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Annual screening for prostate cancer did not reduce mortality from prostate cancer

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randomised controlled trial (Prostate, Lung, Colorectal, and Ovarian [PLCO] Cancer Screening Trial). NCT00002540.




blinded (outcome adjudication committee).†



10 centres in the USA.


76 693 men 55–74 years of age. Exclusion criteria included history of PLCO cancer, current cancer treatment, and >1 prostate-specific antigen (PSA) test in ⩽3 years.


annual screening with PSA testing for 6 years and digital rectal examination for 4 years (n = 38 343) or usual care that might include screening (n = 38 350). A serum PSA concentration >4.0 ng/ml was considered to be a positive result. Men and their primary physicians were informed of test results; they decided on further diagnostic evaluation and treatment, according to standard practice.


incidence of and mortality from prostate cancer at 7 years. {The trial had >90% power to detect a 20% relative reduction in prostate cancer mortality.}*

Follow-up period:

median 12 years.

Participant follow-up:

98% at 7 years (intention-to-screen analysis).


In the screening group, compliance was 85% for PSA testing and 86% for digital rectal examination. In the control group, the rate of PSA testing increased over time from 40% to 52%; the rate of digital rectal examination was 41–46%. At 7 years, more men in the screening group had been diagnosed with prostate cancer, …

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  • *Prorok PC, Andriole GL, Bresalier RS, et al. Control Clin Trials 2000;21(Suppl):273S–309.

    †See glossary.

    Abstract and commentary also appear in ACP Journal Club.

  • Source of funding: National Cancer Institute.

  • Clinical impact ratings: GP/FP/Primary care 6/7; IM/Ambulatory care 6/7; Oncology 6/7; Surgery/Urology 6/7; Oncology/Genitourinary 6/7