A Randomized, Double Blind, Placebo-Controlled Phase II Study of 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