Prostate Cancer
Conditions
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
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.
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 measurement, multiparametric magnetic resonance imaging of the prostate, and 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.
Interventions
DIAGNOSTIC_TESTTransperineal Fusion-Targeted Prostate Biopsy With Intraoperative Frozen Section Examination
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.
PROCEDURERobot-Assisted Radical Prostatectomy With Pelvic Lymph Node Dissection
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.
PROCEDUREStandard Transperineal Fusion Prostate Biopsy
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.
DIAGNOSTIC_TEST68Ga-PSMA PET/CT
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.
Sponsors
Botkin Hospital
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
DIAGNOSTIC
Masking
NONE
Intervention 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.
Eligibility
Sex/Gender
MALE
Age
18 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Diagnostic Concordance of Intraoperative Frozen Section With Final Histopathology | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Operative Duration | During the index procedure | Total duration of the index surgical procedure, measured from the start to the completion of the procedure, will be recorded in minutes. |
| Estimated Intraoperative Blood Loss | During the index procedure | Estimated blood loss during the index surgical procedure will be recorded in milliliters. |
| Duration of Urinary Catheterization | Up to 30 days after the index procedure | The number of days from placement of the urinary catheter during the index procedure until catheter removal will be recorded. |
| Length of Hospital Stay | Up to 30 days after the index procedure | Length of hospital stay will be calculated as the number of days from the index procedure to hospital discharge. |
| Postoperative Complications | Up to 30 days after the index procedure | 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. |
| Positive Surgical Margin Rate | Up to 10 days after radical prostatectomy | 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. |
| Pathological Regional Lymph Node Status | Up to 10 days after radical prostatectomy | 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. |
| Evidence of Recurrence or Progression on 68Ga-PSMA PET/CT | At 6 and 12 months after radical prostatectomy | 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. |
| Postoperative Prostate-Specific Antigen Level | Up to 12 months after radical prostatectomy | 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. |
| Final Histopathological Tumor Characteristics | Up to 10 days after the index procedure | Among participants undergoing radical prostatectomy, final histopathological examination of the radical prostatectomy specimen will be used to determine pathological tumor stage, Gleason score, and 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. |
Countries
Russia
Contacts
CONTACTFilipp A Medvedev, MD
PRINCIPAL_INVESTIGATORAlexander V Govorov, MD, DSc
S. P. Botkin Moscow Multidisciplinary Scientific and Clinical Center
Outcome results
None listed