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

Condition(s) studied

Investigational drug(s) / intervention(s)

characterization of renal function.: Blood and urine sample collection

Handgrip strength test: Assess the peak isometric strength of the hand and forearm muscles, as well as their susceptibility to fatigue.

Questionaires: The questionnaires evaluate quality of life, psychological distress, fear of progression, frailty, pain, decision regret and treatment expectations.

Study 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

Primary outcome measure(s)

• chronic kidney disease frequency — 2 years
  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.

Trial sites (1)

Other trials for the same condition