Radical Prostatectomy Without Prior Biopsy

The study is designed as a pilot comparative clinical study including a prospective cohort and a retrospective comparison cohort. The prospective cohort will include 10 patients with a high probability of clinically significant prostate cancer based on clinical, laboratory, and imaging findings.

All prospective participants will undergo transperineal fusion-targeted prostate biopsy under general anesthesia. Targeted tissue samples obtained from the suspicious prostate lesion will be examined intraoperatively using frozen section histology. The result of the urgent morphological examination will determine the subsequent surgical strategy within the same anesthetic session.

If acinar adenocarcinoma is confirmed by frozen section examination, the patient will undergo robot-assisted radical prostatectomy with pelvic lymph node dissection without nerve-sparing. If malignancy is not confirmed, or if the frozen section result is equivocal or non-informative, radical prostatectomy will not be performed. Instead, the biopsy procedure will be extended to a standard transperineal fusion biopsy protocol, and further diagnostic and therapeutic management will be based on the final histopathological examination of the biopsy specimens.

Preoperative evaluation of prospective participants will include clinical assessment, serum prostate-specific antigen measurement, multiparametric magnetic resonance imaging of the prostate, and 68Ga-PSMA PET/CT. PSMA PET/CT will be used as an additional selection and staging tool and will not serve as an independent indication for radical prostatectomy. The decision to proceed with radical prostatectomy will be based only on intraoperative morphological confirmation of acinar adenocarcinoma.

The diagnostic performance of intraoperative frozen section examination will be assessed by comparison with final histopathology of the radical prostatectomy specimen in patients who undergo surgery, or with final histopathology of the standard transperineal fusion biopsy specimens in patients who do not undergo radical prostatectomy.

Perioperative outcomes and safety parameters will include operative duration, estimated blood loss, duration of urinary catheterization, length of hospital stay, and postoperative complications. Early oncological outcomes in patients undergoing radical prostatectomy will include final pathological tumor characteristics, regional lymph node status, positive surgical margin status, postoperative PSA dynamics, and follow-up 68Ga-PSMA PET/CT findings.

For comparative analysis, a retrospective cohort of 50 patients with comparable baseline clinical and diagnostic characteristics will be identified. These patients were previously treated using the conventional staged pathway consisting of preoperative prostate biopsy with histological confirmation of prostate cancer followed by radical prostatectomy. Perioperative outcomes and postoperative complications will be compared between the prospective and retrospective cohorts.

The present study is designed to maintain histological verification of prostate cancer before radical surgical treatment and thereby comply with current clinical and regulatory requirements. At the same time, it is intended to provide a scientific and clinical foundation for future investigation of a truly biopsy-free treatment pathway in carefully selected patients with an extremely high probability of clinically significant prostate cancer. In such a future protocol, the decision to proceed with radical prostatectomy could potentially be based on an integrated assessment of clinical and laboratory parameters together with advanced imaging findings, without any preoperative or intraoperative histological confirmation. The results of the present pilot study may therefore help define patient selection criteria, estimate the safety and feasibility of this concept, and support the design of subsequent prospective studies evaluating radical prostatectomy without prior morphological verification of the diagnosis.

Inclusion criteria

• Serum prostate-specific antigen (PSA) level ≥20 ng/mL.
• Findings suspicious for prostate cancer on digital rectal examination.
• Multiparametric contrast-enhanced prostate MRI demonstrating a PI-RADS 4 or PI-RADS 5 lesion.
• 68Ga-PSMA PET/CT demonstrating a prostate lesion with SUVmax ≥5.3 and no evidence of distant metastatic disease.
• 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

• Previous prostate biopsy with histopathological confirmation of prostate cancer.
• Evidence of distant metastatic disease on MRI and/or 68Ga-PSMA PET/CT.
• Previous surgical or radiation treatment of the prostate that may affect the planned intervention or assessment of study outcomes.
• Severe decompensated comorbidities or other contraindications to the protocol-defined surgical intervention or general anesthesia.
• Contraindications to mandatory diagnostic procedures required by the study protocol.
• Refusal to participate in the study or to provide written informed consent.