Radical Prostatectomy Without Prior Biopsy

This pilot comparative study will evaluate a one-stage diagnostic and surgical strategy for patients with a high probability of clinically significant prostate cancer who have not undergone a separate preoperative prostate biopsy. In the prospective part of the study, 10 patients will undergo transperineal fusion-targeted prostate biopsy under general anesthesia with immediate frozen section examination of tissue obtained from the suspicious lesion. If acinar adenocarcinoma is confirmed, robot-assisted radical prostatectomy with pelvic lymph node dissection will be performed during the same anesthesia. If cancer is not confirmed, or if the frozen section result is equivocal or non-informative, radical prostatectomy will not be performed and the transperineal fusion biopsy will be extended according to a standard biopsy protocol. The study will assess the diagnostic performance of intraoperative frozen section examination, perioperative safety, and early oncological outcomes. Results from the prospective group will also be compared with a retrospective group of 50 patients previously treated using the conventional staged approach consisting of preoperative prostate biopsy followed by radical prostatectomy after histological confirmation of cancer.

Inclusion Criteria: 1. Serum prostate-specific antigen (PSA) level ≥20 ng/mL. 2. Findings suspicious for prostate cancer on digital rectal examination. 3. Multiparametric contrast-enhanced prostate MRI demonstrating a PI-RADS 4 or PI-RADS 5 lesion. 4. 68Ga-PSMA PET/CT demonstrating a prostate lesion with SUVmax ≥5.3 and no evidence of distant metastatic disease. 5. Written informed consent for participation in the study and for the protocol-defined diagnostic and surgical procedures, with subsequent management determined by the intraoperative frozen section result. Exclusion Criteria: 1. Previous prostate biopsy with histopathological confirmation of prostate cancer. 2. Evidence of distant metastatic disease on MRI and/or 68Ga-PSMA PET/CT. 3. Previous surgical or radiation treatment of the prostate that may affect the planned intervention or assessment of study outcomes. 4. Severe decompensated comorbidities or other contraindications to the protocol-defined surgical intervention or general anesthesia. 5. Contraindications to mandatory diagnostic procedures required by the study protocol. 6. Refusal to participate in the study or to provide written informed consent.