Prostate-Specific Antigen Screening and 15-Year Prostate Cancer Mortality
Author:
Martin Richard M.123, Turner Emma L.1, Young Grace J.1, Metcalfe Chris1, Walsh Eleanor I.1, Lane J. Athene1, Sterne Jonathan A. C.124, Noble Sian1, Holding Peter5, Ben-Shlomo Yoav1, Williams Naomi J.1, Pashayan Nora6, Bui Mai Ngoc6, Albertsen Peter C.7, Seibert Tyler M.8910, Zietman Anthony L.11, Oxley Jon12, Adolfsson Jan13, Mason Malcolm D.14, Davey Smith George13, Neal David E.5, Hamdy Freddie C.5, Donovan Jenny L.1, , Oliver Steven15, Brindle Peter 15, Evans Simon15, Frankel Stephen15, Down Liz15, Tazewell Marta15, Shiarly Pete15, Thorn Joanna15, Harrison Sean15, Hounsome Luke15, Davies Charlotte15, Hughes Laura15, Rowlands Mari-Anne15, Bell Lindsey15, Hill Elizabeth15, Ng Siaw Yein15, Williams Naomi15, Toole Jessica15, Baum Michael15, Roberts Tracy15, Robinson Mary15, Dearnaley David 15, Schröder Fritz15, Peters Tim15, Lennon Teresa15, Bonnington Sue15, Holmberg Lars15, Pickard Robert15, Thompson Simon15, Menon Usha15, McFarlane Jon15, Bryant Richard15, Dormer John15, Reid Colette15, Bahl Amit15, Koupparis Anthony15, Gunnell David15
Affiliation:
1. Department of Population Health Sciences, Bristol Medical School, University of Bristol, Bristol, United Kingdom 2. National Institute for Health Research Bristol Biomedical Research Centre, University Hospitals Bristol and Weston NHS Foundation Trust and University of Bristol, Bristol, United Kingdom 3. MRC Integrative Epidemiology Unit, University of Bristol, Bristol, United Kingdom 4. Health Data Research UK South-West, University of Bristol, Bristol, United Kingdom 5. Nuffield Department of Surgical Sciences, University of Oxford, Oxford, United Kingdom 6. Department of Applied Health Research, University College London, London, United Kingdom 7. Division of Urology, University of Connecticut Health Center, Farmington 8. Department of Radiation Medicine and Applied Sciences, University of California San Diego, La Jolla 9. Department of Radiology, University of California San Diego, La Jolla 10. Department of Bioengineering, University of California San Diego, La Jolla 11. Department of Radiation Oncology, Massachusetts General Hospital, Harvard Medical School, Boston 12. Department of Cellular Pathology, North Bristol NHS Trust, Bristol, United Kingdom 13. Department of Clinical Science, Intervention and Technology, Karolinska Institutet, Stockholm, Sweden 14. School of Medicine, Cardiff University, Cardiff, Wales, United Kingdom 15. for the CAP Trial Group
Abstract
ImportanceThe Cluster Randomized Trial of PSA Testing for Prostate Cancer (CAP) reported no effect of prostate-specific antigen (PSA) screening on prostate cancer mortality at a median 10-year follow-up (primary outcome), but the long-term effects of PSA screening on prostate cancer mortality remain unclear.ObjectiveTo evaluate the effect of a single invitation for PSA screening on prostate cancer–specific mortality at a median 15-year follow-up compared with no invitation for screening.Design, Setting, and ParticipantsThis secondary analysis of the CAP randomized clinical trial included men aged 50 to 69 years identified at 573 primary care practices in England and Wales. Primary care practices were randomized between September 25, 2001, and August 24, 2007, and men were enrolled between January 8, 2002, and January 20, 2009. Follow-up was completed on March 31, 2021.InterventionMen received a single invitation for a PSA screening test with subsequent diagnostic tests if the PSA level was 3.0 ng/mL or higher. The control group received standard practice (no invitation).Main Outcomes and MeasuresThe primary outcome was reported previously. Of 8 prespecified secondary outcomes, results of 4 were reported previously. The 4 remaining prespecified secondary outcomes at 15-year follow-up were prostate cancer–specific mortality, all-cause mortality, and prostate cancer stage and Gleason grade at diagnosis.ResultsOf 415 357 eligible men (mean [SD] age, 59.0 [5.6] years), 98% were included in these analyses. Overall, 12 013 and 12 958 men with a prostate cancer diagnosis were in the intervention and control groups, respectively (15-year cumulative risk, 7.08% [95% CI, 6.95%-7.21%] and 6.94% [95% CI, 6.82%-7.06%], respectively). At a median 15-year follow-up, 1199 men in the intervention group (0.69% [95% CI, 0.65%-0.73%]) and 1451 men in the control group (0.78% [95% CI, 0.73%-0.82%]) died of prostate cancer (rate ratio [RR], 0.92 [95% CI, 0.85-0.99]; P = .03). Compared with the control, the PSA screening intervention increased detection of low-grade (Gleason score [GS] ≤6: 2.2% vs 1.6%; P < .001) and localized (T1/T2: 3.6% vs 3.1%; P < .001) disease but not intermediate (GS of 7), high-grade (GS ≥8), locally advanced (T3), or distally advanced (T4/N1/M1) tumors. There were 45 084 all-cause deaths in the intervention group (23.2% [95% CI, 23.0%-23.4%]) and 50 336 deaths in the control group (23.3% [95% CI, 23.1%-23.5%]) (RR, 0.97 [95% CI, 0.94-1.01]; P = .11). Eight of the prostate cancer deaths in the intervention group (0.7%) and 7 deaths in the control group (0.5%) were related to a diagnostic biopsy or prostate cancer treatment.Conclusions and RelevanceIn this secondary analysis of a randomized clinical trial, a single invitation for PSA screening compared with standard practice without routine screening reduced prostate cancer deaths at a median follow-up of 15 years. However, the absolute reduction in deaths was small.Trial Registrationisrctn.org Identifier: ISRCTN92187251
Publisher
American Medical Association (AMA)
Cited by
12 articles.
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