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Diagnostic accuracy of multiparametric MRI- and microultrasound-targeted biopsy in biopsy-naïve patients with a PI-RADS 5 lesion: a single-institutional study

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Abstract

Purpose

To evaluate the diagnostic accuracy of multiparametric magnetic resonance imaging (MRI)- and microultrasound (microUS)-guided targeted biopsy (TBx) in detecting prostate cancer (PCa) and clinically significant (cs) PCa among men with Prostate Imaging Reporting and Data System (PI-RADS 5) lesions and to compare this combined TBx (CTBx) strategy with CTBx plus systemic biopsy (SBx).

Methods

One hundred and thirty-six biopsy-naïve patients with PI-RADS 5 lesion at multiparametric MRI undergoing CTBx plus SBx were retrospectively evaluated. Analysis of diagnostic performance of microUS-TBx, MRI-TBx, CTBx, SBx and combined CTBx plus SBx was performed. Cost (downgrade, upgrade and biopsy core) to effectiveness (detection rate) was compared.

Results

CTBx achieved a comparable detection rate to CTBx plus SBx in diagnosis of PCa and csPCa (PCa: 78.7% [107/136] vs 79.4% [108/136]; csPCa: 67.6% [92/136] vs 67.6% [92/136]; p > 0.05) and outperformed SBx (PCa: 58.8% [80/136]; csPCa: 47.8% [65/136]; p < 0.001). Using CTB would have avoided 41.1% (56/136) unnecessary SBx, without missing any csPCa. The rate of any upgrading or csPCa upgrading was significantly higher by SBx than by CTBx [33/65 (50.8%) vs 17/65 (26.1%) and 20/65 (30.8%) vs 4/65 (6.15%), respectively, p < 0.05]. Considering csPCa detection rate, microUS showed high sensitivity and positive predictive value (94.6%, 87.9%, respectively), with lower specificity and negative predictive value (25.0% and 44.4%, respectively). At multivariable logistic regression models, positive microUS was identified as an independent predictor of csPCa (p = 0.024).

Conclusions

A combined microUS/MRI-TBx approach could be the ideal imaging tool for characterizing primary disease in PI-RADS five patients, allowing SBx to be avoided.

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Funding

Giovanni Lughezzani certifies that this research did not receive any specific grant from funding agencies in the public, commercial or not-for-profit sectors.

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Authors and Affiliations

  1. Department of Biomedical Sciences, Humanitas University, Via Rita Levi Montalcini 4, 20090, Pieve Emanuele, Milan, Italy

    Pier Paolo Avolio, Vittorio Fasulo, Davide Maffei, Nicola Frego, Marco Paciotti, Giorgio Guazzoni, Nicolò Maria Buffi & Giovanni Lughezzani

  2. Department of Urology, IRCCS Humanitas Research Hospital, Via Manzoni 56, 20089, Rozzano, Milan, Italy

    Pier Paolo Avolio, Vittorio Fasulo, Davide Maffei, Nicola Frego, Massimo Lazzeri, Marco Paciotti, Alberto Saita, Rodolfo Hurle, Giorgio Guazzoni, Paolo Casale, Nicolò Maria Buffi & Giovanni Lughezzani

  3. Division of Urology, Department of Surgery, McGill University, Montréal, Canada

    Rafael Sanchez-Salas

  4. Via Rita Levi Montalcini, 4, 20090, Rozzano, MI, Italy

    Giovanni Lughezzani

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  1. Pier Paolo Avolio
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Contributions

PPA was involved in protocol/project development, data analysis and manuscript—writing/editing. VF was involved in data collection or management and data analysis. RS-S and NMB were involved in manuscript—writing/editing. DM, NF and MP were involved in data collection or management. ML, AS, RH, GG and PC contributed to protocol/project development. GL contributed to protocol/project development and involved in manuscript—writing/editing.

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Correspondence to Giovanni Lughezzani.

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Conflict of interest

Giovanni Lughezzani certifies that all conflicts of interest, including specific financial interests and relationships and affiliations relevant to the subject matter or materials discussed in the manuscript (e.g., employment/affiliation, grants or funding, consultancies, honoraria, stock ownership or options, expert testimony, royalties or patent filed, received or pending), are the following: nothing to disclose.

Research involving human participants and/or animals

All procedures performed in studies involving human participants were in accordance with the ethical standards of the institutional research committee and with the 1964 Helsinki Declaration and its later amendments or comparable ethical standards. All participants provided informed consent for the clinical trial (ICH 003 v1.0 27/09/2017; study number 2004).

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Avolio, P.P., Fasulo, V., Sanchez-Salas, R. et al. Diagnostic accuracy of multiparametric MRI- and microultrasound-targeted biopsy in biopsy-naïve patients with a PI-RADS 5 lesion: a single-institutional study. World J Urol 41, 2335–2342 (2023). https://doi.org/10.1007/s00345-023-04480-2

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