Clinical trial: NCT02420652
Section: Alternatives
Subsections: ('Rn 1'Ott T*Ke Otlttr Merlicincs Lvhile On This Rtudr")

1r: gr-r uu takirlp tltere ttteiltcitle '.  
to tilke.  
Are thcrt an3'btni:litl li.rr ltru if rotr chotst to trrke pllrt in tltis rtrtflrch slutlvi'
'l'hsl.c lllil\: ()l"nlir\. ll()t lre ilrriue l urtrlii.'irl lr*rrclil tL) r\)tt [iorrr tlrkirrg l]art 11] tlti: strrtlr '  
  
!iriri1. litle: A Plrrrre J P,rri,J,.rr:ri;:rLl l)1..\,nrrj:liiiiiou llr;rj:
P:(,:lc1\rr-i!.\fi*r I.L'c;tl ]-lut.ri.\ L,1 1,i,,,!.rl; { ,,r..;r I r;ilrlittilti r.!1 Patldllts '.,, rtl: I-{*r'lli:ur-l)eper:ile:il Itirrnq l\.trrare-!p*ciiic Arrriltcrr f Ir \l'rtrr::t ,ri \lEtl"rxtjrr i]ln. ..\r]rrr tri iPl.L]\1..\ Ir jrrII
-
lhe lirtrrrc.  
\\'hnt At tbis r!"e \'our rllern*tiIes il'r'ou rlon-l lriln( to (*he ptrt in thir stu<1r,1) (ime' thete is no uttiversalll'acr-:epteel standalcl freatnrelt ful y*orr iype olpr,'rsfate cencer Il vmr
. rlt itrl'*fh*r Fl*,:iciart *f'rr,r,, .ir..,.',0;rr*.' f:,.,,,,rr*r:r,i,r, fr.'"ii;ttllii Z*loclex {treatrneut to decretse the level of testosterone ir your tr*dy or to i z{}loclex {treatrneut to decretse the level of testosterone ir your tr*dy or to irtertereivitlr the *,n1..vri'r body uses festosteroue). nronltoring r,vithout treatmenl. or other chnicatr tr:ials.  
I'alk to your d*rtol about y*ur clrr-rir:es [:eii:re turcler uo *bligation to take l)flrt ill this re;earclr thrs stnd-v*. v*u are ti'ee lrr leal,e the rtudv at any 3't.rrr rlecrd* iJ'f,i,u n.rll taku parl irr thrs xturlr,. \'r.rrr iir.t:
illtd\:,. llr,orr tl*cirJe tlnt l.orr du tlol urslr to tnkc 1:art rrr f irue.  
Ilorv u'ill I'ou linfln'if ner,'infirrttt:rtion ir lerrnerl tlr:rt nr:n'rlffect lyhetlrrl. 1'ou sre wiiling lo star.in thir rc.se*rch sturlr".)
During the cottrce *f the study lrilll will he updated aboul ally llew ilrftr11latiorr rlar
)'oll ilre rvilling t{) so ou takrng pail ill the shrrly. If new inti:mrati,.xr is leanret{ rhat the stutly or.vclu t'ollorv-up is conrpletetl- yr"xr iryill be conracte(I.  
rrml'atl'ect whether runl' aflecr \,(}u aller
,lVill there bt *nr.cost to you to take p:rrt in thir stutlr,,'
standart{ 0f care- as \rotl woulcl ltave receiveri rhese services eveu ii"-yorl luere uot pnlticlpat,lg i* r}ris snrdy. These prcceelures irtcltrde dr-rctorlAdvauced Praetice Nr.ure (APN) r.isits. rautiue lab terts
{coruplele bloeid colults. cheutittties. and }}SA.i. and restugiug chest x-rays. 5rlre a16 ('l il,flll srat}$.  
You will be respottsible t'or srly co-pa)'nteutx chre li:r otlice viiitr^ co-irr$nl?rlce$ ancl tle<luctitrles due cur itttY tests an\#tl proceehu'es that are reqrrireel and c*nsiclered stapr{alcl care.  
The stucly to nrouital stncly elrrrg (aspinn) Ievels rvill [re paicl tor b,v collecf ir:ns
Clinical trial: NCT02420652
Section: Confidentiality
Subsections: Protectetl He:Rlth Infol'Nrrrtion|R*'Hat Personnl Inform:Ltion Will Be Ured Or Rlisrlosetl?|Lloll U'Ill Tissue Ernd Inform:Rtion Bc Collecterl?

aurl r-ulates i,-r at leasl i')llc r)1 llle lirll,.lrvlrtg.  
-. The iuclilrchlrl": pil:l Irr\Lr1)l .r tttllllr ph-r'iicn1 or llletllnl hcnltlr
. 'I'ite plovirir-rll i)1'lleilllh Cill* lrr the urtirt'irlnal
. The Ilitsl. plessllt or tltfitte lliil'tllelit lirr healtlt c;ire I"iie ue:it le\\r.pnragriillirr frll 1,111 i1[1ruf lrcru, \,'olil lrerlth iltf'onlati*l rvill Lre llseil (rr tltsclc:ser'l 11r the:
l)r'l rrrll;l I tttltrlltt;tl trrtt please read thls iirthrr|izirtirril rc-ctir.rt) nrrd the couserlt lhnrr ra|ellrlll'. Ark illlesti()1)\ if anvtltitig is n$l utl(lcrslnltrlablt lt, *,'ut t.  
-,luthorization to use ]-our health infornr:rtion f$r reseAr(h purpose$
Because irf'orumtiou ;biult you i'rrul \,orn'health is persoral elrd privnte. it gerrerallY cturl*t L>e used trt tlis research stg{y rvrtfuo1i your ro.ritteu aulhorizatiorr. 1l yotl sigr] this fonn' it *'ill 1:r*virle tltat clixel:setl irr t6e stud1,. y*ur irifi:rnuiltir)r will *rrly be uxed iu ilccordartce u'itlt this auth*rizatlott {irrtrt and tlle irrlbrrrrer1 colsent forrp sncl x* requirsd *r allowed bv law, Please I'ead it csrethlly'hefore siglrirrg it.  
I)o vou hnvt to sign this art(horizrrtion ftrrnr?  
You do rt*t have tr: siSll lllis llutltut'ieiltir.rn tornt. iJttl ii'-vorr do tr:l^ Y01l \\
tlix researclt stntl,v i.tttr.l retetle alll re.{i*lllClt Iel:lte<l prodttcts lluw*r csrrd.itiotl for receivittg ;lll-v nledlenl care otltside the su-tcly' ill et utl lle al-rle lr.r patlieipate tu
"tuttittu lltu li,ttlt i\ ll(11 il
(1NJ*:!  
  
\:erriou dale; 1:,'01 :tf I -
Page l0 af 16 Sndy- fitle: .4' Plrn* Prc,gres:i*n,{ftel Loc*l
"irrli in Pttr*rrtr i,, lfh i{t,t:tri.ittt-Dei-rerrilerrt Ririrrg Ft*ittlie-l|ctific Ariligell rllrrlurti tL( irllergt ,ri }'lcrl,:::l:iIr llltl\ .1\|111:1 iFitIl1'.\ l lirll Pr"irreipal Invesligator If yCIu sign, can you rel:oke your authrlrization or tyith{ht$'Yottr inform*tiun l$ter?  
If you,riicre to iarticiprrte. \\lu ilre fiee tt'r withdrarv your ilulhclrizatiorr resilr(lills tLe ttse atrd clisclor;nre
,.rf -vppr henltll iltbnnnlir,rl iarrtl tu di*r:,:tntinue fllly $lher psrll{ipalioll lx tt}e strd-v*} Rl {lIlY tiille^ Aller arrir 1gr..*,i6u. yolr lrealtl: irrtonrultiou rvill uu lottger be nsed trr dirclosed in tlte *tucl1" escel)t fo the was provirled l:etbre von rvitlrcke\l' v(,lu arrtli*rization if necessaly t* rilflitltilin integriry of the research r)l' if tlte rtata had alreadv heeu xtt \:perl o1'all identitier*.  
l1is rlrrrlr, )"oli llil\.tt(i rr.r t1 tirilrrrg. lrr, cirntlrclrus. flte -'ltttlr l.rrirre rpel ittr'*sltg;tlqrl .

yo*r health irdbmration related to this snrd-v rnay be rmecl or rliscl*sed in corutectiCIr with this tesea:clt irrdicating o, .*l*tirrg to a parficular medrc;ll couilitiou. blood attd otlter lisstte rarltples and r-elaled records. physical exalnil*tinnii. x-rilvs, L.[RI's. *1.. ]'oul pelxr:rtt*l identrt-v^ t]rilt ir your llallle. addr"ers-and other iderrrifiers. r.vill be kept coirliderrtifll. You will have a cocte il$il]ber ailrt your acnral nante rvill not [:e used. Onl-v vonr siudy t'loctor rvill be atrle to link the t:r:de nmnbel'to !'our llill]]e.  
ynur 4ala n*y lre irserl i1rcisurilir:1:rr[:]icntionr. II"t]re lindirrgs li*tu the *fixly are ptrtrlirhi:d. 1'otr t'ill 1ot be i4eltilied lry uaure. Y,-rur rrl*ntiry rvilX tre kepl cuu{idenlial. 'l'lte exceplion tr'r flris rule rvill be rvhen there is a c*urt orcler' or rvherr a inr.v exiilt* requiring tlte study dtlcttx' to report cotrmrutticittrle diseases. In tlis eale. yolr will tre ilfrirrned of the lnterlt l$ <lisclCIse this iufbrrnatlotl lo tl:e state ag,etlcY'
Such a lalv exists in ilierv Jersev for chseases such o$ curlcer. iufeetiotrs tliseases xuch as hepatitis. HI\''.  
vimscs attd umttl* otherr. Ieg.ulallLr' i geuctc\.  
relrclioil tcr l]re sturl)'chrrg.  
l{ho m:ry urie or disclore the information?  
T1e followigg parties are nutholized to use and,'or disclnse yoru'healtli inlorrnatiott in contteclion rvith tldx r:es$arch sttrdv.  
  
