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.

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 18F-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.

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/mL2; 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 18F-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.

We proposed a noninvasive diagnostic strategy consisting sequentially of a diagnostic prediction model and the 18F-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.