Extended Pelvic Lymph Node Dissection vs. No Pelvic Lymph Node Dissection at Radical Prostatectomy in PSMA PET Negative Staged Men: A Multicenter, Randomized Phase III Trial
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 400
- 试验地点
- 17
- 主要终点
- Prostate specific antigen (PSA) persistence
研究概览
简要总结
The aim of the DISSECTION 2.0 study is to determine whether extended pelvic lymph node dissection (ePLND) provides a therapeutic benefit for high-risk prostate cancer patients by improving cancer staging and potentially removing micrometastatic disease, ultimately improving their outcomes.
详细描述
Prostate cancer is the second most common cancer in men globally and a major cause of cancer deaths in Europe. For men with localized prostate cancer (PCa) and a life expectancy of over 10 years, radical prostatectomy (RP) is the standard treatment. It improves survival compared to conservative management. However, there is debate about de benefit of pelvic lymph node dissection (PLND), the removal of lymph nodes in the pelvis, during RP. While PLND can be omitted in low risk PCa patients, extended PLND (ePLND) is recommended in PCa patients at high-risk for recurrence in order to improve nodal staging The DISSECTION 2.0 study aims to investigate whether extended PLND (ePLND) provides additional benefits for men with high-risk PCa. The hypothesis is that ePLND might help by removing undetectable cancer cells (micrometastases) in the lymph nodes or by better staging the disease for treatment planning. While imaging techniques like PSMA-PET are good at detecting cancer spread, they still miss approximately 60% of cancer-bearing lymph nodes, leaving room for ePLND to potentially improve outcomes.
ePLND involves removing more lymph nodes than standard PLND, leading to better detection of cancer spread. However, it also increases surgery time and complications slightly, though serious complications are rare.
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 —（Adult, Older Adult）
- 性别
- Male
- 接受健康志愿者
- 否
入选标准
- •Age ≥ 18 years and life expectancy >15 years
- •Any biopsy-proven WHO/ISUP grade groups III-V PCa
- •High-risk prostate cancer defined as:
- •Any biopsy-proven WHO/ISUP grade group III-V PCa or
- •ISUP grade group II and PSA > 20 ng/ml
- •PSMA-PET: negative staging for regional and distant metastasis
- •multidisciplinary tumorboard recommendation for radical prostatectomy
- •WHO performance status 0-1
- •Adequate condition (ASA ≤ III) for general anesthesia and RP
排除标准
- •ISUP grade group I PCa and cT1 or cT2 (MRI)
- •cT4 (MRI) PCa
- •PSMA-PET: positive staging for local and distant metastasis
- •Any prior neoadjuvant, local or systemic treatment for PCa
- •Previous PLND or pelvic radiotherapy
- •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.
- •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, which affect patient compliance or place the patient at
- •high risk from treatment-related complications.
- •Vulnerable men (participants incapable of judgment or participants under tutelage) will not be included in the study.
结局指标
主要结局
Prostate specific antigen (PSA) persistence
时间窗: 3 month (+/- 2 weeks) postoperatively
defined as failure to reach a PSA value of \<0.1 ng/ml
Biochemical recurrence free survival (BCRFS)
时间窗: within 24 months post surgery
time from randomization to biochemical recurrence, defined as serum PSA level ≥ 0.2 ng/ml
次要结局
- PSA persistence (PSAP) above detection limit(postoperative to the end of the study at 10-15 years)
- Initiation time of adjuvant or salvage therapies(postoperative to the end of the study at 10-15 years)
- Time to loco-regional recurrence(from randomization to end of study at 10-15 years)
- Localization of progression(from randomization to end of study at 10-15 years)
- Time to distant metastasis(postoperative to the end of the study at 10-15 years)
- Prostate cancer-specific survival(postoperative to the end of the study at 10-15 years)
- Overall survival(postoperative to the end of the study at 10-15 years)
- Intraoperative complications(during surgery)
- Postoperative complications(postoperative up to 10-15 years)
- Adverse events (AEs) related to ePLND(postoperative up to 10-15 years)
- Patient-reported outcome measures (PROMs)(postoperative up to 10-15 years)