Multi-institutional Evaluation of the Cost-effectiveness of PSMA-PET/CT for the Detection of Pelvic Lymph Node Invasion in Newly Diagnosed Prostate Cancer Patients
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 706
- 试验地点
- 2
- 主要终点
- Difference in biochemical recurrence rate between groups.
研究概览
简要总结
To determine if the use of Prostate-Specific Membrane Antigen Positron Emission Computer Tomography (PSMA PET/CT) as a selection tool for performing extended lymph node dissection (ePLND) for prostate cancer (PCa) in the primary staging setting results in fewer ePLND procedures and therefore lower overall healthcare costs, lower patient burden in terms of intervention-related complications and morbidity, with comparable disease prognosis, compared to the current European Guideline-recommended standard practice which includes performing ePLND in PCa patients who are candidates for active treatment with a nomogram-calculated lymph node involvement (LNI) risk >5%.
详细描述
Background: Use of prostate-specific membrane antigen (PSMA) positron emission tomography (PET) - computer tomography (CT) has drastically improved the ability to detect and exclude presence of pelvic lymph node invasion (LNI) compared to conventional imaging. However, current standard of care still includes performing extended pelvic lymph node dissection (ePLND) in all patients with primary prostate cancer and a nomogram-based risk of LNI >5%. It is unclear if use of PSMA PET/CT as a triage test can safely reduce the number of ePLND and hence reduce the associated morbidity and costs, without negatively influencing disease prognosis.
Objective
To assess whether PSMA PET/CT can be safely used as a triage test for selecting primary prostate cancer patients for ePLND. We will additionally assess cost-effectiveness of the PSMA PET/ CT triage strategy.
Design, setting and Participants: THE PSMA-SELECT trial includes patients with biopsy-confirmed prostate cancer, without evidence of distant metastasis (M0) on PSMA PET/CT, opting for treatment with radical prostatectomy (RP), with a nomogram-calculated risk of LNI >5%. Patients will be randomized 1:1. In the intervention arm patients will only undergo ePLND in addition to robot-assisted radical prostatectomy (RARP) in case of suspected LNI on PSMA PET/CT (miN1), whereas ePLND will be omitted in those without PSMA positive lymph nodes (miN0). In the control arm, all patients will undergo ePLND in addition to RARP.
Outcome measurements and statistical analysis: The primary endpoint of this study is biochemical recurrence rate at two years post-surgery. Secondary outcome measures are number of ePLNDs indicated and performed, treatment-related adverse events, initiation of salvage treatment, metastasis-free survival, patient-reported outcome measures and individual and cumulative healthcare costs.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Diagnostic
- 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
- •Biopsy proven adenocarcinoma of the prostate
- •Indication for ePLND combined with robot assisted radical prostatectomy (RARP) (MSKCC nomogram >5%, if not applicable when only MRI targeted biopsies are positive, the Briganti nomogram will be used)
- •Suitable for robot-assisted ePLND and RARP
- •Mentally competent and understanding of benefits and potential burden of the study
- •Written informed consent
- •No known allergies for PSMA tracer.
排除标准
- •History of prior diagnosed or treated PCa
- •Known concomitant malignancies (except Basal Cell Carcinoma of the skin)
- •Unwillingness or inability to undergo PSMA PET/CT and/or ePLND and RARP
- •PSMA non-avid PCa (local tumor activity)
- •Presence of distant metastasis (M1)
结局指标
主要结局
Difference in biochemical recurrence rate between groups.
时间窗: 2 years
Biochemical recurrence (BCR) is defined as the occurrence of measurable (\>0.2 ng/ml) prostate specific antigen (PSA), during routinely follow-up up to five years after surgery, determined at two different occasions with at least one week between them.The BCR-rate between the control group and intervention groups will be compared.
次要结局
- Total number of ePLNDs and PSMA PET/CTs performed and their intervention-related healthcare costs(up to 5 years post-surgery)
- Incidence and types of surgical complications after RARP and ePLND(up to 1 year post-surgery)
- Total nodes resected on ePLND and number of positive and negative nodes within and outside of the standard ePLND template(up to 5 years post-surgery)
- Initiation of salvage therapy(up to 5 years post-surgery)
- Metastasis-free survival(up to 5 years post-surgery)
- Hormone-therapy free survival(up to 5 years post-surgery)
- Total loss of productivity and presenteeism (iMTA PCQ) in patients in the control group vs. intervention group(up to 5 years post-surgery)
- Diagnostic accuracy measures of PSMA PET/CT(up to 5 years post-surgery)
- Total health care related costs (iMTA MCQ) in patients in the control group vs. intervention group(up to 5 years post-surgery)
- Occurrence of pelvic lymph node metastasis and distant metastasis (visceral, bone, distant lymph nodes, pelvic lymph nodes) on PSMA-PET/CT during follow-up(up to 5 years post-surgery)
- (Changes) in the EPIC-26 sexual functioning domain score between groups(up to 5 years post-surgery)
- (Changes in) quality-adjusted life-years (EQ-5D-5L) in patients in the control group vs. intervention group(up to 5 years post-surgery)