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).
| Original language | English |
|---|---|
| Pages (from-to) | 337-346 |
| Number of pages | 10 |
| Journal | European Urology |
| Volume | 81 |
| Issue number | 4 |
| DOIs | |
| Publication status | Published - Apr 2022 |
Bibliographical note
Funding Information:Financial disclosures: Peter-Paul M. Willemse certifies that all conflicts of interest, including specific financial interests and relationships and affiliations relevant to the subject matter or materials discussed in the manuscript (eg, employment/affiliation, grants or funding, consultancies, honoraria, stock ownership or options, expert testimony, royalties, or patents filed, received, or pending), are the following: Professor Dr. Nicolas Mottet is a company consultant for Janssen, GE, BMS, Sanofi, and Astellas; has received speaker honoraria from Astellas, Pierre Fabre, Steba, Janssen, and Ferring; and has received fellowships and travel grants from Astellas, Ipsen, Sanofi, Janssen, and Roche. Professor Dr. Philip Cornford is a company consultant for Astellas, Ipsen, and Ferring; has received company speaker honoraria from Astellas, Janssen, Ipsen, and Pfizer; has participated in trials run by Ferring; and has received fellowships and travel grants from Astellas and Janssen. Dr. Erik Briers has received grants and research support from IPSEN, the European Association of Urology, and Bayer; is an ex officio board member for Europa UOMO; is an ethics committee and advisory group member for REQUITE; is a patient advisory board member for PAGMI; and is a member of SCA and EMA PCWP. Professor Dr. Maria De Santis is a company consultant for Amgen, Astellas, AstraZeneca, Bayer, Bristol-Myers Squibb, Celgene, Dendreon, Eisai Inc., ESSA, Ferring, GSK, Incyte, Ipsen, Janssen Cilag, Merck, MSD, Novartis, Pfizer, Pierre Fabre Oncologie, Roche, Sanofi Aventis, SeaGen, Shionogi, Synthon, Takeda, Teva, OncoGenex, and Sandoz; receives speaker honoraria from Amgen, Astellas, AstraZeneca, Bayer, Bristol-Myers Squibb, Ferring, GSK, IPSEN, Janssen Cilag, Merck, MSD, Novartis, Pfizer, Pierre Fabre Oncologie, Roche, Sanofi Aventis, Synthon, and Takeda; participates in trials run by the Technical University Munich, Amgen, Astellas, AstraZeneca, Bayer, Bristol-Myers Squibb, Celgene, Dendreon, Eisai Inc., Ferring, GSK, IPSEN, Incyte, Janssen Cilag, Merck, MSD, Novartis, Pfizer, Pierre Fabre Oncologie, Roche, Sanofi Aventis, SOTIO, and Cancer Research UK; participates in various trials as a member of the EORTC GU Group; and has received research grants from Pierre Fabre Oncologie, and travel grants from Amgen, Astellas, AstraZeneca, Bayer, Bristol-Myers Squibb, Celgene, Dendreon, Ferring, GSK, IPSEN, Incyte, Janssen Cilag, Merck, MSD, Novartis, Pfizer, Pierre Fabre Oncologie, Roche, Sanofi Aventis, SeaGen, Shionogi, Synthon, Takeda, and Teva/OncoGenex. Professor Dr. Silke Gillessen is a company consultant for AAA International, Astellas Pharma, Bayer, Bristol-Myers Squibb, Clovis, CureVac, Ferring, Innocrin Pharmaceuticals, Janssen Cilag, MaxIVAX SA, Orion, Roche, Sanofi Aventis Group, Nectar, and ProteoMediX; has received speaker honoraria from Janssen and Novartis; and participates in multiple trials sponsored by different companies. Professor Dr. Jeremy P. Grummet has received a speaker honorarium from Mundipharma, a travel grant from Astellas, and a research grant from Cancer Australia; and is the owner of MRI PRO Pty Ltd., an online training platform. Professor Dr. Ann M. Henry is a company consultant for Nucletron-Elektra; participates in trials by Cancer Research UK and the National Institute of Health Research (UK); has received travel grants from the Medical Research Council, the National Institute of Health Research (UK), and Cancer Research UK; and has received research grants from Cancer Research UK and the Sir John Fisher Foundation. Dr. Thomas B.L. Lam is a company consultant for and has received company speaker honoraria and travel grants from Pfizer, GSK, Astellas, IPSEN, and Consilient Health. Professor Dr. Malcolm D. Mason is a company consultant for Ellipses Pharma and Oncotherics. Professor Dr. Shane O’Hanlon received travel grants from SIOG and ESMO, and research support from Slaintecare. Professor Dr. Guillaume Ploussard is a company consultant for Janssen, Takeda, Ferring, Ipsen, Astellas, and Koelis; received company speaker honorarium from Janssen, Takeda, Ferring, Ipsen, Astellas, and Bayer; and received research support from Ferring. Professor Dr. Derya Tilki has received speaker honoraria from Astellas and a travel grant from Janssen. Olivier Rouvière received speaker honorarium from EDAP-TMS, travels grants and research support from Philips, and participated in clinical trials by EDAP-TMS and Vermon. Theodorus van der Kwast received research support from Google Inc. Professor Dr. Henk G. van der Poel is a company consultant for Intuitive Surgical; has participated in trials for Astellas and Steba Biotech; and has received grant and research support from Astellas. Professor Dr. Thomas Wiegel is an advisory board member for Ipsen; receives company speaker honoraria from Ipsen and Hexal; is a member of the Janssen Steering Committee; and has participated in the ATLAS/AUO trial. Dr. Thomas Van den Broeck, Dr. Ivo G. Schoots, Dr. Michael Lardas, Mr. Matthew Liew, Dr. Giorgio Gandaglia, Dr. Nicola Fossati, Mr. Marcus Cumberbatch, Dr. Roderick C.N. van den Bergh, Dr. D. Oprea-Lager, Dr. Lisa Moris, Dr. Andrea Farolfi, Dr. Peter-Paul M. Willemse, Dr. Nikos Grivas, Dr. Y. Yuan, Mr. N.F. Davis, Dr. C.C. Paterson, Dr. P. Dell’Oglio, Dr. M.I. Omar, and Dr. S. MacLennan have nothing to disclose.
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© 2021 The Authors
