Systematic Review of Active Surveillance for Clinically Localised Prostate Cancer to Develop Recommendations Regarding Inclusion of Intermediate-risk Disease, Biopsy Characteristics at Inclusion and Monitoring, and Surveillance Repeat Biopsy Strategy.

There is uncertainty regarding the most appropriate criteria for recruitment, monitoring, and reclassification in active surveillance (AS) protocols for localised prostate cancer (PCa).

To perform a qualitative systematic review (SR) to issue recommendations regarding inclusion of intermediate-risk disease, biopsy characteristics at inclusion and monitoring, and repeat biopsy strategy.

A protocol-driven, Preferred Reporting Items for Systematic Reviews and Meta-analyses (PRISMA)-adhering SR incorporating AS protocols published from January 1990 to October 2020 was performed. The main outcomes were criteria for inclusion of intermediate-risk disease, monitoring, reclassification, and repeat biopsy strategies (per protocol and/or triggered). Clinical effectiveness data were not assessed.

Of the 17 011 articles identified, 333 studies incorporating 375 AS protocols, recruiting 264 852 patients, were included. Only a minority of protocols included the use of magnetic resonance imaging (MRI) for recruitment (n = 17), follow-up (n = 47), and reclassification (n = 26). More than 50% of protocols included patients with intermediate or high-risk disease, whilst 44.1% of protocols excluded low-risk patients with more than three positive cores, and 39% of protocols excluded patients with core involvement (CI) >50% per core. Of the protocols, ≥80% mandated a confirmatory transrectal ultrasound biopsy; 72% (n = 189) of protocols mandated per-protocol repeat biopsies, with 20% performing this annually and 25% every 2 yr. Only 27 protocols (10.3%) mandated triggered biopsies, with 74% of these protocols defining progression or changes on MRI as triggers for repeat biopsy.

For AS protocols in which the use of MRI is not mandatory or absent, we recommend the following: (1) AS can be considered in patients with low-volume International Society of Urological Pathology (ISUP) grade 2 (three or fewer positive cores and cancer involvement ≤50% CI per core) or another single element of intermediate-risk disease, and patients with ISUP 3 should be excluded; (2) per-protocol confirmatory prostate biopsies should be performed within 2 yr, and per-protocol surveillance repeat biopsies should be performed at least once every 3 yr for the first 10 yr; and (3) for patients with low-volume, low-risk disease at recruitment, if repeat systematic biopsies reveal more than three positive cores or maximum CI >50% per core, they should be monitored closely for evidence of adverse features (eg, upgrading); patients with ISUP 2 disease with increased core positivity and/or CI to similar thresholds should be reclassified.

We examined the literature to issue new recommendations on active surveillance (AS) for managing localised prostate cancer. The recommendations include setting criteria for including men with more aggressive disease (intermediate-risk disease), setting thresholds for close monitoring of men with low-risk but more extensive disease, and determining when to perform repeat biopsies (within 2 yr and 3 yearly thereafter).

European urology. 2021 Dec 31 [Epub ahead of print]

Peter-Paul M Willemse, Niall F Davis, Nikolaos Grivas, Fabio Zattoni, Michael Lardas, Erik Briers, Marcus G Cumberbatch, Maria De Santis, Paolo Dell'Oglio, James F Donaldson, Nicola Fossati, Giorgio Gandaglia, Silke Gillessen, Jeremy P Grummet, Ann M Henry, Matthew Liew, Steven MacLennan, Malcolm D Mason, Lisa Moris, Karin Plass, Shane O'Hanlon, Muhammad Imran Omar, Daniela E Oprea-Lager, Karl H Pang, Catherine C Paterson, Guillaume Ploussard, Olivier Rouvière, Ivo G Schoots, Derya Tilki, Roderick C N van den Bergh, Thomas Van den Broeck, Theodorus H van der Kwast, Henk G van der Poel, Thomas Wiegel, Cathy Yuhong Yuan, Philip Cornford, Nicolas Mottet, Thomas B L Lam

Department of Urology, Cancer Center, University Medical Center Utrecht, Utrecht, The Netherlands. Electronic address: ., Department of Urology, Beaumont and Connolly Hospitals, Dublin, Ireland; Royal College of Surgeons in Ireland, Dublin, Ireland., Department of Urology, G. Hatzikosta General Hospital, Ioannina, Greece., Urology Unit, Academic Medical Centre Hospital, Udine, Italy., Department of Reconstructive Urology and Surgical Andrology, Metropolitan General, Athens, Greece., Patient Advocate, Hasselt, Belgium., Academic Urology Unit, University of Sheffield, Sheffield, UK., Department of Urology, Charité Universitätsmedizin, Berlin, Germany; Department of Urology, Medical University of Vienna, Austria., Unit of Urology, Division of Oncology, Urological Research Institute, IRCCS Ospedale San Raffaele, Milan, Italy., Academic Urology Unit, University of Aberdeen, Aberdeen, UK; Department of Urology, Aberdeen Royal Infirmary, Aberdeen, UK., Oncology Institute of Southern Switzerland, EOC, Bellinzona, Switzerland; Università della Svizzera Italiana, Lugano, Switzerland; University of Bern, Bern, Switzerland., Department of Surgery, Central Clinical School, Monash University, Melbourne, Australia., Leeds Cancer Centre, St. James's University Hospital and University of Leeds, Leeds, UK., Department of Urology, Wrightington, Wigan and Leigh NHS Foundation Trust, Wigan, UK., Academic Urology Unit, University of Aberdeen, Aberdeen, UK., Division of Cancer and Genetics, School of Medicine Cardiff University, Velindre Cancer Centre, Cardiff, UK., Department of Urology, University Hospitals Leuven, Leuven, Belgium., EAU Guidelines Office, Arnhem, The Netherlands., Department of Geriatric Medicine, St Vincent's University Hospital, Dublin, Ireland., Department of Radiology and Nuclear medicine, Amsterdam University Medical Centers, VU Medical Center, Amsterdam, The Netherlands., University of Canberra, School of Nursing, Midwifery and Public Health, Canberra, Australia., Department of Urology, La Croix du Sud Hospital, Quint Fonsegrives, France; Institut Universitaire du Cancer, Toulouse, France., Department of Radiology, Edouard Herriot Hospital, Lyon, France., Department of Radiology & Nuclear Medicine, Erasmus MC University Medical Center, Rotterdam, The Netherlands., Martini-Klinik Prostate Cancer Center, University Hospital Hamburg-Eppendorf, Hamburg, Germany; Department of Urology, University Hospital Hamburg-Eppendorf, Hamburg, Germany; Department of Urology, Koc University Hospital, Istanbul, Turkey., Department of Urology, Antonius Hospital, Utrecht, The Netherlands., Medicine Program and Princess Margaret Cancer Center, University Health Network, Toronto, Canada., Department of Urology, Netherlands Cancer Institute, Amsterdam, The Netherlands., Department of Radiation Oncology, University Hospital Ulm, Ulm, Germany., Department of Medicine, McMaster University, Hamilton, Canada., Department of Urology, Royal Liverpool and Broadgreen Hospitals NHS Trust, Liverpool, UK., Department of Urology, University Hospital, St. Etienne, France.

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