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Radical Prostatectomy Without Prior Biopsy

RecruitingNAAges 18 Years - anyMaleBotkin Hospital
NCT07819760 on ClinicalTrials.gov ↗
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In plain words

What the trial is, and whether it could suit you

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 intra

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📋 Eligibility rules (as published)
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.
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What it tests

  • 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
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Where

1 site
S.P. Botkin Moscow Multidisciplinary Scientific and Clinical Center
Moscow, Russia
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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