Recruiting NCT06260410
Data Collection in Lutetium Treated Prostate Cancer: Recording of Progression and Tumor Characteristics
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Blood draw for ctDNA and circulating tumor cell collection..
- Who it may be relevant to
- Registry conditions: Prostate Cancer Metastatic. Basic parameters: from 18 years · Male.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Netherlands
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Overview
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.
Interventions
- 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.
Primary outcome measures
- Overall survival [Time frame: 44 months]
Secondary outcome measures (5)
- Progression free survival [Time frame: 44 months]
- Heterogeneity of PSMA-positivity [Time frame: 44 months]
- Effect of CTC PSMA expression on response to treatment. [Time frame: 44 months]
- Effect of biomarkers in blood on response to treatment. [Time frame: 44 months]
- PSMA-PET scan data and response to treatment. [Time frame: 44 months]
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Observational model
- Cohort
Study locations
Netherlands · 1 center
- Erasmus MC — Rotterdam
Identifiers
NCT: NCT06260410 · 10512 · NL84672.078.23