Clinical trial: NCT01940276
Section: Alternatives
Subsections: W H A T A L T E R N A Ti V E S A R E T H E R E T O P A R Ti Ci P A Ti O N I N T Hi S S T U D Y ?

If y o u deci de n ot t o ta ke part i n t his st u d y, ot her a p pr o ve d treat me nts are a vaila ble t o y o u, w hic h t he st u d y d oct or will e x plai n t o y o u. Y o u ma y recei ve treat me nt t o c o ntr ol t he s y m pt o ms y o u ma y be ha vi n g as a res ult of y o ur disease. Ot her o pti o ns ma y i ncl u de c he m ot hera p y a n d ra diati o n t hera p y. Y o u ma y als o c h o ose t o ha ve n o treat me nt f or y o ur ca ncer; recei vi n g o nl y palliati ve care t o ma na ge y o ur s y m pt o ms a n d ma ke y o u feel m ore c o mf orta ble. St u d y staff will disc uss t hese alter nati ve treat me nts a n d t he ris ks a n d be nefits ass ociate d wit h t hese treat me nts wit h y o u bef ore y o u ta ke part i n t his st u d y.  
Please tal k t o y o ur d oct or a b o ut t hese a n d per ha ps ot her o pti o ns.
Clinical trial: NCT01940276
Section: Confidentiality
Subsections: Wi L L M Y I N F O R M A Ti O N B E K E P T C O N Fi D E N Ti A L ?

Partici pati o n i n researc h i n v ol ves s o me l oss of pri vac y. We will d o o ur best t o ma ke s ure t hat i nf or mati o n a b o ut y o u is ke pt c o nfi de ntial, b ut we ca n n ot g uara ntee t otal c o nfi de ntialit y. Y o ur pers o nal i nf or mati o n ma y be vie we d b y i n di vi d uals i n v ol ve d i n t his researc h a n d ma y be see n b y pe o ple i ncl u di n g t h ose c olla b orati n g, f u n di n g, a n d re g ulati n g t he st u d y. We will s hare o nl y t he mi ni m u m necessar y i nf or mati o n i n or der t o c o n d uct t he researc h. Y o ur pers o nal i nf or mati o n ma y als o be gi ve n o ut if re q uire d b y la w.  
As part of t he st u d y, res ults of y o ur st u d y-relate d la b orat or y tests, x-ra ys, a n d pr oce d ures ma y be re p orte d t o Ja nsse n Scie ntific Affairs a n d its affiliates. I n a d diti o n, y o ur rec or ds ma y be re vie we d i n or der t o meet fe deral or state re g ulati o ns. Re vie wers ma y i ncl u de re prese ntati ves fr o m t he F o o d a n d Dr u g A d mi nistrati o n, re prese ntati ves a n d affiliates of Ja nsse n Scie ntific Affairs, t he D u ke U ni versit y Healt h S yste m I nstit uti o nal Re vie w B oar d, a n d ot hers as a p pr o priate. If a n y of t hese gr o u ps re vie w y o ur researc h rec or d, t he y ma y als o nee d t o re vie w y o ur e ntire me dical rec or d.  
St u d y rec or ds t hat i de ntif y y o u will be ke pt c o nfi de ntial as re q uire d b y la w. Fe deral Pri vac y Re g ulati o ns pr o vi de safe g uar ds f or pri vac y, sec urit y, a n d a ut h orize d access. E xce 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 me, s ocial sec urit y n u m ber, a d dress, tele p h o ne n u m ber, or a n y ot her direct pers o nal i de ntifier i n st u d y rec or ds discl ose d o utsi de of D u ke U ni versit y Healt h S yste m ( D U H S). F or rec or ds discl ose d o utsi de of D U H S, y o u will be assi g ne d a u ni q ue c o de n u m ber. T he ke y t o t he c o de   
Acetate pl us Pre d nis o ne i n Africa n A merica n a n d Ca ucasia n Me n wit h metastatic castrate-resista nt pr ostate ca ncer I n vesti gat or: Da niel Ge or ge, M D  
will be ke pt i n a l oc ke d file i n Dr. Ge or ge's office or i n t he office of a desi g nate d st u d y tea m staff me m ber. Neit her t he l ocal sites n or t he patie nts will recei ve i nf or mati o n re gar di n g i n di vi d ual s u bjects' res ults. T he bl o o d a n d tiss ue sa m ples c ollecte d f or t his st u d y will be st ore d at D U H S a n d la bele d wit h y o ur u ni q ue c o de n u m ber, a n d access t o y o ur sa m ples will be li mite d t o desi g nate d st u d y tea m staff me m bers. D U H S ca n n ot ass ure t he de-i de ntificati o n of i ma ges se nt o utsi de of D u ke.  
As part of t his st u d y, Dr. Ge or ge a n d his st u d y tea m will as k y o u t o ha ve certai n tests. S o me of t hese bl o o d a n d x-ra y st u dies w o ul d ha ve bee n d o ne as part of y o ur re g ular care. He will use t hese test res ults b ot h t o treat y o u a n d t o c o m plete t his researc h. T hese test res ults will be rec or de d i n y o ur me dical rec or d a n d will be re p orte d t o t he researc h data office at D u ke. Res ults of tests a n d st u dies d o ne s olel y f or t his researc h st u d y a n d n ot as part of y o ur re g ular care will n ot be i ncl u de d i n y o ur me dical rec or d.  
Y o u als o pr o vi de c o nse nt f or t he release of c o pies of y o ur C T sca ns, la b orat or y test res ults, a n d me dical re p orts f or re vie w as part of t his researc h st u d y. I nf or mati o n a b o ut y o ur disease stat us ma y be re q ueste d a n d re vie we d o n a re g ular basis after y o u ha ve c o m plete d all visits i n t his st u d y. T his is necessar y t o e ns ure t hat t he st u d y is perf or me d acc or di n g t o t he a p pr o ve d pr ot oc ol, a n d t hat t he data c ollecte d is c orrectl y rec or de d. B y si g ni n g t his c o nse nt f or m, y o u are a ut h orizi n g access t o y o ur me dical rec or ds data c ollecte d fr o m y o ur partici pati o n i n t his st u d y. Y o ur rec or ds ma y be re vie we d i n or der t o meet fe deral or state re g ulati o ns. Re vie wers ma y i ncl u de re prese ntati ves fr o m t he F o o d a n d Dr u g A d mi nistrati o n, re prese ntati ves of Ja nsse n Scie ntific Affairs a n d its desi g nees), Nati o nal I nstit utes of Healt h, Nati o nal Ca ncer I nstit ute, D u ke Ca ncer I nstit ute, a n d t he D u ke U ni versit y Healt h S yste m I nstit uti o nal Re vie w B oar d. If a n y of t hese gr o u ps re vie w y o ur researc h rec or d, t he y ma y als o nee d t o re vie w y o ur e ntire me dical rec or d. T his i nf or mati o n ma y be f urt her discl ose d b y t he s p o ns or of t his st u d y, D u ke U ni versit y. If discl ose d b y t he s p o ns or, t he i nf or mati o n is n o l o n ger c o vere d b y t he fe deral pri vac y re g ulati o ns. If t his i nf or mati o n is discl ose d t o o utsi de re vie wers f or a u dit p ur p oses, it ma y be f urt her discl ose d b y t he m a n d ma y n ot be c o vere d b y t he fe deral pri vac y re g ulati o ns.  
T he st u d y res ults will be retai ne d i n y o ur researc h rec or d f or at least si x years after t he st u d y is c o m plete d. At t hat ti me eit her t he researc 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 res ults at D U H S. A n y researc 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.  
S o me i nf or mati o n c ollecte d a b o ut y o u o nl y f or t his researc h st u d y ma y be ke pt i n a researc h st u d y rec or d se parate fr o m y o ur me dical rec or d, a n d s o me researc h i nf or mati o n ma y als o be part of y o ur me dical rec or d. Y o u will n ot ha ve access t o t his researc h i nf or mati o n u ntil t he e n d of t he st u d y.  
H o we ver, it will be a vaila ble t o y o ur p h ysicia ns if nee de d f or y o ur care.  
W hile t he i nf or mati o n a n d data res ulti n g fr o m t his st u d y ma y be prese nte d at scie ntific meeti n gs or p u blis he d i n a scie ntific j o ur nal, y o ur i de ntit y will n ot be re veale d.  
Pr ot o c ol I D: Pr o 0 0 0 4 6 3 8 3 C o nti n ui n g R e vi e w B ef or e: 1 0/ 3/ 2 0 1 8 R ef er e n c e D at e: 3/ 5/ 2 0 1 8 P a g e 1 7 of 2 1 S u bj e ct I niti al s:  
  
