Swiss Cancer Registry on Safety and Efficacy of 177Lu-ITG-PSMA-1 Radionuclide Therapy in Prostate Cancer Patients
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 250
- 试验地点
- 8
- 主要终点
- Frequency and severity of treatment related adverse event
研究概览
简要总结
The goal of this observational study (multicenter, national registry-based) is to evaluate the performance of 177Lu-ITG-PSMA-1 (177Lu-PSMA-I&T) as therapy in patients with metastatic castration resistent prostate cancer (mCRPC).
The main questions are whether the 177Lu-PSMA-I&T is safe and if it works well to treat patients with progressive mCRPC. The data and information in the study are collected under standard medical therapy and follow-up, so called real-world conditions.
Participants will:
- undergo regular radioligand therapy (RLT) with 177Lu-PSMA-I&T
- have clinical, laboratory and imaging follow-up according to the currently available recommendation for PSMA-RLT an in line with their medical needs.
- answer study related set of questionnaires
详细描述
Prospective, multicenter Swiss registry study evaluating the performance of 177Lu-ITG-PSMA-1 (177Lu-PSMA-I&T) as RLT in mCRPC.
Primary endpoint: Safety-
-
frequency and severity of adverse events (measured according to CTCAE 5.0). Secondary endpoints: Efficacy
-
biochemical response: best PSA response, PSA50 (>50% decrease from baseline PSA level) and PSA response at 12 weeks
-
imaging response: Objective response rate evaluated on follow-up morphological imaging CT/MRI and/or on molecular imaging PSMA PET/CT
-
quality of life: evaluated with standardized questionnaires
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
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
- •hormone-refractory and PSMA PET/CT-positive prostate tumors
- •progressed after or are ineligible for chemotherapy, next-generation antihormonal therapy or bone-directed radiation therapy -- male patients with an age above 18 years
排除标准
- •patients who are not eligible for PSMA RLT, according to current, standard medical indications and guidelines
- •patients who for medical or non-medical reasons are unable to give their consent
- •patients withdrawing their consent for participation (NB: the already collected data in such cases will be anonymized and further used for applicable analyses)
研究组 & 干预措施
patient wit progressive mCRPC
干预措施: radionuclide therapy with 177Lu-PSMA-I&T (Drug)
结局指标
主要结局
Frequency and severity of treatment related adverse event
时间窗: performed at baseline (before starting the first therapy cycle), during (before each additional therapy cycle) and at 8-14 weeks after completion of all therapy cycles
frequency and severity of treatment related adverse events evaluated on standard blood tests (CBC, liver and kidney function)-, according to CTCAE 5.0
次要结局
- Efficacy - biochemical response(performed at baseline (before starting the first therapy cycle), during (before each additional therapy cycle) and at 8-14 weeks after completion of all therapy cycles)
- Efficacy - imaging response(PSMA PET/CT performed at baseline (before starting the first therapy cycle), PSMA SPECT/CT during therapy (24-48 hours after each cycle) and PSMA PET/CT (and/or CT/MRI) at 8-14 weeks after completion of all therapy cycles)
- Quality of life - EORTC PR25(performed at baseline, before each therapy cycle and at 8-14 weeks after completion of all therapy cycles)
- Quality of life - pain(performed at baseline, before each therapy cycle and at 8-14 weeks after completion of all therapy cycles)
- Quality of life - Xerostomia(performed at baseline, before each therapy cycle and at 8-14 weeks after completion of all therapy cycles)