- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06260410
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
- Name: Stijn Koolen, PhD
- Phone Number: +31638740656
- Email: s.koolen@erasmusmc.nl
Study Locations
-
-
Zuid-Holland
-
Rotterdam, Zuid-Holland, Netherlands, 3015 CN
- Recruiting
- Erasmus MC
-
Contact:
- Stijn Koolen, PhD
- Phone Number: +31638740656
- Email: s.koolen@erasmusmc.nl
-
-
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
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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