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

Sponsor:	University of Chicago
Collaborator:	Solvay Pharmaceuticals
Information provided by:	University of Chicago
ClinicalTrials.gov Identifier:	NCT00515112

Purpose

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.

Condition	Intervention	Phase
Prostate Cancer	Drug: AndroGel Drug: placebo	Phase II

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double Blind (Subject, Investigator), Placebo Control, Parallel Assignment, Safety/Efficacy Study
Official Title:	A Randomized, Double Blind, Placebo-Controlled Phase II Study of Testosterone Replacement in Men With Non-Metastatic Castrate Resistant Prostate Cancer

Resource links provided by NLM:

MedlinePlus related topics: Cancer Prostate Cancer

Drug Information available for: Testosterone Propionate Methyltestosterone Testosterone Oxymesterone Testosterone enanthate Testosterone undecanoate

U.S. FDA Resources

Further study details as provided by University of Chicago:

Primary Outcome Measures:

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 ]

Secondary Outcome Measures:

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

Estimated Enrollment:	120
Study Start Date:	July 2007
Estimated Primary Completion Date:	January 2010 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
A: Experimental Twenty subjects will receive testosterone gel	Drug: AndroGel Androgel 1%, 10g daily
B: Placebo Comparator Twenty subjects will receive the placebo	Drug: placebo placebo

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

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Male
Accepts Healthy Volunteers:	No

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00515112

Contacts

Contact: Beth Manchen, RN

773-702-4135

emanchen@medicine.bsd.uchicago.edu

Locations

United States, Illinois
University of Chicago	Recruiting
Chicago, Illinois, United States, 60637

Sponsors and Collaborators

University of Chicago

Solvay Pharmaceuticals

Investigators

Principal Investigator:

Walter Stadler, MD

University of Chicago

More Information

No publications provided

Responsible Party:	The University of Chicago ( Walter Stadler, M.D. )
Study ID Numbers:	15393B
Study First Received:	August 9, 2007
Last Updated:	February 12, 2009
ClinicalTrials.gov Identifier:	NCT00515112 History of Changes
Health Authority:	United States: Food and Drug Administration

Keywords provided by University of Chicago:

prostate
cancer
testosterone replacement

AndroGel
prostatic cancer
prostatic neoplasms

Additional relevant MeSH terms:

Antineoplastic Agents, Hormonal
Genital Neoplasms, Male
Prostatic Diseases
Antineoplastic Agents
Physiological Effects of Drugs
Hormones, Hormone Substitutes, and Hormone Antagonists
Urogenital Neoplasms
Methyltestosterone
Genital Diseases, Male
Hormones

Pharmacologic Actions
Testosterone 17 beta-cypionate
Anabolic Agents
Neoplasms
Testosterone
Neoplasms by Site
Therapeutic Uses
Prostatic Neoplasms
Androgens

ClinicalTrials.gov processed this record on February 08, 2010