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

Stopped early · Phase 2 · Has a placebo group

Conditions studied: Prostate Cancer

In brief

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.

Key facts

Study ID

NCT00515112

Run by

University of Chicago

People needed

6

Starts

2007-07-01

Expected to finish

2012-08-01

Last updated by the study team

2014-06-11

Who can join

Age: 18 and older. Sex: male. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• University of Southern California — Los Angeles, California, United States
• University of Colorado — Aurora, Colorado, United States
• Northwestern University — Chicago, Illinois, United States
• University of Chicago — Chicago, Illinois, United States
• NorthShore University Helath System — Evnaston, Illinois, United States
• Ingalls Memorial Hospital — Harvey, Illinois, United States
• Illinois Cancer Care — Peoria, Illinois, United States
• University of Maryland — Baltimore, Maryland, United States
• University of Rochester — Rochester, Maryland, United States
• Baylor College of Medicine — Houston, Texas, United States
• Medical College of Wisconsin — Milwaukee, Wisconsin, United States

Full record on ClinicalTrials.gov

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