
π
π
α
β
−
−
+
−
=
z
z
N
, w here 
1
π
 is t he e x pecte d pr o p orti o n of C y ber K nife treate d patie nts b D F S at 5 years if t he alter nati ve 
h y p ot hesis is tr ue; t he b D F S rate is t he n e x pecte d t o e q ual or e x cee d 0. 9 4. F or p ur p oses of sa m ple 
size esti mati o n, we re q uire 8 0 % p o w er if 
1
π
≥0. 9 4 5.  
0
π
is t he e x pecte d l o wer li mit of 
the  9 5 % c o nfi de n ce i nter val f or π a n d is set e q ual t o 0. 9 0. T he n N = 2 3 2 . All o wi n g 8 % 
sa m ple size de gr a dati o n f or l ost t o f oll o w- u p, t he sa m ple size m ust be i ncrease d t o 2 3 2/ 9 2
.
 = 2 5 3 
s ubjects . 
Pri m ar y S af et y O bjecti ve 
T he pri mar y safet y o bjecti ve is t o esta blis h wit h 9 5 % c o nfi de n ce t hat t he p erce nt a ge of 
C y ber K nife tr eate d p atie nts e x perie nci n g ≥ Gra de 3 t o xicit y is n ot m ore t ha n 5 % hi g h er t ha n t he 
a p pr o xi matel y 9 % 5- year rate e xtra p olate d fr o m T a ble 2, Secti o n 1. 1 5. 
 
Wit h  N = 2 3 2 C y b er K nif e treate d s u bj ects, if t he o bser ve d 
≥ Gra de 3 t o xicit y rate e q u als 9 %, t he n 
wit h 9 5 % c o nfi de nce t he "tr ue" r ate ≤1 2. 6 %. Si nce t he differ e nce bet wee n 1 2. 6 % a n d 9 % is less 
t ha n 5 %, t he sa m ple size of 2 3 2 s u bjects is m ore t ha n lar ge e n o u g h t o meet t he pri mar y saf et y 
o bjecti ve. 
 
1 1. 3. 1  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 v al, 
t heref or e we d o n ot e x pect t o meet t he tar get e d m o nt hl y accr ual rate u ntil after t he first 
t hree m o nt hs.  T he esti m ate d accr ual rate is 2 pati e nts per st u d y site per m o nt h.  
E x pectati o ns of 5 treati n g st u d y sites ass u mes a n accr u al peri o d of a p pr o xi matel y 2 9 
m o nt hs t otal.  
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 O BJ E C TI V E S  
1. Effic ac y 
 
T he l o wer  li mit of a o ne-si de d 9 5 % c o nfi d e 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 he mical diseas e-free s ur vi val ( b D F S) is esti mate d b y L, w h ere 
 
 
)
(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 ar m of t he tri al . 
T he C y b er K nif e i nter ve nti o n will be c o nsi dere d t o be eff ecti ve if t his st u d y’s res ult verifies 
t hat L is n ot bel o w 9 0 %. 

_ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _  
 
_ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _  
 
 
 
P a g e 2 5 of 5 2 
 
 
 
2. S af et y  
 
T he u p per li mit of a o ne-si de d 9 5 % c o nfi de n ce i nt er val f or t h e e x pecte d pr o p orti o n of 
patie nts e x perie nci n g ≥ Gra de 3 gastr oi ntesti nal a n d ge nit o uri nar y t o xicit y is esti mate d b y 
U, w her 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 ≥ Gra de 3 
gastr oi ntesti nal or ge nit o uri nar y t o xicit y . T h e C y ber K nife i nter ve 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 v erifies t hat U is n ot 
m ore t ha n 5 % hi g her t h a n t he literat ure r ate of  9 %.. 
 
1 1. 4. 2. S E C O N D A R Y O BJ E C TI V E S 
1. L oc al a n d Dist a nt T u m o r C o ntr ol  
 
As defi ne d i n Secti o n 9. 4, t he fail ure t o ac hie ve l o cal a n d dista nt t u m or c o ntr ol will be 
d oc u me nte d f or eac h pati e nt. T hese r ates will be s u m marize d a n d descri pti ve statistics 
(sta n dar d de vi ati o ns, c o nfi de nce i nter vals) will cal c ulate d. 
 
2. Q u alit y of Lif e Assess me nts 
 
T he S F- 1 2 t otal s c ore, A U A sc or e, E PI C- 2 6 t otal sc ore a n d t he E PI C-s e x ual d o mai n s u b 
sc ore are use d t o q ua ntif y q ualit y of life ( Q o L) at baseli ne a n d re p eate 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 ner alize d esti mati n g e q uati o n ( G E E) 
met 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 k e i nfere n ce a b o ut 
a vera ge be h a vi or, w h er e t he de pe n d e nt varia ble  de pe n ds n ot o nl y o n t h e “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 peate d 
meas ure me nts. T he G E E a p pr o ac h fits t he m o del t o t he o bser v e d d ata as cl osel y as 
p ossi ble, wei g hti n g eac h patie nts’ “cl uster” of meas ure me nts o v er ti me i n versel y t o its 
varia nce – c o v aria n ce m atri x. Wit h t his met h o d, n o i m p utati o ns are r e q uire d a n d all data 
rec or d e d is use i n t he a n al ysis. Ot her i m p orta nt f eat ures of G E E ar e t hat n o distri b uti o nal 
ass u m pti o ns f or t he de p e n de nt vari a ble are r e q uire d t o use t he m et h o d a n d i n m ost cases 
vali d i nfere n ces are pr o vi de d e ve n w he n t he c orrelati o n str uct ur e is miss-s pecifie d. F or 
eac h sc or e, we will use G E E t o fit a strai g ht li ne t o patie nts’ l o n git u di nal c o urse of 
re peat e d v al 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 gra d u al w orse ni n g f u ncti o n r elati ve t o baseli ne 
o ver t he fi ve- year f oll o w- u p peri o d. T hes e 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 s a me i nstr u me nts, i ncl u di n g R T O G 0 2 3 2 

_ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _
 
_ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _
5 2 
 
a n d 0 4 1 5. W e h y p ot h esize t hat t he sl o pe of a fitt e d li ne will n ot b e si g nifica ntl y l ess t ha n 
zer o; t hat is, Q o L will be mai ntai ne d t hr o u g h o ut t he assess me nt peri o d.  
 
3. A d verse E ve nts 
 
All a d verse e ve nts will be rec or de d o n t he case re p ort f or ms. F or b ot h ac ut e ( < = 9 0 da ys of 
treat me nt start ) a n d late ( > 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 pe of a d verse e v e nt will be prese nte d i n ta b ular f or m, o n b ot h a per- patie nt a n d a 
per-e v e nt basis.  
 
4. S ur vi v al 
 
“ S ur vi val” is vari o usl y d efi ne d i n Secti o ns 1. 1. 5, 2. 0 .  Peri o dicall y o v er t h e e xte n de d 
f oll o w- u p peri o d,  K a 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 v e, 
descri pti ve statistics will be calc ul ate d i ncl u di n g esti mates of s ur vi val rates a n d mea n a n d 
q uartile s ur vi val ti mes. 
 
5. W or k Eff ort 
 
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 tr eat me nt 
s hall be rec or d e d f or all me m ber of t h e 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). T he r e q uire d o n-site s u per vis or y ti me will als o be rec or de d . 
A vera ge ti mes will b e r ec or de d. Ti me s pe nt b y tea m me m bers will be c o m pare d wit h ot her 
o utc o mes (e. g. e x perie nce le vel of tea m 
me m ber, patie nt e nr oll me nt, treat me nt 
pla n ni n g/ deli ver y Q A o utc o mes, t o xicit y, b D F S a n d Q O L o utc o mes) a n d c orrelati o ns 
deter mi ne d.  
 
