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

This study has been completed.

Sponsor:

Collaborator:

Solvay Pharmaceuticals

Information provided by (Responsible Party):

Walter Stadler, University of Chicago

ClinicalTrials.gov Identifier:

NCT00515112

First received: August 9, 2007

Last updated: February 10, 2013

Last verified: February 2013

History of Changes

Tracking Information

First Received Date ^ICMJE

August 9, 2007

Last Updated Date

February 10, 2013

Start Date ^ICMJE

July 2007

Primary Completion Date

November 2010 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

The primary objective of the study is to determine the effect of testosterone replacement progression and time to clinical cancer progression. [ Time Frame: time to progression evaluated every 8 weeks ] [ Designated as safety issue: No ]

Original Primary Outcome Measures ^ICMJE

The primary objective of the study is to determine the effect of testosterone replacement progression and time to clinical cancer progression.

Change History

Complete list of historical versions of study NCT00515112 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

To explore the value of AR expression in circulating tumor cells. [ Time Frame: every 8 weeks ] [ Designated as safety issue: Yes ]

Original Secondary Outcome Measures ^ICMJE

Not Provided

Current Other Outcome Measures ^ICMJE

Not Provided

Original Other Outcome Measures ^ICMJE

Not Provided

Descriptive Information

Brief Title ^ICMJE

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

Official Title ^ICMJE

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

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.

Study Type ^ICMJE

Interventional

Study Phase

Phase 2

Study Design ^ICMJE

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

Condition ^ICMJE

Prostate Cancer

Intervention ^ICMJE

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

Study Arm (s)

Experimental: A
Twenty subjects will receive testosterone gel

Intervention: Drug: AndroGel
Placebo Comparator: B
Twenty subjects will receive the placebo

Intervention: Drug: placebo

Publications *

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.

* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Completed

Enrollment ^ICMJE

Completion Date

August 2012

Primary Completion Date

November 2010 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

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

Gender

Male

Ages

18 Years and older

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

United States

Administrative Information

NCT Number ^ICMJE

NCT00515112

Other Study ID Numbers ^ICMJE

15393B

Has Data Monitoring Committee

Yes

Responsible Party

Walter Stadler, University of Chicago

Study Sponsor ^ICMJE

University of Chicago

Collaborators ^ICMJE

Solvay Pharmaceuticals

Investigators ^ICMJE

Principal Investigator:

Walter Stadler, MD

University of Chicago

Information Provided By

University of Chicago

Verification Date

February 2013

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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