Improving Prostate Biopsy Efficiency: The Finasteride Challenge Test
Overview
- Phase
- Phase 4
- Intervention
- Finasteride
- Conditions
- Prostate Cancer
- Sponsor
- The University of Texas Health Science Center at San Antonio
- Enrollment
- 383
- Locations
- 1
- Primary Endpoint
- Pre/Post Ratio PSA Area Under the Curve (AUC)
- Status
- Completed
- Last Updated
- 8 years ago
Overview
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.
Investigators
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.
Arms & Interventions
Finasteride
Finasteride 5mg tablets every day by mouth for 3 months
Intervention: Finasteride
Placebo
Placebo 5mg tablet every day by mouth for 3 months
Intervention: Placebo
Outcomes
Primary Outcomes
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
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 Outcomes
- PCA3 (Prostate Cancer Antigen 3)Score AUC(Reported at 90 days: assessed at baseline, 30 days, 60 days and 90-day)
- T2:ERG ( A Gene on Chromosome 21q22.2 That Encodes an Androgen-regulated Transmembrane Serine Protease Ratio to Estrogen Related Gene) Score AUC(Reported at 90 days: assessed at baseline, 30 days, 60 days, and 90 days)