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

Completed · Phase 4 · Has a placebo group

Conditions studied: Prostate Cancer

In brief

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.

Key facts

Study ID

NCT01296672

Run by

The University of Texas Health Science Center at San Antonio

People needed

383

Starts

2011-02-01

Expected to finish

2017-01-01

Last updated by the study team

2017-10-06

Who can join

Age: 55 and older. Sex: male. Healthy volunteers: not accepted.

You may qualify if…

• 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.)

You may not qualify if…

• 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.

Where it is running

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

Full record on ClinicalTrials.gov

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