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

Prostate Cancer Clinical Trial

Official title:

Improving Prostate Biopsy Efficiency: The Finasteride Challenge Test

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01296672
• Other study ID #: ROI 10-352H
• Secondary ID: R01CA138627
• Status: Completed
• Phase: Phase 4
• First received: February 3, 2011
• Last updated: September 7, 2017
• Start date: February 2011
• Est. completion date: January 2017

Study information

• Verified date: March 2017
• Source: The University of Texas Health Science Center at San Antonio
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 383
• Est. completion date: January 2017
• Est. primary completion date: November 2016
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 55 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Prostate Cancer
• Prostatic Neoplasms

Intervention

Drug:
• Finasteride
Finasteride 5mg every day by mouth for 3 months
• Placebo
Placebo every day by mouth for 3 months

Locations

Country	Name	City	State
United States	The University of Texas Health Science Center at San Antonio, Medical Arts and Research Center	San Antonio	Texas

Sponsors (3)

Lead Sponsor	Collaborator
The University of Texas Health Science Center at San Antonio	National Cancer Institute (NCI), National Institutes of Health (NIH)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	Reported at 90-days: assessment at baseline, 1 month, 2 months and 3 months
Secondary	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)	Reported at 90 days: assessed at baseline, 30 days, 60 days and 90-day
Secondary	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	Reported at 90 days: assessed at baseline, 30 days, 60 days, and 90 days