Skip to content
Evevident
Original paper
2009NEJMPreventive/Primary Care

PLCO

Mortality results from a randomized prostate-cancer screening trial

RCTCancer screening

On this page

Overview

Organized PSA/DRE screening did not reduce prostate-cancer mortality in PLCO.

Clinical takeaway

PLCO is the US prostate-screening caution trial, emphasizing contamination, overdiagnosis, and why PSA screening requires shared decision-making.

Key result

Prostate-cancer mortality did not differ significantly between screening and usual care.

Practice impact

PSA screening became a preference-sensitive decision rather than a universal routine test.

Evidence

Study design

Randomized screening trial.

Enrollment

76,693

Follow-up

7 to 10 years in the initial mortality report.

Geography

United States

Clinical question

Does organized PSA and DRE screening reduce prostate-cancer mortality compared with usual care?

Population

  • Men 55 to 74 years old.

Intervention

Annual PSA testing for 6 years and digital rectal examination for 4 years.

Comparator

Usual care.

Primary outcome

Prostate-cancer mortality.

Organized screening did not reduce prostate-cancer mortality compared with usual care in PLCO.

Rate ratio / 1.13 / CI 95% CI 0.75-1.70

Key results

  • Prostate-cancer mortality was not significantly reduced.
  • Prostate-cancer diagnosis was more common in the screening group.
  • Usual-care contamination with PSA testing was substantial.

Harms

  • Overdiagnosis, false positives, biopsy complications, and treatment morbidity are key screening harms.

Clinical Use

When to cite

  • When discussing uncertainty and harms of PSA screening.

Practice impact

  • Shaped PSA screening controversy and shared decision-making recommendations.

Applicability

  • Average-risk men considering PSA screening in US-style settings with background opportunistic screening.

Limitations

  • High contamination in usual care limits the contrast between groups.
  • Long natural history of prostate cancer requires long follow-up.

Common misinterpretations

  • Do not use PLCO alone to say PSA screening never helps; interpret with ERSPC and screening-harm data.

Related evidence

ERSPC - Contrasting Result

Citation

Andriole GL, Crawford ED, Grubb RL 3rd, et al. Mortality results from a randomized prostate-cancer screening trial. N Engl J Med. 2009;360(13):1310-1319. doi:10.1056/NEJMoa0810696