TY - JOUR
T1 - 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
AU - Willemse, Peter-Paul M.
AU - Davis, Niall F.
AU - Grivas, Nikolaos
AU - Zattoni, Fabio
AU - Lardas, Michael
AU - Briers, Erik
AU - Cumberbatch, Marcus G.
AU - De Santis, Maria
AU - Dell'Oglio, Paolo
AU - Donaldson, James F.
AU - Fossati, Nicola
AU - Gandaglia, Giorgio
AU - Gillessen, Silke
AU - Grummet, Jeremy P.
AU - Henry, Ann M.
AU - Liew, Matthew
AU - MacLennan, Steven
AU - Mason, Malcolm D.
AU - Moris, Lisa
AU - Plass, Karin
AU - O'Hanlon, Shane
AU - Omar, Muhammad Imran
AU - Oprea-Lager, Daniela E.
AU - Pang, Karl H.
AU - Paterson, Catherine
AU - Ploussard, Guillaume
AU - Rouvière, Olivier
AU - Schoots, Ivo G.
AU - Tilki, Derya
AU - van den Bergh, Roderick C.N.
AU - van den Broeck, Thomas
AU - van der Kwast, Theodorus H.
AU - van der Poel, Henk G.
AU - Wiegel, Thomas
AU - Yuan, Cathy Yuhong
AU - Cornford, Philip
AU - Mottet, Nicolas
AU - Lam, Thomas B.L.
PY - 2022/4/1
Y1 - 2022/4/1
N2 - 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).
AB - 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).
KW - Systematic review
KW - active surveillance
KW - localized prostate cancer
KW - consensus statements
KW - criteria for inclusion and eligibility
KW - monitoring and reclassification
KW - positive cores
KW - core involvement
KW - per-protocol or untriggered repeat biopsies
KW - clinical practice guidelines and recommendations
U2 - 10.1016/j.eururo.2021.12.007
DO - 10.1016/j.eururo.2021.12.007
M3 - Article
VL - 81
SP - 337
EP - 346
JO - European Urology
JF - European Urology
SN - 0302-2838
IS - 4
ER -