Actively Recruiting

Age: 18Years +
MALE
ID06260410

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

Led by Erasmus Medical Center · Updated on 2024-04-22

150

Participants Needed

1

Research Sites

N/A

Total Duration

On this page

AI-Summary

What this Trial Is About

Researchers are collecting data from patients with metastatic prostate cancer who are receiving Lutetium-PSMA (Lu-PSMA) therapy. The study aims to gather real-world information on how effective and safe this treatment is, as well as to collect dosimetry and biomarker data. This will help identify which patients benefit most from Lu-PSMA therapy. The study involves collecting blood samples during routine clinical visits to analyze circulating tumor DNA (ctDNA) and circulating tumor cells. These samples, along with PSMA-PET scans, will be used to evaluate response to treatment and explore biomarkers. There is no intervention beyond standard care; the study is observational and focuses on data collection. Participants will be monitored for up to 44 months to assess overall survival and progression-free survival. Researchers will also study the heterogeneity of PSMA positivity, the effect of biomarkers on treatment response, and scan data. The study is sponsored by Erasmus Medical Center and involves regular clinical follow-ups and blood draws as part of routine care.

CONDITIONS

Brief Title

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

Who Can Participate

Age: 18Years +
MALE

Eligibility Criteria

Eligible

You may qualify if you...

  • 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.
Not Eligible

You will not qualify if you...

History of severe allergic reactions to study medication Currently pregnant or breastfeeding Recent participation in another clinical trial within the last 30 days Presence of uncontrolled medical conditions that could affect safety

AI-Screening

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Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

1 visit (in-person)

Monitoring

Duration - Up to 44 months

Participants who undergo routine care are observed. Blood samples are collected during routine visits to analyze circulating tumor DNA and circulating tumor cells.

Visits aligned with routine clinical care

Trial Site Locations

Total: 1 location

1

Erasmus MC

Rotterdam, South Holland, Netherlands, 3015 CN

Actively Recruiting

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Research Team

S

Stijn Koolen, PhD

How is the study designed?

Study Type

OBSERVATIONAL

Masking

N/A

Allocation

N/A

Model

N/A

Primary Purpose

N/A

Number of Arms

0

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