Testosterone Revival Abolishes Negative Symptoms, Fosters Objective Response and Modulates Enzalutamide Resistance

PHASE2CompletedINTERVENTIONAL
Enrollment

222

Participants

Timeline

Start Date

January 31, 2015

Primary Completion Date

October 26, 2018

Study Completion Date

February 21, 2020

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 (17)

15212

Allegheny Health Network, Pittsburgh

20016

Sibley Memorial Hospital, Washington D.C.

21201

University of Maryland, Baltimore

21205

SKCCC at Johns Hopkins, Baltimore

30318

Piedmont Cancer Institute, Atlanta

35294

Unversity of Alabama, Birmingham

44195

Cleveland Clinic, Cleveland

48109

University of Michigan, Ann Arbor

60637

University of Chicago, Chicago

66160

University of Kansas Cancer Center, Kansas City

68130

Neraska Cancer Specialists, Omaha

70112

Tulane University Medical Center, New Orleans

80045

University of Colorado Cancer Center, Aurora

84112

Huntsman Cancer Institute, Salt Lake City

91010

City of Hope, Duarte

98109

University of Washing, Seattle

08901

Rutgers Cancer Institute of New Jersey, New Brunswick

All Listed Sponsors
collaborator

United States Department of Defense

FED

lead

Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins

OTHER

NCT02286921 - Testosterone Revival Abolishes Negative Symptoms, Fosters Objective Response and Modulates Enzalutamide Resistance | Biotech Hunter | Biotech Hunter