PCPT Facts at-a-Glance

Primary Hypothesis: 

Finasteride can reduce the prevalence of prostate cancer in healthy adult men

Primary Endpoint:

Diagnosis of prostate cancer during 7-year study period or at end-of-study biopsy.

Sponsor:

National Cancer Institute (finasteride donated by Merck & Co.)

Administrator: 

Southwest Oncology Group

Principle Investigator: 

Ian Thompson, M.D.

Study sites:

221 across U.S.

Cost:

$73 million

Participants: 

Men > 55 years of age with a normal digital rectal exam, IPSS < 20, and serum PSA < 3.0 ng/ml.

Number of Men :

·        Enrolled: 24,482

·        Randomized: 18,882

·        In Final Analysis: 9,060 (excluded were men who were lost to follow-up (7-8%), died during study (6-7%), terminated early (13-14%), or refused end-of-study biopsy (20-25%).

Racial breakdown:

White 92%, Black 3.8%, Hispanic 2.8%, Other 1.4%

Design:

Randomized (1:1), placebo-controlled trial, double-blind (after 3 month single blind placebo lead-in), planned 7-year study period

Duration:

Jan, 1994 (1^st man randomized) to Feb 21. 2003, when study terminated 15 months before anticipated conclusion (86.3% of men completed 7 years of study)

Overall Detection of Prostate Cancer:

803/4368 men in finasteride group (18.4%)

1147/4692 men in placebo group (24.4%)

24.8% risk reduction over 7 years (P<0.001)

Occurrence of High-Grade Prostate Cancer (Gleason Score > 7) :

280/757 tumors in finasteride group (37.0%), or 6.4% of entire group

237/1068 tumors in placebo group (22.2%),  or 5.1% of entire group