A Randomized, Double Blind, Placebo-Controlled Phase II Study of Testosterone Replacement in Men With Non-Metastatic Castrate Resistant Prostate Cancer
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.
Interventional
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment
The primary objective of the study is to determine the effect of testosterone replacement progression and time to clinical cancer progression.
time to progression evaluated every 8 weeks
No
Walter Stadler, MD
Principal Investigator
University of Chicago
United States: Food and Drug Administration
15393B
NCT00515112
July 2007
August 2012
Name | Location |
---|---|
Baylor College of Medicine | Houston, Texas 77030 |
Medical College of Wisconsin | Milwaukee, Wisconsin 53226 |
Ingalls Memorial Hospital | Harvey, Illinois 60426 |
University of Colorado | Denver, Colorado 80217 |
Northwestern University | Chicago, Illinois 60611 |
University of Maryland | Baltimore, Maryland 21201 |
University of Chicago | Chicago, Illinois 60637 |
Illinois Cancer Care | Peoria, Illinois 61615 |
University of Southern California | Los Angeles, California 90033 |
NorthShore University Helath System | Evnaston, Illinois 60201 |
University of Rochester | Rochester, Maryland 14642 |