An interventional study of Transperineal Fusion-Targeted Prostate Biopsy With Intraoperative Frozen Section Examination and Robot-Assisted Radical Prostatectomy With Pelvic Lymph Node Dissection in Prostate Cancer, sponsored by Botkin Hospital. Recruiting at 1 site in Russia. Open to male participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-10-20.
Sponsored by Botkin Hospital · Not applicable, Interventional, and Diagnostic
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.
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.
7,046 studies on the registry are indexed under Prostatic Neoplasms; 1,580 are open to participants now.
This study's planned enrollment of 10 is below the median of 60 across 5,348 interventional studies indexed under Prostatic Neoplasms.
Browse Prostatic Neoplasms studies →Botkin Hospital is the lead sponsor of 8 studies on the registry; 6 are open to participants now.
Counted across the registry records on this site, refreshed daily.
The criteria were revised on the registry on Oct 20, 2026. See what changed
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Cancer that has spread from where it began to other parts of the body. “Metastatic” cancer is cancer that has spread this way.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
A biopsy takes a small piece of tissue to examine. “Archival tissue” is a sample already taken, for example at diagnosis, and kept by the hospital.
Whether a stored sample will do depends on when it was taken, how much there is and what the study needs. Ask whether the study accepts your stored sample or needs a new biopsy.
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Metastases
Cancer that has spread from where it began to other parts of the body. “Metastatic” cancer is cancer that has spread this way.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Biopsy and archival tissue
A biopsy takes a small piece of tissue to examine. “Archival tissue” is a sample already taken, for example at diagnosis, and kept by the hospital.
Whether a stored sample will do depends on when it was taken, how much there is and what the study needs. Ask whether the study accepts your stored sample or needs a new biopsy.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraindication
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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
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 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.
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/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 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.
Time frame: Up to 10 days after the index procedure
Operative Duration
Total duration of the index surgical procedure, measured from the start to the completion of the procedure, will be recorded in minutes.
Time frame: During the index procedure
Estimated Intraoperative Blood Loss
Estimated blood loss during the index surgical procedure will be recorded in milliliters.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: Up to 10 days after the index procedure
Plan to share: 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.
Started Oct 2026 (actual). Primary completion is estimated for Dec 2028, 26 months after the start.
Of 1,098 non-industry interventional studies with no phase under Prostatic Neoplasms, half reached primary completion within 43 months of starting (the median), counting those still running; a quarter within 22 and three quarters within 86. This study's planned 26 months is below that.
Counting every sponsor, half of 1,155 studies reached it within 43 months; a quarter within 22 and three quarters within 84.
Start moved once since we started tracking on Sep 25, 2026: Nov 2026 → Oct 2026, on Oct 20, 2026.
Earlier changes are on the record history on ClinicalTrials.gov ↗
How these figures are worked out, and which studies are left out of them.
From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
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