Enzalutamide for Prostate Cancer
(PROSPER Trial)

Recruiting in Palo Alto (17 mi)

+400 other locations

Age: 18+

Sex: Male

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 3

Waitlist Available

Sponsor: Pfizer

No Placebo Group

Pivotal Trial (Near Approval)

Prior Safety Data

Approved in 4 Jurisdictions

Trial Summary

What is the purpose of this trial?The purpose of this study is to assess the safety and efficacy of enzalutamide in patients with non metastatic prostate cancer.

Eligibility Criteria

Men with nonmetastatic, castration-resistant prostate cancer can join this trial. They must be on hormone therapy or have had surgery to lower testosterone levels, have a rising PSA level with a doubling time of 10 months or less, and no signs of the cancer spreading. Participants should be relatively healthy overall, with an expected lifespan of at least one year.

Inclusion Criteria

Estimated life expectancy ≥ 12 months.

PSA doubling time ≤ 10 months

My cancer has not spread to other parts of my body.

+17 more

Exclusion Criteria

Total bilirubin ≥ 1.5 times the upper limit of normal

I have not had major surgery in the last 4 weeks.

I am allergic to certain ingredients in the medication's capsule.

+11 more

Participant Groups

The study is testing Enzalutamide's effectiveness and safety against a placebo in men whose prostate cancer hasn't spread but continues to grow despite low testosterone levels. The goal is to see if Enzalutamide can help control the disease better than no treatment (placebo).

2Treatment groups

Experimental Treatment

Placebo Group

Group I: EnzalutamideExperimental Treatment1 Intervention

160 mg by mouth once daily

Group II: PlaceboPlacebo Group1 Intervention

Sugar pill manufactured to mimic enzalutamide 40 mg capsule

Enzalutamide is already approved in United States, European Union, Canada, Japan for the following indications:

🇺🇸 Approved in United States as Xtandi for: