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
Results First Received: May 12, 2014  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Safety/Efficacy Study;   Intervention Model: Parallel Assignment;   Masking: Double Blind (Subject, Investigator);   Primary Purpose: Treatment
Condition: Prostate Cancer
Interventions: Drug: AndroGel
Drug: placebo

  Participant Flow
  Hide Participant Flow

Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
No text entered.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
No text entered.

Reporting Groups
  Description
Androgel

Three subjects received testosterone gel

AndroGel: Androgel 1%, 10g daily

Placebo

Three subjects received the placebo

Placebo: placebo


Participant Flow:   Overall Study
    Androgel     Placebo  
STARTED     3     3  
COMPLETED     0     0  
NOT COMPLETED     3     3  
Death                 0                 1  
The study was terminated                 3                 2  



  Baseline Characteristics
  Hide Baseline Characteristics

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
No text entered.

Reporting Groups
  Description
Androgel

Three subjects received testosterone gel

AndroGel: Androgel 1%, 10g daily

Placebo

Three subjects received the placebo

Placebo: placebo

Total Total of all reporting groups

Baseline Measures
    Androgel     Placebo     Total  
Number of Participants  
[units: participants]
  3     3     6  
Age  
[units: years]
Mean ± Standard Deviation
  69.4  ± 4.6     63.5  ± 8.6     66.4  ± 7.0  
Gender  
[units: participants]
     
Female     0     0     0  
Male     3     3     6  



  Outcome Measures
  Show All Outcome Measures

1.  Primary:   Progression Free Survival   [ Time Frame: Up to 5 years ]

2.  Secondary:   To Explore the Value of Androgen Receptor (AR) Expression in Circulating Tumor Cells.   [ Time Frame: every 8 weeks ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
  Hide Limitations and Caveats

Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
No text entered.


  More Information
  Hide More Information

Certain Agreements:  
All Principal Investigators ARE employed by the organization sponsoring the study.


Results Point of Contact:  
Name/Title: Dr. Walter Stadler
Organization: The University of Chicago
phone: 773-702-4400
e-mail: wstadler@medicine.bsd.uchicago.edu


No publications provided by University of Chicago

Publications automatically indexed to this study:

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