Kidney Function and Risk Factors in Patients with Metastatic Castration-Resistant Prostate Cancer (mCRPC) Undergoing 177Lutetium-PSMA Radioligand Therapy: a Prospective Observational Study - KiRi-Trial
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: characterization of renal function., Handgrip strength test, Questionaires.
- Who it may be relevant to
- Registry conditions: Kidney Disease, Radiation Nephropathy, Metastatic Castrate Resistant Prostate Cancer (mCRPC). Basic parameters: from 18 years · Male.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Germany
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
177Lu-PSMA-KiRi-trial
Overview
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.
Detailed description
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.
Interventions
- Diagnostic test characterization of renal function.
Blood and urine sample collection - Diagnostic test Handgrip strength test
Assess the peak isometric strength of the hand and forearm muscles, as well as their susceptibility to fatigue. - Diagnostic test Questionaires
The questionnaires evaluate quality of life, psychological distress, fear of progression, frailty, pain, decision regret and treatment expectations.
Primary outcome measures
- chronic kidney disease frequency [Time frame: 2 years]
Secondary outcome measures (6)
- Incidence of chronic kidney disease in patients with long-term survival following 177Lu-PSMA radioligand therapy [Time frame: 5 years]
- Identification of Clinical Risk Factors for the Development of Chronic Kidney Disease (CKD). [Time frame: 2 years]
- Identification and Correlation of Renal Biomarkers for Early Detection of High-Risk Individuals for CKD. [Time frame: 2 years]
- Elucidating Potential Pathomechanisms of Renal Damage through established Serum Biomarkers and Urine Proteomics. [Time frame: 2 years]
- Effects of 177Lu-PSMA Radioligand Therapy and its Side Effects on Patient-Reported Outcomes (PROMs). [Time frame: 2 years]
- Longitudinal evaluation of potential radiation nephropathy. [Time frame: 2 years]
Eligibility criteria
Inclusion criteria
- Patients with mCRPC starting 177Lu-PSMA RLT at the Klinikum rechts der Isar at the time of therapy initiation (1st cycle).
Exclusion criteria
- Missing or incomplete informed consent.
- age below 18 years
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Observational model
- Cohort
Study locations
Germany · 1 center
- Klinikum rechts der Isar, München, Bavaria 81675 — Munich
Identifiers
NCT: NCT06720532 · 2023-402-S-KK