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Clinical Trials/NCT06260410
NCT06260410
Recruiting
Not Applicable

Data Collection in Lutetium Treated Prostate Cancer: Recording of Progression and Tumor Characteristics

Erasmus Medical Center1 site in 1 country150 target enrollmentFebruary 20, 2024

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Prostate Cancer Metastatic
Sponsor
Erasmus Medical Center
Enrollment
150
Locations
1
Primary Endpoint
Overall survival
Status
Recruiting
Last Updated
2 years ago

Overview

Brief Summary

This prospective study aims to collect data and blood biomarkers from patients undergoing Lu-PSMA therapy at the Erasmus MC. In doing so, it will provide real-world efficacy and safety data on the drug, gather dosimetry data and explore putative biomarkers to identify patients who most benefit from Lu-PSMA treatment.

Registry
clinicaltrials.gov
Start Date
February 20, 2024
End Date
February 1, 2027
Last Updated
2 years ago
Study Type
Observational
Sex
Male

Investigators

Responsible Party
Principal Investigator
Principal Investigator

S. L. W. (Stijn) Koolen

Assistant Professor, Hospital Pharmacist, Clinical Pharmacologist

Erasmus Medical Center

Eligibility Criteria

Inclusion Criteria

  • Participants should be at least 18 years old.
  • Participants should be able to understand the written information and be able to provide informed consent.
  • Participants are planned to start treatment with Lu-PSMA as a part of regular clinical care.

Exclusion Criteria

  • None applicable

Outcomes

Primary Outcomes

Overall survival

Time Frame: 44 months

Overall survival will be defined as the time from inclusion to death from any cause.

Secondary Outcomes

  • Progression free survival(44 months)
  • Heterogeneity of PSMA-positivity(44 months)
  • Effect of CTC PSMA expression on response to treatment.(44 months)
  • PSMA-PET scan data and response to treatment.(44 months)
  • Effect of biomarkers in blood on response to treatment.(44 months)

Study Sites (1)

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