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RecruitingNCT06260410LUTRACUpdated Apr 22, 2024

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

An observational study in Prostate Cancer Metastatic, sponsored by Erasmus Medical Center. Recruiting at 1 site in Netherlands. Open to male participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2024-04-22.

Sponsored by Erasmus Medical Center · Observational

From the registry’s dates

  • Started Feb 2024; still recruiting 2 years 7 months later.
Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
150
Ages
18 Years and older
Sex
Male
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Study 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.

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Conditions studied

  • Prostate Cancer Metastatic

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Keywords

  • mCRPC
  • Lu-PSMA
  • Prostate Cancer
  • Radioligand Therapy
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In context

Prostatic Neoplasms

6,370 studies on the registry are indexed under Prostatic Neoplasms; 1,400 are open to participants now.

This study's planned enrollment of 150 is below the median of 200 across 1,181 observational studies indexed under Prostatic Neoplasms.

Browse Prostatic Neoplasms studies →

Lead sponsor

Erasmus Medical Center is the lead sponsor of 466 studies on the registry; 179 are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
18 Years and older
Sexes eligible
Male
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.

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

Exclusion Criteria:

None applicable

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Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
150 participants (estimated)
Patient registry
No
Biospecimen retention
Samples with dna

Interventions

  • Diagnostic testBlood 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.

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What researchers measure

Primary outcomes

  1. Overall survival

    Overall survival will be defined as the time from inclusion to death from any cause.

    Time frame: 44 months

Secondary outcomes

  1. 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.

    Time frame: 44 months

  2. Heterogeneity of PSMA-positivity

    Exploring heterogeneity of PSMA-positivity in circulating tumor cells (CTC) prior to treatment with Lutetium-PSMA.

    Time frame: 44 months

  3. 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.

    Time frame: 44 months

  4. Effect of biomarkers in blood on response to treatment.

    Exploring the association between biomarkers in blood and response to treatment

    Time frame: 44 months

  5. PSMA-PET scan data and response to treatment.

    Exploring associations between PSMA-PET and therapy scans and response to treatment.

    Time frame: 44 months

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Study locations

1 of 1 sites recruiting
  • Erasmus MC
    Rotterdam, Zuid-Holland 3015 CN, Netherlands
    Recruiting
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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Apr 22, 2024, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT06260410
Lead sponsor
Erasmus Medical Center
Responsible party
S. L. W. (Stijn) Koolen (Assistant Professor, Hospital Pharmacist, Clinical Pharmacologist, Erasmus Medical Center) — Principal investigator
First posted
Feb 15, 2024
Start date
Feb 20, 2024
Primary completion
Feb 1, 2027 (estimated)
Completion
Feb 1, 2027 (estimated)
Last update
Apr 22, 2024

Study contacts

Stijn Koolen, PhD
Contact
s.koolen@erasmusmc.nl
+31638740656

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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