RecruitingPhase 2NCT04363164

Sequential Testosterone and Enzalutamide Prevents Unfavorable Progression

A Randomized Phase II Study Comparing Sequential High Dose Testosterone and Enzalutamide to Enzalutamide Alone in Asymptomatic Men With Castration Resistant Metastatic Prostate Cancer

Sponsor

Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins

Enrollment

150 participants

Start Date

Aug 19, 2020

Study Type

INTERVENTIONAL

Conditions

Castration Resistant Metastatic Prostate Cancer

Summary

Asymptomatic men without pain due to prostate cancer progressing with metastatic CRPC after treatment with combination or sequential ADT + Abi will be treated on a randomized, open label study to determine if sequential treatment with high dose T and Enza will improve primary and secondary objectives vs. continuous Enza as standard therapy.

Eligibility

Sex: MALEMin Age: 18 YearsMax Age: 90 Years

Plain Language Summary

Simplified for easier understanding

This study is testing an approach called "bipolar androgen therapy" for men with advanced prostate cancer that has stopped responding to standard hormone-blocking treatments. The strategy alternates between high-dose testosterone injections and enzalutamide (a hormone-blocking drug) to try to resensitize the cancer to treatment. **You may be eligible if:** - You are 18 years or older with confirmed prostate cancer - You have been on continuous hormone-suppressing therapy (medical or surgical castration) and your testosterone is at castrate levels - Your cancer has spread and has been confirmed on CT or bone scans - Your cancer progressed while on abiraterone (a hormone therapy drug) combined with other androgen deprivation therapy - You are in reasonably good health (ECOG performance status 0–2) **You may NOT be eligible if:** - You have not had prior treatment with abiraterone - You have conditions that make high-dose testosterone unsafe (such as certain heart conditions) - Your health status does not meet required thresholds Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGTestosterone cypionate

Depo-Testosterone Injection, for intramuscular injection, contains testosterone cypionate which is the oil-soluble of the androgenic hormone testosterone. Testosterone cypionate is a white or creamy white crystalline powder, odorless or nearly so and stable in air. Depo-Testosterone Injection is available in two strengths, 100 mg/mL and 200 mg/mL testosterone cypionate.

DRUGEnzalutamide

Enzalutamide is a white crystalline non-hygroscopic solid. It is practically insoluble in water. Enzalutamide is provided as liquid-filled soft gelatin capsules for oral administration. Each capsule contains 40 mg of enzalutamide as a solution in caprylocaproyl polyoxylglycerides. The inactive ingredients are caprylocaproyl polyoxylglycerides, butylated hydroxyanisole, butylated hydroxytoluene, gelatin, sorbitol sorbitan solution, glycerin, purified water, titanium dioxide, and black iron oxide.

DRUGTestosterone enanthate

Testosterone Enanthate Injection, for intramuscular injection, contains testosterone enanthate which is the oil-soluble ester of the androgenic hormone testosterone. Enanthate Injection is available as a colorless to pale yellow solution. Each mL contains 200 mg testosterone enanthate in sesame oil with 5 mg chlorobutanol as a preservative.

Locations(6)

University of California, San Diego (UCSD)

San Diego, California, United States

Johns Hopkins University/Sidney Kimmel Cancer Center

Baltimore, Maryland, United States

Dana-Faber Cancer Institute

Boston, Massachusetts, United States

University of Minnesota

Minneapolis, Minnesota, United States

University of Nebraska Medical Center

Omaha, Nebraska, United States

University of Washington/Fred Hutchinson Cancer Center

Seattle, Washington, United States

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NCT04363164

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