Enzalutamide + SRT for Prostate Cancer

Recruiting in Palo Alto (17 mi)

+8 other locations

Overseen by Phuoc Tran, M.D.

Age: 18+

Sex: Male

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 2

Waitlist Available

Sponsor: Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins

Prior Safety Data

Trial Summary

What is the purpose of this trial?

The primary hypothesis of this study is that outcomes for patients with biochemically recurrent prostate cancer following radical prostatectomy will be improved by the addition of enzalutamide for 6-months compared to standard-of-care salvage radiation therapy to allow for further study in the definitive phase III setting. This study builds on the prior success of high-dose bicalutamide (for 24 months) when combined with salvage external radiation therapy (XRT), while using a newer more potent anti-androgen for a shorter duration of time (6 months) in an effort to minimize adverse effects.

Research Team

Phuoc Tran, M.D.

Principal Investigator

The SKCCC at Johns Hopkins

Eligibility Criteria

Men over 18 with prostate cancer that's come back after surgery, but hasn't spread to other parts of the body. They must have a certain PSA level and can't have had hormone therapy before (except with surgery). Participants need good overall health, no serious heart or psychiatric conditions, and they must agree to use two forms of birth control if their partner could get pregnant.

Inclusion Criteria

My prostate cancer has returned, shown by rising PSA levels after surgery.

Patients must have PSA within study range

My testosterone levels are not low and within the study's required range.

Exclusion Criteria

I do not have serious heart issues, seizures, or conditions that could cause seizures.

I do not have serious illnesses like heart, lung, severe liver conditions, or major infections.

My main cancer treatment is radiation therapy.

Treatment Details

Interventions

• Enzalutamide (Anti-androgen)
• Salvage Radiation Therapy (Radiation)

Trial Overview The trial is testing whether adding Enzalutamide (a powerful anti-androgen drug) for six months improves outcomes in men whose prostate cancer returned post-surgery compared to just salvage radiation therapy. The goal is to see if this combination helps more than standard care without causing too many side effects.

Participant Groups

Group I: SRT plus Enzalutamide Experimental Treatment 1 Intervention

Arm 2 (experimental): (SRT) Salvage radiation therapy (Three dimensional conformal radiation therapy (3D-CRT)/IMRT \[Intensity-modulated radiation therapy\]) 66.6-70.2 Gy as 1.8 Gy M-F for 37-39 fx PLUS Enzalutamide (MDV3100) 160 mg PO once daily for 6 months (2 months prior to SRT, 2 months during SRT and 2 months following SRT)

Group II: SRT plus placebo Placebo Group 1 Intervention

Arm 1 (control): Salvage radiation therapy (3D-CRT (Three dimensional conformal radiation therapy)/IMRT (Intensity-modulated radiation therapy)) 66.6-70.2 Gy given 1.8 Gy M-F for 37 -39 fx PLUS Placebo PO daily for 6 months (2 months prior to SRT, 2 months during SRT and 2 months following SRT)

Who Is Running the Clinical Trial?

Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins

Lead Sponsor

Trials

578

Recruited

33,600+

Dr. William G. Nelson

Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins

Director since 1992

MD, PhD

Dr. Elizabeth Jaffee

Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins

Chief Medical Officer since 2023

MD

Astellas Pharma Inc

Industry Sponsor

Trials

700

Recruited

236,000+

Headquarters

Tokyo, Japan

Top Products

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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, Inc.

Industry Sponsor

Trials

76

Recruited

11,200+

Dr. David Hung

Medivation, Inc.

Chief Executive Officer since 2003

MD from University of California, San Francisco; AB in Biology from Harvard College

Dr. Stephen M. Kelsey

Medivation, Inc.

Chief Medical Officer since 2013

MD from University of Birmingham