REALITY Study: Analysis of a Prospective REgistry to Assess Outcome and Toxicity of Targeted RadionucLide TherapY in Patients With mCRPC in Clinical Routine.
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 500
- 试验地点
- 1
- 主要终点
- OS
研究概览
简要总结
This prospective registry aims to assess outcome and toxicity of targeted radionuclide therapies in patients with advanced prostate cancer in clinical routine. While the major investigated treatment modality is prostate-specific membrane antigen (PSMA)-targeted radioligand therapy, also other radionuclide therapies such as Ra223 and liver-directed radioembolization are included. The investigators believe that prospectively assessed long-term outcome data on implementation of radionuclide therapy, especially in the palliative setting of advanced mCRPC, help to better define the real benefits and risks of the respective treatment modalities for patients regarding survival and quality-of-life.
详细描述
Targeted radionuclide therapy is comprised of different modalities that may be applied in advanced prostate cancer, either targeting bone metastases (mainly using Radium-223), any site of metastases with PSMA-expression (ß- / alpha-emitter labelled radioligands) or loco-regionally applying internal radiation (Yttrium-90 microspheres) to metastatic liver disease. While in Germany, each form of treatment is used in clinical routine, data is sparse regarding the real benefits and risks of respective modalities, also when used in a sequential order. As an example, patients receiving Ra223 treatment may later undergo PSMA targeted radioligand therapy, with little data available on dependent response relationships or cumulative risks. Prospective assessment of outcomes and toxicities in a radionuclide therapy registry is apparently superior over retrospective analyses of selected patient populations.
The goal of the REALITY study is to gain a better understanding of the real-life clinical application of radionuclide therapies, with a focus on PSMA-targeted radioligand therapy in a high-volume treatment centre, and the impact of each treatment for patient outcome.
Based on primary and secondary outcome measures the potential prediction of treatment benefit by baseline patient and tumor characteristics, and early changes of biomarkers will be of interest.
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
- •Signed informed consent form (Registry Study Inclusion Form)
- •Inclusion Criteria for PSMA RLT:
- •sufficient tumoral PSMA expression defined as tracer uptake markedly higher than (physiologic) uptake in healthy liver tissue.
- •sufficient bone marrow reserve: leukocytes ≥ 2 G/L, platelets > 75 × 109/L
- •sufficient overall patient condition: Eastern Oncology Cooperative Group (ECOG) performance status ≤ 3
排除标准
- •Inability or unwillingness to provide informed consent
结局指标
主要结局
OS
时间窗: up to 10 years
Overall survival. From date of start of radionuclide therapy until the date of death from any cause assessed
Toxicity (adverse events)
时间窗: up to 10 years
All toxicity occurring after start of radionuclide treatment will be registered according to the Common Terminology Criteria for Adverse Events (CTCAE version 4.03).
Toxicity-related discontinuation of radionuclide treatment
时间窗: up to 10 years
Rate of toxicity-related discontinuation of radionuclide therapy
PSA response
时间窗: up to 10 years
Best PSA response and PSA response after 3 months from start of radionuclide therapy
PSA-PFS
时间窗: up to 10 years
PSA-based progression-free survival (PFS) according to PCWG3 criteria. From date of start of radionuclide therapy until documented and confirmed PSA-progression
次要结局
- Quality-of-life in patients receiving radionuclide therapy(up to 10 years)
- Pain control achieved by radionuclide therapy(up to 10 years)
- Absorbed doses achieved by radionuclide therapy(up to 10 years)
- Conventional imaging response(up to10 years)
- Molecular imaging response(up to 10 years)
研究者
Samer Ezziddin, MD
Director, Dept. of Nuclear Medicine
Universität des Saarlandes