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

April 19, 2024 updated by: S. L. W. (Stijn) Koolen, Erasmus Medical Center
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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Estimated)

150

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Netherlands
    • Zuid-Holland
      • Rotterdam, Zuid-Holland, Netherlands, 3015 CN
        • Recruiting
        • Erasmus MC
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

Patients diagnosed with metastatic castration resistant prostate cancer set to receive treatment with Lutetium-177 Prostate Specific Membrane Antigen (Lu-PSMA) as a part of regular clinical care.

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Overall survival
Time Frame: 44 months
Overall survival will be defined as the time from inclusion to death from any cause.
44 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Progression free survival
Time Frame: 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.
44 months
Heterogeneity of PSMA-positivity
Time Frame: 44 months
Exploring heterogeneity of PSMA-positivity in circulating tumor cells (CTC) prior to treatment with Lutetium-PSMA.
44 months
Effect of CTC PSMA expression on response to treatment.
Time Frame: 44 months
Exploring whether there is an association between the fraction of PSMA positive CTCs and response to Lutetium-PSMA treatment.
44 months
Effect of biomarkers in blood on response to treatment.
Time Frame: 44 months
Exploring the association between biomarkers in blood and response to treatment
44 months
PSMA-PET scan data and response to treatment.
Time Frame: 44 months
Exploring associations between PSMA-PET and therapy scans and response to treatment.
44 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Erasmus Medical Center

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

February 20, 2024

Primary Completion (Estimated)

February 1, 2027

Study Completion (Estimated)

February 1, 2027

Study Registration Dates

First Submitted

February 7, 2024

First Submitted That Met QC Criteria

February 7, 2024

First Posted (Actual)

February 15, 2024

Study Record Updates

Last Update Posted (Actual)

April 22, 2024

Last Update Submitted That Met QC Criteria

April 19, 2024

Last Verified

April 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 10512 (Other Identifier: CTEP)
  • NL84672.078.23 (Other Identifier: CCMO)

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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