177Lu-PSMA-KiRi-trial
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 100
- 试验地点
- 1
- 主要终点
- chronic kidney disease frequency
研究概览
简要总结
The goal of this observational study is to determine the impact of 177Lutetium-Prostate Specific Membrane Antigen (PSMA) Radioligand Therapy (177Lu-PSMA-RLT) on kidney function over time. The main question it aims to answer is:
What is the absolute decline in estimated glomerular filtration rate (eGFR) in patients undergoing 177Lu-PSMA-RLT after 12 and 24 months?
Patients treated with 177Lu-PSMA-RLT will have their kidney function monitored before, during, and after therapy using routine markers like creatinine and cystatin C. Additional biomarkers and urine proteomics will be collected to identify early detection markers and risk factors for chronic kidney disease (CKD). Follow-up examinations will be conducted at regular intervals up to 5 years. The study also aims to correlate clinical risk factors and patient-reported outcomes with kidney insufficiency to assess the impact of therapy and identify vulnerable patient groups.
详细描述
Patients with mCRPC treated at Klinikum rechts der Isar who are newly receiving therapy with 177Lu-PSMA-RLT will be included. To ensure data quality, standard operating procedures (SOPs) will be implemented for both technical measurements and data collection. Data entered into the registry will undergo double data verification against predefined rules for range and consistency with other data fields. This ensures the accuracy and reliability of the collected data. A detailed data dictionary will be maintained, describing each variable used in the registry, including its source, coding information (e.g., TNM staging system), and normal ranges if relevant. Patient reported outcomes (PROM) of cancer related symptoms and quality of life will be collected using standardized questionnaires.
Based on the power calculation, a total of 100 patients will be included in the study. These patients will be followed up for a period of up to 5 years to ensure comprehensive data collection and analysis.
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
- •Patients with mCRPC starting 177Lu-PSMA RLT at the Klinikum rechts der Isar at the time of therapy initiation (1st cycle).
排除标准
- •Missing or incomplete informed consent.
- •age below 18 years
结局指标
主要结局
chronic kidney disease frequency
时间窗: 2 years
The primary objective is to determine the long term frequency of chronic kidney disease as an expression of radiation nephropathy in patients treated with 177Lu-PSMA RLT, measured by the absolute decline in eGFR.
次要结局
- Incidence of chronic kidney disease in patients with long-term survival following 177Lu-PSMA radioligand therapy(5 years)
- Identification of Clinical Risk Factors for the Development of Chronic Kidney Disease (CKD).(2 years)
- Identification and Correlation of Renal Biomarkers for Early Detection of High-Risk Individuals for CKD.(2 years)
- Elucidating Potential Pathomechanisms of Renal Damage through established Serum Biomarkers and Urine Proteomics.(2 years)
- Effects of 177Lu-PSMA Radioligand Therapy and its Side Effects on Patient-Reported Outcomes (PROMs).(2 years)
- Longitudinal evaluation of potential radiation nephropathy.(2 years)
研究者
Hannah Schaefer
Principal Investigator
Technical University of Munich