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

Information source: University of Chicago
ClinicalTrials.gov processed this data on August 20, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Prostate Cancer

Intervention: AndroGel (Drug); placebo (Drug)

Phase: Phase 2

Status: Terminated

Sponsored by: University of Chicago

Official(s) and/or principal investigator(s):
Walter Stadler, MD, Principal Investigator, Affiliation: University of Chicago


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.

Clinical Details

Official title: A Randomized, Double Blind, Placebo-Controlled Phase II Study of Testosterone Replacement in Men With Non-Metastatic Castrate Resistant Prostate Cancer

Study design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Primary outcome: Progression Free Survival

Secondary outcome: To Explore the Value of Androgen Receptor (AR) Expression in Circulating Tumor Cells.

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.


Minimum age: 18 Years. Maximum age: N/A. Gender(s): Male.


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

Locations and Contacts

University of Southern California, Los Angeles, California 90033, United States

University of Colorado, Aurora, Colorado 80045, United States

Northwestern University, Chicago, Illinois 60610, United States

University of Chicago, Chicago, Illinois 60637, United States

NorthShore University Helath System, Evnaston, Illinois 60201, United States

Ingalls Memorial Hospital, Harvey, Illinois 60426, United States

Illinois Cancer Care, Peoria, Illinois 61656, United States

University of Maryland, Baltimore, Maryland 21202, United States

University of Rochester, Rochester, Maryland 14642, United States

Baylor College of Medicine, Houston, Texas 77030, United States

Medical College of Wisconsin, Milwaukee, Wisconsin 53226, United States

Additional Information

Starting date: July 2007
Last updated: May 12, 2014

Page last updated: August 20, 2015

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