search
Back to results

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

Primary Purpose

Prostate Cancer

Status
Completed
Phase
Phase 4
Locations
United States
Study Type
Interventional
Intervention
Finasteride
Placebo
Sponsored by
The University of Texas Health Science Center at San Antonio
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional screening trial for Prostate Cancer focused on measuring Finasteride, Placebo, Prostate cancer, Prostate Specific Antigen (PSA), Men at intermediate risk of prostate cancer, Men scheduled for prostate biopsy

Eligibility Criteria

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

Inclusion Criteria:

  1. Risk of prostate cancer 20-60% calculated with the on-line Prostate Cancer Prevention Trial (PCPT) prostate cancer risk calculator. (www.prostate-cancer-risk-calculator.com). PSA value must be obtained within 3 months prior to study entry. A description of the frequency of these individuals in the population is provided in Specific Aim 2
  2. Patient has been recommended to undergo and plans to have a prostate biopsy.
  3. Patient is willing to delay prostate biopsy for a 3-month finasteride vs placebo treatment.
  4. No allergy to finasteride or other five alpha reductase inhibitors.
  5. Patient is willing to take finasteride vs placebo 5 mg orally daily for 3-month treatment period.
  6. Age 55 or older. (This age is selected as the PCPT risk calculator is only valid for this age range.)

Exclusion Criteria:

  1. Risk of cancer greater than 60% or less than 20%.
  2. Prior history of prostate cancer.
  3. Prior treatment with finasteride or dutasteride in the past 6 months
  4. Younger than age 55.

Sites / Locations

  • The University of Texas Health Science Center at San Antonio, Medical Arts and Research Center

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Finasteride

Placebo

Arm Description

Finasteride 5mg tablets every day by mouth for 3 months

Placebo 5mg tablet every day by mouth for 3 months

Outcomes

Primary Outcome Measures

Pre/Post Ratio PSA Area Under the Curve (AUC)
Pre/Post Ratio prediction area under the receiver operating characteristics curve (AUC) for subjects taking finasteride 5mg every day for 3 months. Measurements of PSA are measured from Baseline until 3 months.

Secondary Outcome Measures

PCA3 (Prostate Cancer Antigen 3)Score AUC
Area under the Receiver Operating Characteristic Curve (ROC-AUC) of the PCA3 (Prostate Cancer Antigen 3) to detect difference in PSA decline between cases and controls (non-cases)
T2:ERG ( A Gene on Chromosome 21q22.2 That Encodes an Androgen-regulated Transmembrane Serine Protease Ratio to Estrogen Related Gene) Score AUC
Area Under the Receiver Operating Characteristic Curve (ROC-AUC) of the T2:ERG ( A Gene on Chromosome 21q22.2 That Encodes an Androgen-regulated Transmembrane Serine Protease Ratio to Estrogen Related Gene) Score to Predict the Risk of Prostate Cancer

Full Information

First Posted
February 3, 2011
Last Updated
September 7, 2017
Sponsor
The University of Texas Health Science Center at San Antonio
Collaborators
National Institutes of Health (NIH), National Cancer Institute (NCI)
search

1. Study Identification

Unique Protocol Identification Number
NCT01296672
Brief Title
3 Month Finasteride Challenge Test Can Significantly Improve the Performance of Screening for Prostate Cancer
Official Title
Improving Prostate Biopsy Efficiency: The Finasteride Challenge Test
Study Type
Interventional

2. Study Status

Record Verification Date
March 2017
Overall Recruitment Status
Completed
Study Start Date
February 2011 (undefined)
Primary Completion Date
November 2016 (Actual)
Study Completion Date
January 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
The University of Texas Health Science Center at San Antonio
Collaborators
National Institutes of Health (NIH), National Cancer Institute (NCI)

