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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

August 9, 2007
May 12, 2014
July 2007
November 2010   (final data collection date for primary outcome measure)
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.
The primary objective of the study is to determine the effect of testosterone replacement progression and time to clinical cancer progression.
Complete list of historical versions of study NCT00515112 on ClinicalTrials.gov Archive Site
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.
Not Provided
Not Provided
Not Provided
 
Testosterone Replacement in Men With Non-Metastatic Castrate Resistant Prostate Cancer
A Randomized, Double Blind, Placebo-Controlled Phase II Study of Testosterone Replacement in Men With Non-Metastatic Castrate Resistant Prostate Cancer

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.

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.

Interventional
Phase 2
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Prostate Cancer
  • Drug: AndroGel
    Androgel 1%, 10g daily
  • Drug: placebo
    placebo
  • Experimental: A
    Twenty subjects will receive testosterone gel
    Intervention: Drug: AndroGel
  • Placebo Comparator: B
    Twenty subjects will receive the placebo
    Intervention: Drug: placebo
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.
 
Terminated
6
August 2012
November 2010   (final data collection date for primary outcome measure)

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
Male
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00515112
15393B
Yes
University of Chicago
University of Chicago
Solvay Pharmaceuticals
Principal Investigator: Walter Stadler, MD University of Chicago
University of Chicago
May 2014

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