what is the is your psa rising? prosper clinical trial? is ...what is the prosper clinical trial?...

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What is the PROSPER Clinical Trial? The PROSPER Clinical Trial is a global Phase 3 clinical research trial that will in- clude about 1500 participants. The trial will test the effects of an oral investigational drug called enzalutamide in men with non- metastatic prostate cancer that continues to progress despite hormonal therapy. The pur- pose of the PROSPER Clinical Trial is to compare how enzalutamide works when com- bined with standard treatment vs. the stan- dard treatment only. You may qualify for the PROSPER Clinical Trial Join the PROSPER Clinical Trial Do you or does someone you care about have a PSA that is continuously rising? If so, please consider taking part in the PROSPER Clinical Trial for patients with prostate cancer that has not spread beyond the prostate, but has pro- gressed on hormonal therapy. In the PROS- PER trial, patients will have a two out of three chance of being randomized to receive enzalu- tamide or a one in three chance of receiving placebo. All patients will receive standard treatment in addition to their respective drug/ placebo assignment. Learn more Ask your doctor or visit www.clinicaltrials.gov for more information (clinicaltrials.gov; Identifier NCT02003924) Is your PSA rising? Is your cancer limited to your prostate? Is your cancer causing no pain?

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Page 1: What is the Is your PSA rising? PROSPER Clinical Trial? Is ...What is the PROSPER Clinical Trial? The PROSPER Clinical Trial is a global Phase 3 clinical research trial that will in-clude

What is the

PROSPER Clinical

Trial?

The PROSPER Clinical Trial is a global

Phase 3 clinical research trial that will in-

clude about 1500 participants. The trial will

test the effects of an oral investigational drug

called enzalutamide in men with non-

metastatic prostate cancer that continues to

progress despite hormonal therapy. The pur-

pose of the PROSPER Clinical Trial is to

compare how enzalutamide works when com-

bined with standard treatment vs. the stan-

dard treatment only.

You may qualify for the

PROSPER Clinical Trial

Join the PROSPER Clinical

Trial

Do you or does someone you care about have a

PSA that is continuously rising? If so, please

consider taking part in the PROSPER Clinical

Trial for patients with prostate cancer that has

not spread beyond the prostate, but has pro-

gressed on hormonal therapy. In the PROS-

PER trial, patients will have a two out of three

chance of being randomized to receive enzalu-

tamide or a one in three chance of receiving

placebo. All patients will receive standard

treatment in addition to their respective drug/

placebo assignment.

Learn more

Ask your doctor or visit www.clinicaltrials.gov

for more information (clinicaltrials.gov; Identifier

NCT02003924)

Is your PSA rising?

Is your cancer limited to your

prostate?

Is your cancer causing no

pain?

Page 2: What is the Is your PSA rising? PROSPER Clinical Trial? Is ...What is the PROSPER Clinical Trial? The PROSPER Clinical Trial is a global Phase 3 clinical research trial that will in-clude

What should you expect

if you join the PROSPER

Clinical Trial?

You will be asked to take your study medica-

tion capsules orally once a day. You will con-

tinue to take medication that lower testoster-

one levels unless you have had an orchiec-

tomy (had your tes-

ticles removed).

Two out of three

trial participants

will receive enzalu-

tamide, the investi-

gational drug being

studied. One in

three of the participants will receive placebo.

You will be seen at the study doctor’s office

one month after entering the study, 3 months

later, and then every 4 months thereafter

while you are taking the prostate cancer trial

medication on a daily basis. At each visit, the

doctor will assess how the treatment is work-

ing and whether you have any side effects. In

addition to the treatment provided by the

study doctor, you will continue to receive

care from your current medical team.

PROSPER Clinical Trial

site locations:

The PROSPER Clinical Trial is taking place

at many sites worldwide.

If you believe that you or someone you care

about meets the PROSPER Clinical Trial en-

try requirements, please speak with your doc-

tor or visit www.clinicaltrials.gov (Identifier:

NCT02003924) for a list of trial site locations.

Who can join the

PROSPER Clinical Trial?

Men whose prostate cancer fits

this description may be able to

join the PROSPER Trial:

• Your cancer has not spread beyond

the prostate

Your PSA is rising despite treat-

ment with hormonal therapy

• Your cancer causes no pain

Other inclusion/exclusion criteria

may apply

V2.0 03 Dec 2014