Radical Prostatectomy Without Prior Biopsy in Men with High-Risk Prostate Cancer

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

In men with a high likelihood of clinically significant prostate cancer, the study uses transperineal fusion-targeted biopsy under general anesthesia with immediate frozen section analysis. If the frozen section confirms acinar adenocarcinoma, robot-assisted radical prostatectomy with pelvic lymph node dissection is performed in the same session; if not, the procedure is adjusted to a standard biopsy protocol without immediate surgery. The prospective cohort of 10 patients is evaluated for diagnostic performance of the intraoperative frozen section, safety, and early oncologic outcomes, with a retrospective comparison group. Preoperative assessments include PSA, multiparametric MRI, and PSMA PET/CT to select eligible patients. The study aims to determine whether the integrated approach can streamline decision-making and treatment in selected high-risk individuals.

Why it matters

Who can join: the full rules

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 Prostate Imaging Reporting and Data System (PI-RADS) category 4 or 5 lesion.
4. 68Ga-PSMA PET/CT demonstrating a prostate lesion with a maximum standardized uptake value (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.

Where it's running

• S.P. Botkin Moscow Multidisciplinary Scientific and Clinical Center
  Moscow, Moscow, Russia Recruiting

Study contacts

• Principal investigator: Alexander V Govorov, MD, DSc — S. P. Botkin Moscow Multidisciplinary Scientific and Clinical Center
• Study coordinator: Filipp A Medvedev, MD
• Email: filippmdvdv@gmail.com
• Phone: +79162002599

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.