Preoperative PSMA PET/CT As Triage for Extended Pelvic Lymph Node Dissection (ePLND) in Patients Scheduled for Robot-Assisted Laparoscopic Radical Prostatectomy (RALP)
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 600
- 试验地点
- 2
- 主要终点
- Difference between Arm A and Arm B in biochemical recurrence (BCR) rate between groups within 2 years after initiation of RALP
研究概览
简要总结
Extended pelvic lymph node dissection (ePLND) is considered the gold standard for nodal staging in men with prostate cancer (PCa). The aim of this project is to determine if preoperative prostate specific membrane antigen (PSMA) positron emission tomography (PET)/computed tomograpy (CT) can safely replace ePLND as a staging method in PCa patients undergoing robot-assisted laparoscopic radical prostatectomy (RALP).
详细描述
Due to the latest change in EAU guidelines in May 2024, all eligible patients will undergo PSMA PET/CT. Patients will then be randomized between RALP and ePLND (Arm A) and RALP +/- ePLND (arm B): If PSMA PET/CT detect suspicious pelvic nodes, the patient will undergo ePLND concomitant with RALP. If PSMA PET/CT is negative, only RALP will be performed .
Primary outcome measures:
Difference in biochemical recurrence (BCR) rate between arm A and arm B within 2 years after initiation of primary treatment (BCR ≥ 0.2 ng/ml).
Secondary outcome measures:
Difference between Arm A and Arm B for surgical complications, persistent PSA after RALP and initiation of salvage therapy
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
- 是
入选标准
- •Biopsy proven diagnosed adenocarcinoma of the prostate
- •Indication for ePLND combined with RALP:
- •High-risk group (EAU) and including MRI findings indicating extra prostatic extension (Likert scale ≥4)
- •-ISUP GG 3 with ≥1 of the following unfavourable risk factors
- •≥50% percentage of positive biopsy cores,
- •PSA 10-20
- •cN1 selected to surgery
- •Written informed consent
- •No known allergies for PSMA tracer
- •18 years and older
排除标准
- •History of previously actively treated PCa
- •Previous malignancies (except basal cell carcinoma of the skin) that has not been recurrence-free past ≥5 years
- •Unwillingness or inability to undergo PSMA PET/CT and/or ePLND and RALP
- •Presence of distant metastasis (cM1) on MRI imaging
结局指标
主要结局
Difference between Arm A and Arm B in biochemical recurrence (BCR) rate between groups within 2 years after initiation of RALP
时间窗: 2 years after initiation of primary treatment
BCR is defined as PSA ≥ 0.2 ng/ml
次要结局
- Difference between Arm A and Arm B in incidence and types of surgical complications(3 months follow up)
- Difference between Arm A and Arm B in persistent PSA after RALP(2 months after RALP)
- Difference between Arm A and Arm B in initiation of salvage therapy(2 years follow up)
研究者
Viktor Berge
Professor
Oslo University Hospital