Prostate Cancer Clinical Trial
Official title:
A Randomized, Double Blind, Placebo-Controlled Phase II Study of Testosterone Replacement in Men With Non-Metastatic Castrate Resistant Prostate Cancer
The purpose of this study is to determine whether prostate cancer growth can be slowed in patients who receive Androgel® 1% at 10 gram dose.
The primary objective of the study is to determine the effect of testosterone replacement on
time to disease progression and time to clinical cancer progression.
The secondary objectives are to describe the effect of testosterone replacement on
patient-reported quality of life (FACT-P, FACT-fatigue and specific measures from the
Expanded Prostate Cancer Index (EPIC): Sexual and Hormonal Assessments), and hand-grip
strength; to describe changes in total testosterone, free testosterone, and PSA levels; to
explore AR levels in circulating tumor cells as a marker of treatment benefit.
;
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment
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