Acetate pl us Pre d nis o ne i n Africa n A merica n a n d Ca ucasia n Me n wit h metastatic castrate-resista nt pr ostate ca ncer I n vesti gat or: Da niel Ge or ge, M D
Clinical trial: NCT01940276
Section: Duration of Study Involvement
Subsections: H O W M A N Y P E O P L E Wi L L T A K E P A R T I N T Hi S S T U D Y ?|H O W L O N G Wi L L I B E I N T Hi S S T U D Y ?

U p t o 1 3 0 pe o ple will ta ke part i n t his st u d y acr oss t he 8 st u d y sites ( D u ke U ni versit y Me dical Ce nter, t he D u ke Ca ncer Net w or k, a n d 6 differe nt h os pitals a n d me dical facilities) wit h u p t o 8 5 pe o ple partici pati n g at all D u ke-affiliate d sites.

If y o u deci de t o partici pate, y o u will be o n t his st u d y f or t he rest of y o ur life. Y o u will be as ke d t o re mai n acti ve o n st u d y dr u g u ntil y o ur ca ncer w orse ns (acc or di n g t o t he C T, M RI, or b o ne sca n res ults),  
y o u are u na ble t o t olerate t he st u d y dr u g, y o ur d oct ors deter mi nes t hat y o u s h o ul d be gi n a n ot her ca ncer treat me nt, or y o u deci de t o wit h dra w c o nse nt. D uri n g y o ur first 3 m o nt hs i n t he st u d y, y o u will ma ke a b o ut 5 visits t o t he cli nic. After war ds, y o u will visit t he cli nic a b o ut o nce e ver y 3 m o nt hs f or u p t o 2 4 m o nt hs. If y o u re mai n o n st u d y f or t he f ull 2 4 m o nt hs, y o u will visit t he cli nic a t otal of a b o ut 1 3 ti mes  
(i ncl u di n g t he e n d of st u d y a n d f oll o w- u p safet y visits).  
After y o ur f oll o w- u p safet y visit, y o u will visit t he cli nic a b o ut o nce e ver y 3 m o nt hs f or u p t o 2 4 m o nt hs after starti n g t he st u d y. If y o u disc o nti n ue d st u d y dr u g f or reas o ns ot her t ha n disease pr o gressi o n, cli nic st u d y staff will c ollect i nf or mati o n relate d t o t he pr o gressi o n of y o ur disease (f or e xa m ple sta n dar d of care sca ns, sta n dar d of care la bs, ne w t hera pies) t o f oll o w y o u u ntil y o ur disease gets w orse. After all of y o ur st u d y visits are c o m plete d, we will c o nti n ue t o c o ntact y o u b y p h o ne e ver y 6 m o nt hs t o fi n d o ut t he stat us of y o ur healt h.  
Y o u ca n c h o ose t o st o p partici pati n g at a n y ti me wit h o ut pe nalt y or l oss of a n y be nefits t o w hic h y o u are e ntitle d. H o we ver, if y o u deci de t o st o p partici pati n g i n t he st u d y, we e nc o ura ge y o u t o tal k t o y o ur d oct or first.
Clinical trial: NCT01940276
Section: Participant Responsibilities
Subsections: S U Bject Res P O Nsi Bilities

If y o u are eli gi ble a n d deci de t o ta ke part i n t he st u d y, y o u will nee d t o d o t he f oll o wi n g t hi n gs:  
Re p ort t o t he st u d y cli nic f or all sc he d ule d visits a n d ot her visits as re q ueste d b y t he st u d y staff F oll o w i nstr ucti o ns o n ta ki n g st u d y dr u gs. A birater o ne acetate m ust be ta ke n o n a n e m pt y st o mac h.  
N o f o o d s h o ul d be c o ns u me d f or at least t w o h o urs bef ore t he d ose of a birater o ne acetate is ta ke n a n d f or at least o ne h o ur after t he d ose of a birater o ne acetate is ta ke n.  
Re p ort a n y reacti o ns or u n wa nte d si de effects (a d verse e ve nts) t o y o ur st u d y d oct or  
  