1 2.  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 u e ntl y 
tra nsferre d i nt o a c o m p ut er data b ase i n a sec ur e file at a r e p uta ble Cli nical Researc h Or ga nizati o n 
t hat is e x perie nce d a n d o perates i n acc or d a nce wit h t he a p plica ble r e 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 m ati 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 mati o n will be s u b mitte d b y o ne of t h e lea d site’s i n vesti gat ors a n d/ or Acc ur a 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 Stere 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 d ata 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 r a diati o n o nc ol o g y, stere otactic ra di os ur ger y, ur ol o g y, cli ni cal 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 d e pe n de nt of t he i n vesti gat ors w h o 
ha ve n o fi na n cial, 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 r e mai ni n g meeti n gs 
occ urri n g via t elec o nf ere 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 

_ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _  
 
_ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _  
 
 
 
P a g e 2 7 of 5 2 
 
 
di sc uss t he pr ot oc ol a n d esta 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 uart erl y meeti n gs 
will be c o n d ucte d via tel ec o nfere n ce.  T he D S M B will m o nit or a n d e val uate all a d vers e e v e nts of all 
gr a des t o esta blis h rel ati o ns hi p t o t he st u d y pr oce d ures.  Base d o n t he re vie w of t o xicities s u m mar y 
t he b oar d will ma ke r ec o m me n dati o ns t o eit her 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 o ar 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 n cer ni n g fi n di n gs f or t he 
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 rel ate d t o 
c o nti n ui n g, c h a 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 
rec o m me n dati o ns will als o be pr o vi de d b y Acc ur a y t o t he rest of t he p artici pati n g sites t o be s har e 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 v erse 
effect o n healt h or s afet 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 
de vice, if t hat effect, pr o ble m, or deat h was n ot pr e vi o usl y i de ntifie d i n nat ure, se verit y, or de gr ee of 
i nci de nce i n t he pr ot o c ol (i ncl u di n g a s u p pl e me ntar y pla n), or a n y ot her u na ntici pate d seri o us 
pr o ble m wit h a de vice t h at relates t o t he ri g hts, safet y, or welf ar e of s u bjects. S h o ul d a n y 
u na ntici pate d a d v erse d e vice effects occ ur d uri n g t he c o urse of t h e 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 h e i n vesti gat or a n d re p orte 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 d a ys aft er t he 
i n vesti gat or first lear ns of t he eff ect(s).  T he r e p ort re gar di n g a n y u n a ntici p ate d a d verse de vi ce 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 ucte 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 ura y’s me di cal m o nit or t o c o n d uct a n e val u ati o n of s uc h eff ects. 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 nr eas o n a ble 
ris k t o s u bjects, t he cli nical e val uati o n will be pa us e d, if dee me d a p pr o pri ate (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. T er 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 da ys after t h e s p o ns or 
recei v es n otice of t he u n a ntici pate d a d vers e de vice effect.   I n t he e v e nt of t er mi nati o n, I R B a p pr o val 
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 t he tri al ( t hr o u g h 2 5 %, 5 0 % a n d 7 5 % e nr oll me nt of 2 3 2 
patie nts) s h o ul d a n e x cessi ve n u m ber of patie nts  e x perie nce ≥ Gra de 3 gastr oi ntesti nal a n d 
ge nit o uri nar y t o xicit y. 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 ntifies 
t o o hi g h a r ate. T he st o p pi n g criteria diff er after  5 8, 1 1 6 a n d 1 7 4 patie nts ha ve bee n e nr olle d 
. C o nsiste nt wit h Secti o n 1. 1. 5, 2. 0  we defi n e a n o bser ve d ≥ Gra de 3 gastr oi ntesti nal a n d 
ge nit o uri nar y t o xicit y  rate of o ver 1 4 % as t o o hi g h. T he 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 v e d cases wit h ≥ Gra de 3 t o xicit y m ust be fe w e n o u g h s o t h at 
t here is a 9 5 % c ha nce t hat t he “tr ue” rate d oes n ot e x cee d 1 4 %.  
 
