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

Prostate Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT00515112
• Other study ID #: 15393B
• Status: Terminated
• Phase: Phase 2
• First received: August 9, 2007
• Last updated: May 12, 2014
• Start date: July 2007
• Est. completion date: August 2012

Study information

• Verified date: May 2014
• Source: University of Chicago
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

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 information / eligibility

• Status: Terminated
• Enrollment: 6
• Est. completion date: August 2012
• Est. primary completion date: November 2010
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 18 Years and older

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

Study Design

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

Related Conditions & MeSH terms

• Prostate Cancer
• Prostatic Neoplasms

Intervention

Drug:
• AndroGel
Androgel 1%, 10g daily
• placebo
placebo

Locations

Country	Name	City	State
United States	University of Colorado	Aurora	Colorado
United States	University of Maryland	Baltimore	Maryland
United States	Northwestern University	Chicago	Illinois
United States	University of Chicago	Chicago	Illinois
United States	NorthShore University Helath System	Evnaston	Illinois
United States	Ingalls Memorial Hospital	Harvey	Illinois
United States	Baylor College of Medicine	Houston	Texas
United States	University of Southern California	Los Angeles	California
United States	Medical College of Wisconsin	Milwaukee	Wisconsin
United States	Illinois Cancer Care	Peoria	Illinois
United States	University of Rochester	Rochester	Maryland

Sponsors (2)

Lead Sponsor	Collaborator
University of Chicago	Solvay Pharmaceuticals

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	Up to 5 years	No
Secondary	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.	every 8 weeks	Yes