Radical prostatectomy without prostate biopsy based on a noninvasive diagnostic strategy: a prospective single-center study.

[BACKGROUND] Prostate biopsy is the most common approach for diagnosing prostate cancer (PCa); however, it has inherent limitations, such as the invasive procedure, postoperative complications, and false negative results. We aimed to provide a noninvasive diagnostic strategy for patients with highly suspected PCa and to evaluate the feasibility of performing biopsy-spared radical prostatectomy.

[METHODS] This prospective study included a total of 57 patients between November 10, 2022, and December 1, 2023. All 57 patients underwent radical prostatectomy without prior prostate biopsy based on a noninvasive diagnostic strategy consisting of a diagnostic prediction model [comprised of the prostate imaging-reporting and data system (PI-RADS) score and prostate-specific antigen density (PSAD)] and the F-prostate-specific membrane antigen (PSMA)-1007 positron emission tomography (PET)/computed tomography (CT) examination. The primary endpoint was the positive predictive value (PPV) of clinically significant PCa [the International Society of Urological Pathology (ISUP) grade ≥2, Gleason score ≥3 + 4]. The secondary endpoints were a PPV of any-grade PCa (ISUP grade ≥ 1, Gleason score ≥3 + 3) and high-grade PCa (ISUP grade ≥3, Gleason score ≥4 + 3), and the false positive rate of the diagnostic strategy.

[RESULTS] Of the 371 screened patients with clinically suspected PCa, 57 patients fulfilled the criteria and consented to participate in this study. The median PSAD level was 0.56 (0.42-0.82) ng/mL; 13 (22.8%) patients were identified as having a PI-RADS score of 4, and 44 (77.2%) patients with a PI-RADS score of 5. The median SUVmax of F-PSMA-1007 PET/CT was 21.6 (15.8-33.0). For the 57 enrolled patients who received radical prostatectomy directly, the PPV of clinically significant PCa was 98.2% [56/57, 95% confidence interval (CI): 90.6-100%]. Only 1.8% (1/57, 95% CI: 0.0-9.4%) of patients were diagnosed with clinically insignificant PCa (ISUP grade = 1, Gleason score = 3 + 3). The PPV of any-grade PCa and high-grade PCa were 100% and 73.7% (42/57, 95% CI: 60.3-84.5%), respectively. No one had a false positive result.

[CONCLUSIONS] We proposed a noninvasive diagnostic strategy consisting sequentially of a diagnostic prediction model and the F-PSMA-1007 PET/CT examination for diagnosing PCa. Despite some limitations, our initial findings suggest the potential feasibility of radical prostatectomy without prior prostate biopsy.