Acetate pl us Pre d nis o ne i n Africa n A merica n a n d Ca ucasia n Me n wit h metastatic castrate-resista nt pr ostate ca ncer I n vesti gat or: Da niel Ge or ge, M D  
Re p ort ta ki n g a n y a d diti o nal me dicati o ns t o y o ur st u d y d oct or. T his i ncl u des vita mi ns, dietar y s u p ple me nts, her bal or alter nati ve re me dies, me dicati o ns t hat are prescri be d b y a d oct or, a n d o vert he-c o u nter me dicati o ns. If y o u feel t hat y o u nee d t o ta ke a ne w me dicati o n or her bal re me d y, y o u m ust call t he st u d y d oct or a n d get a p pr o val bef ore ta ki n g t he me dicati o n.  
T he st u d y staff will rec or d t he a b o ve i nf or mati o n i n y o ur st u d y rec or ds a n d f oll o w a n y a d verse e ve nt  
(si de effect) t hat ma y occ ur. It is i m p orta nt t hat y o u i m me diatel y re p ort a n y ne w s y m pt o ms or w orse ni n g of s y m pt o ms t hat y o u ha ve t o t he st u d y staff.  
Recei vi n g a n y ot her pr ostate ca ncer t hera p y or ot her i n vesti gati o nal dr u gs is n ot all o we d w hile y o u are ta ki n g t he st u d y dr u gs. Ta ki n g ster oi ds ot her t ha n pre d nis o ne s h o ul d be disc usse d first wit h y o ur st u d y d oct or. T he st u d y staff will disc uss t hese restricti o ns wit h y o u i n m ore detail.  
Partici pati o n i n t his researc h st u d y is c o m pletel y v ol u ntar y. If y o u c h o ose n ot t o si g n t his c o nse nt f or m y o u will c o nti n ue t o recei ve care, b ut n ot as part of t his st u d y.
Clinical trial: NCT01940276
Section: Possible Risks, Discomforts, and Inconveniences
Subsections: W H A T A R E T H E Ri S K S O F T H E S T U D Y ?|Re Pr O D Ucti Ve Ris Ks:|Ris Ks Of R A Di Ati O N:|Ris Ks Of Dr A Wi N G Bl O O D:|A R E T H E R E B E N E Fi T S T O T A Ki N G P A R T I N T H E S T U D Y ?|W H A T A B O U T R E S E A R C H R E L A T E D I N J U Ri E S ?

M ore t ha n 1 9 0 0 male s u bjects wit h pr ostate ca ncer ha ve recei ve d a birater o ne acetate, eit her al o ne or c o m bi ne d wit h ot her dr u gs. Si nce t he wa y t he a birater o ne is bei n g use d i n t his st u d y is i n vesti gati o nal, n ot all of t he p ote ntial a d verse ( ba d) effects i n h u ma ns are k n o w n. Als o t he ris ks or disc o mf orts descri be d bel o w ma y occ ur m ore ofte n or be m ore se vere t ha n bee n pre vi o usl y see n. I n a d diti o n t o t he p ossi ble a d verse effects liste d bel o w, t here is al wa ys t he p ossi bilit y of u nc o m m o n or u ne x pecte d a d verse effects t hat y o u ma y e x perie nce.  
Y o u ma y ha ve si de effects fr o m ta ki n g t he st u d y dr u g (a birater o ne acetate, pre d nis o ne). E ver y o ne ta ki n g part i n t he st u d y will be watc he d caref ull y f or a n y si de effects. H o we ver, d oct ors d o n't k n o w all t he si de effects t hat ma y ha 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 c o ul d gi ve y o u me dici nes t o treat t he si de effects. Ma n y si de effects ca use d b y st u d y me dicati o n ma y g o a wa y s o o n after y o u st o p ta ki n g t he st u d y re gi me n. I n s o me cases si de effects ca n be seri o us, l o n g lasti n g, or ma y ne ver g o a wa y. It is n ot p ossi ble t o tell w hic h si de effect will affect y o u or h o w mil d or se vere t he si de effect mi g ht bec o me. We ca n o nl y tell y o u w hat ot her pe o ple ha ve e x perie nce d. Please tal k wit h y o ur d oct or a b o ut t hese si de effects.  
Y o u s h o ul d tell y o ur d oct or a b o ut a n y si de effects, pr o ble ms or u n us ual e x perie nces t hat y o u ha ve w hile ta ki n g part i n t his st u d y. T his will decrease t he c ha nce t hat t he si de effects c o nti n ue or bec o me w orse.  
  
Acetate pl us Pre d nis o ne i n Africa n A merica n a n d Ca ucasia n Me n wit h metastatic castrate-resista nt pr ostate ca ncer I n vesti gat or: Da niel Ge or ge, M D  
S o meti mes t here are ot her me dicati o ns t hat y o ur st u d y d oct or ca n gi ve y o u t o ma ke t he si de effects better or ma ke y o u m ore c o mf orta ble. If se vere si de effects d o de vel o p, y o u a n d y o ur st u d y d oct or ma y deci de it is i n y o ur best i nterest t o st o p ta ki n g part i n t he st u d y.  
At prese nt, k n o w n si de effects t hat c o ul d be relate d t o t he a birater o ne acetate i ncl u de:  
Fre q ue nt ( 2 0 % or m ore) [ Ma y occ ur i n 2 0 or m ore patie nts i n 1 0 0]  
e de ma peri p heral (s welli n g of t he le gs as a res ult of t he b o d y kee pi n g t o o m uc h fl ui d)  
h y p o kalae mia (l o w bl o o d p otassi u m, a mi neral t hat hel ps re g ulate heart rate/f u ncti o n, fl ui d bala nce i n t he b o d y a n d is nee de d f or a de q uate b o d y f u ncti o n)  
h y perte nsi o n ( hi g h bl o o d press ure)  
Ver y C o m m o n ( 1 0 % t o 1 9 %) [ Ma y occ ur bet wee n 1 0 a n d 1 9 patie nts i n 1 0 0]  
Ala ni ne a mi n otra nsferase i ncrease d a n d/ or as partate a mi n otra nsferase i ncrease d (e nz y mes i n t he  
```
bl o o d t hat meas ure t hte f u ncti o n of t he li ver)

uri nar y tract i nfecti o n


