177Lu-PSMA-KiRi-trial

Status: Recruiting
Location: See location...
Intervention Type: Diagnostic test
Study Type: Observational
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
Participation Requirements
Sex: Male
Minimum Age: 18
Healthy Volunteers: f
View:

• Patients with mCRPC starting 177Lu-PSMA RLT at the Klinikum rechts der Isar at the time of therapy initiation (1st cycle).

Locations
Other Locations
Germany
Klinikum rechts der Isar, München, Bavaria 81675
RECRUITING
Munich
Contact Information
Primary
Hannah Schäfer/ Christoph Schmaderer
hannah.schaefer@mri.tum.de
+49 - 89 4140 8383
Time Frame
Start Date: 2024-08-05
Estimated Completion Date: 2031-08-01
Participants
Target number of participants: 100
Treatments
mCRPC Patients with 177Lutetium-PSMA RLT
Patients diagnosed with metastatic castration-resistant prostate carcinoma (mCRPC) undergoing initial treatment with 177Lutetium-PSMA radioligand therapy at the Klinikum rechts der Isar.
Related Therapeutic Areas
Sponsors
Leads: Hannah Schaefer

This content was sourced from clinicaltrials.gov