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Follow-up on patients with initial negative mpMRI target and systematic biopsy for PI-RADS ≥ 3 lesions – an EAU-YAU study enhancing prostate cancer detection

Abstract

Purpose

To investigate the detection and predictors of prostate cancer (PCA) and clinically significant prostate cancer (csPCA) in patients with positive multiparametric MRI (mpMRI) followed by a negative MRI – guided target biopsy (TB) and systematic biopsy (SB).

Materials and methods

This retrospective multicenter study included 694 patients from 10 tertiary referral centers with an initial positive mpMRI (PI-RADS ≥ 3) and negative results on both MRI-TB and SB. Patients were classified into three groups based on follow-up: Group 1 (prostate re-biopsy without new mpMRI), Group 2 (standardized second prostate mpMRI and subsequent re-biopsy), and Group 3 (follow-up with mpMRIs and biopsy based on clinical and radiological triggers). The primary outcomes were the detection of any PCA and csPCA during follow up. Study groups were compared according to their probability of PCA and csPCA assessed with the ERSPC-MRI risk calculator. Statistical analysis included Kaplan – Meier analysis, Cox regression, and multivariable analysis for the detection of (cs)PCa.

Results

The overall detection of PCA and csPCA was 26.8% and 19.3%, respectively, with varying rates in different PI-RADS groups. Group 3 had the highest 2-year and 5-year PCA–free survival (94 and 84%) and csPCA – free survival (96 and 86%). Multivariable analysis revealed a significantly higher risk of PCA and csPCA in Group 1 and 2 compared to Group 3 (p < 0.01). Clinical and radiological predictors for PCA and csPCA included higher age, prostate volume, PI-RADS score, the presence of atypical small acinar proliferation (ASAP), and a smaller number of TB and SB performed during the initial biopsy. Study limitations, include the retrospective design and reliance on clinical and radiological triggers for follow–up decisions.

Conclusions

Patients with positive mpMRI but negative TB and SB results exhibit varying rates of PCA and csPCA depending on the follow up scheme. Tailored follow-up strategies are essential for optimal management in this clinical scenario.

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Fig. 1: Sankey Diagram: Patient Progression from Initial MRI to Final Diagnosis.
Fig. 2: Prostate cancer-free survival in the whole cohort.
Fig. 3: Survival estimates by study groups.
Fig. 4: Survival estimates by PI-RADS score.

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Data availability

The data that support the findings of this study are available for sharing but restrictions apply to the availability of these data, which were used under license for the current study, and so are not publicly available. Data are however available from the authors upon reasonable request and with permission of authors.

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Authors

Contributions

Protocol/project development: F Zattoni, G Gandaglia, G Novara, R C N van den Bergh, A Briganti. Data collection or management: LJ.Paulino Pereira, G Marra, M Valerio, J Olivier, I Puche – SanzI, M Maggi, R Campi, D Amparore, S De Cillis, Z Junlong, H Guo, G La Bombarda, A Fuschi., A Veccia, F Ditonno, A Marquis, F Barletta, R Leni, S Serni, Data analysis: F Zattoni, G Novara, F Dal Moro, Sebastiaan Remmers, Monique J. Roobol. Manuscript writing/editing: F Zattoni, G Novara, R C N van den Bergh, A Antonelli, K Veeru, P Rajwa

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Correspondence to Fabio Zattoni.

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The authors declared that they have no conflict of interests. All included patients undergoing radical treatment provided written informed consent for surgery. All procedures performed in studies involving human participants were in accordance with the ethical standards of the institutional and/or national research committee and with the 1964 Helsinki declaration and its later amendments or comparable ethical standards. Institutional review board apply to each center due to observational and retrospective nature of the study.

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Zattoni, F., Gandaglia, G., van den Bergh, R.C.N. et al. Follow-up on patients with initial negative mpMRI target and systematic biopsy for PI-RADS ≥ 3 lesions – an EAU-YAU study enhancing prostate cancer detection. Prostate Cancer Prostatic Dis 28, 435–443 (2025). https://doi.org/10.1038/s41391-024-00904-1

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