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

Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexMale
Age18+
SponsorHannah Schaefer

About this trial

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

Qualifiers

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

Disqualifiers

Missing or incomplete informed consent.

age below 18 years

Trial design

Treatments tested in this trial

  • characterization of renal function.
  • Handgrip strength test
  • Questionaires

Treatment groups

100 Participants
are divided into 1 treatment group

Sponsors and collaborators

Hannah Schaefer

Lead sponsor

Technical University of Munich

Sponsor institution