drugset / Trial / NCT00577980
Testosterone in Castration-Resistant Prostate Cancer
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
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Testosterone | Small molecule | 200 mg | Intramuscular |
| Subject | Testosterone | Small molecule | 400 mg | Intramuscular |