Added value of systematic biopsy in men with a clinical suspicion of prostate cancer undergoing biparametric MRI-targeted biopsy: multi-institutional external validation study

doi:10.1007/s00345-020-03393-8

Multicenter Study

. 2021 Jun;39(6):1879-1887.

doi: 10.1007/s00345-020-03393-8. Epub 2020 Aug 10.

Added value of systematic biopsy in men with a clinical suspicion of prostate cancer undergoing biparametric MRI-targeted biopsy: multi-institutional external validation study

Ugo Falagario^{1

2}, Ivan Jambor^{3

4

5}, Pekka Taimen⁶, Kari T Syvänen⁷, Esa Kähkönen⁷, Harri Merisaari^{3

8}, Ileana Montoya Perez^{3

8}, Juha Knaapila⁷, Aida Steiner^{3

5}, Janne Verho^{3

5}, Ashutosh Tewari⁹, Hannu J Aronen^{3

5}, Giuseppe Carrieri¹⁰, Peter J Boström⁷, Otto Ettala⁷

Affiliations

¹ Department of Urology and Organ Transplantation, University of Foggia, Foggia, Italy. ugofalagario@gmail.com.
² Department of Urology, Icahn School of Medicine At Mount Sinai, New York, NY, USA. ugofalagario@gmail.com.
³ Department of Radiology, University of Turku, Turku, Finland.
⁴ Department of Radiology, Icahn School of Medicine At Mount Sinai, New York, NY, USA.
⁵ Medical Imaging Centre of Southwest Finland, Turku University Hospital, Turku, Finland.
⁶ Institute of Biomedicine, University of Turku and Department of Pathology, Turku University Hospital, Turku, Finland.
⁷ Department of Urology, University of Turku and Turku University Hospital, Turku, Finland.
⁸ Department of Future Technologies, University of Turku, Turku, Finland.
⁹ Department of Urology, Icahn School of Medicine At Mount Sinai, New York, NY, USA.
¹⁰ Department of Urology and Organ Transplantation, University of Foggia, Foggia, Italy.

PMID: 32778912
PMCID: PMC8217016
DOI: 10.1007/s00345-020-03393-8

Free PMC article

Multicenter Study

Added value of systematic biopsy in men with a clinical suspicion of prostate cancer undergoing biparametric MRI-targeted biopsy: multi-institutional external validation study

Ugo Falagario et al. World J Urol. 2021 Jun.

Free PMC article

. 2021 Jun;39(6):1879-1887.

doi: 10.1007/s00345-020-03393-8. Epub 2020 Aug 10.

Authors

Affiliations

¹ Department of Urology and Organ Transplantation, University of Foggia, Foggia, Italy. ugofalagario@gmail.com.
² Department of Urology, Icahn School of Medicine At Mount Sinai, New York, NY, USA. ugofalagario@gmail.com.
³ Department of Radiology, University of Turku, Turku, Finland.
⁴ Department of Radiology, Icahn School of Medicine At Mount Sinai, New York, NY, USA.
⁵ Medical Imaging Centre of Southwest Finland, Turku University Hospital, Turku, Finland.
⁶ Institute of Biomedicine, University of Turku and Department of Pathology, Turku University Hospital, Turku, Finland.
⁷ Department of Urology, University of Turku and Turku University Hospital, Turku, Finland.
⁸ Department of Future Technologies, University of Turku, Turku, Finland.
⁹ Department of Urology, Icahn School of Medicine At Mount Sinai, New York, NY, USA.
¹⁰ Department of Urology and Organ Transplantation, University of Foggia, Foggia, Italy.

PMID: 32778912
PMCID: PMC8217016
DOI: 10.1007/s00345-020-03393-8

Abstract

Purpose: We aimed to develop and externally validate a nomogram based on MRI volumetric parameters and clinical information for deciding when SBx should be performed in addition to TBx in man with suspicious prostate MRI.

Materials and methods: Retrospective analyses of single (IMPROD, NCT01864135) and multi-institution (MULTI-IMPROD, NCT02241122) clinical trials. All men underwent a unique rapid biparametric magnetic resonance imaging (IMPROD bpMRI) consisting of T2-weighted imaging and three separate DWI acquisitions. Men with IMPROD bpMRI Likert scores of 3-5 were included. Logistic regression models were developed using IMPROD trial (n = 122) and validated using MULTI-IMPROD trial (n = 262) data. The model's performance was evaluated in the terms of PCa detection with Gleason Grade Group 1 (clinically insignificant prostate cancer, iPCa) and > 1 (clinically significant prostate cancer, csPCa). Net benefits and decision curve analyses (DCA) were compared. Combined biopsies were used for reference.

Results: The developed nomogram included age, PSA, prostate volume, MRI suspicion score (IMPROD bpMRI Likert or PIRADsv2.1 score), MRI-suspicion lesion volume percentage, and lesion location. All these variables were significant predictors of csPCa in SBx in multivariable analysis. In the validation cohort (n = 262) using different nomogram cutoffs, 19-43% of men would have avoided SBx while missing 1-4% of csPCa and avoiding detection of 9-20% of iPCa. Similar performance was found for nomograms using IMPROD bpMRI Likert score or v2.1.

Conclusions: The developed nomogram demonstrated potential to select men with a clinical suspicion of PCa who would benefit from performing SBx in addition to TBx. Public access to the nomogram is provided at: https://petiv.utu.fi/multiimprod/ .

