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.

Study Type: Interventional

Study Design: Treatment, Randomized, Double Blind (Subject, Investigator), Placebo Control, Parallel Assignment, Safety/Efficacy Study

Study Primary Completion Date: January 2010

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.

Intervention(s) in this Clinical Trial

• Drug: AndroGel
  • Androgel 1%, 10g daily
• Drug: placebo
  • placebo

Arms, Groups and Cohorts in this Clinical Trial

• Experimental: A
  • Twenty subjects will receive testosterone gel
• Placebo Comparator: B
  • Twenty subjects will receive the placebo

Primary Measures

• The primary objective of the study is to determine the effect of testosterone replacement progression and time to clinical cancer progression.
  • Time Frame: time to progression evaluated every 8 weeks
    Safety Issue?: No

Secondary Measures

• To explore the value of AR expression in circulating tumor cells.
  • Time Frame: every 8 weeks
    Safety Issue?: Yes

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

Gender Eligibility for this Clinical Trial: Male

Minimum Age for this Clinical Trial: 18 Years

Maximum Age for this Clinical Trial: N/A

Are Healthy Volunteers Accepted for this Clinical Trial?: No

Lead Sponsor: University of Chicago

Overall Clinical Trial Officials and Contacts

Walter Stadler, MD Principal Investigator University of Chicago  

Overall Contact: Beth Manchen, RN 773-702-4135 emanchen@medicine.bsd.uchicago.edu

Information obtained from ClinicalTrials.gov on August 28, 2008

Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00515112

Study ID Number: 15393B

ClinicalTrials.gov Identifier: NCT00515112

Health Authority: United States: Food and Drug Administration