NCT06720532 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
| NCT ID | NCT06720532 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Hannah Schaefer |
| Condition | Kidney Disease |
| Study Type | OBSERVATIONAL |
| Enrollment | 100 participants |
| Start Date | 2024-08-05 |
| Primary Completion | 2027-08-01 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 100 participants in total. It began in 2024-08-05 with a primary completion date of 2027-08-01.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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 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
Contact & Investigator
Frequently Asked Questions
Who can join the NCT06720532 clinical trial?
This trial is open to male participants only, aged 18 Years or older, studying Kidney Disease. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06720532 currently recruiting?
Yes, NCT06720532 is actively recruiting participants. Contact the research team at hannah.schaefer@mri.tum.de for enrollment information.
Where is the NCT06720532 trial being conducted?
This trial is being conducted at Munich, Germany.
Who is sponsoring the NCT06720532 clinical trial?
NCT06720532 is sponsored by Hannah Schaefer. The trial plans to enroll 100 participants.
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