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Design of a magnetic resonance imaging-based screening program for early diagnosis of prostate cancer: preliminary results of a randomized controlled trial—Prostate Cancer Secondary Screening in Sapienza (PROSA)

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Abstract

Objectives

The main objective is to propose an MRI-based screening protocol, investigating the role of MRI without the injection of contrast media (bi-parametric MRI, bpMRI) as a secondary prevention test for prostate cancer (PCa) early diagnosis, comparing MRI with the prostate specific antigen (PSA) test. For this reason, preliminary results of Prostate Cancer Secondary Screening in Sapienza (PROSA) are presented, to investigate the efficiency of an MRI-based screening protocol.

PROSA is a prospective, randomized, single-center study. To date, 351 men have been enrolled and blindly randomized into two different arms:

  1. (A)

    Men underwent a bpMRI regardless of their PSA values (175);

  2. (B)

    Men followed as per clinical practice: those with increased PSA (61) were referred to bpMRI, while those with normal PSA (112) were not.

Men who screened positive on MRI were directed to MR-directed targeted biopsy.

On arm A, 4 clinically significant PCa have been detected, while none was found on arm B (p = 0.046).

To evaluate the efficiency of the screening protocol, we calculated the experimental event rate (EER, 3.6%), control event rate (CER, 1.2%.), absolute risk reduction (ARR, 2.5%), and number needed to treat (NNT, 40.3).

PROSA represents an interesting experience in the field of imaging-based PCa screening. The preliminary data from this trial highlight the promising role of non-contrast MRI as a screening tool for early detection of PCa. Further data will finally validate the most appropriate screening program.

Clinical relevance statement

PROSA depicts an interesting experience in the field of research focused on imaging-based prostate cancer screening. Its preliminary data highlight the promising role of non-contrast MRI as a screening tool for early detection of PCa.

Key Points

• Promotion of an MRI-based screening protocol, investigating the role of non-contrast MRI as a secondary prevention test for prostate cancer early diagnosis, comparing MRI with PSA test.

• Prostate Cancer Secondary Screening in Sapienza (PROSA) represents an interesting experience in the field of research focused on imaging-based prostate cancer screening; its preliminary results indicate that it is possible to use non-contrast MRI as a screening tool for early detection of PCa.

• This new approach to PCa screening could facilitate the early diagnosis of clinically significant prostate cancer while reducing the number of unnecessary prostate biopsies and the detection of clinically insignificant prostate cancer.

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Fig. 1
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Abbreviations

ADC:

Apparent diffusion coefficient

ARR:

Absolute risk reduction

bpMRI:

Bi-parametric MRI

CER:

Control event rate

ciPCa:

Clinically insignificant PCa

csPCa:

Clinically significant PCa

DWI:

Diffusion-weighted imaging

EER:

Experimental event rate

MRDB:

MR-Directed biopsies

NND:

Number needed to diagnose

NNT:

Number needed to treat

PCa:

Prostate cancer

PI-RADS:

Prostate Imaging Reporting and Data System

PSA:

Prostate-specific antigen

TRUS-MRI Fusion:

Trans-rectal ultrasound-magnetic resonance imaging fusion

References  

  1. Pecoraro M, Messina E, Bicchetti M et al (2021) The future direction of imaging in prostate cancer: MRI with or without contrast injection. Andrology. https://doi.org/10.1111/andr.13041

    Article  PubMed  Google Scholar 

  2. Shoag JE, Nyame YA, Gulati R et al (2020) Reconsidering the trade-offs of prostate cancer screening. N Engl J Med 382:2465–2468. https://doi.org/10.1056/NEJMsb2000250

    Article  PubMed  PubMed Central  Google Scholar 

  3. Van Poppel H, Roobol MJ, Chapple CR et al (2021) Prostate-specific antigen testing as part of a risk-adapted early detection strategy for prostate cancer: European Association of Urology Position and Recommendations for 2021. Eur Urol 80:703–711. https://doi.org/10.1016/j.eururo.2021.07.024

