NCT07819760Recruiting
Radical Prostatectomy Without Prior Biopsy
Radical Prostatectomy Without Prior Prostate Biopsy Following Intraoperative Frozen Section Verification in Patients With a High Probability of Clinically Significant Prostate Cancer: A Pilot Comparative Study
Source: ClinicalTrials.gov · Last updated 20 Oct 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Recruiting
- Study type
- Interventional
- Enrollment
- 10 (estimated)
- First submitted
- 9 Sept 2026
- Start date
- 15 Oct 2026
- Primary completion date
- Dec 2028
- Lead sponsor
- Botkin Hospital
- Diseases
- Prostate cancer
- NCT number
- NCT07819760
What you commit to
- Study type: Interventional
- Planned participants: 10
- From 15 Oct 2026 to the primary completion date, Dec 2028
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Previous prostate biopsy with histopathological confirmation of prostate cancer.
- 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.
Other illness
- Evidence of distant metastatic disease on MRI and/or 68Ga-PSMA PET/CT.
Other
- Contraindications to mandatory diagnostic procedures required by the study protocol.
- Refusal to participate in the study or to provide written informed consent.
Who the study is looking for
- 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 Prostate Imaging Reporting and Data System (PI-RADS) category 4 or 5 lesion.
- 68Ga-PSMA PET/CT demonstrating a prostate lesion with a maximum standardized uptake value (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.
Age in the registry: 18 years to - · Sex: Male · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| S.P. Botkin Moscow Multidisciplinary Scientific and Clinical Center Coordinator of this site? Confirm its status | Moscow | Russia | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.