 
 
≥ Gr a de 3 t oxicity   St o p pi n g Criteri a  
P artici p a nts t o 
be e nr olle d: 2 5 3 
St o p st u d y if t he n u m ber of p atie nts wit h gr a de 3- 5 t o xicit y  
e q u als or e xcee ds: 
    E nr oll me nt 1- 5 8:    4  E ve nts 
     E nr oll me nt 1- 1 1 6:  1 0  E ve nts 
     E nr oll me nt 1- 1 7 8: 1 7 E ve nts 

_ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _
 
_ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _
5 2 
 
 
 
 
 
 
 
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 ote ntial safet y iss ues will als o be 
pr o vi de d t o Acc ura y’s R e g ul at or y Aff airs D e part me nt.  S uc h re p orts will be e val uat e d a n d r e 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 r e q uire d. 
 
1 3.  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: 
1 3. 1. 1.  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 racial, ge n d er a n d et h nic c haract eristics 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 h e 
site’s res pecti ve de m o gr a p hics.  N o e x cl usi o n criteria s hall b e bas e 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 patie 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 b e recr uite d b y r eferrals 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 recr uit me nt, a n y s u c h 
a d vertise me nt will re q uir e a p pr o val b y t he res pecti ve site’s I R B pri or t o us e. 
1 3. 2  Recr uit me nt Pr oce d ur es: 
1 3. 1. 2.  After e val u ati o n b y a ur ol o gist a n d a ra 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 n cer will be offere d C y ber K nife treat me nt.  After 
t he decisi o n is ma de b y b ot h t he patie nt a n d his p h ysicia n(s) t o pr ocee d wit h C y b er K nif e 
treat me nt, t he y will be scree n e d f or i ncl 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 pat e, t he patie nts will be as ke 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: 
1 3. 1. 3.  I n t he 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 restricte d t o eac h r es pecti ve cli nical site.  
S u bject-s pecific i de ntifi cati o n re q uir e d t o c o n d uct 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 restricte d t o t he n u m ber assi g n e d t o t hat 
s u bject at t he ti me of re gistrati o n.  
 
 
 
 
 
1 4.  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 di cal 
tea m perf or mi n g t he pr oce d ure will disc uss t he p ot e 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 disease pr o gressi o n, des pite t he li mite d 
cli nical e x perie nce. 

_ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _
 
_ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _
5 2 
 
 
1 4. 2  
R is ks: 
1 4. 1. 1.  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. 
 
1 4. 1. 2.  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 treat e d.  Rare b ut seri o us eff ects 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: 
1 4. 1. 3.  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 o di u m will be 
prescri be d if necessar y. 
 
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, a ntis pas m o dic, a nti-i nfla m mat or y or ot her a p pr o priate s y m pt o matic me dici nes will be 
prescri 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 necessar 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 m e dical t her a p y m a y be r e q uire 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 ot es 
1, 2, 3. A d diti o n of “ b ul k” (e. g. Meta m ucil) t o diet, or I 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 m a y 
be re q uir e d; bl o o d tra nsf usi o ns, , p h ot oc oa g ulati o n, t o pical c he mical c o a g ulati o n , h y per b aric 
o x y ge n tr eat me nts. I n e xtre mel y rare cases, c ol ost o m y ma y be n ecessar y. 

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5 2 
 
 
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 ( R ar e):  s ee n otes 2, 3. F ole y cat heter, 
i nter mitte nt strai g ht cat h eterizati o n, or s u pra p u bic cat heter m a y be 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 ( R are, 
b ut seri o us):  s ee n otes 2, 3. C yst osc o p y, tra ns- uret hra i ncisi o n, a n d/ or dilati 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. 
 
