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Related Experiment Videos

Design of the Prostate Cancer Prevention Trial (PCPT)

P Feigl¹, B Blumenstein, I Thompson

¹Southwest Oncology Group Statistical Center, Fred Hutchinson Cancer Research Center, Seattle, Washington 90104-2092, USA.

Controlled Clinical Trials

|June 1, 1995

Summary

This study evaluated finasteride for prostate cancer prevention in healthy men over 55. Researchers monitored biopsy results and prostate-specific antigen (PSA) levels during the 7-year trial.

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Area of Science:

Oncology
Pharmacology
Clinical Trials

Background:

Prostate cancer is a leading concern for aging men.
Chemoprevention strategies aim to reduce cancer incidence.
Finasteride's effect on prostate cancer screening requires careful study design.

Purpose of the Study:

To assess the efficacy of finasteride in preventing prostate cancer.
To establish a robust trial design accounting for finasteride's impact on prostate-specific antigen (PSA).
To evaluate finasteride's role in prostate cancer chemoprevention.

Main Methods:

The Prostate Cancer Prevention Trial (PCPT) randomized 18,000 healthy men aged 55+.
Participants received either finasteride (5 mg/day) or a placebo for 7 years.

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The primary endpoint was biopsy-proven prostate cancer presence or absence.

Main Results:

The trial was designed with 92% power to detect a 25% reduction in prostate cancer prevalence.
Finasteride's known effect on PSA levels complicated the interpretation of screening tests.
The study design considered alternative approaches before finalizing the chosen methodology.

Conclusions:

The PCPT employed a rigorous design to evaluate finasteride for prostate cancer prevention.
Careful monitoring of key assumptions was crucial for the trial's 9-year duration.
The study provides insights into chemoprevention trial design, particularly concerning PSA screening impacts.