    Article  PubMed  Google Scholar 

  4. Printz C (2020) Prostate cancer mortality projections reach a new high: with prostate cancer deaths projected to rise to their highest level in 20 years, some experts worry that changes to screening guidelines made in 2012 could be a factor. Cancer 126:3893–3894. https://doi.org/10.1002/cncr.33127

    Article  PubMed  Google Scholar 

  5. Eklund M, Jäderling F, Discacciati A et al (2021) MRI-targeted or standard biopsy in prostate cancer screening. N Engl J Med 385:908–920. https://doi.org/10.1056/NEJMoa2100852

    Article  PubMed  Google Scholar 

  6. Welch HG, Albertsen PC (2020) Reconsidering prostate cancer mortality — the future of PSA screening. N Engl J Med 382:1557–1563. https://doi.org/10.1056/NEJMms1914228

    Article  PubMed  Google Scholar 

  7. Van Poppel H, Hogenhout R, Albers P et al (2021) Early detection of prostate cancer in 2020 and beyond: facts and recommendations for the European Union and the European Commission. Eur Urol 79:327–329. https://doi.org/10.1016/j.eururo.2020.12.010

    Article  PubMed  Google Scholar 

  8. Cipollari S, Guarrasi V, Pecoraro M et al (2022) Convolutional neural networks for automated classification of prostate multiparametric magnetic resonance imaging based on image quality. Magn Reson Imaging 55:480–490. https://doi.org/10.1002/jmri.27879

    Article  Google Scholar 

  9. Kasivisvanathan V, Rannikko AS, Borghi M et al (2018) MRI-targeted or standard biopsy for prostate-cancer diagnosis. N Engl J Med 378:1767–1777. https://doi.org/10.1056/NEJMoa1801993

    Article  PubMed  PubMed Central  Google Scholar 

  10. El-Shater Bosaily A, Parker C, Brown LC et al (2015) PROMIS — Prostate MR imaging study: a paired validating cohort study evaluating the role of multi-parametric MRI in men with clinical suspicion of prostate cancer. Contemp Clin Trials 42:26–40. https://doi.org/10.1016/j.cct.2015.02.008

    Article  CAS  PubMed  PubMed Central  Google Scholar 

  11. van der Leest M, Cornel E, Israël B et al (2019) Head-to-head comparison of transrectal ultrasound-guided prostate biopsy versus multiparametric prostate resonance imaging with subsequent magnetic resonance-guided biopsy in biopsy-naïve men with elevated prostate-specific antigen: a large prospective multicenter clinical study. Eur Urol 75:570–578. https://doi.org/10.1016/j.eururo.2018.11.023

    Article  PubMed  Google Scholar 

  12. Rouvière O, Puech P, Renard-Penna R et al (2019) Use of prostate systematic and targeted biopsy on the basis of multiparametric MRI in biopsy-naive patients (MRI-FIRST): a prospective, multicentre, paired diagnostic study. Lancet Oncol 20:100–109. https://doi.org/10.1016/S1470-2045(18)30569-2

    Article  PubMed  Google Scholar 

  13. Drost F-JH, Osses D, Nieboer D et al (2020) Prostate magnetic resonance imaging, with or without magnetic resonance imaging-targeted biopsy, and systematic biopsy for detecting prostate cancer: a Cochrane systematic review and meta-analysis. Eur Urol 77:78–94. https://doi.org/10.1016/j.eururo.2019.06.023

    Article  PubMed  Google Scholar 

  14. Schröder FH, Hugosson J, Roobol MJ et al (2014) Screening and prostate cancer mortality: results of the European Randomised Study of Screening for Prostate Cancer (ERSPC) at 13 years of follow-up. Lancet 384:2027–2035. https://doi.org/10.1016/S0140-6736(14)60525-0

