Testosterone Replacement in Men With Non-Metastatic Castrate Resistant Prostate Cancer
NCT ID: NCT00515112
Last Updated: 2014-06-11
Study Results
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View full resultsBasic Information
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TERMINATED
PHASE2
6 participants
INTERVENTIONAL
2007-07-31
2012-08-31
Brief Summary
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Detailed Description
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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.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
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A
Twenty subjects will receive testosterone gel
AndroGel
Androgel 1%, 10g daily
B
Twenty subjects will receive the placebo
placebo
placebo
Interventions
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AndroGel
Androgel 1%, 10g daily
placebo
placebo
Eligibility Criteria
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Inclusion Criteria
* 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 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
18 Years
MALE
No
Sponsors
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Solvay Pharmaceuticals
INDUSTRY
University of Chicago
OTHER
Responsible Party
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Principal Investigators
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Walter Stadler, MD
Role: PRINCIPAL_INVESTIGATOR
University of Chicago
Locations
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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
Countries
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References
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Geynisman DM, Szmulewitz RZ, Stadler WM. A trial postmortem: challenges in conducting a randomized, double-blind, phase 2 study in men with castration-resistant prostate cancer. Eur Urol. 2012 Nov;62(5):864-6. doi: 10.1016/j.eururo.2012.08.030. Epub 2012 Aug 25. No abstract available.
Other Identifiers
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15393B
Identifier Type: -
Identifier Source: org_study_id
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