Clinical trial · Observational
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
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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
Conditions (3)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Kidney Disease | — | UNRESOLVED | — |
| Metastatic Castrate Resistant Prostate Cancer (mCRPC) | — | UNRESOLVED | — |
| Radiation Nephropathy | — | UNRESOLVED | — |
Interventions
Interventions (3)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| characterization of renal function. | Diagnostic Test | — | UNRESOLVED |
| Handgrip strength test | Diagnostic Test | — | UNRESOLVED |
| Questionaires | Diagnostic Test | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- label
- mCRPC Patients with 177Lutetium-PSMA RLT
- description
- Patients diagnosed with metastatic castration-resistant prostate carcinoma (mCRPC) undergoing initial treatment with 177Lutetium-PSMA radioligand therapy at the Klinikum rechts der Isar.
- interventionNames
- Diagnostic Test: characterization of renal function.
- Diagnostic Test: Handgrip strength test
- Diagnostic Test: Questionaires
Primary outcomes (1)
- measure
- chronic kidney disease frequency
- timeFrame
- 2 years
- description
- 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.
Secondary outcomes (6)
- measure
- Incidence of chronic kidney disease in patients with long-term survival following 177Lu-PSMA radioligand therapy
Eligibility
Eligibility (as posted)
- Sex
- Male
- Minimum age
- 18 Years
Show eligibility criteria text
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
References
Publications (0)
Data not yet available