Low-risk prostate lesions - An evidence review to inform discussion on losing the “cancer” label

Sep 24, 2026

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Active surveillance mitigates harms from overtreatment of low-risk prostate lesions, but changing diagnostic thresholds or adopting alternative labels may increase uptake and continuation. PubMed and EMBASE searches through October 2021 synthesized evidence on active surveillance outcomes, subclinical prostate cancer at autopsy, histopathological reproducibility, and diagnostic drift. Results summarize mortality, metastasis, termination rates, prevalence of subclinical disease, and proportions upgraded or downgraded under contemporary criteria.

LanguageEnglish

CategoryHealthcare

FormatPDF

Pages18

Reading Time45 min

AccessFree to download

Abstract

Background

Methods

Results

Conclusions

Introduction

PSA screening and low-risk diagnosis trends

Harms and the role of active surveillance

DOI: 10.1002/pros.24493 REV I EW ART I CLE Low‐risk prostate lesions: An evidence review to inform discussion on losing the “cancer” label Caitlin R. Semsarian BSc, MD1 | Tara Ma BSc (Med), MBBS, MMed, MPH, PhD1 | Brooke Nickel BSc (Hons), MIPH, PhD1 | Alexandra Barratt MBBS, MPH, PhD1 | Murali Varma MBBS, MD, FRCPath, FCAP2 | Brett Delahunt MD, FRCPA, FRCPath3 | Jeremy Millar BMedSci, MBChB, FRANZCR, FAChPMed4 | Lisa Parker BMedSci, MBBS, MMed, MBE, PhD5,6 | Paul Glasziou MBBS, PhD, FRACGP, AO7 | Katy J. L. Bell MBChB, MMed, PhD1 1Sydney School of Public Health, Faculty of Medicine and Health, The University of Sydney, Sydney, Australia 2Department of Cellular Pathology, University Hospital of Wales, Cardiff, UK 3Wellington School of Medicine and Health Sciences, University of Otago, Wellington, New Zealand 4Alfred Health Radiation Oncology, The Alfred, Melbourne, Australia 5Charles Perkins Centre, Sydney School of Pharmacy, Faculty of Medicine and Health, The University of Sydney, Sydney, Australia 6Department of Radiation Oncology, Royal North Shore Hospital, St Leonards, Australia 7Institute for Evidence‐Based Healthcare, Faculty of Health Sciences and Medicine, Bond University, Gold Coast, Australia Correspondence Katy J. L. Bell, MBChB, MMed, PhD, Sydney School of Public Health, Faculty of Medicine and Health, The University of Sydney, Sydney, Australia. Email: [katy.bell@sydney.edu.au](katy.bell@sydney.edu.au) Funding information National Health and Medical Research Council Abstract Background: Active surveillance (AS) mitigates harms from overtreatment of low‐risk prostate lesions. Recalibration of diagnostic thresholds to redefine which prostate lesions are considered “cancer” and/or adopting alternative diagnostic labels could increase AS uptake and continuation. Methods: We searched PubMed and EMBASE to October 2021 for evidence on: (1) clinical outcomes of AS, (2) subclinical prostate cancer at autopsy, (3) reproducibility of histopathological diagnosis, and (4) diagnostic drift. Evidence is presented via narrative synthesis. Results: AS: one systematic review (13 studies) of men undergoing AS found that prostate cancer‐specific mortality was 0%−6% at 15 years. There was eventual termination of AS and conversion to treatment in 45%−66% of men. Four additional cohort studies reported very low rates of metastasis (0%−2 . 1%) and prostate cancer‐ specific mortality (0%−0 . 1%) over follow‐up to 15 years. Overall, AS was terminated without medical indication in 1%−9% of men. Subclinical reservoir: 1 systematic review (29 studies) estimated that the subclinical cancer prevalence was 5% at <30 years, and increased nonlinearly to 59% by >79 years. Four additional autopsy studies (mean age: 54−72 years) reported prevalences of 12%−43% . Reproducibility: 1 recent well‐conducted study found high reproducibility for low‐risk prostate cancer diagnosis, but this was more variable in 7 other studies. Diagnostic drift: 4 studies provided consistent evidence of diagnostic drift, with the mostrecent (published 2020) reporting that 66% of cases were upgraded and 3% were downgraded when using contemporary diagnostic criteria compared to original diagnoses (1985−1995) . This is an open access article under the terms of the Creative Commons Attribution License, which permits use, distribution and reproduction in any medium, provided the original work is properly cited. © 2023 The Authors. The Prostate published by Wiley Periodicals LLC. SEMSARIAN ET AL. 499 Conclusions: Evidence collated may inform discussion of diagnostic changes for low‐ risk prostate lesions. KEYWO R DS classification, diagnosis, pathology, prostate, terminology, treatment 1 | INTRODUCTION In higher income countries including the USA,1 Australia,2 and Canada,3 a dramatic increase in the incidence of prostate cancer diagnoses occurred in the late 1980s and 1990s with the widespread uptake of prostate‐specif

FAQs

Why might diagnostic relabeling affect active surveillance for low-risk prostate lesions?

Recalibrating diagnostic thresholds or using alternative diagnostic labels could redefine what is considered “cancer,” potentially improving active surveillance uptake and continuation by reducing perceived treatment necessity.

What does the evidence report about outcomes of active surveillance?

A systematic review found prostate cancer-specific mortality of 0%–6% at 15 years, with eventual termination of active surveillance and conversion to treatment in 45%–66% of men. Additional cohort studies reported very low metastasis rates (0%–2.1%) and prostate cancer-specific mortality (0%–0.1%) up to 15 years.

What evidence is presented regarding diagnostic drift?

Four studies reported consistent diagnostic drift, and a most recent study (published 2020) reported that 66% of cases were upgraded and 3% were downgraded when contemporary criteria were used compared with original diagnoses (1985–1995).

Sep 24, 2026

Uploaded by awa