Prostate CancerNCT07819760
Radical Prostatectomy Without Prior Biopsy
A study testing Transperineal Fusion-Targeted Prostate Biopsy With Intraoperative Frozen Section Examination, Robot-Assisted Radical Prostatectomy With Pelvic Lymph Node Dissection and Standard Transperineal Fusion Prostate Biopsy in people with Prostate Cancer, run by Botkin Hospital at 1 site in Russia.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older, men only
- Conditions the study is for
- Prostate Cancer
- What is being tested?
- Transperineal Fusion-Targeted Prostate Biopsy With Intraoperative Frozen Section Examination, Robot-Assisted Radical Prostatectomy With Pelvic Lymph Node Dissection and Standard Transperineal Fusion Prostate Biopsy
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- 1 siteRussia
- Study dates
- 15 Oct 2026to Dec 2029
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Men only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Russia1 site, 1 recruiting
- Recruiting
S.P. Botkin Moscow Multidisciplinary Scientific and Clinical Center
Moscow, Moscow, 125284
Filipp A Medvedev, MD, +79162002599, filippmdvdv@gmail.com
Alexander V Govorov, MD, DSc
About this study
Official title: 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
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.
Read the detailed description
The study is designed as a pilot comparative clinical study including a prospective cohort and a retrospective comparison cohort. The prospective cohort will include 10 patients with a high probability of clinically significant prostate cancer based on clinical, laboratory, and imaging findings.
All prospective participants will undergo transperineal fusion-targeted prostate biopsy under general anesthesia. Targeted tissue samples obtained from the suspicious prostate lesion will be examined intraoperatively using frozen section histology. The result of the urgent morphological examination will determine the subsequent surgical strategy within the same anesthetic session.
If acinar adenocarcinoma is confirmed by frozen section examination, the patient will undergo robot-assisted radical prostatectomy with pelvic lymph node dissection without nerve-sparing. If malignancy is not confirmed, or if the frozen section result is equivocal or non-informative, radical prostatectomy will not be performed. Instead, the biopsy procedure will be extended to a standard transperineal fusion biopsy protocol, and further diagnostic and therapeutic management will be based on the final histopathological examination of the biopsy specimens.
Preoperative evaluation of prospective participants will include clinical assessment, serum prostate-specific antigen (PSA) measurement, multiparametric magnetic resonance imaging (MRI) of the prostate, and positron emission tomography/computed tomography (PET/CT) with a gallium-68 (68Ga)-labeled prostate-specific membrane antigen (PSMA)-targeted radiotracer (68Ga-PSMA PET/CT). PSMA PET/CT will be used as an additional selection and staging tool and will not serve as an independent indication for radical prostatectomy. The decision to proceed with radical prostatectomy will be based only on intraoperative morphological confirmation of acinar adenocarcinoma.
The diagnostic performance of intraoperative frozen section examination will be assessed by comparison with final histopathology of the radical prostatectomy specimen in patients who undergo surgery, or with final histopathology of the standard transperineal fusion biopsy specimens in patients who do not undergo radical prostatectomy.
Perioperative outcomes and safety parameters will include operative duration, estimated blood loss, duration of urinary catheterization, length of hospital stay, and postoperative complications. Early oncological outcomes in patients undergoing radical prostatectomy will include final pathological tumor characteristics, regional lymph node status, positive surgical margin status, postoperative PSA dynamics, and follow-up 68Ga-PSMA PET/CT findings.
For comparative analysis, a retrospective cohort of 50 patients with comparable baseline clinical and diagnostic characteristics will be identified. These patients were previously treated using the conventional staged pathway consisting of preoperative prostate biopsy with histological confirmation of prostate cancer followed by radical prostatectomy. Perioperative outcomes and postoperative complications will be compared between the prospective and retrospective cohorts.
The present study is designed to maintain histological verification of prostate cancer before radical surgical treatment and thereby comply with current clinical and regulatory requirements. At the same time, it is intended to provide a scientific and clinical foundation for future investigation of a truly biopsy-free treatment pathway in carefully selected patients with an extremely high probability of clinically significant prostate cancer. In such a future protocol, the decision to proceed with radical prostatectomy could potentially be based on an integrated assessment of clinical and laboratory parameters together with advanced imaging findings, without any preoperative or intraoperative histological confirmation. The results of the present pilot study may therefore help define patient selection criteria, estimate the safety and feasibility of this concept, and support the design of subsequent prospective studies evaluating radical prostatectomy without prior morphological verification of the diagnosis.
- Conditions
- Prostate Cancer
- 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
- 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
- Medical subject headings
- Prostatic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Transperineal Fusion-Targeted Prostate Biopsy With Intraoperative Frozen Section ExaminationDiagnostic 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.
Robot-Assisted Radical Prostatectomy With Pelvic Lymph Node DissectionProcedure or surgery
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.
Standard Transperineal Fusion Prostate BiopsyProcedure or surgery
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.
68Ga-PSMA PET/CTDiagnostic 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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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 |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Up to 10 days after the index procedure
Secondary outcomes (10)
Operative Duration
Total duration of the index surgical procedure, measured from the start to the completion of the procedure, will be recorded in minutes.
