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3 Month Finasteride Challenge Test Can Significantly Improve the Performance of Screening for Prostate Cancer

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT01296672
Recruitment Status : Completed
First Posted : February 15, 2011
Results First Posted : September 8, 2017
Last Update Posted : October 6, 2017
Sponsor:
Collaborators:
Information provided by (Responsible Party):

Study Type: Interventional
Study Design: Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Triple (Participant, Care Provider, Investigator);   Primary Purpose: Screening
Condition: Prostate Cancer
Interventions: Drug: Finasteride
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
No text entered.

Reporting Groups
  Description
Finasteride Finasteride 5mg every day by mouth for 3 months
Placebo Placebo every day by mouth for 3 months

Participant Flow:   Overall Study
    Finasteride   Placebo
STARTED   306   77 
COMPLETED   233   59 
NOT COMPLETED   73   18 
Lost to Follow-up                73                18 



  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
Finasteride

Finasteride 5mg tablets every day by mouth for 3 months

Finasteride: Finasteride 5mg every day by mouth for 3 months

Placebo

Placebo 5mg tablet every day by mouth for 3 months

Placebo: Placebo every day by mouth for 3 months

Total Total of all reporting groups

Baseline Measures
   Finasteride   Placebo   Total 
Overall Participants Analyzed 
[Units: Participants]
 306   77   383 
Age 
[Units: Years]
Median (Inter-Quartile Range)
 65 
 (61 to 68) 
 66 
 (61 to 68) 
 65 
 (61 to 68) 
Sex: Female, Male 
[Units: Participants]
Count of Participants
     
Female      0   0.0%      0   0.0%      0   0.0% 
Male      306 100.0%      77 100.0%      383 100.0% 
Race/Ethnicity, Customized 
[Units: Participants]
Count of Participants
     
Race       
Non-Hispanic white      125  40.8%      31  40.3%      156  40.7% 
Non-Hispanic black      42  13.7%      12  15.6%      54  14.1% 
Hispanic      134  43.8%      34  44.2%      168  43.9% 
Other race      5   1.6%      0   0.0%      5   1.3% 
Region of Enrollment 
[Units: Participants]
     
United States   306   77   383 
Prostate Specific Antigen 
[Units: Ng/ml]
Median (Inter-Quartile Range)
 5.2 
 (4.3 to 6.6) 
 5.3 
 (4.5 to 6.7) 
 5.2 
 (4.3 to 6.6) 


  Outcome Measures

1.  Primary:   Pre/Post Ratio PSA Area Under the Curve (AUC)   [ Time Frame: Reported at 90-days: assessment at baseline, 1 month, 2 months and 3 months ]

2.  Secondary:   PCA3 (Prostate Cancer Antigen 3)Score AUC   [ Time Frame: Reported at 90 days: assessed at baseline, 30 days, 60 days and 90-day ]

3.  Secondary:   T2:ERG ( A Gene on Chromosome 21q22.2 That Encodes an Androgen-regulated Transmembrane Serine Protease Ratio to Estrogen Related Gene) Score AUC   [ Time Frame: Reported at 90 days: assessed at baseline, 30 days, 60 days, and 90 days ]


  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
No text entered.


  More Information

Certain Agreements:  
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
The agreement is:
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is more than 60 days but less than or equal to 180 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
unchecked Other disclosure agreement that restricts the right of the PI to discuss or publish trial results after the trial is completed.


Results Point of Contact:  
Name/Title: Jonathan Gelfond
Organization: UT Health
phone: 210 567-0836
e-mail: gelfondjal@uthscsa.edu



Responsible Party: The University of Texas Health Science Center at San Antonio
ClinicalTrials.gov Identifier: NCT01296672     History of Changes
Other Study ID Numbers: ROI 10-352H
R01CA138627 ( U.S. NIH Grant/Contract )
First Submitted: February 3, 2011
First Posted: February 15, 2011
Results First Submitted: June 26, 2017
Results First Posted: September 8, 2017
Last Update Posted: October 6, 2017