  
tIRlS-t c()tlrlllttee I
Who nrrrv r(ceil'e/ult the inform:ltion?  
-l'he parties listed in the precediug pl{rngrap}r rnay pelsonii arld organizalroils ibr theu' use ill collllectl all r LI.$. Fr:ocl nnd Dnrg Adrnittistrntion (fDA)
r )ialtotal ltlstttttfe. *,1Heliltlr {NIH)
r 'i'he Ollicc.tirr Iiurrxrn Il.rsrar.rh I)rulec{ittts iOtillP} irr the [1.S. I)r:]ritltlIi*lll I trurtiiltt Setlicer t DI lllS t ttrisclox* your health iufurnriltitril 10 ltr* tbllowiilg with this research xtuelV:
ol' IL'altlr arrtl rl llttl' :ife lla)t your iufi:*,ation urav be re-elisclosecl (sharecl) tr-v tlre recipietts described *bove' requirecl by larv r{r protecf the privac,v of the iutarutation.  
\Yhtn rvill 1'our *uthorizrtion expirt?  
Your autltorrzatiott rvill expire 5i5 l'rjxlr illiet' y*rn' shrdl' data u'ill be cleslro-veil' rtlrh' c{lllll-)ltltotl. .\t tlli' littt'-: tlt* ltttk hcllvtett li'lt iltttl Will access to Yrrur nrrdir:al r*cor:cl bt limit*el tluring the *tud'v'l
.[o mairrtaiu the inlegrirl. ol'this resealctr stucl.v, yon rl]sy ilot have nccess t$ fluy ]realth inl'onuatir:n cleveloped ,l$ pfifi *f this stucly r*rtil ir ir conipler*d. ,qt thai poinr, you woulcl ltnve acces* (o strch health inti-rt*ati*n if lt were *secl ro urake medi**i o, billing clecisic,ns nbottt yott ntrtl was iucluded itt yurtu otlcinl medical retortl.  
Where cfln Iou gct morr informationi' Y,,:u tttav tall the Natir.rttitl ('nttc*r Ittslitttte's (
\.'ote: l-800-'1-(.\N( ER t i-800-{ll-62-17)
'alICet lrtibrttutl it.rtt Serl'tce al :
Yuu rnay also visil the N( I \\ieb site F*r NCI's c:linical trials inlbrrrtatir"ru' For N('I's gellerflI irtlirrrrxrtiott atrnttt p* to: ltI!ti-,,.i.:ltucgl ti:.:,i:Itl:if lj-i-i lil:
(irllcd't. uu lr; j:ilil, -!;liJ
vou il(] II.)t rrehsiles and ritlter itrfirnnatii:tt a c0lllpll{el iil ilii\,r-t ;tCCC.:' l(! i] l)f l \t)lllll cOllllliltUI . \'()ll ltlil\ il{Ct'5\ l]lt'ir' '
irt 1lte l{tst,ttttc Ittlrl i.tillrtittg ( cli{{}l iin tlte secr'llti1 l}'lrit'ul' l1{1 Ct^}\l f1t \'1}tt.  
t ltr' Consent to Stnre Tis.lue $nd llefilth Informntion for Future Resetrch l"lse:
The irlrestigiltor is asking yi:ru'perurissinu to sforc any left-over bh:ocl specitrrens fcrr fitttue resealch snrtlies. if _vou agree. the"sittirrirus lvill tre kept ancl nmy tre use<l to leartt utorrr aboul ciillcet' Yotr nral stlll partir-:ipnte i, tle rnaip st1il1, er.eu ii1,'ou cio not agree to alluu-1'*ttr specitttert' to tre sttrt'ed {irr luture retearclt.  
Horv and where wilt vour tis*ue and henlth information be s(ored *nd by whonr]
iii* u*urpt*s will6rl kept urrtil the1, are u;ed ttp ar de*fr*1etl. 'l'he snruples are givclt a c*tle to protect yourpr-lvacy beirr" the--v aie usecl. Au1, relatetl irrt*rruatir:rn given to rexearchets rvill also be coded.  
ll-"1;,,t, 1)lrg* ll iti l6  
  
iltril' Iiilc: .1, Phare I F.rri;!rl:rizerl l)t(i{)ltulii.ltiorr llil} :
Pt0grctrt,.rtt.!tl<r l-iluirl )-iru.t1,., Ii.,r Pr,,rt.rr,.(.,rlr.{r l.\:rlri;:!tll}e I
lu Pll:slt: r.,,rllr Ht;"r:r*li-De1>errilelrl F.iiirrs Fr.ci\lrte-Spc*ific A*irgcrr
. flir -\r.:r*rgr ,:i ^'tlerl'lrnri* Illur ,.\:;.ru:,rr rl,l.ll\1..\ 'l riril l Ilre saurples aud ltealtlr rrrfirnrntiorr rvill tx rforecl
$s,'lg|,,'i11rl\'\clvlLc {l}l{S} ,JILS i> rr lrr:rre hirnk I,rrr.l l,,crrletlo,ff

$nldy pl'ocedures. Any' leti-over saruples rvrll he pr'*ce$sed and trnltrl'eu'ecl ir the BRS tixsue balk. Nr:r aciditronal lrloud sp*cilrells lvill bt r)eliected tor st*mge at]rllirtule trsr'. [nl'rrnnalilrn Ijuu \,olu rnedicfll record ll,ill tle collecfed. hut r.vill llot cnllfairl ftrly personal intirnrralirx. Aly related urfrxnation siven to researchets will trc co(lt:d.
Clinical trial: NCT02420652
Section: Duration of Study Involvement
Subsections: Ouring The Studv:

