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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 |
| 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 (1st 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 |