CompletedPhase 4

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

United States383 participantsStarted 2011-02

Plain-language 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.

Who can participate

Age range55 Years

SexMALE

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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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.

What they're measuring

Pre/Post Ratio PSA Area Under the Curve (AUC)

Timeframe: Reported at 90-days: assessment at baseline, 1 month, 2 months and 3 months

Trial details

NCT IDNCT01296672

SponsorThe University of Texas Health Science Center at San Antonio

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2016-11

Results submitted2017-06-26

View on ClinicalTrials.gov More Prostate Cancer trials