Radical Prostatectomy Without Prior Biopsy in Selected Patients Evaluated by ¹⁸ F-Labeled Prostate-Specific Membrane Antigen–Ligand Positron Emission Tomography/Computed Tomography and Multiparameter Magnetic Resonance Imaging: A Single-Center, Prospective, Single-Arm Trial

Abstract

Purpose:This study aimed to verify the feasibility and short-term prognosis of prostatectomy without biopsy.Materials and Methods:Patients with a rising PSA level ranging from 4 to 30 ng/mL were scheduled for multiparametric (mp) MRI and 18F-labeled prostate-specific membrane antigen (PSMA) positron emission tomography (PET). Forty-seven patients (cT2N0M0) with Prostate Imaging Reporting and Data System ≥ 4 and molecular imaging PSMA score ≥ 2 were enrolled. All candidates underwent robot-assisted laparoscopic radical prostatectomy without biopsy. Prostate cancer detection rate, index tumors localization correspondence rate, positive surgical margin, complications, postoperative hospital stay, and PSA level in a 6-week postoperative follow-up visit were collected.Results:All the patients with positive mpMRI and PSMA PET were diagnosed with clinically significant prostate cancer. A total of 80 lesions were verified as cancer by pathology, of which 63 cancer lesions were clinically significant prostate cancer. Fifty-one lesions were simultaneously found by mpMRI and PSMA PET. A total of 23 lesions were invisible on either image, and all lesions were ≤ International Society of Urological Pathology 2 or ≤ 15 mm. Forty-five (95.7%) index tumors found by mpMRI combined with PSMA PET were consistent with pathology. Nine patients reported positive surgical margin.Conclusions:Biopsy-free prostatectomy is safe and feasible for patients with evaluation strictly by mpMRI combined with 18F-PSMA PET/CT.

Editorial Comment

“…We congratulate the authors on this very interesting study investigating radical prostatectomy (RP) without biopsy in patients suspected of prostate cancer (PCa) based on MRI and prostate-specific membrane antigen (PSMA) positron emission tomography (PET). 1 The authors report 100% clinically significant PCa diagnosis in this cohort of 47 patients with Prostate Imaging Reporting and Data System (PI-RADS) ! 4 and molecular imaging PSMA score !…”