    Article  PubMed  PubMed Central  Google Scholar 

  15. International Agency for Research on Cancer (IARC) (2021) Population Factsheet Europe. https://gco.iarc.fr/today/data/factsheets/populations/908-europe-fact-sheets.pdf.  Accessed May 2023

  16. Wu B, Li SS, Song J et al (2020) Total cost of care for castration-resistant prostate cancer in a commercially insured population and a medicare supplemental insured population. J Med Econ 23:54–63. https://doi.org/10.1080/13696998.2019.1678171

    Article  PubMed  Google Scholar 

  17. Forsmark A, Gehrman J, Angenete E et al (2018) Health economic analysis of open and robot-assisted laparoscopic surgery for prostate cancer within the prospective multicentre LAPPRO Trial. Eur Urol 74:816–824. https://doi.org/10.1016/j.eururo.2018.07.038

    Article  PubMed  Google Scholar 

  18. Schoots IG, Barentsz JO, Bittencourt LK et al (2021) PI-RADS Committee Position on MRI without contrast medium in biopsy-naive men with suspected prostate cancer: narrative review. AJR Am J Roentgenol 216:3–19. https://doi.org/10.2214/AJR.20.24268

    Article  PubMed  Google Scholar 

  19. Eldred-Evans D, Burak P, Connor MJ et al (2021) Population-based prostate cancer screening with magnetic resonance imaging or ultrasonography: the IP1-PROSTAGRAM Study. JAMA Oncol 7:395. https://doi.org/10.1001/jamaoncol.2020.7456

    Article  PubMed  PubMed Central  Google Scholar 

  20. Marsden T, Lomas DJ, McCartan N et al (2021) ReIMAGINE Prostate Cancer Screening Study: protocol for a single-centre feasibility study inviting men for prostate cancer screening using MRI. BMJ Open 11:e048144. https://doi.org/10.1136/bmjopen-2020-048144

    Article  PubMed  PubMed Central  Google Scholar 

  21. American College of Radiology. Prostate Imaging – Reporting and Data System version 2.1. Published (2019). https://www.acr.org/-/media/ACR/Files/RADS/PI-RADS/PIRADS-V2-1.pdf. Accessed May 2023

  22. Boesen L, Nørgaard N, Løgager V et al (2018) Assessment of the diagnostic accuracy of biparametric magnetic resonance imaging for prostate cancer in biopsy-naive men: the Biparametric MRI for Detection of Prostate Cancer (BIDOC) Study. JAMA Netw Open 1:e180219. https://doi.org/10.1001/jamanetworkopen.2018.0219

    Article  PubMed  PubMed Central  Google Scholar 

  23. Del Monte M, Cipollari S, Del Giudice F et al (2022) MRI-directed biopsy for primary detection of prostate cancer in a population of 223 men: MRI IN-BORE vs MRI-transrectal ultrasound fusion-targeted techniques. Br J Radiol 95:20210528. https://doi.org/10.1259/bjr.20210528

    Article  PubMed  Google Scholar 

  24. Mottet N, Cornford P, van den Bergh RCN et al (2022) EAU Guidelines. Edn. presented at the EAU Annual Congress Amsterdam. ISBN 978–94–92671–16–5

  25. Panebianco V, Valerio MC, Giuliani A et al (2018) Clinical utility of multiparametric magnetic resonance imaging as the first-line tool for men with high clinical suspicion of prostate cancer. Eur Urol Oncol 1:208–214. https://doi.org/10.1016/j.euo.2018.03.008

    Article  PubMed  Google Scholar 

  26. Faria R, Soares MO, Spackman E et al (2018) Optimising the diagnosis of prostate cancer in the era of multiparametric magnetic resonance imaging: a cost-effectiveness analysis based on the Prostate MR Imaging Study (PROMIS). Eur Urol 73:23–30. https://doi.org/10.1016/j.eururo.2017.08.018

    Article  PubMed  PubMed Central  Google Scholar 

  27. Hugosson J, Carlsson S, Aus G et al (2010) Mortality results from the Göteborg randomised population-based prostate-cancer screening trial. Lancet Oncol 11:725–732. https://doi.org/10.1016/S1470-2045(10)70146-7

