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

This study has been terminated.
(This study has been terminated due to poor accrual)
Sponsor:
Collaborator:
Solvay Pharmaceuticals
Information provided by (Responsible Party):
University of Chicago
ClinicalTrials.gov Identifier:
NCT00515112
First received: August 9, 2007
Last updated: May 12, 2014
Last verified: May 2014
  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 2

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


Further study details as provided by University of Chicago:

Primary Outcome Measures:
  • Progression Free Survival [ Time Frame: Up to 5 years ] [ Designated as safety issue: No ]
    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.


Secondary Outcome Measures:
  • To Explore the Value of Androgen Receptor (AR) Expression in Circulating Tumor Cells. [ Time Frame: every 8 weeks ] [ Designated as safety issue: Yes ]
    The AR is defined as 4 categories by the observed data: no detectable cells, low AR expression, normal AR expression, and high AR expression.


Enrollment: 6
Study Start Date: July 2007
Study Completion Date: August 2012
Primary Completion Date: November 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: A
Twenty subjects will receive testosterone gel
Drug: AndroGel
Androgel 1%, 10g daily
Placebo Comparator: B
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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

Locations
United States, California
University of Southern California
Los Angeles, California, United States, 90033
United States, Colorado
University of Colorado
Aurora, Colorado, United States, 80045
United States, Illinois
University of Chicago
Chicago, Illinois, United States, 60637
Northwestern University
Chicago, Illinois, United States, 60610
NorthShore University Helath System
Evnaston, Illinois, United States, 60201
Ingalls Memorial Hospital
Harvey, Illinois, United States, 60426
Illinois Cancer Care
Peoria, Illinois, United States, 61656
United States, Maryland
University of Maryland
Baltimore, Maryland, United States, 21202
University of Rochester
Rochester, Maryland, United States, 14642
United States, Texas
Baylor College of Medicine
Houston, Texas, United States, 77030
United States, Wisconsin
Medical College of Wisconsin
Milwaukee, Wisconsin, United States, 53226
Sponsors and Collaborators
University of Chicago
Solvay Pharmaceuticals
Investigators
Principal Investigator: Walter Stadler, MD University of Chicago
  More Information

No publications provided by University of Chicago

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: University of Chicago
ClinicalTrials.gov Identifier: NCT00515112     History of Changes
Other Study ID Numbers: 15393B
Study First Received: August 9, 2007
Results First Received: May 12, 2014
Last Updated: May 12, 2014
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:
Prostatic Neoplasms
Genital Neoplasms, Male
Urogenital Neoplasms
Neoplasms by Site
Neoplasms
Genital Diseases, Male
Prostatic Diseases
Testosterone
Testosterone enanthate
Testosterone undecanoate
Testosterone 17 beta-cypionate
Methyltestosterone
Androgens
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Pharmacologic Actions
Antineoplastic Agents, Hormonal
Antineoplastic Agents
Therapeutic Uses
Anabolic Agents

ClinicalTrials.gov processed this record on September 30, 2014