article310

PCPT

"Finasteride in the Prevention of Prostate Cancer".The New England Journal of Medicine. 2003.

1 Clinical Question
2 Bottom Line
3 Major Points
4 Guidelines
5 Design
6 Population
6.1 Inclusion Criteria
6.2 Exclusion Criteria
6.3 Baseline Characteristics
7 Interventions
8 Outcomes
8.1 Primary Outcome
8.2 Secondary Outcomes
9 Funding
10 Further Reading

Clinical Question

Does finasteride reduce the risk of prostate cancer in men 55 years of age or older?

Bottom Line

Finasteride reduced the risk of prostate cancer by 24.8% but was associated with an increased risk of high-grade prostate cancer and sexual side effects, whereas urinary symptoms were more common in men receiving placebo.

Major Points

Finasteride is known to inhibit the conversion of testosterone to dihydrotestosterone, potentially affecting the development of prostate cancer. This double-blind, placebo-controlled trial aimed to test the effects of finasteride on the prevention of prostate cancer in men 55 years and older.

Guidelines

At the time of publication, guidelines for the use of finasteride as a preventive measure against prostate cancer were not established.

Design

- Placebo-controlled, double-blind, randomized controlled trial
- N=18,882 men aged 55 or older
- Finasteride 5 mg per day vs. placebo
- Mean follow-up: 7 years (terminated 15 months early)

Population

Inclusion Criteria
- Men aged 55 years or older
- Normal digital rectal examination
- Prostate-specific antigen (PSA) level of 3.0 ng per milliliter or lower

Exclusion Criteria
- Clinically significant coexisting conditions that would prevent compliance
- American Urological Association symptom score of 20 or higher

Baseline Characteristics
- Median age, race or ethnicity, family history of prostate cancer, PSA level at randomization not detailed in the Wiki

Interventions

- Finasteride 5 mg daily or placebo for seven years
- Annual digital rectal examinations and PSA measurements

Outcomes

Primary Outcome
- Prevalence of prostate cancer during the seven-year study period (18.4% in the finasteride group vs. 24.4% in the placebo group)

Secondary Outcomes
- Tumors with a Gleason grade of 7-10 were more common in the finasteride group (37.0%) than in the placebo group (22.2%)
- Sexual side effects more common in finasteride group
- Urinary symptoms more common in placebo group

Funding

Supported in part by Public Health Service grants from the National Cancer Institute.