drugset / Trial / NCT00577980

Testosterone in Castration-Resistant Prostate Cancer

NCT00577980

Phase 2 Withdrawn M.D. Anderson Cancer Center
NaSingle-groupOpen-labelTreatment

Summary

Primary Objective: 1\. To assess the prostate-specific antigen (PSA)-response (50% decline) to Testosterone Replacement Therapy (TRT) in men with "intermediate and good-risk" Castration-Resistant Prostate Cancer (CRPC). Secondary Objectives: 1. To assess the objective response and time-to-progression with TRT in CRPC. 2. To assess serial changes in quality of life with TRT in these CRPC subsets. 3. Translational: To study kinetics of circulating tumor cells with TRT and molecular correlates of response to TRT in CRPC.

Timeline

Start
2007-12
Primary completion
2008-06
Completion
2008-06

Drugs

EvaluationDrugModalityDoseRoute
Subject Testosterone Small molecule 200 mg Intramuscular
Subject Testosterone Small molecule 400 mg Intramuscular

Indications