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

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

  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
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

  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
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

  Show All 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 ]

  Show Outcome Measure 1

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 ]

  Show Outcome Measure 2

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 ]

  Show Outcome Measure 3

  Serious Adverse Events

  Show Serious Adverse Events

  Other Adverse Events

  Show 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:  

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: 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 less than or equal to 60 days. The sponsor cannot require changes to the communication and cannot extend the embargo. 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. 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