```  
C o m m o n ( 5 % t o 9 %) [ Ma y occ ur bet wee n 5 t o 9 patie nts i n 1 0 0]  
d ys pe psia ( u nc o mf orta ble feeli n g i n u p per bell y, i n di gesti o n)  
he mat uria ( prese nce of bl o o d i n t he uri ne)  
fract ures ( a brea k i n t he b o ne)  
Less C o m m o n (less t ha n 5 % [ Ma y occ ur i n fe wer t ha n 5 patie nts i n 1 0 0]  
h y pertri gl yceri dae mia ( hi g h le vels of fats (tri gl yceri des) i n t he bl o o d)  
car diac fail ure ( heart fail ure, t he heart is u na ble t o s u p pl y e n o u g h bl o o d fl o w t o meet t he b o d y's nee ds.)  
a n gi na pect oris (c hest pai n)  
arr h yt h mia (c ha n ges i n t he r h yt h m of t he heart)  
atrial fi brillati o n (a fast a n d irre g ular heart beat)  
tac h ycar dia (ra pi d heart beats)  
U nc o m m o n (less t ha n 1 %) [ Ma y occ ur bet wee n 1 a n d 9 patie nts i n 1 0 0 0]  
a dre nal i ns ufficie nc y ( decrease d f u ncti o n of a dre nal gla n ds t hat n or mall y hel p mai ntai n bl o o d press ure, bala nce mi nerals a n d fl ui d i n y o ur b o d y)  
R ha b d o m y ol ysis ( brea k d o w n of m uscle tiss ue) a n d m y o pat h y ( m uscle wea k ness a n d/ or m uscle pai n).  
Rare (less t ha n 0. 1 %) [ Ma y occ ur bet wee n 1 a n d 1 0 patie nts i n 1 0 0 0 0]
Pr ot o c ol I D: Pr o 0 0 0 4 6 3 8 3 C o nti n ui n g R e vi e w B ef or e: 1 0/ 3/ 2 0 1 8 R ef er e n c e D at e: 3/ 5/ 2 0 1 8 P a g e 1 0 of 2 1 S u bj e ct I niti al s:  
  
Acetate pl us Pre d nis o ne i n Africa n A merica n a n d Ca ucasia n Me n wit h metastatic castrate-resista nt pr ostate ca ncer I n vesti gat or: Da niel Ge or ge, M D  
aller gic al ve olitis (s welli n g a n d irritati o n of t he l u n g)  
fail ure of t he li ver t o f u ncti o n (calle d ac ute li ver fail ure).  
T here is a s mall c ha nce of se vere aller gic reacti o n t o t he dr u g w hic h ma y be life-t hreate ni n g.  
A birater o ne Acetate s h o ul d be use d wit h ca uti o n i n s u bjects wit h a hist or y of car di o vasc ular disease.  
Bef ore ta ki n g a birater o ne acetate, hi g h bl o o d press ure m ust be c o ntr olle d a n d l o w p otassi u m m ust be c orrecte d. O ne s u bject die d w hile ta ki n g a birater o ne acetate wit h o ut pre d nis o ne i n a n earl y trial. His d oct or felt t hat he die d as a res ult of a heart attac k ass ociate d wit h se verel y l o w bl o o d p otassi u m, a n d t hat t his was pr o ba bl y relate d t o a birater o ne acetate. P otassi u m is nee de d f or pr o per f u ncti o n of y o ur heart a n d ot her esse ntial b o d y s yste ms. It is es peciall y i m p orta nt t hat y o u c o ntact y o ur st u d y d oct or ri g ht a wa y if y o u ca n n ot c o me t o y o ur re g ularl y sc he d ule d visit or get y o ur bl o o d tests, si nce s o me s u bjects ha ve n o s y m pt o ms w he n t heir bl o o d p otassi u m is l o w. C o ntact y o ur st u d y d oct or i m me diatel y if y o u feel wea k, if y o u ha ve c o nsti pati o n, or if y o u ha ve m uscle pai n or cra m ps. T hese s y m pt o ms ma y be ca use d b y l o w bl o o d p otassi u m. Als o, if y o ur a p petite decreases, or if y o u de vel o p diarr hea, y o u s h o ul d c o ntact t he st u d y d oct or, si nce p otassi u m ma y bec o me l o w if y o u are n ot eati n g well, or y o ur p otassi u m ma y be l ost t hr o u g h diarr hea.  
Pre d nis o ne t o get her wit h a birater o ne acetate, will be gi ve n t o y o u i n t his st u d y i n or der t o re d uce or eli mi nate s o me si de effects, s uc h as hi g h bl o o d press ure, l o w bl o o d p otassi u m, a n d s welli n g of t he le gs as a res ult of t he b o d y kee pi n g t o o m uc h fl ui d.  
N o s pecific la b orat or y e x peri me nts i n a ni mals were perf or me d t o i n vesti gate t he effect of a birater o ne acetate o n t he fertilit y of male a n d fe male a ni mals or t he effect of a birater o ne acetate o n t he fet us i n pre g na nt a ni mals. H o we ver, i n ge neral t o xicit y st u dies i n la b orat or y a ni mals a birater o ne acetate affecte d t he re pr o d ucti ve or ga ns i n male a n d fe male a ni mals. T heref ore a birater o ne acetate m ust n ot be ta ke n b y w o me n w h o ma y bec o me pre g na nt.  
O ne of t he p ote ntial si de effects of t his st u d y dr u g is t hat it ma y re d uce t he pr o d ucti o n of c ortis ol, a h or m o ne, b y t he a dre nal gla n ds. T he a dre nal gla n ds are res p o nsi ble f or t he pr o d ucti o n of se veral h or m o nes t hat re g ulate salt a n d water rete nti o n, bl o o d press ure, s u gar le vels a n d t he b o d y's a bilit y t o res p o n d t o stress (s uc h as ill ness or se vere i nj ur y). I n t his st u d y, y o u will be ta ki n g pre d nis o ne, a me dicati o n t hat w or ks li ke c ortis ol, w hic h ma y i m pr o ve t he st u d y re gi me n si de effects. H o we ver, pre d nis o ne ma y re d uce y o ur b o d y's a bilit y t o res p o n d t o stress. T heref ore, if y o u e x perie nce a n y ill ness or se vere i nj ur y y o u s h o ul d n otif y y o ur st u d y d oct or or a n y ot her healt hcare pr o vi der i m me diatel y, as a n i ncrease d d ose of pre d nis o ne or c ortic oster oi d ma y be re q uire d. We will still be m o nit ori n g all si de effects liste d a b o ve. Ot her si de effects will als o be caref ull y watc he d. If t he y d o ha p pe n, a p pr o priate me dicati o n will be prescri be d.  
  
