RE-sensitizing With Supraphysiologic Testosterone to Overcome REsistance (The RESTORE Study)

PHASE2CompletedINTERVENTIONAL
Enrollment

112

Participants

Timeline

Start Date

August 25, 2014

Primary Completion Date

November 11, 2021

Study Completion Date

November 11, 2021

Conditions
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 and will be administered at 400mg IM every 28 days.

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. Will be administered at 400mg IM every 28 days.

DRUG

Abiraterone acetate

Abiraterone is an inhibitor of CYP17 (17α-hydroxylase/C17,20-lyase). Each ZYTIGA tablet contains 250 mg of abiraterone acetate.

DRUG

Enzalutamide

XTANDI is provided as liquid-filled soft gelatin capsules for oral administration. Each capsule contains 40 mg of enzalutamide as a solution in caprylocaproyl polyoxylglycerides.

Trial Locations (2)

20016

Sibley Memorial Hospital, Washington D.C.

21231

The Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins, Baltimore

All Listed Sponsors
collaborator

National Cancer Institute (NCI)

NIH

lead

Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins

OTHER

NCT02090114 - RE-sensitizing With Supraphysiologic Testosterone to Overcome REsistance (The RESTORE Study) | Biotech Hunter | Biotech Hunter