#0231

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

T. tao¹, C. Wang¹, Y. Ma¹, J. Xiao¹

¹The First Affiliated Hospital of USTC, Department of urology, Hefei, China

Introduction:

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.

Material and 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 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.

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/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.