Measured: During the index procedure
Estimated Intraoperative Blood Loss
Estimated blood loss during the index surgical procedure will be recorded in milliliters.
Measured: During the index procedure
Duration of Urinary Catheterization
The number of days from placement of the urinary catheter during the index procedure until catheter removal will be recorded.
Measured: Up to 30 days after the index procedure
Length of Hospital Stay
Length of hospital stay will be calculated as the number of days from the index procedure to hospital discharge.
Measured: Up to 30 days after the index procedure
Postoperative Complications
The number and percentage of participants experiencing postoperative complications related to the index procedure will be recorded and graded according to the Clavien-Dindo classification.
Measured: Up to 30 days after the index procedure
Positive Surgical Margin Rate
Among participants undergoing radical prostatectomy, the presence or absence of a positive surgical margin will be assessed on final histopathological examination of the radical prostatectomy specimen. The outcome will be reported as the number and percentage of participants with a positive surgical margin.
Measured: Up to 10 days after radical prostatectomy
Pathological Regional Lymph Node Status
Among participants undergoing radical prostatectomy with pelvic lymph node dissection, regional lymph node involvement will be assessed by final histopathological examination and reported as the number and percentage of participants with pathologically confirmed lymph node metastases.
Measured: Up to 10 days after radical prostatectomy
Evidence of Recurrence or Progression on 68Ga-PSMA PET/CT
Among participants undergoing radical prostatectomy, follow-up 68Ga-PSMA PET/CT will be evaluated for evidence of recurrent or progressive prostate cancer. The outcome will be reported as the number and percentage of participants with imaging evidence of recurrence or progression.
Measured: At 6 and 12 months after radical prostatectomy
Postoperative Prostate-Specific Antigen Level
Serum prostate-specific antigen (PSA) level will be assessed after radical prostatectomy as part of postoperative oncological follow-up. PSA values will be recorded to evaluate postoperative biochemical response and identify evidence of persistent or recurrent disease.
Measured: Up to 12 months after radical prostatectomy
Final Histopathological Tumor Characteristics
Among participants undergoing radical prostatectomy, final histopathological examination of the radical prostatectomy specimen will be used to determine pathological tumor stage, Gleason score, and International Society of Urological Pathology (ISUP) Grade Group. Among participants who do not undergo radical prostatectomy and instead undergo completion of a standard transperineal fusion biopsy, final histopathological examination of the biopsy specimens will be used to determine the Gleason score of detected prostate cancer.
Measured: Up to 10 days after the index procedure
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Sep 2026
- Study start15 Oct 2026
- Primary completionDec 2028 (estimated)
- Study completionDec 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Prostate CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- 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.
- Masking
- None (open label)
- Enrolment
- 10 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Botkin Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Drozdov Pavel, Botkin Hospital
- Investigators
- Alexander V Govorov, MD, DSc, Principal investigator, S. P. Botkin Moscow Multidisciplinary Scientific and Clinical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07819760
- Sponsor's protocol ID
- RARP-NPB-2026-01
- Status last verified
- Oct 2026
- First submitted
- 9 Sep 2026
- Last updated
- 20 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Individual participant data are not planned to be shared with other researchers. Study results will be reported in aggregate form in scientific publications and presentations.
Publications
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.
PubMed 42293831Jiao 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.
PubMed 34373749Chaloupka 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.
PubMed 36831608Meissner 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.
PubMed 34887117
Study at a glance
From the registry record, last updated by the sponsor on 20 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT07819760
- Acronym / sponsor ID
- RARP-NPB-2026-01
- 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
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 10 participants (estimated)
- Lead sponsor
- Botkin HospitalUniversity, hospital or other
- Study start
- 15 Oct 2026 (actual)
- Primary completion
- Dec 2028 (estimated)
- Study completion
- Dec 2029 (estimated)
- First posted
- 15 Sep 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
The study is designed as a pilot comparative clinical study including a prospective cohort and a retrospective comparison cohort. The prospective cohort will include 10 patients with a high probability of clinically significant prostate cancer based on clinical, laboratory, and imaging findings.
All prospective participants will undergo transperineal fusion-targeted prostate biopsy under general anesthesia. Targeted tissue samples obtained from the suspicious prostate lesion will be examined intraoperatively using frozen section histology. The result of the urgent morphological examination will determine the subsequent surgical strategy within the same anesthetic session.
If acinar adenocarcinoma is confirmed by frozen section examination, the patient will undergo robot-assisted radical prostatectomy with pelvic lymph node dissection without nerve-sparing. If malignancy is not confirmed, or if the frozen section result is equivocal or non-informative, radical prostatectomy will not be performed. Instead, the biopsy procedure will be extended to a standard transperineal fusion biopsy protocol, and further diagnostic and therapeutic management will be based on the final histopathological examination of the biopsy specimens.