If you decicle to particrpnte ott tltis sntdl' morlth ever1. dn-Y firr li:ur iltolltlls' This is vlri \\:11l h* it:ketl {l titk* 1\\'{l illllqi. ilrl-}11ll) itltti tttc{lrltttitt br refent'tt fr) rt: the Rttn-In Stltgt" '11'tlte -'ltttlr' u"ill be :t;'ttleil ill luls l,;trl .t,1,.' ullctl. r 1..'-
;rt l:ctlttttt* tllltlv
\',-ru q,ili fake *tre 1l ) "-\.pirirr Sl lrr:r trrl:lcl tltil-r"rt'tllt lil.lii \letlirt'ttttlt treattttettl il l i(10 rrrg trt'ic* lt d;r1' 11 11!1 lirr)ti If ;lfir'r' llr',r ueekr' vr)ll (ltr liol llil\'e itllv llfllrrtil. r,oirtrtrrrsithcu rt u,rllll* lllClc'ir:crJ trl 5t)0 tllg.\lllllllreilklilrt;rrrd ltXi()rttg lbr llrr' 1rr'l irrd \'trll lll *
3te l.)iltl irl'llt* llL)lllllll
\'*rr rvill he iltottit,'lt't'rl ."ritlt l:lr"rlil 1t:fr lttttl 1ltrn'ricnl exitl:l\ \rvrr\j filtll t'eeks  
  
takilg fhe rfrtclv tltltgs lt: rlesctllrerl b*li:u'. hlosl .f lltere lcst: itre rr'ittlttte ltticl 1111g .rf rilbiccts \\'illl unllcrt cttclt il" )'rrlu r r lleftrre rtllltill. lltc slttrlr tllc(1l..i{i.ll: r'r,'rrt PS,'\ levc'l ri'rl} l':e tltttketi.  
-Ihe PS,\ ,.l',11 nl"r b*  
  
checked lurtlthlt' rvhilc vorr aru rerri\iirrg slrrdr. tl*atrn*rt.  
Plii sicaI exilurilriltien Vital $isns {bl.r,rri pr"rsslue^ hciul r'nte. letiplriltt}ry li}l*, ruill feru}lgrilnllcj I,Ieasrrre r.*ru' lrer*ht arril u,erp.ht
{-ip tri 3 teilsl;lr,..tts..i-rll he takeu fiirttt vorrr veirr rrr nlclsiuc litrx'r'orrr kichrer,r ancl lir.el nre a
-
a I
a trloeitl cells arrrl plutele t-r ille rlr.rnrrirl.  
' , Bl.rurl \iltlll)lrs tllitv l)* litkttt ttr slitdr,chttrl le',clr.il'alr;rh'z* bl(rcheuile al rttnrker, R*tord:iuv srcle *tlbets vrrlt iu.€ htvurg lirrur tlie snrdr.uiedicatic,u tttirsed n da)ie ruithin,1 ltltur,rf ttrte lnre vc)u weLe *lrerlrrletl tr.' 1akc. il. \'()n rllir\ tak* thc tii:se nt flrrrt lirtt*:'ltttl tr.rtttitttte rl'itlr tlrt ttcrl tt:gttl;rr rr.:hcrdtrlrti rLrrt'. II"rt lrirr lre.:rl (t*it111 llrlln.l ltolu.,. "krp tlu rio.r ilrtrl citlltllul* u'ttlt iltc' rtcrl qelretlrrl(rl il,,.,t'.  
.\llct ciltttplelurg l(i tr.',-"ks ()l'llr'irtlrICnt. yrlll t,rll lrar,c a l:)S.\ lrrc'l rlrar,l'rr l() crrl]rlri]l'(f ti: tlre PS..\ lrrcl lirkett b*l'ore )rllu \farlerl the slrrelr'lrealrueltf . l)eperrclilr.$ r.rrr 1]re le5ults r',-.u riill either.  
;l) ('Ontinttc on the tI'e,Ilmr:nt rli(lt m*tlornrin ilnrl lnpirin lrr.u;rrrs* \'r.,lu I)S.'\ llrr tl*urerrrd lrr, luore fhall l50l lrl*ttt'lsetl hr,- t,tte tatrntlt. ltrl ulslltrtce tht PS.,\ Irlrs rlc'clrtrle.l lii:rrl l{tng uil, 1,,
7,5tt$..:ttl" ) tlrttpattil tu thc l:a.elute valrre.  
Ilircontinur trrlrlnrrnl it\ llnt't of thir ttudv l;tturrr. r"our P\A lrar ilrcr.:lstrl lrr rnore tltilrr -i{)(u cotttltareii lrr flte h;trrlirrc ltrlrre 1-ollr di)[tor u,iil cliscrrsr 11[rer llr.rterrtial t]elllnlt'ltl\ \\lth \ou i, t'r.rtt iliscr.rtttlllud tlcitlluclll ii\ Il;rr I rrl'tltri slrri,lt
(lontinut' trerrtnren( in the Rrntlourizrtion Stlrgr rll' lhe rtuclv Lr*cau:e t'.'llr lla\.e n i)SA ler,el b)
cj 500 u.  
In (he R:rndotniz:ttion Phrtre \'olr \\rll lrt irs:rsuur.l bt,clrirtcc l* *lie r.rl'lu'rr lrnrs rlcstrrbr'rl bt'Lrn'.  
ttiedicltlir.rttJ rltrittu tlti: itrrrlttrtt rrl llrr'rtrrch'. Ilris i. r*lbrreil ttr iir it "rli.rrrhle bltrrd" slltrl\',
AR\I l: (Jrte (1) Aspirrn tlnrs tnltlet per clitv aud uretl'.inuiu tluee 5{)t)rug tirlr}etr elailr'{orre rahlet iu llte tnrrtttittq aud ttto tltlrlc"tr nt lr.'rltiru*1.  
,4^k\I 1: {)le il.} placebn as1:iriu (a tab}et that looks like ai;pirinl pel clal.'fitel })lacebo ureti'onril* {a t*[:let tirat lcoks like urelt'orruilr] rlaih,{one trblet ur fhe rn*nring ancl two ralrlets at rriglrti.  
']lr'ittlltr:ttl ilt lltr'trtttrl)ltll,/iili!r1) pltit..l xrill crrutirnrr, lirr rrlr lir {i rtrrlntlrr. J)ulinu bu checkttl ltt(ullltl\'. l{eF.arrll.r'.,rl'rrlrieli luul \,(-)r.l Lrlr iu. it'the P5.\ iuclca'er ernttqlle it ittcr*ir.e" tir)ln l{}rrg rrr[, 1{l l5rrg,rrrI. i tlr*rr snrctrr. tt'rjl1t1rlellt tlris tirrrt'),our PSA llill try rn*re than 500'o ilirr rvill be cliscontiuuecl.  
  
