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 Journal Articles uri icon

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abstract

  • 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).

authors

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

publication date

  • April 2022