Radical Prostatectomy Without Prior Biopsy

NCT07819760 | Not Yet Recruiting

• 1 other identifier: RARP-NPB-2026-01
• Study Type: interventional
• Target: 10
• Locations: 1 country
• Sites: 1

Brief Summary

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

Prostate Cancer

Keywords

Clinically Significant Prostate Cancer; Radical Prostatectomy; Frozen Section; Transperineal Fusion Biopsy; PSMA PET/CT; Prostate Biopsy; Radical Prostatectomy Without Prior Biopsy; Robot-Assisted Radical Prostatectomy

Outcome Measures

Primary Outcomes (1)

• Diagnostic Concordance of Intraoperative Frozen Section With Final Histopathology

  The intraoperative frozen section diagnosis for the presence or absence of acinar adenocarcinoma will be compared with the final histopathological diagnosis. For participants undergoing radical prostatectomy, the reference standard will be the final histopathological examination of the radical prostatectomy specimen. For participants who do not undergo radical prostatectomy, the reference standard will be the final histopathological examination of the completed standard transperineal fusion biopsy. The outcome will be reported as the number and percentage of participants with concordant frozen section and final histopathological results.

  Up to 10 days after the index procedure

Secondary Outcomes (10)

• Operative Duration

  During the index procedure

• Estimated Intraoperative Blood Loss

  During the index procedure

• Duration of Urinary Catheterization

  Up to 30 days after the index procedure

• Length of Hospital Stay

  Up to 30 days after the index procedure

• Postoperative Complications

  Up to 30 days after the index procedure

Study Arms (1)

Frozen Section-Guided One-Stage Strategy

EXPERIMENTAL

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.

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

Interventions

Transperineal Fusion-Targeted Prostate Biopsy With Intraoperative Frozen Section Examination DIAGNOSTIC_TEST

Under general anesthesia, transperineal fusion-targeted biopsy specimens are obtained from the suspicious prostate lesion and immediately examined using frozen section histology. The intraoperative pathological result is used to determine subsequent management during the same anesthetic session. If acinar adenocarcinoma is confirmed, the patient proceeds to robot-assisted radical prostatectomy with pelvic lymph node dissection. If the result is negative, equivocal, or non-informative, radical prostatectomy is not performed and the biopsy is extended to a standard transperineal fusion biopsy protocol.

Frozen Section-Guided One-Stage Strategy

Robot-Assisted Radical Prostatectomy With Pelvic Lymph Node Dissection PROCEDURE

Robot-assisted radical prostatectomy with pelvic lymph node dissection without nerve-sparing is performed during the same anesthetic session only in patients with intraoperative frozen section confirmation of acinar adenocarcinoma of the prostate. The procedure is not performed if the frozen section result is negative, equivocal, or non-informative.

Frozen Section-Guided One-Stage Strategy

Standard Transperineal Fusion Prostate Biopsy PROCEDURE

In patients with a negative, equivocal, or non-informative intraoperative frozen section result, radical prostatectomy is not performed. During the same anesthetic session, the transperineal fusion biopsy is extended to a standard biopsy protocol with targeted and systematic sampling. Further diagnostic and treatment decisions are based on the final histopathological examination of the biopsy specimens.

Frozen Section-Guided One-Stage Strategy

68Ga-PSMA PET/CT DIAGNOSTIC_TEST

68Ga-PSMA PET/CT is performed during preoperative patient selection to assess PSMA uptake in the suspicious prostate lesion and to exclude distant metastatic disease. Eligibility requires a prostate lesion with SUVmax ≥5.3 and no evidence of distant metastases. In participants who undergo radical prostatectomy, 68Ga-PSMA PET/CT is repeated at 6 and 12 months after surgery as part of protocol-defined oncological follow-up.

Frozen Section-Guided One-Stage Strategy

Eligibility Criteria

• Age: 18 Years+
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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 PI-RADS 4 or PI-RADS 5 lesion.
• Ga-PSMA PET/CT demonstrating a prostate lesion with 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.

You may not qualify if:

• Previous prostate biopsy with histopathological confirmation of prostate cancer.
• Evidence of distant metastatic disease on MRI and/or 68Ga-PSMA PET/CT.
• 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.
• Contraindications to mandatory diagnostic procedures required by the study protocol.
• Refusal to participate in the study or to provide written informed consent.

Sponsors & Collaborators

• Botkin Hospital: lead

Study Sites (1)

S.P. Botkin Moscow Multidisciplinary Scientific and Clinical Center

Moscow, Moscow, 125284, Russia

Location

Related Publications (4)

• Zhu 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 BACKGROUND

• Jiao 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 BACKGROUND

• Chaloupka 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 BACKGROUND

• Meissner 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 BACKGROUND

MeSH Terms

Conditions

Prostatic Neoplasms

Condition Hierarchy (Ancestors)

Genital Neoplasms, Male; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Prostatic Diseases; Male Urogenital Diseases

Study Officials

• Alexander V Govorov, MD, DSc

  S. P. Botkin Moscow Multidisciplinary Scientific and Clinical Center

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Filipp A Medvedev, MD

CONTACT

+79162002599; filippmdvdv@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Senior Researcher

Model Details: All prospectively enrolled participants undergo the same initial study strategy consisting of transperineal fusion-targeted prostate biopsy with intraoperative frozen section examination. Subsequent management within the same anesthetic session is determined by the frozen section result. Patients with confirmed acinar adenocarcinoma undergo robot-assisted radical prostatectomy with pelvic lymph node dissection, whereas patients with a negative, equivocal, or non-informative frozen section result undergo completion of a standard transperineal fusion biopsy without radical prostatectomy.

Study Record Dates

• First Submitted: September 9, 2026
• First Posted: September 15, 2026
• Study Start (Estimated): November 1, 2026
• Primary Completion (Estimated): December 1, 2028
• Study Completion (Estimated): December 1, 2029
• Last Updated: September 15, 2026

Record last verified: 2026-09

Data Sharing

• IPD Sharing: Will not share

Locations

RU (1)