    Article  PubMed  PubMed Central  Google Scholar 

  28. Cipollari S, Pecoraro M, Forookhi A et al (2022) Biparametric prostate MRI: impact of a deep learning-based software and of quantitative ADC values on the inter-reader agreement of experienced and inexperienced readers. Radiol Med 127:1245–1253. https://doi.org/10.1007/s11547-022-01555-9

    Article  PubMed  PubMed Central  Google Scholar 

  29. Messina E, Pecoraro M, Laschena L et al (2023) Low cancer yield in PI-RADS 3 upgraded to 4 by dynamic contrast-enhanced MRI: is it time to reconsider scoring categorization? Eur Radiol 33(8):5828–5839. https://doi.org/10.1007/s00330-023-09605-0

    Article  CAS  PubMed  PubMed Central  Google Scholar 

  30. Zeng J, Cheng Q, Zhang D et al (2021) Diagnostic ability of dynamic contrast-enhanced magnetic resonance imaging for prostate cancer and clinically significant prostate cancer in equivocal lesions: a systematic review and meta-analysis. Front Oncol 11:620628. https://doi.org/10.3389/fonc.2021.620628

    Article  PubMed  PubMed Central  Google Scholar 

  31. Picchio M, Mapelli P, Panebianco V et al (2015) Imaging biomarkers in prostate cancer: role of PET/CT and MRI. Eur J Nucl Med Mol Imaging 42:644–655. https://doi.org/10.1007/s00259-014-2982-5

    Article  CAS  PubMed  Google Scholar 

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Funding

The authors state that this work has not received any funding.

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Authors and Affiliations

  1. Department of Radiological Sciences, Oncology and Pathology, Sapienza University/Policlinico Umberto I, Viale del Policlinico 155, 00185, Rome, Italy

    Emanuele Messina, Martina Pecoraro, Martina Lucia Pisciotti, Carlo Catalano & Valeria Panebianco

  2. Department of Public Health and Infectious Diseases, Sapienza University/Policlinico Umberto I, Viale del Policlinico 155, 00185, Rome, Italy

    Giuseppe La Torre

  3. Department of Maternal-Infant and Urological Sciences, Sapienza University/Policlinico Umberto I, Viale del Policlinico 155, 00185, Rome, Italy

    Alessandro Sciarra

  4. Department of Clinical Research and Clinical Competence, DG AOU Policlinico Umberto I, Viale del Policlinico 155, 00161, Rome, Italy

    Roberto Poscia

Authors
  1. Emanuele Messina
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  2. Giuseppe La Torre
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  3. Martina Pecoraro
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  4. Martina Lucia Pisciotti
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  5. Alessandro Sciarra
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  6. Roberto Poscia
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  7. Carlo Catalano
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  8. Valeria Panebianco
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Corresponding author

Correspondence to Valeria Panebianco.

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Guarantor

The scientific guarantor of this publication is Valeria Panebianco.

Conflict of interest

Valeria Panebianco is a member of the European Radiology Scientific Editorial Board but has not taken part in the review or selection process of this article.

The remaining authors of this manuscript declare no relationships with any companies, whose products or services may be related to the subject matter of the article.

Statistics and biometry

No complex statistical methods were necessary for this paper.

Informed consent

Written informed consent was obtained from all subjects (patients) in this study.

Ethical approval

Institutional Review Board approval was obtained (approval 09/09/2020, Ref. 5996).

Study subjects or cohorts overlap

N.A.

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Messina, E., La Torre, G., Pecoraro, M. et al. Design of a magnetic resonance imaging-based screening program for early diagnosis of prostate cancer: preliminary results of a randomized controlled trial—Prostate Cancer Secondary Screening in Sapienza (PROSA). Eur Radiol 34, 204–213 (2024). https://doi.org/10.1007/s00330-023-10019-1

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