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

Phase 2

Terminated

Brief Summary: 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.

Detailed Description: 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.

Recruitment & Eligibility

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

Arm && Interventions

Group	Intervention	Description
A	AndroGel	Twenty subjects will receive testosterone gel
B	placebo	Twenty subjects will receive the placebo

Primary Outcome Measures

Name	Time	Method
Progression Free Survival	Up to 5 years	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.

Secondary Outcome Measures

Name	Time	Method
To Explore the Value of Androgen Receptor (AR) Expression in Circulating Tumor Cells.	every 8 weeks	The AR is defined as 4 categories by the observed data: no detectable cells, low AR expression, normal AR expression, and high AR expression.

Locations (11): University of Colorado
🇺🇸
Aurora, Colorado, United States
Baylor College of Medicine
🇺🇸
Houston, Texas, United States
Northwestern University
🇺🇸
Chicago, Illinois, United States
Illinois Cancer Care
🇺🇸
Peoria, Illinois, United States
University of Rochester
🇺🇸
Rochester, Maryland, United States
University of Southern California
🇺🇸
Los Angeles, California, United States
Ingalls Memorial Hospital
🇺🇸
Harvey, Illinois, United States
University of Chicago
🇺🇸
Chicago, Illinois, United States
NorthShore University Helath System
🇺🇸
Evnaston, Illinois, United States
Medical College of Wisconsin
🇺🇸
Milwaukee, Wisconsin, United States
University of Maryland
🇺🇸
Baltimore, Maryland, United States