Acetate pl us Pre d nis o ne i n Africa n A merica n a n d Ca ucasia n Me n wit h metastatic castrate-resista nt pr ostate ca ncer I n vesti gat or: Da niel Ge or ge, M D  
If y o u e x perie nce a n y ill ness or disc o mf ort d uri n g t he st u d y, y o u s h o ul d n otif y y o ur st u d y d oct or i m me diatel y. Y o ur d oct or will t he n e xa mi ne y o u t o deter mi ne if y o u s h o ul d c o nti n ue i n t he st u d y.

Y o ur partici pati o n i n t his researc h ma y da ma ge y o ur s per m, w hic h c o ul d ca use har m t o a c hil d t hat y o u ma y fat her w hile o n t his st u d y. S uc h har m ma y be c urre ntl y u nf oreseea ble. If y o u are se x uall y acti ve, y o u m ust a gree t o use a c o n d o m use d wit h a s per mici de i n or der t o be i n t his st u d y a n d f or 1 wee k after war d. E ve n if y o u ha ve ha d a s ur gical sterilizati o n (s uc h as a vasect o m y) y o u s h o ul d use a c o n d o m wit h a s per mici de beca use of k n o w n ris ks t o a de vel o pi n g fet us. C o ntrace pti ve meas ures s uc h as Pla n B  
( T M), s ol d f or e mer ge nc y use after u n pr otecte d se x, are n ot acce pta ble met h o ds f or r o uti ne use. Y o u s h o ul d i nf or m y o ur part ner of t he p ote ntial f or har m t o a n u n b or n c hil d. S he s h o ul d k n o w t hat if pre g na nc y occ urs, y o u will nee d t o re p ort it t o t he st u d y d oct or, a n d s he s h o ul d pr o m ptl y n otif y her d oct or.  
Base d o n its mec ha nis m of acti o n, A birater o ne acetate ma y har m a de vel o pi n g fet us. T heref ore, w o me n w h o are pre g na nt or w o me n w h o ma y be pre g na nt s h o ul d n ot ha n dle a birater o ne acetate wit h o ut pr otecti o n, e. g. gl o ves.

All tests a n d pr oce d ures i n v ol vi n g ra diati o n f or t his st u d y are c o nsi dere d sta n dar d of care, mea ni n g t he y are r o uti nel y d o ne f or y o ur disease t y pe. Y o u will n ot recei ve a n y e xtra ra diati o n b y partici pati n g i n t his st u d y.

Ris ks ass ociate d wit h dra wi n g bl o o d fr o m y o ur ar m i ncl u de m o me ntar y disc o mf ort a n d/ or br uisi n g.  
I nfecti o n, e xcess blee di n g, cl otti n g, or fai nti n g are als o p ossi ble, alt h o u g h u nli kel y.  
Dr u g I nter acti o ns: F or y o ur safet y, y o u m ust tell t he st u d y d oct or or n urse a b o ut all t he prescri be d me dical f o o ds a n d dr u gs, her bal pr o d ucts, o ver-t he-c o u nter ( O T C) dr u gs, vita mi ns, nat ural re me dies, a n d alc o h ol t hat y o u are ta ki n g bef ore y o u start t he st u d y a n d bef ore ta ki n g a n y of t hese pr o d ucts w hile y o u are o n t he st u d y.  
T here ma y be ris ks, disc o mf orts, dr u g i nteracti o ns or si de effects t hat are n ot yet k n o w n.   
Acetate pl us Pre d nis o ne i n Africa n A merica n a n d Ca ucasia n Me n wit h metastatic castrate-resista nt pr ostate ca ncer I n vesti gat or: Da niel Ge or ge, M D

T here is n o pr o mise t hat t he st u d y dr u g y o u recei ve will hel p y o u. Partici pati o n i n t his researc h st u d y is base d o n t he e x pectati o n t hat t he be nefit ass ociate d wit h partici pati o n, e ve n c o nsi deri n g t he ris k of har mf ul reacti o ns t o t he st u d y dr u gs, ma y be better t ha n t he alter nati ve treat me nts. Please disc uss wit h y o ur st u d y d oct or w hic h alter nati ve treat me nts are a vaila ble f or y o u. It is h o pe d t hat p ote ntial be nefits ma y i ncl u de i m pr o vi n g disease relate d s y m pt o ms a n d decreasi n g t he size of y o ur t u m or. Y o u s h o ul d be a ware t hat t his st u d y re gi me n y o u recei ve ma y be har mf ul. I nf or mati o n o btai ne d fr o m y o ur partici pati o n ma y hel p ot her pe o ple wit h y o ur c o n diti o n i n t he f ut ure.

I m me diate necessar y me dical care is a vaila ble at D u ke U ni versit y Me dical Ce nter i n t he e ve nt t hat y o u are i nj ure d as a res ult of y o ur partici pati o n i n t his researc h st u d y. H o we ver, t here is n o c o m mit me nt b y D u ke U ni versit y, D u ke U ni versit y Healt h S yste m, I nc., y o ur D u ke p h ysicia ns or Ja nsse n Scie ntific Affairs t o pr o vi de m o netar y c o m pe nsati o n or free me dical care t o y o u i n t he e ve nt of a st u d y-relate d i nj ur y.  
F or q uesti o ns a b o ut t he st u d y or researc h-relate d i nj ur y, c o ntact Dr. Ge or ge at d uri n g re g ular b usi ness h o urs a n d at a n d as k f or Dr. Ge or ge t o be pa ge d after h o urs a n d o n wee ke n ds a n d h oli da ys.
Clinical trial: NCT01940276
Section: Procedures
Subsections: W H A T I S I N V O L V E D I N T H E S T U D Y ?|Visits D Uri N G St U D Y Dr U G

If y o u a gree t o be i n t his st u d y, y o u will be as ke d t o si g n a n d date t his c o nse nt f or m. Y o u will ha ve t he f oll o wi n g tests a n d pr oce d ures t o ma ke s ure t hat y o u are eli gi ble:  
Y o u will be as ke d q uesti o ns a b o ut y o urself a n d y o ur healt h pr o ble ms, i ncl u di n g past s ur geries  
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a n d past treat me nts f or C R P C.

Y o u will be as ke d a b o ut me dicati o ns t hat y o u are c urre ntl y ta ki n g, i ncl u di n g o ver-t he-c o u nter

me dicati o ns, her bal re me dies, vita mi ns, a n d s u p ple me nts.

Y o u will ha ve a p h ysical e xa mi nati o n, w hic h will i ncl u de meas uri n g y o ur te m perat ure, bl o o d

press ure, hei g ht, wei g ht, heart rate, breat hi n g rate, a n d healt h stat us.