Per m a ne nt 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 b e 
re q uire d. I n e xtre mel y rare cas es maj or s ur ger y s u c h as uri nar y di versi o n c o ul d be re q uire 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 pi c), a nal gesics, or ot her m e dicati o ns place d i n t he 
bla d der, 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 gra, M use, etc …), ot h er er ectile ai ds ( e. g. pe nil e p u m p), or s ur ger y (i m pla nta ble pe nile 
pr ost hesis). 
 
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:  T his c o n diti o n is hi g hl y li kel y 
f oll o wi n g treat me nt si nce t he tar get i ncl u des str u ct ures w hic h c o ntri b ute t o se me 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 r e q uire 
a nal gesics. 
 
Rect 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):  s ee 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 geri es.  
 
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 vices, 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 r ect 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 ber K nife fre q u e ntl y i ma ges t he pr ostate a n d 
c orrects f or m o ve me nt of t he patie nt or t he pr ostat e. T his all o ws p h ysici a ns t o treat a s maller 
re gi o n ar o u n d t he pr ostat e c o m par e d t o ot her c o m m o nl y use d e xter nall y ge nerate d ra diati o n 
met h o ds. 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 ur es. T he desi g n 
c haracteristics of t he C y b er K nife t h us i ntri nsicall y mi ni mize t he ris k f or si de eff ects or a d vers e 
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 car ef ull y 
c o nsi dere d, a n d li kel y acce pta ble t oler a nces ha ve bee n calc ulate d. T h ese n or mal tiss ue c o nstrai nts 

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P a g e 3 1 of 5 2 
 
 
are liste d i n secti o n 8. 3. 2. D V H a nal ys es will be perf or me d as s pecifie d, t o i ns ure a d her e nce t o 
t hese 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 n or mal str uct ures. T he h y p ofracti o nati o n sc h e me t his 
re d uces t h e ris k of si de effects or a d vers e effects. 
 
1 4. 2.  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 m e nt, 
a nti o bi otic treat me nt will be prescri be d. 
 
1 4. 4  
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 n creas e d ris k fr o m a n a d v erse e v e 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 oce d ur e t o ass ur e t hat a n y ac ute a d verse effects ar e detecte d i n a 
ti mel y ma n ner s o t h at 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 n e n u m bers, i n t he e ve nt t he y 
e x perie nce a n y c o m plicati o ns. 
 
1 4. 5  
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 bea m ra di ati o n t hera p y i n ot her p arts 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 be n efits: 
 
•  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. 6  
Earl y Ter mi nati o n: 
S u bjects 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 we ver, t he y ma y be re q uest e 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 picall y o cc urs pri or t o c o n ve nti o nal ra di ati o n t hera p y.  T heref 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 oci ate 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 pa n y u n der a n a p pr o priate c o d e.  T his will i ncl u de all 
o perati ve, f acilit y- base d a n d h os pital- base d c h ar ges.  F oll o w- u p ass ess me nt als o is n o differe nt 
t ha n w hat t y pi call y occ urs f oll o wi n g a c o n ve nti o n al ra di ot her a p y a n d treat me nt f or t his p o p ulati o n 

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5 2 
 
of p atie nts.  T her ef or e, t he patie nt’s i ns ura n ce will be bille d f or all tests a n d i ma gi n g ass oci ate 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 me nt, salar y s u p p ort a n d s u p plies will be pr o vi de d b y A cc ur a y I n c., S u n n y v ale, C A 
( pr oject s p o ns or). 
 
 

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5 2 
 
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 
 
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 te n ( 1 0) years after y o ur tr eat me nt.  If y o u deci d e t o partici pate i n t his e val uati o n, 
y o u will nee d t o meet a n u m ber of re q uire me nts b ef ore y o ur d oct ors d eter 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. 
 
