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

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ClinicalTrials.gov Identifier: NCT00515112
Recruitment Status : Terminated (This study has been terminated due to poor accrual)
First Posted : August 13, 2007
Results First Posted : June 11, 2014
Last Update Posted : June 11, 2014
Sponsor:
Collaborator:
Solvay Pharmaceuticals
Information provided by (Responsible Party):
University of Chicago

Study Type: Interventional
Study Design: Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Double (Participant, Investigator);   Primary Purpose: Treatment
Condition: Prostate Cancer
Interventions: Drug: AndroGel
Drug: placebo

  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
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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

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 
Overall Participants Analyzed 
[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

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

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
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  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


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
First Submitted: August 9, 2007
First Posted: August 13, 2007
Results First Submitted: May 12, 2014
Results First Posted: June 11, 2014
Last Update Posted: June 11, 2014