External Validation of the PROMOD Strategy, Combining PI-RADS Score and PSA Density, to Select Patients for Prostatic...

Area of Science:

• Urology
• Radiology
• Oncology

Background:

• Prostate biopsy (PBx) decisions can be optimized by integrating MRI PI-RADS scores with prostate-specific antigen density (PSAd).
• The PROMOD strategy combines PI-RADS and PSAd to refine biopsy decision-making.
• External validation of the PROMOD strategy is crucial for its clinical adoption.

Purpose of the Study:

• To externally validate the PROMOD strategy for optimizing prostate biopsy decisions.
• To evaluate the effectiveness of combining PI-RADS scores with PSAd in guiding PBx.
• To assess the impact of the PROMOD strategy on biopsy rates and detection of clinically significant prostate cancer (csPCa).

Main Methods:

• Retrospective analysis of 972 men undergoing PBx (systematic and MRI-FUSION targeted) between 2013-2022.
• Exclusion of patients with PSA > 20 ng/mL or prior prostate cancer (PCa).
• Evaluation of 10 strategies using Decision Curve Analysis (DCA) to assess net benefit, avoided biopsies, and missed csPCa (ISUP grade ≥2).

Main Results:

• Strategies 8 and 7 (combining PI-RADS with specific PSAd thresholds) demonstrated the highest net benefit in biopsy-naïve men, reducing biopsies by 18-20% while missing 5-8% csPCa.
• Strategy 10 offered a more conservative approach, avoiding 12% of biopsies and missing only 2% of csPCa.
• Similar trends were observed in patients with prior negative biopsies.

Conclusions:

• The PROMOD strategy provides an effective tool for tailored prostate biopsy decisions.
• It facilitates shared decision-making between patients and clinicians based on acceptable risk levels.
• The PROMOD strategy supports informed choices regarding the necessity of PBx.