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.
Patients with mCRPC starting 177Lu-PSMA RLT at the Klinikum rechts der Isar at the time of therapy initiation (1st cycle).
Missing or incomplete informed consent.
age below 18 years
All mCRPC patients starting with 177Lu-PSMA RLT at the Klinikum rechts der Isar
Cohort
Prospective
characterization of renal function.
Diagnostic testBlood and urine sample collection
Handgrip strength test
Diagnostic testAssess the peak isometric strength of the hand and forearm muscles, as well as their susceptibility to fatigue.
Questionaires
Diagnostic testThe questionnaires evaluate quality of life, psychological distress, fear of progression, frailty, pain, decision regret and treatment expectations.
chronic kidney disease frequency
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.
Incidence of chronic kidney disease in patients with long-term survival following 177Lu-PSMA radioligand therapy
Determination of the incidence of chronic kidney disease in long-term survivors following 177Lu-PSMA radioligand therapy (RLT), measured by the absolute decline in eGFR.
Identification of Clinical Risk Factors for the Development of Chronic Kidney Disease (CKD).
Detection of clinical risk factors that promote the development of chronic kidney disease (CKD).
Identification and Correlation of Renal Biomarkers for Early Detection of High-Risk Individuals for CKD.
Identification of renal biomarkers for the early detection of individuals at high risk of developing chronic kidney disease (CKD). Correlation of these biomarkers with the severity and timing of CKD onset. Measurement of established markers of glomerular injury, tubular damage, endothelial dysfunction, or functional impairment using ELISA.
Elucidating Potential Pathomechanisms of Renal Damage through established Serum Biomarkers and Urine Proteomics.
Deciphering potential pathomechanisms of renal damage using established serum biomarkers and urine proteomics via targeted and untargeted analyses.
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Hannah Schaefer
Lead sponsor
Technical University of Munich
Sponsor institution
