Conditions: Prostate Cancer
Keywords: prostate cancer testosterone replacement AndroGel prostatic cancer prostatic neoplasms
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 6
Healthy volunteers: no

Brief summary:
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.

Detailed description:
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.

Arms:
arm 1: Twenty subjects will receive testosterone gel arm 2: Twenty subjects will receive the placebo

Interventions: intervention 1: AndroGel intervention 2: placebo
Intervention descriptions: intervention 1: Androgel 1%, 10g daily intervention 2: placebo

Protocol document: