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  • Individualised non-contrast MRI-based risk estimation and shared decision-making in men with a suspicion of prostate cancer: protocol for multicentre randomised controlled trial (multi-IMPROD V.2.0)

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Urology
Protocol
Individualised non-contrast MRI-based risk estimation and shared decision-making in men with a suspicion of prostate cancer: protocol for multicentre randomised controlled trial (multi-IMPROD V.2.0)
  1. Otto Ettala1,
  2. Ivan Jambor2,3,
  3. Ileana Montoya Perez3,4,
  4. Marjo Seppänen5,
  5. Antti Kaipia6,7,
  6. Heikki Seikkula8,
  7. Kari T Syvänen1,
  8. Pekka Taimen9,10,
  9. Janne Verho3,
  10. Aida Steiner3,
  11. Jani Saunavaara11,
  12. Ekaterina Saukko3,
  13. Eliisa Löyttyniemi12,
  14. Daniel D Sjoberg13,
  15. Andrew Vickers14,
  16. Hannu Aronen3,
  17. Peter Boström1
  1. 1Department of Urology, TYKS Turku University Hospital and University of Turku, Turku, Varsinais-Suomi, Finland
  2. 2Department of Radiology, Icahn School of Medicine at Mount Sinai, New York, New York, USA
  3. 3Medical Imaging Centre of Southwest Finland, TYKS Turku University Hospital, Turku, Varsinais-Suomi, Finland
  4. 4Department of Computing, University of Turku, Turku, Varsinais-Suomi, Finland
  5. 5Department of Urology, Satakunta Hospital District, Pori, Satakunta, Finland
  6. 6Department of Urology, Tampere University, Tampere, Pirkanmaa, Finland
  7. 7Department of Urology, Tampere University Hospital, Tampere, Finland
  8. 8Department of Urology, Central Finland Central Hospital, Jyvaskyla, Finland
  9. 9Department of Pathology, TYKS Turku University Hospital, Turku, Varsinais-Suomi, Finland
  10. 10Institute of Biomedicine, University of Turku, Turku, Varsinais-Suomi, Finland
  11. 11Department of Medical Physics, TYKS Turku University Hospital, Turku, Varsinais-Suomi, Finland
  12. 12Department of Biostatistics, University of Turku, Turku, Varsinais-Suomi, Finland
  13. 13Department of Epidemiology & Biostatistics, Memorial Sloan Kettering Cancer Center, New York, New York, USA
  14. 14Integrative Medicine, Memorial Sloan Kettering Cancer Center, New York, New York, USA
  1. Correspondence to Dr Otto Ettala; otto.ettala{at}tyks.fi

Abstract

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
http://creativecommons.org/licenses/by-nc/4.0/

This is an open access article distributed in accordance with the Creative Commons Attribution Non Commercial (CC BY-NC 4.0) license, which permits others to distribute, remix, adapt, build upon this work non-commercially, and license their derivative works on different terms, provided the original work is properly cited, appropriate credit is given, any changes made indicated, and the use is non-commercial. See: http://creativecommons.org/licenses/by-nc/4.0/.

http://dx.doi.org/10.1136/bmjopen-2021-053118

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    Footnotes

    • 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.

    • Supplemental material This content has been supplied by the author(s). It has not been vetted by BMJ Publishing Group Limited (BMJ) and may not have been peer-reviewed. Any opinions or recommendations discussed are solely those of the author(s) and are not endorsed by BMJ. BMJ disclaims all liability and responsibility arising from any reliance placed on the content. Where the content includes any translated material, BMJ does not warrant the accuracy and reliability of the translations (including but not limited to local regulations, clinical guidelines, terminology, drug names and drug dosages), and is not responsible for any error and/or omissions arising from translation and adaptation or otherwise.