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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 · Status: RECRUITING · Type: OBSERVATIONAL · Enrollment: 100

Last updated 2024-12-06

No results posted yet for this 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.

Conditions

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

Interventions

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.

Sponsors & Collaborators

  • Hannah Schaefer

    lead OTHER

Eligibility

Min Age
18 Years
Sex
MALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2024-08-05
Primary Completion
2027-08-01
Completion
2031-08-01

Countries

  • Germany

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06720532 on ClinicalTrials.gov