Enzalutamide for Prostate Cancer

(PROSPER Trial)

Recruiting at400 trial 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.

Research Team

Pfizer CT.gov Call Center

Principal Investigator

Pfizer

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.

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.

Treatment Details

Interventions

• Enzalutamide (Antiandrogen)
• Placebo ()

Trial Overview 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).

Participant Groups

Group I: Enzalutamide Experimental Treatment 1 Intervention

160 mg by mouth once daily

Group II: Placebo Placebo Group 1 Intervention

Sugar pill manufactured to mimic enzalutamide 40 mg capsule

Enzalutamide is already approved in Canada, Japan for the following indications:

Approved in Canada as Xtandi for:

• Metastatic castration-resistant prostate cancer (mCRPC)
• Non-metastatic castration-resistant prostate cancer (nmCRPC)

Approved in Japan as Xtandi for:

• Metastatic castration-resistant prostate cancer (mCRPC)
• Non-metastatic castration-resistant prostate cancer (nmCRPC)

Who Is Running the Clinical Trial?

Pfizer

Lead Sponsor

Trials

4,712

Recruited

50,980,000+

Known For

Vaccine Innovations

Top Products

Viagra, Zoloft, Lipitor, Prevnar 13

Albert Bourla

Pfizer

Chief Executive Officer since 2019

PhD in Biotechnology of Reproduction, Aristotle University of Thessaloniki

Patrizia Cavazzoni

Pfizer

Chief Medical Officer

MD from McGill University

Astellas Pharma Inc

Industry Sponsor

Trials

700

Recruited

236,000+

Headquarters

Tokyo, Japan

Top Products

- Xtandi (enzalutamide) for prostate cancer, - Xospata (gilteritinib) for AML, - Padcev (enfortumab vedotin) for bladder cancer, - Prograf (tacrolimus) for organ rejection prevention

Tadaaki Taniguchi

Astellas Pharma Inc

Chief Medical Officer since 2023

MD, PhD

Naoki Okamura

Astellas Pharma Inc

Chief Executive Officer since 2023

University of Tokyo, Faculty of Pharmacy

Medivation LLC, a wholly owned subsidiary of Pfizer Inc.

Industry Sponsor

Trials

24

Recruited

10,200+