Skip to main content
OpenTrials
Recruiting

NCT Number: 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

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.

Recruiting

Interested in participating?

Request Info

Key information

Conditions

Kidney Disease Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Kidney Diseases Male Urogenital Diseases Metastatic Castrate Resistant Prostate Cancer (mCRPC) Radiation Nephropathy Urogenital Diseases Urologic Diseases

Age range

18 year and older

Sex eligibility

Male

Study type

Observational

Primary location

Klinikum rechts der Isar, München, Bavaria 81675

Munich, Germany

Location status: Recruiting

Location contact

Hannah/Christoph Schäfer/Schmaderer

CONTACT

[email protected], [email protected]

+498941408383, +498941405053

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

characterization of renal function.

Diagnostic Test

Blood and urine sample collection

Handgrip strength test

Diagnostic Test

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

Questionaires

Diagnostic Test

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

Primary outcomes

  1. chronic kidney disease frequency

    Time frame: 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.

Secondary outcomes

  1. Incidence of chronic kidney disease in patients with long-term survival following 177Lu-PSMA radioligand therapy

    Time frame: 5 years

    Determination of the incidence of chronic kidney disease in long-term survivors following 177Lu-PSMA radioligand therapy (RLT), measured by the absolute decline in eGFR.

  2. Identification of Clinical Risk Factors for the Development of Chronic Kidney Disease (CKD).

    Time frame: 2 years

    Detection of clinical risk factors that promote the development of chronic kidney disease (CKD).

  3. Identification and Correlation of Renal Biomarkers for Early Detection of High-Risk Individuals for CKD.

    Time frame: 2 years

    Identification of renal biomarkers for the early detection of individuals at high risk of developing chronic kidney disease (CKD). Correlation of these biomarkers with the severity and timing of CKD onset. Measurement of established markers of glomerular injury, tubular damage, endothelial dysfunction, or functional impairment using ELISA.

  4. Elucidating Potential Pathomechanisms of Renal Damage through established Serum Biomarkers and Urine Proteomics.

    Time frame: 2 years

    Deciphering potential pathomechanisms of renal damage using established serum biomarkers and urine proteomics via targeted and untargeted analyses.

  5. Effects of 177Lu-PSMA Radioligand Therapy and its Side Effects on Patient-Reported Outcomes (PROMs).

    Time frame: 2 years

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

  6. Longitudinal evaluation of potential radiation nephropathy.

    Time frame: 2 years

    Regular assessments of kidney function will be conducted over a period of 2 years. This will allow for the identification of the onset of kidney function impairments.

Study contacts

Contact information is provided by the study sponsor or research team.

Hannah Schäfer/ Christoph Schmaderer

CONTACT

[email protected]

+49 - 89 4140 8383 ext. +498941405053

Sponsors and collaborators

Lead sponsor

Hannah Schaefer

Other

Registry information

Official study title

177Lu-PSMA-KiRi-trial

Acronym: KiRi

Important dates

Study start
2024
Primary completion
2027
Study completion
2031
First posted
Dec 6, 2024
Registry last updated
Dec 6, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.