Y o u will be as ke d a b o ut a n y disease-relate d s y m pt o ms y o u are e x perie nci n g.

Y o u will be as ke d t o fill o ut a q uesti o n naire a b o ut y o ur race a n d et h nicit y.

Y o u will ha ve a n electr ocar di o gra m ( E C G) perf or me d t o meas ure t he electrical acti vit y of y o ur

heart.

Y o u will ha ve a c o m p ute d t o m o gra p h y ( C T) sca n or a ma g netic res o na nce i ma gi n g ( M RI) of

y o ur c hest, a b d o me n, a n d pel vis, a n d if nee de d, ot her areas t o e val uate y o ur disease. A C T sca n

uses s pecial x-ra y e q ui p me nt t o ta ke pict ures of t he b o d y. T he M RI sca n uses ma g netic a n d ra di o

wa ves, mea ni n g t hat t here is n o e x p os ure t o i o nizi n g ra diati o n. F or t he C T a n d M RI sca n, y o u

will be as ke d t o lie d o w n a n d kee p still i n t he sca n ner f or a p pr o xi matel y 2 0 mi n utes. A n x-ra y of

y o ur c hest ma y als o be perf or me d if necessar y.

Y o u will ha ve a b o ne sca n t o i de ntif y a b n or mal pr ocesses i n v ol vi n g t he b o ne s uc h as t u m or,

i nfecti o n, or fract ure. A b o ne sca n uses b o ne-see ki n g ra di oacti ve material t hat is i njecte d i nt o a

vei n s o it tra vels t hr o u g h t he bl o o dstrea m. T he ra diati o n is detecte d b y a ca mera t hat sl o wl y

sca ns y o ur b o d y a n d ta kes pict ures of h o w m uc h t he ra di oacti ve material c ollects i n t he b o nes.

A s mall sa m ple of y o ur bl o o d (a b o ut 3 t o 4 ta bles p o o ns) will be c ollecte d. D o n ot ha ve a n yt hi n g

t o eat or dri n k, e xce pt water, f or 1 2 h o urs bef ore y o ur bl o o d is dra w n. T his bl o o d will be

c ollecte d f or r o uti ne safet y bl o o d tests, Pr ostate S pecific A nti ge n ( P S A) a n d test oster o ne le vels,

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Acetate pl us Pre d nis o ne i n Africa n A merica n a n d Ca ucasia n Me n wit h metastatic castrate-resista nt pr ostate ca ncer I n vesti gat or: Da niel Ge or ge, M D  
a n d f or ot her s pecialize d researc h la b orat or y tests. T hese s pecialize d researc h la b orat or y tests are  
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use d f or bi o mar ker a n d D N A researc h.

If a vaila ble, arc hi val t u m or tiss ue will be c ollecte d fr o m y o ur pre vi o us bi o ps y or s ur gical

s peci me n f or D N A researc h.

If y o u are eli gi ble t o ta ke part i n t he st u d y, y o u will be as ke d t o ret ur n t o t he cli nic t o recei ve y o ur st u d y

dr u g. If y o u are n ot eli gi ble, t he st u d y staff will disc uss ot her treat me nt o pti o ns wit h y o u.


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Eli gi ble s u bjects will recei ve a birater o ne acetate wit h i nstr ucti o ns t o ta ke 4 ta blets o nce dail y i n t he m or ni n g, o ne h o ur bef ore a li g ht brea kfast at a p pr o xi matel y t he sa me ti me eac h da y. A birater o ne acetate s h o ul d be ta ke n o n a n e m pt y st o mac h, wit h n o f o o d f or 2 h o urs bef ore a n d at least 1 h o ur after t he d ose is ta ke n. S u bjects will als o be i nstr ucte d t o ta ke 1 ta blet of pre d nis o ne b y m o ut h t wice dail y.  
F or t he p ur p oses of t his d oc u me nt, "st u d y dr u g" will refer t o a birater o ne acetate i n c o m bi nati o n wit h pre d nis o ne.  
T he st u d y ca n be di vi de d i nt o peri o ds of ti me calle d "c ycles". A c ycle i n t his st u d y will last 2 8 da ys. At t he start of eac h c ycle, y o u will be as ke d t o visit t he cli nic t o ha ve re g ular pre-sc he d ule d c hec k- u ps a n d la b assess me nts. D uri n g C ycle 1 of t his st u d y y o u will be as ke d t o c o me t o t he cli nic t wice f or assess me nts: o n Da y 1 a n d Da y 1 5.

If y o u q ualif y f or t he st u d y, y o u will recei ve a o ne-c ycle s u p pl y of st u d y dr u gs at t he C ycle 1, Da y 1 visit. Y o u will t he n ret ur n t o t he cli nic at t he start of eac h c ycle (a b o ut o nce a m o nt h), f or C ycles 2, 3, a n d 4. After t he C ycle 4 cli nic visit, y o u will o nl y ret ur n t o cli nic e ver y 3 c ycles (a b o ut o nce e ver y 3 m o nt hs). D uri n g C ycle 1, y o u will be as ke d t o ma ke a n a d diti o nal visit o n Da y 1 5.  
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O n St u d y Da y 1 a n d Da y 1 5 of C ycle 1:

Y o u will be as ke d a b o ut me dicati o ns y o u are c urre ntl y ta ki n g, i ncl u di n g o ver-t he-c o u nter

me dicati o ns, her bal re me dies, vita mi ns, a n d s u p ple me nts.

Y o u will be as ke d a b o ut a n y ne w or c o nti n ui n g si de effects or ill nesses y o u ha ve ha d si nce y o ur

last visit.

Y o u will ha ve a p h ysical e xa mi nati o n, w hic h will i ncl u de ha vi n g y o ur wei g ht, te m perat ure,

bl o o d press ure, heart rate, a n d breat hi n g rate meas ure d.

A sa m ple of y o ur bl o o d (a b o ut 2 t o 3 ta bles p o o ns) will be c ollecte d. T his bl o o d will be teste d

f or r o uti ne safet y bl o o d tests a n d P S A le vel ( da y 1 o nl y).


