Systematic review of active surveillance for clinically localized prostate cancer to develop recommendations regarding inclusion of intermediate-risk disease, biopsy characteristics at inclusion and monitoring, and surveillance repeat biopsy strategy

Peter-Paul M. Willemse* (Corresponding Author), 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 PlassShane O'Hanlon, Muhammad Imran Omar, Daniela E. Oprea-Lager, Karl H. Pang, Catherine 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

*Corresponding author for this work

Research output: Contribution to journalArticlepeer-review

Abstract

Context: There is uncertainty regarding the most appropriate criteria for recruitment, monitoring and reclassification in active surveillance (AS) protocols for localized 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, 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 17,011 articles identified, 333 studies incorporating 375 AS protocols, recruiting 264,852 patients were included. Only a minority of protocols included use of 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 >3positive cores, and 39% of protocols excluded patients with core involvement (CI) >50%/core. ≥80% of protocols mandated a confirmatory TRUS biopsy. 72% (n=189) of protocols mandated per-protocol repeat biopsies, with 20% performing this annually, and 25% every 2 years. 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 use of MRI is not mandatory or absent, we recommend the following: (1) AS can be considered in patients with low-volume ISUP 2 (≤3 positive cores and cancer involvement ≤50% CI/core) or another single element of intermediate-risk disease; patients with ISUP 3 should be excluded; (2) Per-protocol confirmatory prostate biopsies should be performed within 2 years, and per-protocol surveillance repeat biopsies should be performed at least once every 3 years for the first 10 years; and (3) For patients with low-volume, low-risk disease at recruitment, if repeat systematic biopsies reveal >3 positive cores or maximum CI>50%/core, they should be monitored closely for evidence of adverse features (e.g. 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 localized prostate cancer. The recommendations include setting criteria for including men with more aggressive disease (intermediate-risk disease), thresholds for close monitoring of men with low-risk but more extensive disease, and when to perform repeat biopsies (within 2 years and 3 yearly thereafter).
Original languageEnglish
JournalEuropean Urology
Publication statusAccepted/In press - 2 Dec 2021

Keywords

  • Systematic review
  • active surveillance
  • localized 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

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