Comparing blood PSMA-positive tumor cells with PSMA PET imaging and outcomes in prostate cancer

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This prospective, single-center proof-of-concept study enrolls adults with histologically confirmed prostate adenocarcinoma who are referred for 18F-PSMA PET imaging. Each participant gives a blood sample before their standard PET scan to detect PSMA-positive circulating tumor cells (CTC-PSMA). Imaging will be used to classify tumor burden into no, low/medium, or high-volume groups and those results will be correlated with CTC-PSMA status and subsequent clinical outcomes. The study aims to determine whether a liquid biopsy can mirror PSMA PET findings and relate to patient prognosis.

Why it matters

Who can join: the full rules

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).

Where it's running

• Iuct-O
  Toulouse, France Recruiting

Study contacts

• Study coordinator: Thibaut CASSOU-MOUNAT
• Email: Cassou-Mounat.Thibaut@iuct-oncopole.fr
• Phone: +33 (0)5 31 15 65 49

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.