Looking for volunteers
Radical Prostatectomy Without Prior Biopsy
NCT07819760 · Botkin Hospital · Updated 20 Oct 2026
- What is being tested
- Transperineal Fusion-Targeted Prostate Biopsy With Intraoperative Frozen Section Examination; Robot-Assisted Radical Prostatectomy With Pelvic Lymph Node Dissection; Standard Transperineal Fusion Prostate Biopsy; 68Ga-PSMA PET/CT
- For
- Prostate Cancer
- Kind of study
- Tests a treatment or device on volunteers. No drug phase (a device or procedure study).
- Who can join
- Ages 18 years and older. About 10 people. The full rules are on the registry page.
- Where
- Russia
- When
- Starts or started 15 Oct 2026, ends Dec 2029. Registered 15 Sept 2026.
- Results
- None posted yet.
In the researchers' words
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.
Sites
- S.P. Botkin Moscow Multidisciplinary Scientific and Clinical CenterMoscow, Moscow, Russia
