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

Prostate Cancer Metastatic Clinical Trial

— LUTRAC  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06260410
• Other study ID #: 10512
• Secondary ID: NL84672.078.23
• Status: Recruiting
• Start date: February 20, 2024
• Est. completion date: February 1, 2027

Study information

• Verified date: April 2024
• Source: Erasmus Medical Center
• Contact: Stijn Koolen, PhD
• Phone: +31638740656
• Email: s.koolen[@]erasmusmc.nl
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 150
• Est. completion date: February 1, 2027
• Est. primary completion date: February 1, 2027
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Prostate Cancer Metastatic
• Prostatic Neoplasms

Intervention

Diagnostic Test:
• Blood draw for ctDNA and circulating tumor cell collection.
During routine blood sample collection, additional blood will be drawn for analysis of ctDNA and to collect Circulating Tumor Cells.

Locations

Country	Name	City	State
Netherlands	Erasmus MC	Rotterdam	Zuid-Holland

Sponsors (1)

Lead Sponsor	Collaborator
Erasmus Medical Center

Country where clinical trial is conducted

Netherlands, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Overall survival	Overall survival will be defined as the time from inclusion to death from any cause.	44 months
Secondary	Progression free survival	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.	44 months
Secondary	Heterogeneity of PSMA-positivity	Exploring heterogeneity of PSMA-positivity in circulating tumor cells (CTC) prior to treatment with Lutetium-PSMA.	44 months
Secondary	Effect of CTC PSMA expression on response to treatment.	Exploring whether there is an association between the fraction of PSMA positive CTCs and response to Lutetium-PSMA treatment.	44 months
Secondary	Effect of biomarkers in blood on response to treatment.	Exploring the association between biomarkers in blood and response to treatment	44 months
Secondary	PSMA-PET scan data and response to treatment.	Exploring associations between PSMA-PET and therapy scans and response to treatment.	44 months