Health TrialsbyHealthPanel

Radical Prostatectomy Without Prior Biopsy

ConditionProstate Cancer
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexMale
Age18+
SponsorBotkin Hospital

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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.

68Ga-PSMA PET/CT demonstrating a prostate lesion with SUVmax ≥5.3 and no evidence of distant metastatic disease.

Disqualifiers

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.

Trial design

Design model

Single group

Treatments tested in this trial

  • 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.

  • Robot-Assisted Radical Prostatectomy With Pelvic Lymph Node Dissection

    Procedure/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 Biopsy

    Procedure/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/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.

Treatment groups

10 Participants
are divided into 1 treatment group
Group A: Frozen Section-Guided One-Stage StrategyExperimental treatment 4 interventions

Trial outcomes

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.

Time frame
Up to 10 days after the index procedure

Secondary outcomes

1

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
2

Estimated Intraoperative Blood Loss

Estimated blood loss during the index surgical procedure will be recorded in milliliters.

Time frame
During the index procedure
3

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
4

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

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Botkin Hospital

Lead sponsor

Source ClinicalTrials.gov

This trial is not recruiting at the moment. You can still explore other options: