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

Recruiting

• Conditions: Prostate Cancer Metastatic

• Registration Number: NCT06260410
• Lead Sponsor: Erasmus Medical Center

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2024-02-07
• Study First Submitted QC: 2024-02-07
• Study First Posted: 2024-02-15
• Study Start: 2024-02-20
• Status Verified: 2024-04
• Last Update Submitted: 2024-04-19
• Last Update Posted: 2024-04-22
• Primary Completion: 2027-02-01
• Study Completion: 2027-02-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: Male
• Target Recruitment: 150

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Overall survival	44 months	Overall survival will be defined as the time from inclusion to death from any cause.

Secondary Outcome Measures

Name	Time	Method
Progression free survival	44 months	Progression free survival will be defined as clinical, radiological or PSA progression according to Prostate Cancer Working Group 3 (PCWG3) or death, whichever occurs first.
Heterogeneity of PSMA-positivity	44 months	Exploring heterogeneity of PSMA-positivity in circulating tumor cells (CTC) prior to treatment with Lutetium-PSMA.
Effect of CTC PSMA expression on response to treatment.	44 months	Exploring whether there is an association between the fraction of PSMA positive CTCs and response to Lutetium-PSMA treatment.
PSMA-PET scan data and response to treatment.	44 months	Exploring associations between PSMA-PET and therapy scans and response to treatment.
Effect of biomarkers in blood on response to treatment.	44 months	Exploring the association between biomarkers in blood and response to treatment

Trial Locations

Locations (1)

Erasmus MC; 🇳🇱 Rotterdam, Zuid-Holland, Netherlands