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

Willemse, P.P.M.; Davis, N.F.; Grivas, N.; Zattoni, F.; Lardas, M.; Briers, E.; ... ; Lam, T.B.L. (2022)

Article / Letter to editor

Context: There is uncertainty regarding the most appropriate criteria for recruitment, monitoring, and reclassification in active surveillance (AS) protocols for localised prostate cancer (PCa).Objective: 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.Evidence acquisition: 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.Evidence synthesis: 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.Conclusions: 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.Patient summary: 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). (C) 2021 The Authors. Published by Elsevier B.V. on behalf of European Association of Urology.

• Systematic review
• Active surveillance
• Localised prostate cancer
• Consensus statements
• Criteria for inclusion and eligibility
• Monitoring and reclassification
• Positive cores
• Core involvement
• Per-protocol or untriggered repeat biopsies
• Clinical practice guidelines and recommendations

• All authors: Willemse, P.P.M.; Davis, N.F.; Grivas, N.; Zattoni, F.; Lardas, M.; Briers, E.; Cumberbatch, M.G.; Santis, M. de; Dell'Oglio, P.; Donaldson, J.F.; Fossati, N.; Gandaglia, G.; Gillessen, S.; Grummet, J.P.; Henry, A.M.; Liew, M.; MacLennan, S.; Mason, M.D.; Moris, L.; Plass, K.; O'Hanlon, S.; Omar, M.I.; Oprea-Lager, D.E.; Pang, K.H.; Paterson, C.C.; Ploussard, G.; Rouviere, O.; Schoots, I.G.; Tilki, D.; Bergh, R.C.N. van den; Broeck, T. van den; Kwast, T.H. van der; Poel, H.G. van der; Wiegel, T.; Yuan, C.Y.; Cornford, P.; Mottet, N.; Lam, T.B.L.
• Date: 2022-04-01
• Journal: European Urology
• Volume: 81
• Issue: 4
• Pages: 337 - 346
• DOI: doi:10.1016/j.eururo.2021.12.007