Combination Therapy for Prostate Cancer

Age: 18+

Sex: Male

Trial Phase: Phase 1

Sponsor: Thomas Jefferson University

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: Unknown

Duration: 6-24 months

25 Participants Needed

Trial Summary

What is the purpose of this trial?

This phase I trial studies the side effects and best way to give enzalutamide, radiation therapy, and hormone therapy in treating patients with intermediate or high-risk prostate cancer. Androgens can cause the growth of prostate cancer cells. Antihormone therapy, such as enzalutamide, may lessen the amount of androgens made by the body. Radiation therapy uses high energy x rays to kill tumor cells. Giving enzalutamide, radiation therapy, and hormone therapy may be an effective treatment for prostate cancer.

Research Team

Robert B. Den

Principal Investigator

Thomas Jefferson University

Eligibility Criteria

Men over 18 with intermediate or high-risk prostate cancer that hasn't spread far (no distant metastases), a Gleason score ≥7, PSA ≥10 ng/ml, or T2b+ disease. They must have good organ function and blood counts, be able to use contraception, and not have had certain treatments or conditions that could complicate the trial.

Inclusion Criteria

I agree to use effective birth control during and for 3 months after treatment.

Total bilirubin < Upper limit of normal (ULN)(except for Gilbert's disease)

My prostate cancer has not spread, with a high Gleason score, PSA level, or is T2b or greater.

Exclusion Criteria

I have a history of lower GI issues that could worsen with radiation.

I am not taking itraconazole or similar medications.

I have had seizures or brain-related health issues in the past year.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive enzalutamide orally once daily for 6 months. LHRH agonist therapy begins 2 weeks after enzalutamide and continues for 6 months (intermediate risk) or 24 months (high risk) post-radiation. Radiation therapy begins 8 weeks after LHRH therapy start and continues for 8 weeks.

6-24 months

Radiation

Participants undergo either intensity modulated radiation therapy (IMRT) or volumetric arc therapy (VMAT) daily five days a week for 8 weeks.

8 weeks

Follow-up

Participants are monitored for safety and effectiveness after treatment completion every 3 months for 2 years, every 6 months for 2 years, and then annually.

Long-term

Treatment Details

Interventions

• Enzalutamide
• Goserelin acetate
• Leuprolide acetate
• Radiation Therapy

Trial Overview This phase I trial is testing how well patients tolerate combining enzalutamide with radiation therapy and hormone therapy using leuprolide acetate or goserelin acetate. The goal is to see if this combination can effectively treat prostate cancer by reducing the body's production of androgens.

Participant Groups

Group I: Treatment (enzalutamide, radiation therapy, hormone therapy) Experimental Treatment 4 Interventions

Patients receive enzalutamide PO QD for 6 months. Beginning 2 weeks after start of enzalutamide, patients receive LHRH agonist therapy with goserelin acetate SC or leuprolide acetate IM or SC for 6 months (intermediate risk patients) or 24 months (high risk patients) post-radiation therapy. Beginning 8 weeks after the start of LHRH therapy, patients undergo either IMRT or VMAT daily five days a week for 8 weeks.

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

Approved in United States as Xtandi for:

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

Approved in European Union as Xtandi for:

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

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?

Thomas Jefferson University

Lead Sponsor

Trials

475

Recruited

189,000+

Sidney Kimmel Cancer Center at Thomas Jefferson University

Lead Sponsor

Trials

164

Recruited

10,900+

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, 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