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O n St u d y Da y 1 of C ycles 2 a n d 3:
Pr ot o c ol I D: Pr o 0 0 0 4 6 3 8 3 C o nti n ui n g R e vi e w B ef or e: 1 0/ 3/ 2 0 1 8 R ef er e n c e D at e: 3/ 5/ 2 0 1 8 P a g e 3 of 2 1 S u bj e ct I niti al s:  
  
Acetate pl us Pre d nis o ne i n Africa n A merica n a n d Ca ucasia n Me n wit h metastatic castrate-resista nt pr ostate ca ncer I n vesti gat or: Da niel Ge or ge, M D  
Y o u will be as ke d a b o ut me dicati o ns y o u are c urre ntl y ta ki n g, i ncl u di n g o ver-t he-c o u nter  
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me dicati o ns, her bal re me dies, vita mi ns, a n d s u p ple me nts.

Y o u will be as ke d a b o ut a n y ne w or c o nti n ui n g si de effects or ill nesses y o u ha ve ha d si nce y o ur

last visit.

Y o u will ha ve a p h ysical e xa mi nati o n, w hic h will i ncl u de ha vi n g y o ur wei g ht, te m perat ure,

bl o o d press ure, heart rate, a n d breat hi n g rate meas ure d.

A sa m ple of y o ur bl o o d (a b o ut 2 t o 3 ta bles p o o ns) will be c ollecte d. T his bl o o d will be teste d

f or r o uti ne safet y bl o o d tests, P S A le vel, a n d bi o mar ker tests ( C ycle 2 o nl y).


O n St u d y Da y 1 of C ycle 4 a n d E ver y 3

r d
S u bse q ue nt C ycle:


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Y o u will be as ke d a b o ut me dicati o ns y o u are c urre ntl y ta ki n g, i ncl u di n g o ver-t he-c o u nter  
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me dicati o ns, her bal re me dies, vita mi ns, a n d s u p ple me nts.

Y o u will be as ke d a b o ut a n y ne w or c o nti n ui n g si de effects or ill nesses y o u ha ve ha d si nce y o ur

last visit.

Y o u will ha ve a p h ysical e xa mi nati o n, w hic h will i ncl u de ha vi n g y o ur wei g ht, te m perat ure,

bl o o d press ure, heart rate, a n d breat hi n g rate meas ure d.

Y o u will ha ve a C T sca n or M RI of y o ur c hest, a b d o me n, a n d pel vis, i ncl u di n g ot her areas if

nee de d, a n d a b o ne sca n pri or t o seei n g y o ur st u d y d oct or. A n assess me nt of y o ur disease

pr o gressi o n will be c o n d ucte d at t hese visits.

Y o ur st u d y d oct or will deter mi ne y o ur res p o nse t o t he st u d y dr u g. If y o ur ca ncer a p pears t o be

pr o gressi n g ( getti n g w orse) o n t he b o ne sca n, y o u will be as ke d t o ret ur n f or a n ot her b o ne sca n

i n a p pr o xi matel y 6 t o 8 wee ks later. T he sec o n d sca n is nee de d t o c o nfir m w het her or n ot t he

ca ncer is tr ul y pr o gressi n g.

A sa m ple of y o ur bl o o d (a b o ut 3 t o 4 ta bles p o o ns) will be c ollecte d. T his bl o o d will be teste d

f or r o uti ne safet y bl o o d tests ( Da y 1 of e ver y C ycle), P S A le vel ( Da y 1 of e ver y C ycle),

circ ulati n g t u m or cell c o u nt ( Da y 1 of e ver y 3 C ycles), a n d ser u m li pi d a n d h or m o ne le vels

( C ycle 4 Da y 1). D o n ot ha ve a n yt hi n g t o eat or dri n k, e xce pt water, f or 1 2 h o urs bef ore y o ur

bl o o d is dra w n o n C ycle 4 Da y 1 o nl y.


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E n d of St u d y Visit:  
A n E n d of St u d y visit will be sc he d ule d wit hi n 7 da ys of y o ur last d ose of st u d y dr u g. At t his visit, t he f oll o wi n g pr oce d ures will be perf or me d:  
Y o u will be as ke d a b o ut me dicati o ns y o u are c urre ntl y ta ki n g, i ncl u di n g o ver-t he-c o u nter me dicati o ns, her bal re me dies, vita mi ns, a n d s u p ple me nts.  
  
Acetate pl us Pre d nis o ne i n Africa n A merica n a n d Ca ucasia n Me n wit h metastatic castrate-resista nt pr ostate ca ncer I n vesti gat or: Da niel Ge or ge, M D  
Y o u will be as ke d a b o ut a n y ne w or c o nti n ui n g si de effects or ill nesses si nce y o ur last visit.  
Y o u will ha ve a p h ysical e xa mi nati o n, w hic h will i ncl u de ha vi n g y o ur wei g ht, te m perat ure, bl o o d press ure, heart rate, a n d breat hi n g rate meas ure d.  
A sa m ple of y o ur bl o o d (a b o ut 3 t o 4 ta bles p o o ns) will be c ollecte d. T his bl o o d will be teste d f or r o uti ne safet y bl o o d tests, P S A le vel, circ ulati n g t u m or cell c o u nt, a n d ser u m h or m o ne le vels.  
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F oll o w- u p Safet y Visit:

A f oll o w- u p safet y visit will be sc he d ule d 2 5- 3 1 da ys after y o ur last d ose of st u d y dr u g. At t his visit, t he

f oll o wi n g pr oce d ures will be perf or me d:

Y o u will be as ke d a b o ut me dicati o ns y o u are c urre ntl y ta ki n g, i ncl u di n g o ver-t he-c o u nter

me dicati o ns, her bal re me dies, vita mi ns, a n d s u p ple me nts.

Y o u will be as ke d a b o ut a n y ne w or c o nti n ui n g si de effects or ill nesses si nce y o ur last visit.

Y o u will ha ve a p h ysical e xa mi nati o n, w hic h will i ncl u de ha vi n g y o ur wei g ht, te m perat ure,

bl o o d press ure, heart rate, a n d breat hi n g rate meas ure d.

Y o u will ha ve a C T sca n or M RI of y o ur c hest, a b d o me n, a n d pel vis, i ncl u di n g ot her areas if

nee de d, a n d a b o ne sca n pri or t o seei n g y o ur st u d y d oct or.

A sa m ple of y o ur bl o o d (a b o ut 2 t o 3 ta bles p o o ns) will be c ollecte d. T his bl o o d will be teste d

f or r o uti ne safet y bl o o d tests.