Keywords: Biparametric MRI; MRI; PSA; Prostate cancer; Systematic biopsy; Targeted biopsy.

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Conflict of interest statement

The authors declare that they have no conflict of interest.

Figures

**Fig. 1**
Actual Probability of Prostate cancer diagnosis in systematic and targeted biopsy cores as a function of MRI-suspicion lesion volume percentage

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References

1. Perez IM, Jambor I, Kauko T, et al. Qualitative and quantitative reporting of a unique biparametric MRI: towards biparametric MRI-based nomograms for prediction of prostate biopsy outcome in men with a clinical suspicion of prostate cancer (IMPROD and MULTI-IMPROD Trials) J Magn Reson Imaging. 2020;51:1556–1567. doi: 10.1002/jmri.26975. - DOI - PubMed
1. Jambor I, Bostrom PJ, Taimen P, et al. Novel biparametric MRI and targeted biopsy improves risk stratification in men with a clinical suspicion of prostate cancer (IMPROD Trial) J Magn Reson Imaging. 2017;46:1089–1095. doi: 10.1002/jmri.25641. - DOI - PubMed
1. Ahmed HU, El-Shater Bosaily A, Brown LC, et al. Diagnostic accuracy of multi-parametric MRI and TRUS biopsy in prostate cancer (PROMIS): a paired validating confirmatory study. Lancet. 2017;25(389):815–822. doi: 10.1016/S0140-6736(16)32401-1. - DOI - PubMed
1. Kasivisvanathan V, Rannikko AS, Borghi M, et al. MRI-targeted or standard biopsy for prostate-cancer diagnosis. N Engl J Med. 2018;10(378):1767–1777. doi: 10.1056/NEJMoa1801993. - DOI - PubMed
1. Rouvière O, Puech P, Renard-Penna R, et al. 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. 2019;20:100–109. doi: 10.1016/S1470-2045(18)30569-2. - DOI - PubMed

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[1] Perez IM, Jambor I, Kauko T, et al. Qualitative and quantitative reporting of a unique biparametric MRI: towards biparametric MRI-based nomograms for prediction of prostate biopsy outcome in men with a clinical suspicion of prostate cancer (IMPROD and MULTI-IMPROD Trials) J Magn Reson Imaging. 2020;51:1556–1567. doi: 10.1002/jmri.26975. - DOI - PubMed

[2] Perez IM, Jambor I, Kauko T, et al. Qualitative and quantitative reporting of a unique biparametric MRI: towards biparametric MRI-based nomograms for prediction of prostate biopsy outcome in men with a clinical suspicion of prostate cancer (IMPROD and MULTI-IMPROD Trials) J Magn Reson Imaging. 2020;51:1556–1567. doi: 10.1002/jmri.26975. - DOI - PubMed

[3] Jambor I, Bostrom PJ, Taimen P, et al. Novel biparametric MRI and targeted biopsy improves risk stratification in men with a clinical suspicion of prostate cancer (IMPROD Trial) J Magn Reson Imaging. 2017;46:1089–1095. doi: 10.1002/jmri.25641. - DOI - PubMed

[4] Jambor I, Bostrom PJ, Taimen P, et al. Novel biparametric MRI and targeted biopsy improves risk stratification in men with a clinical suspicion of prostate cancer (IMPROD Trial) J Magn Reson Imaging. 2017;46:1089–1095. doi: 10.1002/jmri.25641. - DOI - PubMed

[5] Ahmed HU, El-Shater Bosaily A, Brown LC, et al. Diagnostic accuracy of multi-parametric MRI and TRUS biopsy in prostate cancer (PROMIS): a paired validating confirmatory study. Lancet. 2017;25(389):815–822. doi: 10.1016/S0140-6736(16)32401-1. - DOI - PubMed

[6] Ahmed HU, El-Shater Bosaily A, Brown LC, et al. Diagnostic accuracy of multi-parametric MRI and TRUS biopsy in prostate cancer (PROMIS): a paired validating confirmatory study. Lancet. 2017;25(389):815–822. doi: 10.1016/S0140-6736(16)32401-1. - DOI - PubMed

[7] Kasivisvanathan V, Rannikko AS, Borghi M, et al. MRI-targeted or standard biopsy for prostate-cancer diagnosis. N Engl J Med. 2018;10(378):1767–1777. doi: 10.1056/NEJMoa1801993. - DOI - PubMed

[8] Kasivisvanathan V, Rannikko AS, Borghi M, et al. MRI-targeted or standard biopsy for prostate-cancer diagnosis. N Engl J Med. 2018;10(378):1767–1777. doi: 10.1056/NEJMoa1801993. - DOI - PubMed

[9] Rouvière O, Puech P, Renard-Penna R, et al. 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. 2019;20:100–109. doi: 10.1016/S1470-2045(18)30569-2. - DOI - PubMed

[10] Rouvière O, Puech P, Renard-Penna R, et al. 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. 2019;20:100–109. doi: 10.1016/S1470-2045(18)30569-2. - DOI - PubMed

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Added value of systematic biopsy in men with a clinical suspicion of prostate cancer undergoing biparametric MRI-targeted biopsy: multi-institutional external validation study

Affiliations

Added value of systematic biopsy in men with a clinical suspicion of prostate cancer undergoing biparametric MRI-targeted biopsy: multi-institutional external validation study

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Abstract

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