e, i,"{',,,i i,,t:..tit,r,,,, f lliett rlt* rlrtthr lreillltlol]{ \\'ill ho rliruoltlittttetl
.{.t e*ch l'irit. the $trr{h, tlocttr or rtttff ttttv tlo iln\ (}r :rll tl'the follorl'ing:
r Piti 'ical c\illllilliltlr'll r Vittrl ,ii.rrr. {},1,,,,,1Prr.:rlltt, lr..,rtl llrtL. ld\l]llrt()lV l.lt( ,,\lal tcllll)t'lillltle]
r Nleasrtre ,r'*tir lteiultt attrl u'*iultf r ('heck Yr-rltr IISA
cell:
. lJltioil slturl:1e. iluir"l:* lilkrll lr) rtuih iLttg ler,els. rtt ill)ith'le 1.ri,.:,':1tttI}ir:lil lltarker-.  
r Recorel artr iitle-el'lects \ rlrl lre ltrn ing fttrttt llte rntlll' tueclicuf i0tt r ltr:1)efi1 (- i rtr HlLl seirrrr; tl \.(:U lt:rr,i: rvrttpt,.)1ll\ 1hfi{ \'r}lll lllr}stillc cill}edr l}lilv llil\c slleail
.\lier cotttpletittg lreilttl1.111f lolt rri1l Itltr'*.  
r l'lrr':te.tl (\iillllll;lll')ll r yitll sigltr (lrllt'il ptc\rll1't' ltsltrt r;llt l!:\l)ilitt(\ll l:11( t)tltl tetttllelalltle)
r I,1r ltl I lcrlt:l.lrrrrllr i.r1 lrllrlr11 11'1|| lre '"ititrttt lirt r*ttlttlt lt:sls
\\'h*t *r.e the r.irkl :rntl,:rr tliscomfortr vou nriglr{ experitnct if l'oil tlkc F:lrt in this qtu(l\"'l
\\ihilc $ll Ili* slrriir'. \oil iire irt rlrt li,r rtrr* riilc *ller:tr rl-rrr,":tiherl lrc"ltrtr:. It'tt nltiittk[ r'lirults: llrcse rvlth te{eil,r'r.'rtirer r.l:trgr t,: nurkc srtlc ctleclr ltlsr:r.rit.rtrr iltrcl 1.r., liturI}It(}ltllirl*. \lllrt}'rrclt'elliclr r$ 11wll\'
s5orlh,ntler.clelrothel.irl.rr t: rtrrp],rr'rl. l:luf rrt srtnre ciiies. lttle eftects ci'ttt 1->* scrlolls r-rr [iti llueatetttttg' lotts lit.littu {)l' l){ftllil)}L'ltl r't Iitlal.
Clinical trial: NCT02420652
Section: Possible Risks, Discomforts, and Inconveniences
Subsections: Riskr Of Metlormin:|I{.Iskr Of * }{Ri St*N:|L$Hnt *Re The Risks Of H*Rm To R.Ou?

r \lilil gilstr(rlllte $ttttill *r'tl4rlrrttls {l}x}\l ci}lllll}(lt} I uttt ttl' ltl)"
: Diatthei't
,, Nxttseil
, \:rit]lillllg.  
'', Esce:xit'c rlits treiltl)letIi. CiilsfLrrurtestrnill rrtle et'lict* cnrl lx)ssil)l)'be avotrlecl i1'rtiett*rtttitt ts takett t{tllt ttteali rtabi6zeri rxi iui)"rlirse,.il'ruelli,r'urin. e.rultl be ilue ttr lactic it,":iitr,:l: trl dlllel \cll!ill\ clireart {:te lit'Lru'!  
r l_actic nqjdosir l$ i., \,er' l,ill.e t I 10.0(x)) hul serrous c$ull)licilllori. thn{ itlletl: [:r.rtlY ultettuiltr';lttcl that cnu Lrccur due rrl llleltllullirr ircrrr:rurlntiou dttlirtgtreiltntettt. The 1:t't'setcr'of-lnctic rrticltirir c;rtt pirrrelrt ,i,1ce i.t irrrti$llr cintira r\rII|.)lrrrll$ )lrlrilxr lrl 0llter'(olnili{)rt 1,:tthlcttti ttte it l't-* s.rttllls 1l1t'd hi l}r*re ldvattceel cit\es f)t lilttir lrcrtltsrs. tltere rrt:rv l)e ursocrilterl exllellle ll'enkltesi r'r llte{11}c"sr'  
i'.::It:{)i:{ 1-  
  
