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

Status: Recruiting
Location: See location...
Intervention Type: Other
Study Type: Interventional
Study Phase: Not Applicable
SUMMARY

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).

Eligibility
Participation Requirements
Sex: Male
Minimum Age: 18
Healthy Volunteers: f
View:

• 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.

Locations
Other Locations
France
IUCT-O
RECRUITING
Toulouse
Contact Information
Primary
Thibaut CASSOU-MOUNAT
Cassou-Mounat.Thibaut@iuct-oncopole.fr
+33 (0)5 31 15 65 49
Backup
Frédéric COURBON
courbon.frederic@iuct-oncopole.fr
+33 (0)5 31 15 56 27
Time Frame
Start Date: 2025-09
Estimated Completion Date: 2028-12
Participants
Target number of participants: 80
Treatments
Other: Patients with prostate cancer
Related Therapeutic Areas
Sponsors
Leads: Institut Claudius Regaud

This content was sourced from clinicaltrials.gov