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

Overview

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.

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

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Parallel Assignment
    • Primary Purpose: Treatment
    • Masking: Double (Participant, Investigator)
  • Study Primary Completion Date: November 2010

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.

Interventions

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

Arms, Groups and Cohorts

  • Experimental: A
    • Twenty subjects will receive testosterone gel
  • Placebo Comparator: B
    • Twenty subjects will receive the placebo

Clinical Trial Outcome Measures

Primary Measures

  • Progression Free Survival
    • Time Frame: Up to 5 years
    • 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 Measures

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

Participating in This Clinical Trial

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 Eligibility: Male

Minimum Age: 18 Years

Maximum Age: N/A

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • University of Chicago
  • Collaborator
    • Solvay Pharmaceuticals
  • Provider of Information About this Clinical Study
    • Sponsor
  • Overall Official(s)
    • Walter Stadler, MD, Principal Investigator, University of Chicago

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