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
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 10
- 试验地点
- 1
- 主要终点
- Diagnostic Concordance of Intraoperative Frozen Section With Final Histopathology
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Diagnostic
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Male
- 接受健康志愿者
- 否
入选标准
- •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.
- •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.
排除标准
- •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.
研究组 & 干预措施
Frozen Section-Guided One-Stage Strategy
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.
干预措施: Transperineal Fusion-Targeted Prostate Biopsy With Intraoperative Frozen Section Examination (Diagnostic Test)
Frozen Section-Guided One-Stage Strategy
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.
干预措施: Robot-Assisted Radical Prostatectomy With Pelvic Lymph Node Dissection (Procedure)
Frozen Section-Guided One-Stage Strategy
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.
干预措施: Standard Transperineal Fusion Prostate Biopsy (Procedure)
Frozen Section-Guided One-Stage Strategy
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.
干预措施: 68Ga-PSMA PET/CT (Diagnostic Test)
结局指标
主要结局
Diagnostic Concordance of Intraoperative Frozen Section With Final Histopathology
时间窗: 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.
次要结局
- 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)
- Positive Surgical Margin Rate(Up to 10 days after radical prostatectomy)
- Pathological Regional Lymph Node Status(Up to 10 days after radical prostatectomy)
- Evidence of Recurrence or Progression on 68Ga-PSMA PET/CT(At 6 and 12 months after radical prostatectomy)
- Postoperative Prostate-Specific Antigen Level(Up to 12 months after radical prostatectomy)
- Final Histopathological Tumor Characteristics(Up to 10 days after the index procedure)
研究者
Drozdov Pavel
Senior Researcher
Botkin Hospital