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

NCT06720532 | Recruiting

• 1 other identifier: 2023-402-S-KK
• Study Type: observational
• Target: 100
• Locations: 1 country
• Sites: 1

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.

Conditions

Kidney Disease; Radiation Nephropathy; Metastatic Castrate Resistant Prostate Cancer (mCRPC)

Keywords

mCRPC; 177Lutetium; 177Lu-PSMA; radioligand therapy

Outcome Measures

Primary Outcomes (1)

• chronic kidney disease frequency

  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.

  2 years

Secondary Outcomes (6)

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

  5 years

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

  2 years

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

  2 years

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

  2 years

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

  2 years

Study Arms (1)

mCRPC Patients with 177Lutetium-PSMA RLT

Patients diagnosed with metastatic castration-resistant prostate carcinoma (mCRPC) undergoing initial treatment with 177Lutetium-PSMA radioligand therapy at the Klinikum rechts der Isar.

Diagnostic Test: characterization of renal function.; Diagnostic Test: Handgrip strength test; Diagnostic Test: Questionaires

Interventions

characterization of renal function. DIAGNOSTIC_TEST

Blood and urine sample collection

mCRPC Patients with 177Lutetium-PSMA RLT

Handgrip strength test DIAGNOSTIC_TEST

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

mCRPC Patients with 177Lutetium-PSMA RLT

Questionaires DIAGNOSTIC_TEST

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

mCRPC Patients with 177Lutetium-PSMA RLT

Eligibility Criteria

• Age: 18 Years+
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

All mCRPC patients starting with 177Lu-PSMA RLT at the Klinikum rechts der Isar

You may qualify if:

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

You may not qualify if:

• Missing or incomplete informed consent.
• age below 18 years

Sponsors & Collaborators

• Hannah Schaefer: lead

Study Sites (1)

Klinikum rechts der Isar, München, Bavaria 81675

Munich, Germany

RECRUITING

Biospecimen

Retention: SAMPLES WITH DNA

Blood and urine samples are collected from the participants.

MeSH Terms

Conditions

Kidney Diseases

Condition Hierarchy (Ancestors)

Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases

Central Study Contacts

Hannah Schäfer/ Christoph Schmaderer

CONTACT

+49 - 89 4140 8383; hannah.schaefer@mri.tum.de

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 5 Years
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: December 2, 2024
• First Posted: December 6, 2024
• Study Start: August 5, 2024
• Primary Completion (Estimated): August 1, 2027
• Study Completion (Estimated): August 1, 2031
• Last Updated: December 6, 2024

Record last verified: 2024-12

Data Sharing

• IPD Sharing: Will not share

Locations

DE (1)