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

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STUDY DESIGN

Design:

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

Allocation:

{concealed}*.†

Blinding:

blinded (outcome adjudication committee).†

STUDY QUESTION

Setting:

10 centres in the USA.

Participants:

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.

Intervention:

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.

Outcomes:

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).

MAIN RESULTS

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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Footnotes

  • *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

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