 
 
 
 
 

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5 2 
 
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 2 5 3 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 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 

_ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _
 
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5 2 
 
irra diati o n.  T he i ma ges o btai ne d d uri n g t h e sca n will be use d t o pla n t he C y b er K nife tr eat me nts.  Y o u 
will als o ha ve a n M RI sca n of t he pel vis, u nless m e dicall y c o ntrai n dicate d (f or e x a m ple if y o u h a ve a 
pace ma k er) w hic h will be use d f or tr eat me nt pla n ni n g p ur p oses.   
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 f o ur se p arate C y b er K nife treat me nts us uall y d eli vere d o ver 4 c o ns ec uti ve wee k 
da ys ( ma xi m u m 7 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 4- 7 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.  Y o u will als o be as ke d t o c o m plete t he sa me 
q uesti o n naires y o u c o m plete d pri or t o C y b er K nif e treat me nt.  T hese q u esti o n naires will as k 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, as w ell as m o o d, acti vit y a n d e ner g y le v els, 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 a n d test oster o ne le vels.  T his is t he 
sta n dar d pr oce d ur e f or f oll o w- u p visits a n d will occ ur e ver y 6 m o nt hs t hereafter f or 5 years a n d yearl y 
t hr o u g h year 1 0.  At s o m e of t hese visits, y o u als o will be as ke d t o c o m plet e 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 u alit 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  
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. 
 

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5 2 
 
T he b i 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 orar 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. 
W hile 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. 

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P a g e 3 7 of 5 2 
 
 
  
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 UI O N S P E CI FI C I N F O R M A TI O N H E R E] 
 
W h at 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 ? 

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5 2 
 
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 

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P a g e 3 9 of 5 2 
 
 
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 
 
 
 

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5 2 
 
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 5 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 
 
 
 
 
  
 
 
 

_ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _
 
_ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _
5 2 
 
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 

_ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _
 
_ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _
5 2 
 
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). 
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: 

_ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _
 
_ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _
5 2 
 
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 are a n d t o c hec k t he effecti ve n ess of treat me nt. 6 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 
 

_ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _
 
_ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _
5 2 
 
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 u l 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 
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 ... 

_ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _
 
_ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _
5 2 
 
 

_ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _
 
_ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _
5 2 
 
 

_ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _
 
_ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _
5 2 
 
 
 

_ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _
 
_ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _
5 2 
 
 

_ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _
 
_ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _
5 2 
 
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  
 

_ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _
 
_ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _
5 2 
 
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 _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ 
(Utili 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) 

_ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _
 
_ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _
5 2 
 
 
1 7.  Refere n ces 
 
1 . 
Mi d dlet o n R G, T h o m ps o n I M, A uste nfiel d M S, et al. Pr ostate ca ncer cli nical g ui deli nes p a nel 
s u m mar y re p ort o n t he 
ma na ge me nt of cli nicall y l o calize d pr ost ate ca ncer.  J 
Ur ol. 
1 9 9 5; 1 5 4: 2 1 4 4- 2 1 4 8. 
2.  
Ki n g C R, Le h ma n n J, A dler J R, Hai J.  C y ber K nife ra di ot hera p y f or l ocalize d pr ostate ca ncer: 
rati o nale a n d tec h nical f easi bilit y.  Tec h n ol C a ncer Res Tre at.  2 0 0 3; 2( 1): 2 5- 3 0. 
3.  
F u n g A Y, E n ke C A, A y ya n gar K M, et al. Pr ostate m oti o n a n d is oce nter a dj ust me nt fr o m 
ultras o u n d- base d l ocalizati o n d uri n g d eli ver y of ra diati o n t hera p y. I nt J R a di ati o n O nc ol o gy Bi ol 
P hys.  2 0 0 5; 6 1( 4): 9 8 4- 9 9 2. 
4.  
W o n g J R, Gri m m L, U e mats u M, et al. I ma ge- g ui de d r a di ot hera p y f or pr ostate ca ncer b y C T-
li near accel erat or c o m bi nati o n: pr ostate m o ve me nts a n d d osi metric c o nsi derati o ns.  I nt J R a di at 
O nc ol Bi ol P hys.  2 0 0 5; 6 1( 2.): 5 6 1- 5 6 9. 
5.  
C ha n g S D, Mai n W, Marti n D P, et al.  A n a n al ysis of t he acc urac y of t he C y ber K nife: a r o b oti c 
fra meless stere otactic ra di os ur gical s yste m.  Ne ur os ur gery.  2 0 0 3; 5 2( 1): 1 4 0- 1 4 6. 
6.  
F o wler J F.  T he ra di o bi ol o g y of pr ostate ca ncer i ncl u di n g ne w as pects of fracti o nat e d 
ra di ot hera p y.  A ct a O nc ol.  2 0 0 5; 4 4( 3): 2 6 5- 2 7 6. 
7.  
Li vse y J E, C o wa n R A, W ylie J P, et al.  H y p ofracti o nate d c o nf or m al ra di ot hera p y i n car ci n o ma of 
t he pr ostate: fi ve- year o utc o me a nal ysis.  I nt J R a di at O nc ol Bi ol P hys. 2 0 0 3; 5 7( 5): 1 2 5 4- 1 2 5 9. 
8.        Grills I S, Marti nez A A, H olla n der M, et al.  Hi g h d ose rate brac h yt hera p y as pr ostate ca n cer 
m o n ot hera p y re d u ces t o xicit y c o m par e d t o l o w d ose rate palla di u m see ds. J Ur ol. 2 0 0 4; 1 7 1: 1 0 9 8-
1 1 0 4. 
9.        Bl ute M L, Ber gsrtal h EJ, Parti n, A W, et al. Vali dati o n of Parti n Ta bles f or pre dicti n g pat h ol o gi cal 
sta ge of cli nicall y l ocalize d pr ostate ca ncer. J Ur ol  1 6 5: 1 5 9 1- 1 5 9 5, 2 0 0 0. 
1 0.        Blas k o J C, Gri m m P D, S yl vester J E, et al. Palla di u m- 1 0 3 Br ac h yt her a p y f or Pr ostate Carci n o ma. 
I nt J R a di at O nc ol Bi ol P hys. 2 0 0 0; 4 6( 4): 8 3 9- 8 5 0 
1 1.        Gri m m P D, Blas k o J C, S yl vester J E, 1 0 year bi oc he mical ( pr ostate-s pecific a nti ge n) c o ntr ol of 
pr ostate ca n cer wit h ( 1 2 5)I brac h yt h er a p y. I nt J R a di at O nc ol Bi ol P hys. 2 0 0 1: 5 1( 1): 3 1- 4 0 
1 2.       C ha o K K, G ol dstei n N S, Ya n D, et al, Cli nic o pat h ol o gic e val uati o n of e xtraca ps ular e xte nsi o n i n 
pr ostate  ca n cer: s h o ul d t he cli nical tar get v ol u me be e x pa n de d p oster olater all y t o acc o u nt f or 
micr osc o pic e xte nsi o n?  I nt J R a di at O nc ol Bi ol P hys. 2 0 0 6; 6 5( 4): 9 9 9- 1 0 0 7 
1 3.  
J ol y F, Br u ne D, C o uett e J E, et al. H ealt h- Relate d q ualit y of life a n d s e q uelae i n p atie nts treate d 
wit h brac h yt her a p y a n d e xter nal bea m irr a diati o n f or l ocalize d pr ostate ca ncer. A n n al of O nc ol . 
1 9 9 8; 9: 7 5 1- 7 5 7. 
1 4.    Hara 
W, Patel D, Pa wlic ki T, C otr utz C, Presti J, Ki n g C, . H y p ofracti o nate d Stere otactic 
Ra di ot hera p y f or Pr ostat e Ca ncer: E arl y Res ults, I nt J R a di at O n c ol Bi ol P hys. 1 N o v e m ber 2 0 0 6 
( V ol 6 6, Iss ue 3, pa ges S 3 2 4- S 3 2 5).  
1 5.    G hileza n M, V ar gas C, G ustafs o n G, H olla n der M, Balas u br a ma nia m M, C he n P, Br a b bi ns D, 
K or ma n H, Se bastia n E, E d m u ns o n G, G o nzales J, 
Marti nez A. H D R vers us L D R ( P D- 1 0 3 
per ma ne nt i m pla nts) br ac h yt her a p y as m o m ot hera p y fr pr ostate ca ncer. Ti mi n g t o o nset a n d 
pre dict ors of erestile d ysf u ncti o n.  I nt J R a di at O nc ol Bi ol P hys. 2 0 0 4; 6 0( 1): S 4 4 2. 
1 6.    W ei J, D u n n R, Lit wi n M, Sa n dler H, a n d Sa n da M. " De v el o p me nt a n d Vali dati o n of t he E x pa n de d 
Pr ostate Ca ncer I n de x C o m p osite ( E PI C) f or C o m pre he nsi ve Assess me nt of Healt h- Relate d 
Q ualit y of Lif e i n Me n wit h Pr ostate Ca ncer", Ur ol o g y. 5 6: 8 9 9- 9 0 5, 2 0 0 0. 

_ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _
 
_ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _
5 2 
 
1 7.    W ei J T, D u n n R L, Sa n dler H M, Mc La u g hli n P W, M o ntie J E, Lit wi n M S, N y q uist L, Sa n da M G. 
C o m pre he nsi ve c o m p aris o n of healt h-relate d q ualit y of life after c o nt e m p orar y t h era pies f or 
l ocalize d pr ostate ca n cer. J Cli n O nc ol. 2 0 0 2 J a n 1 5; 2 0( 2): 5 5 7- 6 6. 
1 8.   Hi g h D ose Rat e M o n ot hera p y f or Pr ostat e Ca ncer. Sc h o ur L, De ma nes DJ, Altieri G A, Bra n dt D, 
Bar n a ba M, S k o olisari ya p or n P. 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 
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) 
1 9.   G hileza n M, Var gas C, G ustafs o n G, B oi ke T, C ha o K, Kesti n L, Grills I, Se bastia n E, Marti nez A. 
Si milar 5- year Cli nical O utc o me f or Hi g h D ose Rate ( H D R) a n d L o w D ose Rate ( L D R) 
Brac h yt her a p y ( B T) f or Earl y Pr ostate Ca ncer Patie nts. 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 7) 
2 0.  . Mar k RJ, Valla b ha n G, A ki ns P, A n ders o n P, Nair M, Ne u ma n n T, W hite D, G urle y S. I nterstitial 
Hi g h D ose Rate ( H D R) Brac h yt her a p y f or Earl y Sta ge 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, 1 Oct o ber 2 0 0 5 ( V ol 6 3, Pa ge S 3 0 4) 
2 1.    R o gers L, Ha yes J, C hil ds R, Ha nse n R, S pear ma n J, S weet J, Gar za M, Al der S. Hi g h D ose Rate 
( H D R) Brac h yt her a p y as 
M o n ot hera p y f or Cli nicall y L o calize d Pr ostat e Ca ncer, 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 N o ve m ber  2 0 0 6 ( V ol 6 6, Iss u e 3, Pa ges 
S 3 7 7- S 3 7 8) 
2 2.    Y os hi o ka Y, K o nis hi K, O h R, Ya maza ki H, Na ka m ur a S, Nis hi m ura K, N o n o m ura N, O k u ya ma A, 
I n o u e T. Hi g h d ose rate brac h yt her a p y wit h o ut e xter nal bea m irra diati o n f or l ocall y a d va nce d 
pr ostate 
                                                 
1 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. 
 
2T 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 
 
3 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 
rad iati 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. 
 
4 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 ostate 
Bra c h yt her a p y. I nt J Ra d O nc ol Bi ol P h ys. 1 O ct 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) 
 
5 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. 
  
6 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