Efficacy and Safety of Radical Prostatectomy (RP) With or Without Salvage Radiotherapy Versus RP With Extended Pelvic Lymph Node Dissection for Localized Intermediate- and High-risk Prostate Cancer With a Briganti Nomogram≥7%: an Open-label, Single-center, Non-inferiority Randomized Controlled Study
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 270
- 试验地点
- 1
- 主要终点
- 2-year Biochemical-recurrence Free Survival rate (2-year BFS)
研究概览
简要总结
The goal of this clinical trial is to evaluate efficacy and safety of radical prostatectomy (RP) with or without salvage radiotherapy versus RP with extended pelvic lymph node dissection (ePLND) in males who have localized intermediate/high-risk prostate cancer with a Briganti nomogram no less than 7%. The main questions this study aim to answer are:
- Is RP with or without salvage radiotherapy non-inferior to RP with ePLND in efficacy for patients with localized intermediate/high-risk prostate cancer with a Briganti nomogram no less than 7%?
- Will complication rates of RP with or without salvage radiotherapy be significantly lower than those of RP with ePLND?
Researchers will compare the experimental arm (robot-assisted laparoscopic radical prostatectomy with or without salvage radiotherapy) versus the control arm (robot-assisted laparoscopic radical prostatectomy with ePLND) to see if differences exist in oncological efficacy and safety outcomes.
Participants will:
-
Undergo one of the following surgical interventions:
-
Robot-assisted laparoscopic radical prostatectomy (RARP) with extended pelvic lymph node dissection (ePLND), OR
-
RARP alone, followed by salvage radiotherapy only if biochemical recurrence occurs postoperatively
-
Complete scheduled monitoring activities:
-
Serum PSA testing: Monthly or every 3 months within 2 years after surgery
-
PSMA PET/CT scans: Annually until study completion
-
Report all treatment-related complications within 24 hours of onset
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
- •Provided signed and dated informed consent form.
- •Be male aged 18-80 years at consent.
- •Commit to protocol compliance and complete all study procedures.
- •Medically fit to tolerate interventions, including PSMA PET imaging, RARP, pelvic radiotherapy.
- •Diagnosis of localized intermediate/high-risk prostate cancer (miN0M0):
- •i. Confirmed by: systematic biopsy + PSA + PSMA PET/MRI. ii. Briganti nomogram (2017)≥7%. iii. Candidate for radical prostatectomy. iv. D'Amico:
- •Intermediate-risk: PSA 10-20ng/mL OR Gleason 7 (ISUP Grade 2/3) OR cT2b;
- •High-risk: PSA>20ng/mL OR Gleason>7 (ISUP Grade 4/5) OR cT2c.
排除标准
- •Prior treatments for prostate cancer, including radiotherapy, chemotherapy or endocrine therapy.
- •Non-acinar adenocarcinoma histology on biopsy.
- •Preoperative evidence of metastasis: nodal(N1), locally advanced(T3-4), or distant(M1) disease on imaging.
- •History of pelvic lymphadenectomy or radiotherapy.
- •Other malignancies within 5 years.
- •Contraindications to radical prostatectomy or being deemed surgically inoperable upon clinical assessment.
- •Contraindications to radiotherapy or intolerance determined by radiation oncologists.
- •Severe allergy to PSMA PET ligands or excipients.
- •Any other conditions precluding PSMA PET examination.
研究组 & 干预措施
Experimental group
Participants in the experimental group will receive robot-assisted laparoscopic radical prostatectomy (RARP), followed by salvage radiotherapy only if biochemical recurrence occurs postoperatively.
干预措施: RARP±SRT (Procedure)
Control group
Participants in the control group will receive RARP with extended pelvic lymph node dissection, per guideline recommendations.
干预措施: RARP+ePLND (Procedure)
结局指标
主要结局
2-year Biochemical-recurrence Free Survival rate (2-year BFS)
时间窗: 2 years from randomization
The 2-year biochemical recurrence-free survival rate (2-year BFS) will be recorded from randomization. Biochemical recurrence (BCR) is defined as serum PSA≥0.2ng/mL confirmed by at least one repeat test \>6 weeks postoperatively. Time to first BCR event is measured: 1. For control group: After RARP completion. 2. For experimental group: After salvage radiotherapy completion.
次要结局
- PSA doubling time, PSADT(baseline and 2 years)
- Time to First biochemical recurrence (BCR) event in the experimental group(2 years from randomization)
- Overall survival, OS(2 years from randomization)
- Radiographic progression-free survival, rPFS(2 years from randomization)