Comparing blood PSMA-positive tumor cells with PSMA PET imaging and outcomes in prostate cancer
Prostate Cancer Burden and Heterogeneity Evaluation Towards Liquid Biopsy: a Correlation Study to 18FDCFPyL PET and Patients Outcome
This will test whether PSMA-positive circulating tumor cells in a blood sample match 18F-PSMA PET scan results and help predict outcomes for people with prostate cancer getting PSMA PET imaging.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 80 (estimated) |
| Ages | 18 Years and up |
| Sex | Male |
| Sponsor | Institut Claudius Regaud Academic / other |
| Locations | 1 site (Toulouse) |
| Trial ID | NCT06917781 on ClinicalTrials.gov |
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.
Who should consider this trial
Good fit: Adults (≥18) with histologically confirmed prostate adenocarcinoma who are scheduled for 18F-PSMA PET imaging, can give informed consent, and are affiliated with French social health insurance.
Not a fit: Patients with neuroendocrine prostate cancer, concurrent PSMA-expressing non-prostate cancers, contraindications to PSMA PET, or who cannot provide informed consent are unlikely to benefit from this protocol.
Why it matters
Potential benefit: If successful, a blood test for PSMA-positive circulating tumor cells could offer a less invasive way to reflect imaging tumor burden and help guide prognosis or monitoring.
How similar studies have performed: Previous work has separately measured PSMA PET imaging and PSMA-positive circulating tumor cells, but direct correlations with imaging and outcome data are limited, making this a relatively novel proof-of-concept.
Eligibility criteria
Show full inclusion / exclusion criteria
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 this trial is running
Toulouse
- 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
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.