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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, …
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