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

• Status: Terminated
• Trial end date: 2012-08-01
• Target enrollment: 0
• Participant gender: Male

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: University of Chicago
• Collaborator: Solvay Pharmaceuticals
• Treatments: Methyltestosterone; Testosterone; Testosterone 17 beta-cypionate; Testosterone enanthate; Testosterone undecanoate

Criteria

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