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RECRUITINGOBSERVATIONAL

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

Important: This information is not medical advice. Talk to your doctor about whether a clinical trial is right for you.

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.

Who May Be Eligible (Plain English)

Who May Qualify: - Patients with mCRPC starting 177Lu-PSMA RLT at the Klinikum rechts der Isar at the time of therapy initiation (1st cycle). Who Should NOT Join This Trial: - Missing or incomplete willing to sign a consent form. - age below 18 years Always talk to your doctor about whether this trial is right for you.

Original Eligibility Criteria

View original clinical language
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

Treatments Being Tested

DIAGNOSTIC_TEST

characterization of renal function.

Blood and urine sample collection

DIAGNOSTIC_TEST

Handgrip strength test

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

DIAGNOSTIC_TEST

Questionaires

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

Locations (1)

Klinikum rechts der Isar, München, Bavaria 81675
Munich, Germany