Enzalutamide + Leuprolide for Prostate Cancer

Recruiting at269 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

Trial Summary

What is the purpose of this trial?

The purpose of this study is to assess enzalutamide plus leuprolide in patients with high-risk nonmetastatic prostate cancer progressing after radical prostatectomy or radiotherapy or both. The randomized / blinded portion of the study is now completed following primary endpoint analyses. The study remains ongoing in open label format.

Research Team

Pfizer CT.gov Call Center

Principal Investigator

Pfizer

Eligibility Criteria

Men with high-risk, nonmetastatic prostate cancer that's progressing after surgery or radiation can join. They need a PSA doubling time of ≤9 months and certain PSA levels depending on prior treatments. Exclusions include recent use of specific drugs, brain metastasis, distant metastases, previous hormonal therapy (with some exceptions), chemotherapy for prostate cancer, major surgery within the last month, or another invasive cancer in the past 3 years.

Inclusion Criteria

Serum testosterone ≥ 150 ng/dL (5.2 nmol/L)

My PSA level is above 1 ng/mL after prostate surgery or 2 ng/mL above the lowest point after radiotherapy.

My prostate cancer was initially treated with surgery or radiation aimed at curing it.

Exclusion Criteria

I have not taken finasteride or dutasteride in the last 4 weeks.

I have received specific treatments for prostate cancer.

My cancer has spread to distant parts of my body, confirmed by scans.

Treatment Details

Interventions

• Enzalutamide (Antiandrogen)
• Leuprolide (LHRH Agonist)

Trial Overview The study is testing enzalutamide combined with leuprolide against prostate cancer that hasn't spread elsewhere in the body. The trial was initially randomized and blinded but now continues as an open-label study where everyone receives the actual treatment without any placebo.

Participant Groups

Group I: Enzalutamide plus leuprolide Experimental Treatment 2 Interventions

Enzalutamide (160 mg) administered as four 40-mg capsules by mouth once daily in combination with leuprolide administered as as a single intramuscular or subcutaneous injection once every 12 weeks

Group II: Enzalutamide monotherapy Experimental Treatment 1 Intervention

Enzalutamide (160 mg) administered as four 40-mg capsules by mouth once daily

Group III: Leuprolide plus placebo Active Control 1 Intervention

Enzalutamide placebo (placebo) capsules (identical in appearance to enzalutamide) administered as 4 capsules by mouth once daily in combination with leuprolide administered as a single intramuscular or subcutaneous injection once every 12 weeks. The randomized blinded portion of the study has concluded following primary endpoint analyses. In the Open Label Period the placebo is no longer applicable in this study arm, and patients continue to receive leuprolide alone.

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+