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Prostate Cancer Burden and Heterogeneity Evaluation Towards Liquid Biopsy: a Correlation Study to 18FDCFPyL PET and Patients Outcome

RecruitingNAAges 18 Years - anyMaleInstitut Claudius Regaud
NCT06917781 on ClinicalTrials.gov ↗
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In plain words

What the trial is, and whether it could suit you

This is a prospective, monocentric, proof of concept study aims to identify in prostate cancer patients, a potential relationship between CTC-PSMA positivity and 18F-PET-PSMA results as well as patient outcome. Patients with 18F-PET-PSMA indication will perform imaging extension work-up as part of current practice. If they agree to participate in the study, a blood sample will be performed prior to the 18F-PET-PSMA standard imaging (T1). In order to evaluate the potential relationship between CTC-PSMA and 18F-PET-PSMA imaging, the study will be presented to all patients seen in consultation for an extension workup for prostate cancer. This will allow to analyze the results in patients with different level of tumor burden afterward to define the following three groups based on imaging results: Group 1 : no tumor volume Negative 18F-PET-PSMA (patients without uptake lesion) Group 2 : l

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📋 Eligibility rules (as published)
Inclusion Criteria: 1. Age ≥ 18 years 2. Histologically confirmed adenocarcinoma of the prostate 3. Indication for 18F-PET-PSMA imaging 4. Signed written informed consent 5. Patient able to participate and willing to give informed consent prior performance of any study-related procedures and to comply with the study protocol 6. Patient affiliated to a Social Health Insurance in France. Exclusion Criteria: 1. Patients with a contraindication to 18F-PET-PSMA 2. Patient with an established neuro endocrine prostate cancer 3. Concurrent malignancy known to express a significant amount of PSMA (renal cancer, salivary gland tumors) 4. Any psychological, familial, geographic or social situation, according to the judgment of investigator, potentially preventing the provision of informed consent or compliance to study procedure 5. Patient who has forfeited his freedom by administrative or legal award or who is under legal protection (curatorship and guardianship, protection of justice).
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What it tests

  • Patients with 18F-PET-PSMA indication
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Where

1 site
IUCT-O
Toulouse, France
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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