Sequential Testosterone and Enzalutamide Prevents Unfavorable Progression

PHASE2RecruitingINTERVENTIONAL
Enrollment

150

Participants

Timeline

Start Date

August 19, 2020

Primary Completion Date

July 31, 2026

Study Completion Date

July 31, 2027

Conditions
Castration Resistant Metastatic Prostate Cancer
Interventions
DRUG

Testosterone 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.

DRUG

Enzalutamide

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.

DRUG

Testosterone 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.

Trial Locations (6)

21287

RECRUITING

Johns Hopkins University/Sidney Kimmel Cancer Center, Baltimore

55455

RECRUITING

University of Minnesota, Minneapolis

68198

RECRUITING

University of Nebraska Medical Center, Omaha

92037

RECRUITING

University of California, San Diego (UCSD), San Diego

98109

RECRUITING

University of Washington/Fred Hutchinson Cancer Center, Seattle

02215

RECRUITING

Dana-Faber Cancer Institute, Boston

All Listed Sponsors
collaborator

United States Department of Defense

FED

lead

Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins

OTHER