Clinical trial NCT00515112: Testosterone Replacement in Men With Non-Metastatic Castrate Resistant Prostate Cancer
Official title: A Randomized, Double Blind, Placebo-Controlled Phase II Study of Testosterone Replacement in Men With Non-Metastatic Castrate Resistant Prostate Cancer
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE2
Conditions: Prostate Cancer
Keywords: prostate
cancer
testosterone replacement
AndroGel
prostatic cancer
prostatic neoplasms
Lead sponsor: University of Chicago
Sponsor class: OTHER
Collaborators: name: Solvay Pharmaceuticals
First posted: 2007-08-13
Enrollment: 6
Sex: MALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility 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

Primary outcomes:
measure: Progression Free Survival
timeFrame: Up to 5 years
Secondary outcomes:
measure: To Explore the Value of Androgen Receptor (AR) Expression in Circulating Tumor Cells.
timeFrame: every 8 weeks
Other outcomes:
Locations:
city: Los Angeles
country: United States
facility: University of Southern California
state: California
city: Aurora
country: United States
facility: University of Colorado
state: Colorado
city: Chicago
country: United States
facility: Northwestern University
state: Illinois
city: Chicago
country: United States
facility: University of Chicago
state: Illinois
city: Evnaston
country: United States
facility: NorthShore University Helath System
state: Illinois
city: Harvey
country: United States
facility: Ingalls Memorial Hospital
state: Illinois
city: Peoria
country: United States
facility: Illinois Cancer Care
state: Illinois
city: Baltimore
country: United States
facility: University of Maryland
state: Maryland
city: Rochester
country: United States
facility: University of Rochester
state: Maryland
city: Houston
country: United States
facility: Baylor College of Medicine
state: Texas
city: Milwaukee
country: United States
facility: Medical College of Wisconsin
state: Wisconsin
Study officials:
affiliation: University of Chicago
name: Walter Stadler, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Geynisman DM, Szmulewitz RZ, Stadler WM. A trial postmortem: challenges in conducting a randomized, double-blind, phase 2 study in men with castration-resistant prostate cancer. Eur Urol. 2012 Nov;62(5):864-6. doi: 10.1016/j.eururo.2012.08.030. Epub 2012 Aug 25. No abstract available.