search
Back to results

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

Primary Purpose

Prostate Cancer

Status
Terminated
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
AndroGel
placebo
Sponsored by
University of Chicago
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Prostate Cancer focused on measuring prostate, cancer, testosterone replacement, AndroGel, prostatic cancer, prostatic neoplasms

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)MaleDoes not accept healthy volunteers

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

Sites / Locations

  • University of Southern California
  • University of Colorado
  • Northwestern University
  • University of Chicago
  • NorthShore University Helath System
  • Ingalls Memorial Hospital
  • Illinois Cancer Care
  • University of Maryland
  • University of Rochester
  • Baylor College of Medicine
  • Medical College of Wisconsin

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

A

B

Arm Description

Twenty subjects will receive testosterone gel

Twenty subjects will receive the placebo

Outcomes

Primary Outcome Measures

Progression Free Survival
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.
The AR is defined as 4 categories by the observed data: no detectable cells, low AR expression, normal AR expression, and high AR expression.

Full Information

First Posted
August 9, 2007
Last Updated
May 12, 2014
Sponsor
University of Chicago
Collaborators
Solvay Pharmaceuticals
search

1. Study Identification

Unique Protocol Identification Number
NCT00515112
Brief Title
Testosterone Replacement in Men With Non-Metastatic Castrate Resistant Prostate Cancer
Official Title
A Randomized, Double Blind, Placebo-Controlled Phase II Study of Testosterone Replacement in Men With Non-Metastatic Castrate Resistant Prostate Cancer
Study Type
Interventional

2. Study Status

Record Verification Date
May 2014
Overall Recruitment Status
Terminated
Why Stopped
This study has been terminated due to poor accrual
Study Start Date
July 2007 (undefined)
Primary Completion Date
November 2010 (Actual)
Study Completion Date
August 2012 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Chicago
Collaborators
Solvay Pharmaceuticals

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Prostate Cancer
Keywords
prostate, cancer, testosterone replacement, AndroGel, prostatic cancer, prostatic neoplasms

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
6 (Actual)

8. Arms, Groups, and Interventions

Arm Title
A
Arm Type
Experimental
Arm Description
Twenty subjects will receive testosterone gel
Arm Title
B
Arm Type
Placebo Comparator
Arm Description
Twenty subjects will receive the placebo
Intervention Type
Drug
Intervention Name(s)
AndroGel
Intervention Description
Androgel 1%, 10g daily
Intervention Type
Drug
Intervention Name(s)
placebo
Intervention Description
placebo
Primary Outcome Measure Information:
Title
Progression Free Survival
Description
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.
Time Frame
Up to 5 years
Secondary Outcome Measure Information:
Title
To Explore the Value of Androgen Receptor (AR) Expression in Circulating Tumor Cells.
Description
The AR is defined as 4 categories by the observed data: no detectable cells, low AR expression, normal AR expression, and high AR expression.
Time Frame
every 8 weeks

10. Eligibility

Sex
Male
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Walter Stadler, MD
Organizational Affiliation
University of Chicago
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Southern California
City
Los Angeles
State/Province
California
ZIP/Postal Code
90033
Country
United States
Facility Name
University of Colorado
City
Aurora
State/Province
Colorado
ZIP/Postal Code
80045
Country
United States
Facility Name
Northwestern University
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60610
Country
United States
Facility Name
University of Chicago
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60637
Country
United States
Facility Name
NorthShore University Helath System
City
Evnaston
State/Province
Illinois
ZIP/Postal Code
60201
Country
United States
Facility Name
Ingalls Memorial Hospital
City
Harvey
State/Province
Illinois
ZIP/Postal Code
60426
Country
United States
Facility Name
Illinois Cancer Care
City
Peoria
State/Province
Illinois
ZIP/Postal Code
61656
Country
United States
Facility Name
University of Maryland
City
Baltimore
State/Province
Maryland
ZIP/Postal Code
21202
Country
United States
Facility Name
University of Rochester
City
Rochester
State/Province
Maryland
ZIP/Postal Code
14642
Country
United States
Facility Name
Baylor College of Medicine
City
Houston
State/Province
Texas
ZIP/Postal Code
77030
Country
United States
Facility Name
Medical College of Wisconsin
City
Milwaukee
State/Province
Wisconsin
ZIP/Postal Code
53226
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
22939385
Citation
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. No abstract available.
Results Reference
derived

Learn more about this trial

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

We'll reach out to this number within 24 hrs