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A d diti o nal bl o o d:  
If y o ur bl o o d c ollecte d at baseli ne f or D N A researc h is n ot e val ua ble, a a d diti o nal sa m ple of y o ur bl o o d  
(a b o ut 1 teas p o o n) ma y be c ollecte d i n or der t o c o m plete t he D N A researc h. T his sa m ple ca n be c ollecte d a n yti me d uri n g t he st u d y. Y o ur st u d y d oct or or n urse will e x plai n if t his a p plies t o y o u.
Clinical trial: NCT01940276
Section: Purpose of Research
Subsections: W H Y I S T Hi S S T U D Y B Ei N G D O N E ?

T he p ur p ose of t his st u d y is t o e val uate t he res p o nse t o a birater o ne acetate a n d pre d nis o ne i n Africa n A merica n a n d Ca ucasia n me n wit h metastatic castrate resista nt pr ostate ca ncer.  
A birater o ne acetate is use d i n t he treat me nt of metastatic pr ostate ca ncer. O n A pril 2 8, 2 0 1 1, t he U nite d States F o o d a n d Dr u g A d mi nistrati o n a p pr o ve d a birater o ne acetate i n c o m bi nati o n wit h pre d nis o ne t o treat patie nts wit h late-sta ge ( metastatic) castrati o n-resista nt pr ostate ca ncer w h o ha ve recei ve d pri or d oceta xel (c he m ot hera p y). A birater o ne acetate is a dr u g t hat bl oc ks t he re mai ni n g or resi d ual male h or m o nes i n t he b o d y t hat ma y be hel pi n g y o ur pr ostate ca ncer t o gr o w. O n Dece m ber 1 0, 2 0 1 2, t he U nite d States F o o d a n d Dr u g A d mi nistrati o n a p pr o ve d a birater o ne acetate i n c o m bi nati o n wit h pre d nis o ne t o treat patie nts wit h late-sta ge ( metastatic) castrati o n-resista nt pr ostate ca ncer w h o ha ve n ot recei ve d pri or c he m ot hera p y. A birater o ne acetate is bei n g use d i n t his st u d y i n i n di vi d uals w h o ha ve n ot recei ve d pri or d oceta xel t hera p y f or castrati o n-resista nt pr ostate ca ncer.  
Pre d nis o ne is a ma n- ma de h or m o ne c o m m o nl y referre d t o as a "ster oi d". Pre d nis o ne has bee n a p pr o ve d i n t he U S, Ca na da, a n d E ur o pe f or vari o us dis or ders a n d diseases, s uc h as ast h ma, L u p us, a n d c hr o nic  
  
Acetate pl us Pre d nis o ne i n Africa n A merica n a n d Ca ucasia n Me n wit h metastatic castrate-resista nt pr ostate ca ncer I n vesti gat or: Da niel Ge or ge, M D  
o bstr ucti ve l u n g disease. Alt h o u g h pre d nis o ne is c o m m o nl y prescri be d t o patie nts wit h castrateresista nt pr ostate ca ncer ( C R P C), it has n ot bee n a p pr o ve d t o treat t his disease b y t he F D A.
Clinical trial: NCT01940276
Section: Withdrawal from Study
Subsections: W H A T A B O U T M Y Ri G H T S T O D E C Li N E P A R Ti Ci P A Ti O N O R Wi T H D R A W F R O M T H E

S T U D Y ?  
Y o u ma y c h o ose n ot t o be i n t he st u d y, y o ur partici pati o n is v ol u ntar y. If y o u a gree t o be i n t he st u d y, y o u ma y wit h dra w fr o m t he st u d y at a n y ti me. If y o u wit h dra w fr o m t he st u d y, n o ne w data a b o ut y o u will be c ollecte d f or st u d y p ur p oses u nless t he data c o ncer n a n a d verse e ve nt (a ba d effect) relate d t o t he st u d y. If s uc h a n a d verse e ve nt occ urs, we ma y nee d t o re vie w y o ur e ntire me dical rec or d. All data t hat ha ve alrea d y bee n c ollecte d f or st u d y p ur p oses, a n d a n y ne w i nf or mati o n a b o ut a n a d verse e ve nt relate d t o t he st u d y, will be se nt t o Ja nsse n Scie ntific Affairs.  
Y o ur decisi o n n ot t o partici pate or t o wit h dra w fr o m t he st u d y will n ot i n v ol ve a n y pe nalt y or l oss of be nefits t o w hic h y o u are e ntitle d, a n d will n ot affect y o ur access t o healt h care at D u ke. If y o u d o deci de t o wit h dra w, we as k t hat y o u c o ntact Dr. Ge or ge i n writi n g a n d let hi m k n o w t hat y o u are wit h dra wi n g fr o m t he st u d y. His maili n g a d dress is Y o ur d oct or ma y deci de t o ta ke y o u off t his st u d y if y o ur c o n diti o n gets w orse, if y o u ha ve seri o us si de effects, if y o ur st u d y d oct or deter mi nes t hat it is n o l o n ger i n y o ur best i nterest t o c o nti n ue, y o u d o n ot f oll o w t he pr oce d ures of t he st u d y, or y o u start a n ot her C R P C t hera p y. Ja nsse n Scie ntific Affairs, D u ke U ni versit y, or re g ulat or y a ge ncies ma y st o p t his st u d y at a n y ti me wit h o ut y o ur c o nse nt. If t his occ urs, y o u will be n otifie d, a n d, y o ur st u d y d oct or will disc uss ot her o pti o ns f or treat me nt.  
Y o u ma y wit h dra w y o ur c o nse nt at a n y ti me . T he i nf or mati o n c ollecte d pri or t o y o ur wit h dra wal of c o nse nt will still be part of t he st u d y data. H o we ver, n o ne w i nf or mati o n will be c ollecte d.   
Acetate pl us Pre d nis o ne i n Africa n A merica n a n d Ca ucasia n me n wit h metastatic castrate-resista nt pr ostate ca ncer I n vesti gat or: Da niel Ge or ge, M D  
At t he c o ncl usi o n of t he st u d y, or if y o u deci de t o wit h dra w fr o m t he st u d y, y o u m ust ret ur n all u n use d st u d y dr u g t o Dr. Ge or ge. Dr. Ge or ge ma y re q uest t hat y o u ret ur n f or a c hec k u p bef ore y o u st o p y o ur st u d y dr u g if he t hi n ks t hat st o p pi n g t he dr u g s u d de nl y ma y har m y o u. He ma y als o as k y o u t o c o m plete t he tests t hat w o ul d or di naril y occ ur w he n a pers o n c o m pletes t he st u d y.  
We will tell y o u a b o ut ne w i nf or mati o n t hat ma y affect y o ur healt h, welfare, or willi n g ness t o sta y i n t his st u d y.