Testosterone Replacement in Men With Non-Metastatic Castrate Resistant Prostate Cancer

Inclusion Criteria:

• Prostate cancer
• Patient must have received primary definitive local therapy to the prostate (surgery and/or radiotherapy)
• Patient was surgically or pharmacologically castrated at least 6 months prior to starting the study
• Patient must have had a previous trial of anti-androgen therapy
• Patient must have a rising PSA
• No evidence of distant metastatic disease
• ECOG performance status < 2
• Age >18 years
• Patients must have normal hepatic function

Exclusion Criteria:

• Patients with a history of any previous cytotoxic therapy or radionuclide therapy (such as rhenium, strontium, or samarium)
• Patients may not be receiving any other investigational agents
• Uncontrolled intercurrent illness including, but not limited to ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, uncontrolled cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements
• Patients receiving renal dialysis
• Patients with significant pulmonary disease who have received chronic or pulse steroid therapy within the last 3 months prior to randomization will be excluded
• Patients who have known hypersensitivity to any of the AndroGel ingredients, including testosterone that is chemically synthesized from soy