I)atc 5,ri l6
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rllCh i\'ltllltOn}I ilnd lrru lllr-rl nrllll'\ th* (1t)tl\)r irtrrilerjlllclr i1'thev (,{cnr. l^*c{r* nctclosis is ir rut*tircrl enlergenc!'llliit rrurri lie'lreirtetl irt lt,r11:ttal. 11"1'rrrr r.lcvul*F lirclte ltcirl*sis ll*1 lirn11111 5|lottltl lre eli sc rintnilre cl irlhuerliir t e ll n uti pre1s1111*rr11t' Filliqirr i l - lt) r,ul ol: Xi)t) pltir"rrtr)
lleadachr" (I -10 i.)ul trl I(llllrrrti*nfsi
\lctallrc lirrle l,r lir.i,l.,rtettlrlllg lll rll)l)lrl\llll;llclr \ i,ttl (\l'l{X)1';rtiCrtls Skirt leelrtcss. 1r*r'r: rir'rr a a
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a

Yitrt ltlitS' I*ul c l;lrrttli:;ti i'. :l't'.:
riltllitt*il }i]"'i*(. "l'IIo'ri: i)lt Ilil ri tll lrr' ttrlr'et*rl 1lt!t' lll{ '" L"ilr ,
;ulil in *glriitr lt*lxLtlt*l'tt
{.}t itti\li}tln r.ll'Y{}11tlt:r\ ltll.'.',i1\L''ltiii':i :'t'd itll*itt jl1}lll l!'ltl*' 111 ir l,]1,r!-r.r: *i'i*r{s titiur *>i1:L:rtxf t{r lhr }ting1}(t1{ t-r*lii' .l 1t* t.rtrir:i1 i;g43{:;Jr.'*
itlrij tlr;i\'(i1trr* !'r.)ti lp ixl.rtt:ti,:ttti Itiltrtnrti:l' lt.:gi.lll*1t*' ili'll llarir*" 1!1:-'r11q'r:i

Use of Your P*rsonrrl Informiltion: 'l'he grealest risk to --vou is l'elease of 1,r^1r irtlix.uraliol fi.our yoru'health records. To reduce this risk ,vllil'nanre and persoual iuf*rrnatiou lsuch as date pf birth or nredical record rlunlber') rvill n*t be uxed. Ytlru sanrple* will trc corled ivith a stuily itlerllilicntiou ltutrber lo protecl \'our Fersonal intbnrmtion. 'I'he ilatnblses {evelopitcl t"irr tlris plo"iect will be secnrecl nttcl onlt' the stnd.v drctnrs ancl authorized persorurel rvill har,e access tp il. However'. people rrtnv clevtrlup \\iri\:s ur the lirtrue that wotrlcl allow soureone lo llnk ytrul rlredical iufonualiott back to vurt" It is also possible the computer svsten* can [:e ]rncked bv rutatrthorieed peoplc" l\re will do our best tn 1.:rclecl veur por$otral ink:rruati*n.  
Rirk of Gtnetic Testing: \'rrur spe,rinrerrs will be rued in the frrnre t* le*nr mr:re about horv to l)rcvettt. diagnose. lleat r:ancer arrcl ruay'be used t'or gerrelic lesturg. f]re results ti'om the tesfilg r.vrll not be placed il Yoru rlrerlical lecortjs and nsed tr"rr rese*lch r:nlv. y*u rvill uor be c*ntattedor 1g'cgl1:g' lhe resrtltr ii'r'ull gcl)eltc t*slrrrg.  
Although yonr genetic irriorruatir:n is unique t() vou. you do share s*me genetic inlbmration rvith ye[u'chiLt'en, parellt.t. brollters. srsters, aud other blood relntives. It umy tre possil:le that genetic intounation fi"t'rm thern coulcl be used fo itlenti{v }rr)u. It nm-v also be pr:ssible that genetic i:r{trrnratrun fi'r:rn you currld trc usetl to irelp itletrLily th*nr.  
New health itftrrrnati*u al:rout genetic traits that uright at]bct vorJ nr yom bloncl relatives cr:rrl{
lre forurd drrriug a researclt slttd\'. \:ery rarell,' healt]: ut' geuetrr intbruration c*nld tre urisusrd l.rr..  
health providers. lile irrsurarrce cnmpanies. and others. For example. lilb inrurauce cornpilllres rnay cltarpte a higher ratt basecl *n llris inltlrrrmtiorr.'fhe rixk ol rnisuse ul'your gr:uetic infonnatiotr is very srnall. I'lris is lrecause the researchers lra:i takeu specinl steps trl keep your intbruatiort nttcl resttlts er:ufielertial. lhere are $tflte autl lbcleral laws thal pr'otect ilgainxt qeuetic discrirninatron.  
Gcnetic Inform:rtion [,arv: '['here is r ledelal lau, r:all ilre (ienrtic lrilbtrrstir.:rrr I'{cutdi;criluirtatiou Act iUINA). }r gt'rreral. tfiis lag, urakes rt illegal lbl healtfi iusuraltce cotupauies. lirollp ltealth 1:laris. artrl urrist *nrpluvers to cliscrrrnirlflte ilg1{liltst you basecl oll your genetic irfonuatiou" This law Setrerall-v will protecr you iu the i'ollor,viug rvays. il) heatth  
  
  
Pr irlril,,rl !t'e\ti.jnlrlr f
"qellrtic ittfcrtrtriltieitt \l'ltett tttlkius (leclsii:!li r*Fnrdirrc lr:rrr cligibilit\: or'l)l'ellirrrrrs: arlri (ii el.tl1:litl'Crs r.vith l^( qrr nl$r(,errll"rlr.rVers rllit\, llr.}l ils* \,$lll UeUeltc tttlirnttititiltr tltat r.le Set lirtrtt tltis researcit rvltett ntakitts a decisitru to hiie. pron,rit*. orlflre \'olr oI 1,6err r.,1iug the fe:.:,s tri' litb iusultrrce. dtluhilitv irrsru*rrcu. r.rr loug-terut car.e ilisru.lulur.  
'l"ltr.rc nls* nrrrl lre t>llrer llll\itc)'rrrl,: tlrirt t.rrc rutkn*u.ri.  
\\ lr:rt lrc lhr hentfitr ul'prrr.tie iprrtion':)
tttil-v lrelp irnesfrgalr'rrs trntlerrtirrril. pru'ertt. r:)r lrent th* dis*:rrc-, il11el crrrtelilifrrr strrruccl irr llre ]rrrruc.  
Hox'n'ill infornrltion:l116tt( t'ttu rtntl r'our tircue slnr;rler lle kellr prir.-lte anrl conli6t,nfitl'.)
d;tlt trl'lltttlt. itr.ltIt*:.. i,] trlllt'] l)t'1:rrrr;rl rilurrlllr'rrrg nriirrrnirlrorr. rill rrtt 1x, lrrrketl rr.itlr thc sirutpl,,,s Vdll {iYe
Clinical trial: NCT02420652
Section: Procedures
Subsections: Befort St*Rtin G Trtutm*:Nt :

yo* rvill tre asked to c*rue ter the clinic to have screening lests dolre tLr tind ort if ,vo1t cfill be lI] tlte snrdy. The results of rhere testr flre u$ed to ctetennine if y,:u ere ahle to go sn this stucly tllxl {re paft of
,*g,il* callcer rnre. The scleet]lng tesrs include the foll.u,'ing.  
-  
Screening rtill ctlnrisi of:
r Sigrring titis ittiotrtted (()llrel)1 li)rlll r yr-lu rvrll be rrskrcl;llrirut \,,rlu lr*altlr rrrcl rtt..tlrcnl ltt.tillr'. \'*n $rl1 alril tle l.k.ecl al:t'ttl ;'lttl' tlt*dir:ttiiltlr \'\rtl all'o I *klrt g.
reslttralotr' ;ttlcl ltclt t ultr"'
r Bl,i:d reilt {lr[trrrl I lflr>p,r,rltr \\lll he takett ti'cittt "''t.rttt rt*tni
,) ('olulllulu bl*,rtl crllllll i( If(')
i C'lreuri*tr.t tesls ti) hclyr eleterrtrire h*rv voru kicltte.ri itlxl h\jet lre litltcttc'ttirr'-t
,., PSA lt) ltldllltor \'r)ul (llsiiil\e slalill c .{n \lRI i:r C'J'rrtitu trl:\'ouI hr,rlt ttl utclttitcr t'*ttt tlirellst'!tiitlls
,. ,\ ('l'i( rrilrlrrrlr-,rl '[()it(rgl ,tl)lt\) \eall is il slrlih'ttsittg x-t;t., 1l,'['ith iit t)l]t l)ill-l r)l'\'r!tu' i:oilv.  
t-; ,\rr \lll"l i\lirguutrr Rrrrrrrilure lrrragiug) ir intagrrrg lltitt tt:cs a sltlrttg lllilslltlllu ir*kl t':
loilk at ')lle pill t tll l"tttt trr:tl\'
r Ilrltte scart r.tt'1.1111 lrorre tr, nlt'rlrl\ll tl'llte 1ltoslitl('t'illlt'{l ltilt rFteilil 1{) \'{}lll'lroltfr Il is r,ert,i*r1;i.rrt;t*t flr,,l rrrrr rrll tlrc .t11ilr.sltlirrl':rll rhe rn*rlierliottr \'o11 at{ titktttt. 'I"ltru itrcltrtlc' bollt illly quesli{}ns ahrrrrl rrlher nrerlielltr)t]' \rr!ll witl]t lo take tJtttittg tltt rltxlv.
Clinical trial: NCT02420652
Section: Voluntary Participation
Subsections: Signnture Of Investig*Tor/[Ndir,Itluul Obtaining Consent :

