Clinical trial · Interventional
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
- Retrieved
- Sep 16, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260916-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Prostate Cancer | Malignant Prostate Neoplasm | CURATED_EXACT | 0.92 |
Interventions
Interventions (4)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| 68Ga-PSMA PET/CT | Diagnostic Test | — | UNRESOLVED |
| Robot-Assisted Radical Prostatectomy With Pelvic Lymph Node Dissection | Procedure | — | UNRESOLVED |
| Standard Transperineal Fusion Prostate Biopsy | Procedure | — | UNRESOLVED |
| Transperineal Fusion-Targeted Prostate Biopsy With Intraoperative Frozen Section Examination | Diagnostic Test | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Frozen Section-Guided One-Stage Strategy
- description
- All prospectively enrolled participants undergo transperineal fusion-targeted prostate biopsy under general anesthesia with intraoperative frozen section examination. If acinar adenocarcinoma is confirmed, robot-assisted radical prostatectomy with pelvic lymph node dissection without nerve-sparing is performed during the same anesthetic session. If the frozen section result is negative, equivocal, or non-informative, radical prostatectomy is not performed and the biopsy is extended to a standard transperineal fusion biopsy protocol.
- interventionNames
- Diagnostic Test: Transperineal Fusion-Targeted Prostate Biopsy With Intraoperative Frozen Section Examination
- Procedure: Robot-Assisted Radical Prostatectomy With Pelvic Lymph Node Dissection
- Procedure: Standard Transperineal Fusion Prostate Biopsy
- Diagnostic Test: 68Ga-PSMA PET/CT
Primary outcomes (1)
- measure
- Diagnostic Concordance of Intraoperative Frozen Section With Final Histopathology
- timeFrame
- Up to 10 days after the index procedure
- description
Eligibility
Eligibility (as posted)
- Sex
- Male
- Minimum age
- 18 Years
Show eligibility criteria text
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 PI-RADS 4 or PI-RADS 5 lesion. 4. 68Ga-PSMA PET/CT demonstrating a prostate lesion with 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.
References
Publications (4)
- BACKGROUNDZhu LY, Fang M, Luan Y, Huang TB, Lu SM, Xiao Q, Chen J, Tan X, Ding XF. Utilizing intraoperative frozen section examination (IFSE) for diagnosis and treatment in a high-clinical-suspicion prostate cancer (PCa) cohort based on 18F-PSMA PET/CT and MRI: a pilot study. Transl Androl Urol. 2026 May 30;15(5):159. doi: 10.21037/tau-2026-1-0032. Epub 2026 May 26. PMID 42293831
- BACKGROUNDJiao J, Kang F, Zhang J, Quan Z, Wen W, Zhao X, Ma S, Wu P, Yang F, Guo W, Yang X, Yuan J, Shi Y, Wang J, Qin W. Establishment and prospective validation of an SUVmax cutoff value to discriminate clinically significant prostate cancer from benign prostate diseases in patients with suspected prostate cancer by 68Ga-PSMA PET/CT: a real-world study. Theranostics. 2021 Jul 25;11(17):8396-8411. doi: 10.7150/thno.58140. eCollection 2021. PMID 34373749
- BACKGROUNDChaloupka M, Apfelbeck M, Pyrgidis N, Marcon J, Weinhold P, Stief CG. Radical Prostatectomy without Prior Biopsy in Patients with High Suspicion of Prostate Cancer Based on Multiparametric Magnetic Resonance Imaging and Prostate-Specific Membrane Antigen Positron Emission Tomography: A Prospective Cohort Study. Cancers (Basel). 2023 Feb 16;15(4):1266. doi: 10.3390/cancers15041266. PMID 36831608
- BACKGROUNDMeissner VH, Rauscher I, Schwamborn K, Neumann J, Miller G, Weber W, Gschwend JE, Eiber M, Heck MM. Radical Prostatectomy Without Prior Biopsy Following Multiparametric Magnetic Resonance Imaging and Prostate-specific Membrane Antigen Positron Emission Tomography. Eur Urol. 2022 Aug;82(2):156-160. doi: 10.1016/j.eururo.2021.11.019. Epub 2021 Dec 6. PMID 34887117