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

NCT06260410 | Recruiting

• 2 other identifiers: 10512NL84672.078.23
• Study Type: observational
• Target: 150
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Prostate Cancer Metastatic

Keywords

mCRPC; Lu-PSMA; Prostate Cancer; Radioligand Therapy

Outcome Measures

Primary Outcomes (1)

• Overall survival

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

  44 months

Secondary Outcomes (5)

• Progression free survival

  44 months

• Heterogeneity of PSMA-positivity

  44 months

• Effect of CTC PSMA expression on response to treatment.

  44 months

• Effect of biomarkers in blood on response to treatment.

  44 months

• PSMA-PET scan data and response to treatment.

  44 months

Interventions

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.

Eligibility Criteria

• Age: 18 Years+
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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.

You may not qualify if:

• None applicable

Sponsors & Collaborators

• Erasmus Medical Center: lead

Study Sites (1)

Erasmus MC

Rotterdam, South Holland, 3015 CN, Netherlands

RECRUITING

Biospecimen

Retention: SAMPLES WITH DNA

Circulating tumor DNA is obtained as part of this study to explore PSMA expression and how this relates to therapy outcomes. Plasma samples are stored according to standard of conservation.

MeSH Terms

Conditions

Prostatic Neoplasms

Interventions

Blood Specimen Collection

Condition Hierarchy (Ancestors)

Genital Neoplasms, Male; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Prostatic Diseases; Male Urogenital Diseases

Intervention Hierarchy (Ancestors)

Specimen Handling; Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Punctures; Surgical Procedures, Operative; Investigative Techniques

Central Study Contacts

Stijn Koolen, PhD

CONTACT

+31638740656; s.koolen@erasmusmc.nl

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor, Hospital Pharmacist, Clinical Pharmacologist

Study Record Dates

• First Submitted: February 7, 2024
• First Posted: February 15, 2024
• Study Start: February 20, 2024
• Primary Completion (Estimated): February 1, 2027
• Study Completion (Estimated): February 1, 2027
• Last Updated: April 22, 2024

Record last verified: 2024-04

Locations

NL (1)