Actively Recruiting
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
Led by Hannah Schaefer · Updated on 2024-12-06
100
Participants Needed
1
Research Sites
364 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
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
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Patients with metastatic castration-resistant prostate cancer starting 177Lu-PSMA Radioligand Therapy at Klinikum rechts der Isar at the time of first therapy cycle
- Male gender
- Age 18 years or older
You will not qualify if you...
- Missing or incomplete informed consent
- Age below 18 years
AI-Screening
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Trial Site Locations
Total: 1 location
1
Klinikum rechts der Isar, München, Bavaria 81675
Munich, Germany
Actively Recruiting
Research Team
H
Hannah Schäfer/ Christoph Schmaderer
CONTACT
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
1
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