Extended Pelvic Lymph Node Dissection vs. no Pelvic Lymph Node Dissection at Radical Prostatectomy for intermediate-and High-risk Prostate Cancer: An International, Multicenter, Randomized Phase III Trial
试验速览
- 阶段
- 3 期
- 状态
- 终止
- 入组人数
- 57
- 试验地点
- 22
- 主要终点
- Time to biochemical recurrence (BCR)
研究概览
简要总结
For patients with intermediate-risk prostate cancer plus a predicted risk of >5% for positive lymph nodes and with high-risk prostate cancer, international guidelines recommend ePLND along with the RP. Besides an improved accuracy in staging, the therapeutic role of ePLND remains controversial. We hypothesize that ePLND prolongs time to biochemical recurrence (BCR) and prostate cancer-specific survival (PCSS) in intermediate- and high-risk PCa patients.
详细描述
Radical prostatectomy (RP) is the surgical standard treatment for men with localized prostate cancer (PCa) and a life expectancy of > 10 years. RP is a treatment option for localized PCa that shows benefit in prostate cancer-specific survival (PCSS) and overall survival compared to conservative management. According to the guideline recommendations of the European Association of Urology (EAU), RP should be accompanied by extended pelvic lymph node dissection (ePLND) in patients with intermediate-risk PCa (D'Amico classification) and > 5% nomogram (Briganti) predicted risk of positive lymph nodes and in all high-risk PCa cases.
Besides an improved accuracy in staging, the therapeutic role of ePLND remains controversial. The primary goal of this trial is to provide high-level evidence regarding the therapeutic benefit of ePLND in intermediate- and high-risk PCa patients without clinical evidence of nodal involvement. It is hypothesized that ePLND prolongs time to biochemical recurrence (BCR) and prostate cancer-specific survival (PCSS) in intermediate- and high-risk PCa patients.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- Male
- 接受健康志愿者
- 否
入选标准
- •Written informed consent according to ICH/GCP regulations before registration and prior to any trial specific procedures.
- •Histologically proven localized adenocarcinoma of the prostate.
- •High-risk prostate cancer or intermediate-risk prostate cancer defined by D'Amico classification system, with an estimated risk of >5% of lymph node metastasis.
- •Patients with a prior malignancy and treated with curative intention are eligible if all treatment of that malignancy was completed at least 2 years before registration and the patient has no evidence of disease at registration. Less than 2 years is acceptable for malignancies with low risk of recurrence and/or no late recurrence.
- •Age ≥ 18 years and ≤ 80 years.
- •WHO performance status 0-
- •Adequate condition (ASA ≤ III) for general anesthesia and radical prostatectomy surgery.
- •Baseline Quality of Life (QoL) questionnaires have been completed.
排除标准
- •Any pre-operative evidence for T4 disease.
- •Metastatic prostate cancer according to staging or evidence of lymph node metastasis by imaging, defined as any pelvic lymph node >9 mm in the short axis or positive lymph nodes detected by imaging techniques with sensitivities similar or better than PSMA-PET or Choline-PET prior to surgery.
- •PSA ≥ 50 ng/ml.
- •Any prior neo-adjuvant, local or systemic treatment for prostate cancer (alpha reductase inhibitors for treatment of benign hyperplasia are allowed)
- •Previous pelvic lymph node dissection.
- •Any uncontrolled active systemic infection requiring intravenous (iv) antimicrobial treatment.
- •Any other serious underlying medical, psychiatric, psychological, familial or geographical condition, which in the judgment of the investigator may interfere with the planned staging, treatment and follow-up, affect patient compliance or place the patient at high risk from treatment-related complications.
结局指标
主要结局
Time to biochemical recurrence (BCR)
时间窗: From the date of randomization until the date of biochemical recurrence, assessed up to 15 years after surgery
The primary endpoint of this trial is time to BCR, defined as time from randomization to biochemical recurrence, defined as serum PSA level ≥ 0.2 ng/ml, with a second confirmatory serum PSA level ≥ 0.2 ng/ml. Patients not experiencing an event will be censored at the date of the last available assessment or at the start of adjuvant or salvage treatment, if any.
次要结局
- Time to initiation of adjuvant or salvage therapies(From the date of randomization until the date of start of any type of adjuvant or salvage therapy, assessed up to 15 years after surgery)
- Overall survival (OS)(From the date of randomization until the date of death, assessed up to 15 years after surgery)
- Intraoperative complications(During surgery)
- Prostate-specific antigen (PSA) persistence(From the date of surgery to 14 weeks after surgery)
- Time to loco-regional recurrence(From the date of randomization until the date of local or regional recurrence, assessed up to 15 years after surgery)
- Time to distant metastasis(From the date of randomization until the date of first occurrence of distant metastasis, assessed up to 15 years after surgery)
- Prostate cancer-specific survival (PCSS)(From the date of randomization until the date of death due to prostate cancer, assessed up to 15 years after surgery)
- Postoperative complications(From the date of surgery to 14 weeks after surgery)
- Adverse events (AE)(From the date of registration to 15 years after surgery)