Radioguided SALVAGE Lymph Node Dissection In Oligometastatic Prostate Cancer: A Prospective Randomized controLled Trial Comparing 99mTc-PSMA-radioguided Salvage Lymph Node Dissection With PSMA-PET Based Lymph Node Dissection (The SALVAGE Study)
试验速览
- 阶段
- 2 期
- 状态
- 尚未招募
- 入组人数
- 62
- 主要终点
- Pathologic metastatic yield
研究概览
简要总结
The goal of this clinical trial is to learn whether radioguided surgery can help surgeons find and remove lymph nodes containing prostate cancer in men whose cancer has returned in a small number of lymph nodes after previous prostate cancer treatment. It will also learn about the safety of this approach, changes in prostate-specific antigen (PSA), quality of life, and longer-term cancer outcomes.
The main questions the study aims to answer are:
Does radioguided surgery increase the proportion of removed lymph nodes that are found to contain prostate cancer compared with standard surgery? How well do the lymph nodes identified on imaging scans match the cancer found when the removed lymph nodes are examined in the laboratory? Does radioguided surgery lead to a greater decrease in PSA after surgery? What side effects or surgical complications occur? How does each type of surgery affect quality of life, the need for additional cancer treatment, and the risk of the cancer spreading? Researchers will compare radioguided salvage lymph node surgery with standard salvage lymph node surgery. Salvage lymph node surgery is an operation to remove lymph nodes after prostate cancer has returned.
Participants will:
Be randomly assigned to one of two treatment groups. Have surgery to remove lymph nodes suspected of containing prostate cancer. If assigned to the radioguided group, receive a radioactive PSMA-targeting tracer called 99mTc-MIP-1404, undergo a SPECT/CT scan, and have surgery the following day. During surgery, the surgeon will use a handheld detector to locate lymph nodes that have taken up the tracer.
If assigned to the standard-surgery group, have surgery planned using a standard PSMA-PET/CT scan, without the handheld radioguidance procedure.
Have PSA blood tests, assessments for complications, and quality-of-life questionnaires after surgery.
Be followed for cancer outcomes for up to two years.
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
- •Oligorecurrent prostate cancer following definitive treatment who demonstrate a maximum of four positive lymph nodes within no more than three nodal basins on 68Ga-PSMA-PET/CT Considered suitable candidates for salvage surgery.
排除标准
- •Not meeting inclusion criteria
研究组 & 干预措施
Salvage pelvic lymph node dissection
Salvage radioguided pelvic lymph node dissection
干预措施: Salvage pelvic lymph node dissection (Other)
PSMA technetium assisted radioguided salvage lymph node dissection
Participants will be administered PSMA technetium pre-operatively to assess effect of radioguided lymph node dissection on oncologic, quality of life and functional outcomes
干预措施: PSMA 99mTc-MIP-1404 radioguided salvage lymph node dissection (Procedure)
结局指标
主要结局
Pathologic metastatic yield
时间窗: 2-4 weeks post-op
The ratio of metastatic (histopathologically confirmed) lymph nodes to the total number of lymph nodes removed during salvage lymph node dissection.
次要结局
- PSMA PET/CT and pathologic node concordance(2-4 weeks post-op)
- Biochemical response at Week 6(Surgery to 6 week post-op)
- Patient-reported quality-of-life outcomes(Date of surgery until 2 years post-operative)
- Long-term biochemical and clinical outcomes at 2 years post-lymph node dissection(Surgery to 2 years post-operative)
研究者
Miles Mannas
Principal Investigator
University of British Columbia