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NCT06917781Recruiting

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

Source: ClinicalTrials.gov · Last updated 18 Nov 2025

Brief summary (registry, in English)

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 : low or medium tumor volume Positive 18F-PET-PSMA (patients with an uptake in prostate bed or with an oligo-metastatic extension (number of lesions \< 6)) Group 3 : high tumor volume Positive 18F-PET-PSMA (patients with a polymetastastatic extension (number of lesions ≥ 6)). In each of these groups, the rate of patients with positive PSMA CTC will be analyzed (i.e. patient having at least one CTC-PSMA positive). For patients with an indication of treatment by 177LuPSMA-617 (PLUVICTO®) according to standard practices, additional blood samples will also be collected at the following time points: 2nd cycle (T2) and 4th cycle of treatment (T3), just before injection. For these patients, data will be collected up to 6 months after the last treatment injection (clinical and biological data; results of tumor assessments based on 18F-PET-PSMA imaging).

Status (registry)
Recruiting
Study type
Interventional
Enrollment
80 (estimated)
First submitted
1 Apr 2025
Start date
28 Oct 2025
Primary completion date
Oct 2027
Lead sponsor
Institut Claudius Regaud
NCT number
NCT06917781

What you commit to

  • Study type: Interventional
  • Planned participants: 80
  • From 28 Oct 2025 to the primary completion date, Oct 2027
  • 1 site in 1 country
  • Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Prior treatment

  • Concurrent malignancy known to express a significant amount of PSMA (renal cancer, salivary gland tumors)

Other illness

  • Patient with an established neuro endocrine prostate cancer

Other

  • Patients with a contraindication to 18F-PET-PSMA
  • 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
  • Patient who has forfeited his freedom by administrative or legal award or who is under legal protection (curatorship and guardianship, protection of justice).

Who the study is looking for

  • Age ≥ 18 years
  • Histologically confirmed adenocarcinoma of the prostate
  • Indication for 18F-PET-PSMA imaging
  • Signed written informed consent
  • Patient able to participate and willing to give informed consent prior performance of any study-related procedures and to comply with the study protocol
  • Patient affiliated to a Social Health Insurance in France.

Age in the registry: 18 years to - · Sex: Male · Does not accept healthy volunteers

Full criteria on ClinicalTrials.gov

Sites (1)

Sites in registry order. Save your city in your profile to sort them by distance.

SiteCityCountrySite status
IUCT-O
Coordinator of this site? Confirm its status
ToulouseFranceRecruiting

This page is information, not medical advice. Discuss any trial with your doctor.