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.
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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
6
University of Southern California
Los Angeles, California, United States
University of Colorado
Aurora, Colorado, United States
Northwestern University
Chicago, Illinois, United States
Progression Free Survival
Time to progression is measured from the date of randomization until the onset of the earliest of one of the following events: in the absence of a 50% decline in prostate-specific antigen (PSA), a PSA increase to 3 times the nadir PSA or an absolute PSA value of 50 ng/ml, whichever comes first; if at least a 50% decline in PSA is achieved from PSA peak value, a PSA increase of 50% above the nadir provided the increase is at least 5 ng/ml or back to baseline; one or more new skeletal lesions as shown on any bone scan or minimum of 1.5 cm in longest diameter on any computed tomography or magnetic resonance imaging scan; tumor flair; the occurrence of a clinical event, including death, determined by the investigator to represent disease progression.
Time frame: Up to 5 years
To Explore the Value of Androgen Receptor (AR) Expression in Circulating Tumor Cells.
The AR is defined as 4 categories by the observed data: no detectable cells, low AR expression, normal AR expression, and high AR expression.
Time frame: every 8 weeks
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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
...and 1 more locations