Introduction European Association of Urology and UK National Institute for Health and Care Excellence guidelines recommend that all men with suspicions of prostate cancer should undergo prebiopsy contrast enhanced, that is, multiparametric prostate MRI. Subsequent prostate biopsies should also be performed if MRI is positive, that is, Prostate Imaging–Reporting and Data System (PI-RADS) scores 3–5. However, several retrospective post hoc analyses have shown that this approach still leads to many unnecessary biopsy procedures. For example, 88%–96% of men with PI-RADS, three findings are still diagnosed with clinically non-significant prostate cancer or no cancer at all.
Methods and analysis This is a prospective, randomised, controlled, multicentre trial, being conducted in Finland, to demonstrate non-inferiority in clinically significant cancer detection rates among men undergoing prostate biopsies post-MRI and men undergoing prostate biopsies post-MRI only after a shared decision based on individualised risk estimation. Men without previous diagnosis of prostate cancer and with abnormal digital rectal examination findings and/or prostate-specific antigen between 2.5 ug/L and 20.0 ug/L are included. We aim to recruit 830 men who are randomised at a 1:1 ratio into control (all undergo biopsies after MRI) and intervention arms (the decision to perform biopsies is based on risk estimation and shared decision-making). The primary outcome of the study is the proportion of men with clinically significant prostate cancer (Gleason 4+3 prostate cancer or higher). We will also compare the overall biopsy rate, benign biopsy rate and the detection of non-significant prostate cancer between the two study groups.
Ethics and dissemination The study (protocol V.2.0, 4 January 2021) was approved by the Ethics Committee of the Hospital District of Southwest Finland (IORG number: 0001744, IBR number: 00002216; trial number: 99/1801/2019). Participants are required to provide written informed consent. Full reports of this study will be submitted to peer-reviewed journals, mainly urology and radiology.
Trial registration number NCT04287088; the study is registered at ClinicalTrials.gov.
- magnetic resonance imaging
- urological tumours
- prostate disease
- urological tumours
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Contributors OE, IJ, IMP, KTS, PT, EL, JS, DDS, AV, HA, PB contributed to the planning of the study. OE, IJ, MS, AK, HS, KS, PT, JV, AS, ES, PB participated in the conduction of the study. All authors contributed to the reporting of the study.
Funding This work is supported by an academic grant from the Finnish Cancer Society. Grant number is not applicable.
Disclaimer The funding organisation will not have any authority over study design; collection, management, analysis and interpretation of data; writing of the report; and the decision to submit the report for publication.
Competing interests PT reports representation as a member of the Data Management Committee in the ProScreen trial. AV is named as a co-inventor on US patent number: 9 672 329 for a statistical method to predict the result of prostate biopsy. Patent has been commercialised and will receive royalties from clinical use. AV is also a co-inventor of the 4kscore, a commercially available reflex test for predicting prostate biopsy. He may receive royalties from sales of the test. He owns stock options in Opko, which offers the test. Otherwise, no competing interest was declared.
Provenance and peer review Not commissioned; externally peer reviewed.
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