To the best of ,votu'abilitl'. vou lrrve eriplaineel aud cliscusseel lhe tirll conlent* of the sfitdf iucludins all r:f the inlonnstiou conlaiued ur this conreut tbnn. All queitiens of the t'esearclt sub.iect attrl fltose of his:trer p*r"errt or bgll grulldirrrr lttr.'r" tl*r,:n scttrnlt"ll,*ttsrvrlred.  
Iuverti gnti:r/Persol Obtauring {'oltse}tt :,  
Siguature I)ate.rTr:rre:
Clinical trial: NCT02420652
Section: Withdrawal from Study
Subsections: I{ It Kr N T' R} \ Jril'{Xr :

Itret * ;t*ti rril"i{}u\ qirlt' r'li*r ln r Itlcreittecl lirk uf'bl,:erirn* il ii lrtc. l.nrl lnlp{-tftanl s}de etLect *lirr1:rrrtr 'l-ittr t" ntrtsl ul{*u reen rile:
rlf bleedutg r; in fhe gilstrorrrtestinlrl lrirct {rtonrach. esrphauus} x{tere lt rtlii\.he'iissoctilletl rvtdt 10.0()(,) pdoplr trr hirr,e selit)rls lrlrrriirrg iu lhe rlourilch Fer ),ral t)liter titclrrtr rltch i'l! \{)tlt it!lt'.  
\\clgltl" use irl'ci.rltir*tlci:rrril rnir1, 1rrtlllcl1!:r \'(]llr tisk rl'rlcvtl,',1ltttF \f{ltll;lell lrltci'lrrrg o Dirttiage lo tlre lirrrrrs rrl-thc rttrrrreeir i.rrtri errrph;lStts u'ithrrnt ltldcilirtg ll]:t\'{)culx txleh' ller Yeiir.  
r R*],u's svtrdt*trte lJ ir lrre hnl \rn('flrs cr,,rtditi,-rti llt.itt ciitts*: su'clhitg rtt llrc livcr llttll trrstlt. Rtye's sr,nrlr*nre rurlil utiell ilt"teci: clrrldr*rr ancl tc:ertRqers tec$\'rrrlts liirttt I viri'rl itttcctttrtt. tnlst col)llr)olllt tlrr: flu or clrick*nllos .,\rl)ilrrI ttse lt,ns heerr lrnlietl 1\'rth Revc'\ stttrltilttttt. Il.ele'o
{ it}fluelrza )
Rare iiucl prrteulialh' serroll! ritie cl]'ects trl.lslluttt are r Slrrrtrircli ul)ret r Dtlrlrltr'a r ('oustipalir,l r Rarh irrtel ltile:
r Allersrc relicllolli x'itlr li|. l"ete and tlur:at srvellin"c lltat u:ay cau.ie ditftculry bleathing in this silld\i ilr"e r L{eart aud trli,,"ril \'(s-\els: lllr'gulilt heilrllierlll. l*g sruellirru. lorv blr,trrtl llresstlrc. ltst lteilrl rate c Brain fln{ilterves: "{gitiltirrn. lxanr 'wellit}g. coll}a. crrnlitsiol). tltzz-ittesr. fatistre. lteat{nche" hrtllt lloilv l*rrtpc"r'nlru t sle*pirte sn r filartrlr: lrigh bL:orl susilt. lrigh hi,,oil ll()til\\ll.llll
' (.iilltrolltlertlltiil: ilr)lilrch llllrct' slrrtttlch plitt' ttattselr' r'trtlitlitl:l  
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I)irs* 6 fri l6
*rth !{c,rrrr,.rtte.l)e1t:rdelrt l{i>;tig liti:'rt:rlt-spetiiic Atili:c:i
,.r: I'lell,rrrttill iltlttr'{rl;tt rtt rP}'1111'{ hi*l I
\lr:.ir ] irlc .\ !'li''c - l-l rri i 'r'tt;c I I)t""ri'tr"r ';1"1' ': "' :t' i''"rct"'
l,r,.lr...t,,tt.\ltct I \,a.rl llrut.ri, l.'t i't., '.'r; ( l,{.!l I i titt'rttt'i !l'u \111ull}
c Riooil: l,w reil hl*iul cell r:ouuts {nuernin). ltxv pla{elctr {ue*ded 1* ltilp trlc*diig). r;kitt l:ftstttg' iurbilit-v ttt stitp irle*tlirrg r I.rver: irrtlarrrrnatiolt \it the ltr,'ct. datttage to tlte ltver'^ itltrt;lre itt trcrrels *1'ltrtt 1:toteills iil the hlilr:d r Brrtte: itotte destntctt,:tt.  
o I{trscle: trtltscle ht't'itktlc'n'tt cirtt:itt!. kttlnel' rlntttage' r'r'eakltcsl r !I*uirtg. lteattttg l,'r:r. tutgitr$ irt llrt" t;rts r Kichre-v: r-lecreirserl krrluel, liurt:tr*u. iutlauuuati,-iu iu the kidne-v- kichrel' lailul'e' kiihley pairr r Lrurgsi: rvhe*ziilg.. brenlhing tirsi. rLllictrltv bt ealhin$-
r Nuse: l'lllulv ll05e
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Ilisli *f lll*lrtl l.)t:luillg: 1 i , .:, .. .,
x"prtr{ed ilr x relttli r:l'lil* dl't'