Leonard P Bokhorst1, Chris H Bangma2, Geert J L H van Leenders3, Jan J Lous4, Sue M Moss5, Fritz H Schröder2, Monique J Roobol2. 1. Department of Urology, Erasmus University Medical Center, Rotterdam, The Netherlands. Electronic address: l.bokhorst@erasmusmc.nl. 2. Department of Urology, Erasmus University Medical Center, Rotterdam, The Netherlands. 3. Department of Pathology, Erasmus University Medical Center, Rotterdam, The Netherlands. 4. STAR-Medical Diagnostic Center, Rotterdam, The Netherlands. 5. Centre for Cancer Prevention, Wolfson Institute for Preventive Medicine, Queen Mary University of London, London, United Kingdom.
Abstract
BACKGROUND: Large randomized screening trials provide an estimation of the effect of screening at a population-based level. The effect of screening for individuals, however, is diluted by nonattendance and contamination in the trial arms. OBJECTIVE: To determine the prostate cancer (PCa) mortality reduction from screening after adjustment for nonattendance and contamination. DESIGN, SETTING, AND PARTICIPANTS: A total of 34,833 men in the core age group, 55-69 yr, were randomized to a screening or control arm in the Rotterdam section of the European Randomized Study of Screening for Prostate Cancer (ERSPC). Prostate-specific antigen (PSA) testing was offered to all men in the screening arm at 4-yr intervals. A prostate biopsy was offered to men with an elevated PSA. The primary end point was PCa-specific mortality. OUTCOME MEASUREMENTS AND STATISTICAL ANALYSIS: Nonattendance was defined as nonparticipation in the screening arm. Contamination in the control arm was defined as receiving asymptomatic PSA testing or a prostate biopsy in the absence of symptoms. Relative risks (RRs) were calculated with an intention to screen (ITS) analysis and after correction for nonattendance and contamination using a method that preserves the benefits obtained by randomization. RESULTS AND LIMITATIONS: The ITS analysis resulted in an RR of 0.68 (95% confidence interval [CI], 0.53-0.89) in favor of screening at a median follow-up of 13 yr. Correction for both nonattendance and contamination resulted in an RR of 0.49 (95% CI, 0.27-0.87) in favor of screening. CONCLUSIONS: PCa screening as conducted in the Rotterdam section of the ERSPC can reduce the risk of dying from PCa up to 51% for an individual man choosing to be screened repeatedly compared with a man who was not screened. This benefit of screening should be balanced against the harms of overdiagnosis and subsequent overtreatment. TRIAL REGISTRATION: ISRCTN49127736.
RCT Entities:
BACKGROUND: Large randomized screening trials provide an estimation of the effect of screening at a population-based level. The effect of screening for individuals, however, is diluted by nonattendance and contamination in the trial arms. OBJECTIVE: To determine the prostate cancer (PCa) mortality reduction from screening after adjustment for nonattendance and contamination. DESIGN, SETTING, AND PARTICIPANTS: A total of 34,833 men in the core age group, 55-69 yr, were randomized to a screening or control arm in the Rotterdam section of the European Randomized Study of Screening for Prostate Cancer (ERSPC). Prostate-specific antigen (PSA) testing was offered to all men in the screening arm at 4-yr intervals. A prostate biopsy was offered to men with an elevated PSA. The primary end point was PCa-specific mortality. OUTCOME MEASUREMENTS AND STATISTICAL ANALYSIS: Nonattendance was defined as nonparticipation in the screening arm. Contamination in the control arm was defined as receiving asymptomatic PSA testing or a prostate biopsy in the absence of symptoms. Relative risks (RRs) were calculated with an intention to screen (ITS) analysis and after correction for nonattendance and contamination using a method that preserves the benefits obtained by randomization. RESULTS AND LIMITATIONS: The ITS analysis resulted in an RR of 0.68 (95% confidence interval [CI], 0.53-0.89) in favor of screening at a median follow-up of 13 yr. Correction for both nonattendance and contamination resulted in an RR of 0.49 (95% CI, 0.27-0.87) in favor of screening. CONCLUSIONS: PCa screening as conducted in the Rotterdam section of the ERSPC can reduce the risk of dying from PCa up to 51% for an individual man choosing to be screened repeatedly compared with a man who was not screened. This benefit of screening should be balanced against the harms of overdiagnosis and subsequent overtreatment. TRIAL REGISTRATION: ISRCTN49127736.
Authors: Eveline A M Heijnsdijk; Jan Adolfsson; Anssi Auvinen; Monique J Roobol; Jonas Hugosson; Harry J de Koning Journal: Eur Urol Date: 2019-04-26 Impact factor: 20.096
Authors: Richard M Martin; Jenny L Donovan; Emma L Turner; Chris Metcalfe; Grace J Young; Eleanor I Walsh; J Athene Lane; Sian Noble; Steven E Oliver; Simon Evans; Jonathan A C Sterne; Peter Holding; Yoav Ben-Shlomo; Peter Brindle; Naomi J Williams; Elizabeth M Hill; Siaw Yein Ng; Jessica Toole; Marta K Tazewell; Laura J Hughes; Charlotte F Davies; Joanna C Thorn; Elizabeth Down; George Davey Smith; David E Neal; Freddie C Hamdy Journal: JAMA Date: 2018-03-06 Impact factor: 56.272
Authors: Harry J de Koning; Roman Gulati; Sue M Moss; Jonas Hugosson; Paul F Pinsky; Christine D Berg; Anssi Auvinen; Gerald L Andriole; Monique J Roobol; E David Crawford; Vera Nelen; Maciej Kwiatkowski; Marco Zappa; Marcos Luján; Arnauld Villers; Tiago M de Carvalho; Eric J Feuer; Alex Tsodikov; Angela B Mariotto; Eveline A M Heijnsdijk; Ruth Etzioni Journal: Cancer Date: 2017-12-06 Impact factor: 6.860
Authors: Salah Alzghoul; Mohammad Hailat; Sandra Zivanovic; Long Que; Girish V Shah Journal: Biosens Bioelectron Date: 2015-10-09 Impact factor: 10.618