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
The investigators will propose a novel method to improve prostate cancer screening with PSA, using a 3-month treatment with finasteride, a drug used to treat Benign Prostatic Hyperplasia (BPH) and proven to reduce a man's risk of developing prostate cancer. The investigators will also examine three additional promising tests that may further improve diagnosis of prostate cancer.
Detailed Description
The primary goal of this proposal is to determine if a 5-alpha reductase 'challenge' improves screening performance of PSA and DRE in men who are scheduled for prostate biopsy. Currently a higher PSA level leads to a recommendation for prostate biopsy, causing hundreds of thousands of unnecessary biopsies annually in the U.S. We will show that a three-month treatment with finasteride for men with high PSA levels will better predict the man who should have a prostate biopsy. PSA performance after finasteride 'challenge' will also be compared with new tests for prostate cancer. Finasteride is supplied by Merck and Company, Incorporated.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Prostate Cancer
Keywords
Finasteride, Placebo, Prostate cancer, Prostate Specific Antigen (PSA), Men at intermediate risk of prostate cancer, Men scheduled for prostate biopsy

7. Study Design

Primary Purpose
Screening
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigator
Allocation
Randomized
Enrollment
383 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Finasteride
Arm Type
Experimental
Arm Description
Finasteride 5mg tablets every day by mouth for 3 months
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Placebo 5mg tablet every day by mouth for 3 months
Intervention Type
Drug
Intervention Name(s)
Finasteride
Other Intervention Name(s)
Proscar®, Propecia®
Intervention Description
Finasteride 5mg every day by mouth for 3 months
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
Placebo every day by mouth for 3 months
Primary Outcome Measure Information:
Title
Pre/Post Ratio PSA Area Under the Curve (AUC)
Description
Pre/Post Ratio prediction area under the receiver operating characteristics curve (AUC) for subjects taking finasteride 5mg every day for 3 months. Measurements of PSA are measured from Baseline until 3 months.
Time Frame
Reported at 90-days: assessment at baseline, 1 month, 2 months and 3 months
Secondary Outcome Measure Information:
Title
PCA3 (Prostate Cancer Antigen 3)Score AUC
Description
Area under the Receiver Operating Characteristic Curve (ROC-AUC) of the PCA3 (Prostate Cancer Antigen 3) to detect difference in PSA decline between cases and controls (non-cases)
Time Frame
Reported at 90 days: assessed at baseline, 30 days, 60 days and 90-day
Title
T2:ERG ( A Gene on Chromosome 21q22.2 That Encodes an Androgen-regulated Transmembrane Serine Protease Ratio to Estrogen Related Gene) Score AUC
Description
Area Under the Receiver Operating Characteristic Curve (ROC-AUC) of the T2:ERG ( A Gene on Chromosome 21q22.2 That Encodes an Androgen-regulated Transmembrane Serine Protease Ratio to Estrogen Related Gene) Score to Predict the Risk of Prostate Cancer
Time Frame
Reported at 90 days: assessed at baseline, 30 days, 60 days, and 90 days

10. Eligibility

Sex
Male
Minimum Age & Unit of Time
55 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Risk of prostate cancer 20-60% calculated with the on-line Prostate Cancer Prevention Trial (PCPT) prostate cancer risk calculator. (www.prostate-cancer-risk-calculator.com). PSA value must be obtained within 3 months prior to study entry. A description of the frequency of these individuals in the population is provided in Specific Aim 2 Patient has been recommended to undergo and plans to have a prostate biopsy. Patient is willing to delay prostate biopsy for a 3-month finasteride vs placebo treatment. No allergy to finasteride or other five alpha reductase inhibitors. Patient is willing to take finasteride vs placebo 5 mg orally daily for 3-month treatment period. Age 55 or older. (This age is selected as the PCPT risk calculator is only valid for this age range.) Exclusion Criteria: Risk of cancer greater than 60% or less than 20%. Prior history of prostate cancer. Prior treatment with finasteride or dutasteride in the past 6 months Younger than age 55.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Javier Hernandez, MD
Organizational Affiliation
The University of Texas Health Science Center at San Antonio
Official's Role
Principal Investigator
Facility Information:
Facility Name
The University of Texas Health Science Center at San Antonio, Medical Arts and Research Center
City
San Antonio
State/Province
Texas
ZIP/Postal Code
78229
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
30300367
Citation
Hernandez J, Gelfond J, Goros M, Liss MA, Liang Y, Ankerst D, Thompson IM Jr, Leach RJ. The effect of 3-month finasteride challenge on biomarkers for predicting cancer outcome on biopsy: Results of a randomized trial. PLoS One. 2018 Oct 9;13(10):e0204823. doi: 10.1371/journal.pone.0204823. eCollection 2018.
Results Reference
derived

Learn more about this trial

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

We'll reach out to this number within 24 hrs