RecruitingNCT06720532

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

177Lu-PSMA-KiRi-trial

Sponsor

Hannah Schaefer

Enrollment

100 participants

Start Date

Aug 5, 2024

Study Type

OBSERVATIONAL

Conditions

Metastatic Castrate Resistant Prostate Cancer (mCRPC)Kidney Disease Radiation Nephropathy

Summary

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.

Eligibility

Sex: MALEMin Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study is monitoring kidney function in men with advanced prostate cancer who are receiving a radioactive treatment called lutetium-177 PSMA therapy (Lu-PSMA). This treatment targets prostate cancer cells throughout the body using a radioactive substance, but it can pass through the kidneys, and researchers want to understand any long-term effects on kidney health. **You may be eligible if...** - You have metastatic castration-resistant prostate cancer (prostate cancer that has spread and is no longer responding to hormone therapy) - You are starting your first cycle of lutetium-177 PSMA radioligand therapy at the Klinikum rechts der Isar - You are at least 18 years old - You have provided informed consent **You may NOT be eligible if...** - You are under 18 years old - You have not provided complete or valid informed consent Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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