Testosterone Replacement in Men With Non-Metastatic Castrate Resistant Prostate Cancer
Information source: University of Chicago
Information obtained from ClinicalTrials.gov on October 19, 2009
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Prostate Cancer
Intervention: AndroGel (Drug); placebo (Drug)
Phase: Phase 2
Status: Recruiting
Sponsored by: University of Chicago Official(s) and/or principal investigator(s):
Walter Stadler, MD, Principal Investigator, Affiliation: University of Chicago
Overall contact:
Beth Manchen, RN, Phone: 773-702-4135, Email: emanchen@medicine.bsd.uchicago.edu
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.
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: Treatment, Randomized, Double Blind (Subject, Investigator), Placebo Control, Parallel Assignment, Safety/Efficacy Study
Primary outcome: The primary objective of the study is to determine the effect of testosterone replacement progression and time to clinical cancer progression.
Secondary outcome: To explore the value of 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.
Eligibility
Minimum age: 18 Years.
Maximum age: N/A.
Gender(s): Male.
Criteria:
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
Beth Manchen, RN, Phone: 773-702-4135, Email: emanchen@medicine.bsd.uchicago.edu
University of Chicago, Chicago, Illinois 60637, United States; Recruiting
Additional Information
Starting date: July 2007
Last updated: February 12, 2009
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