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NCT Number: NCT06260410

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

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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Key information

Conditions

Prostate Cancer Metastatic Genital Diseases Genital Diseases, Male Genital Neoplasms, Male Male Urogenital Diseases Neoplasms Neoplasms by Site Prostatic Diseases Prostatic Neoplasms Urogenital Diseases Urogenital Neoplasms

Age range

18 year and older

Sex eligibility

Male

Study type

Observational

Primary location

Erasmus MC

Rotterdam, South Holland, 3015 CN, Netherlands

Location status: Recruiting

Location contact

Stijn Koolen, PhD

CONTACT

[email protected]

+31638740656

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Blood draw for ctDNA and circulating tumor cell collection.

Diagnostic Test

During routine blood sample collection, additional blood will be drawn for analysis of ctDNA and to collect Circulating Tumor Cells.

Primary outcomes

  1. Overall survival

    Time frame: 44 months

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

Secondary outcomes

  1. 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.

  2. Heterogeneity of PSMA-positivity

    Time frame: 44 months

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

  3. 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.

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

    Time frame: 44 months

    Exploring the association between biomarkers in blood and response to treatment

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

    Time frame: 44 months

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

Study contacts

Contact information is provided by the study sponsor or research team.

Stijn Koolen, PhD

CONTACT

[email protected]

+31638740656

Sponsors and collaborators

Lead sponsor

Erasmus Medical Center

Other

Registry information

Acronym: LUTRAC

Important dates

Study start
2024
Primary completion
2027
Study completion
2027
First posted
Feb 15, 2024
Registry last updated
Apr 22, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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