Preoperative evaluation of prospective participants will include clinical assessment, serum prostate-specific antigen (PSA) measurement, multiparametric magnetic resonance imaging (MRI) of the prostate, and positron emission tomography/computed tomography (PET/CT) with a gallium-68 (68Ga)-labeled prostate-specific membrane antigen (PSMA)-targeted radiotracer (68Ga-PSMA PET/CT). PSMA PET/CT will be used as an additional selection and staging tool and will not serve as an independent indication for radical prostatectomy. The decision to proceed with radical prostatectomy will be based only on intraoperative morphological confirmation of acinar adenocarcinoma.
The diagnostic performance of intraoperative frozen section examination will be assessed by comparison with final histopathology of the radical prostatectomy specimen in patients who undergo surgery, or with final histopathology of the standard transperineal fusion biopsy specimens in patients who do not undergo radical prostatectomy.
Perioperative outcomes and safety parameters will include operative duration, estimated blood loss, duration of urinary catheterization, length of hospital stay, and postoperative complications. Early oncological outcomes in patients undergoing radical prostatectomy will include final pathological tumor characteristics, regional lymph node status, positive surgical margin status, postoperative PSA dynamics, and follow-up 68Ga-PSMA PET/CT findings.
For comparative analysis, a retrospective cohort of 50 patients with comparable baseline clinical and diagnostic characteristics will be identified. These patients were previously treated using the conventional staged pathway consisting of preoperative prostate biopsy with histological confirmation of prostate cancer followed by radical prostatectomy. Perioperative outcomes and postoperative complications will be compared between the prospective and retrospective cohorts.
The present study is designed to maintain histological verification of prostate cancer before radical surgical treatment and thereby comply with current clinical and regulatory requirements. At the same time, it is intended to provide a scientific and clinical foundation for future investigation of a truly biopsy-free treatment pathway in carefully selected patients with an extremely high probability of clinically significant prostate cancer. In such a future protocol, the decision to proceed with radical prostatectomy could potentially be based on an integrated assessment of clinical and laboratory parameters together with advanced imaging findings, without any preoperative or intraoperative histological confirmation. The results of the present pilot study may therefore help define patient selection criteria, estimate the safety and feasibility of this concept, and support the design of subsequent prospective studies evaluating radical prostatectomy without prior morphological verification of the diagnosis.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- 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.
| Arm | Type | Receives |
|---|---|---|
| Frozen Section-Guided One-Stage Strategy | Experimental | 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/CTAll 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (6 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Transperineal Fusion-Targeted Prostate Biopsy With Intraoperative Frozen Section ExaminationUnder 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. | Diagnostic test | Frozen Section-Guided One-Stage Strategy |
| Robot-Assisted Radical Prostatectomy With Pelvic Lymph Node DissectionRobot-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. | Procedure or surgery | Frozen Section-Guided One-Stage Strategy |
| Standard Transperineal Fusion Prostate BiopsyIn 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. | Procedure or surgery | Frozen Section-Guided One-Stage Strategy |
| 68Ga-PSMA PET/CT68Ga-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. | Diagnostic test | Frozen Section-Guided One-Stage Strategy |
Primary outcome
Diagnostic Concordance of Intraoperative Frozen Section With Final Histopathology
Time frame: Up to 10 days after the index procedure
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.
10 secondary outcomes
Operative Duration
Time frame: During the index procedure
Estimated Intraoperative Blood Loss
Time frame: During the index procedure
Duration of Urinary Catheterization
Time frame: Up to 30 days after the index procedure
Length of Hospital Stay
Time frame: Up to 30 days after the index procedure
Postoperative Complications
Time frame: Up to 30 days after the index procedure
Positive Surgical Margin Rate
Time frame: Up to 10 days after radical prostatectomy
Pathological Regional Lymph Node Status
Time frame: Up to 10 days after radical prostatectomy
Evidence of Recurrence or Progression on 68Ga-PSMA PET/CT
Time frame: At 6 and 12 months after radical prostatectomy
Postoperative Prostate-Specific Antigen Level
Time frame: Up to 12 months after radical prostatectomy
Final Histopathological Tumor Characteristics
Time frame: Up to 10 days after the index procedure
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Oct 2026.
- Background: PubMed 42293831Zhu 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.
- Background: PubMed 34373749Jiao 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.
- Background: PubMed 36831608Chaloupka 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.
- Background: PubMed 34887117Meissner 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.
- Individual participant dataSharing planned: No. Individual participant data are not planned to be shared with other researchers. Study results will be reported in aggregate form in scientific publications and presentations.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Alexander V Govorov, MD, DSc principal investigator
S. P. Botkin Moscow Multidisciplinary Scientific and Clinical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Transperineal Fusion-Targeted Prostate Biopsy With Intraoperative Frozen Section Examination, Robot-Assisted Radical Prostatectomy With Pelvic Lymph Node Dissection and Standard Transperineal Fusion Prostate Biopsy in people with Prostate Cancer, run by Botkin Hospital at 1 site in Russia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 20 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Russia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Filipp A Medvedev, MD (+79162002599, filippmdvdv@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Diagnostic Concordance of Intraoperative Frozen Section With Final Histopathology (time frame: Up to 10 days after the index procedure). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07819760, which also lists 4 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Oct 2026.