Clinical trial NCT06720532: 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
Official title: 177Lu-PSMA-KiRi-trial
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Kidney Disease
Radiation Nephropathy
Metastatic Castrate Resistant Prostate Cancer (mCRPC)
Keywords: mCRPC
177Lutetium
177Lu-PSMA
radioligand therapy
Lead sponsor: Technical University of Munich
Sponsor class: OTHER
First posted: 2024-12-06
Enrollment: 100
Sex: MALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: All mCRPC patients starting with 177Lu-PSMA RLT at the Klinikum rechts der Isar

Brief 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.

Detailed description: Patients with mCRPC treated at Klinikum rechts der Isar who are newly receiving therapy with 177Lu-PSMA-RLT will be included. To ensure data quality, standard operating procedures (SOPs) will be implemented for both technical measurements and data collection. Data entered into the registry will undergo double data verification against predefined rules for range and consistency with other data fields. This ensures the accuracy and reliability of the collected data. A detailed data dictionary will be maintained, describing each variable used in the registry, including its source, coding information (e.g., TNM staging system), and normal ranges if relevant. Patient reported outcomes (PROM) of cancer related symptoms and quality of life will be collected using standardized questionnaires.

Based on the power calculation, a total of 100 patients will be included in the study. These patients will be followed up for a period of up to 5 years to ensure comprehensive data collection and analysis.

Eligibility criteria: 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

Primary outcomes:
measure: chronic kidney disease frequency
timeFrame: 2 years
Secondary outcomes:
measure: Incidence of chronic kidney disease in patients with long-term survival following 177Lu-PSMA radioligand therapy
timeFrame: 5 years
measure: Identification of Clinical Risk Factors for the Development of Chronic Kidney Disease (CKD).
timeFrame: 2 years
measure: Identification and Correlation of Renal Biomarkers for Early Detection of High-Risk Individuals for CKD.
timeFrame: 2 years
measure: Elucidating Potential Pathomechanisms of Renal Damage through established Serum Biomarkers and Urine Proteomics.
timeFrame: 2 years
measure: Effects of 177Lu-PSMA Radioligand Therapy and its Side Effects on Patient-Reported Outcomes (PROMs).
timeFrame: 2 years
measure: Longitudinal evaluation of potential radiation nephropathy.
timeFrame: 2 years
Other outcomes:
Locations:
city: Munich
country: Germany
facility: Klinikum rechts der Isar, München, Bavaria 81675
Study officials:
References: