Prostate Cancer Burden and Heterogeneity Evaluation Towards Liquid Biopsy: a Correlation Study to 18FDCFPyL PET and Patients Outcome
NCT ID: NCT06917781
Last Updated: 2025-11-18
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
NA
80 participants
INTERVENTIONAL
2025-10-28
2028-10-31
Brief Summary
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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).
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Detailed Description
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Conditions
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Study Design
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NA
SINGLE_GROUP
OTHER
NONE
Study Groups
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Patients with prostate cancer
Patients with 18F-PET-PSMA indication
Blood samples taken on several occasions:
* before the 18F-PSMA PET scan for extension assessment, for all patients.
* at 2nd and 4th treatment cycles (prior to treatment administration), only for patients receiving PLUVICTO® therapy.
During the 1st treatment cycle, samples (optional for the patient) may also be taken at 5 different post-perfusion times.
In addition, all imaging examinations performed during the study (standard 18F-PSMA PET scans) will be collected and centralized by the Sponsor for analysis.
Interventions
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Patients with 18F-PET-PSMA indication
Blood samples taken on several occasions:
* before the 18F-PSMA PET scan for extension assessment, for all patients.
* at 2nd and 4th treatment cycles (prior to treatment administration), only for patients receiving PLUVICTO® therapy.
During the 1st treatment cycle, samples (optional for the patient) may also be taken at 5 different post-perfusion times.
In addition, all imaging examinations performed during the study (standard 18F-PSMA PET scans) will be collected and centralized by the Sponsor for analysis.
Eligibility Criteria
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Inclusion Criteria
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
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).
18 Years
MALE
No
Sponsors
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Institut Claudius Regaud
OTHER
Responsible Party
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Locations
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IUCT-O
Toulouse, , France
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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25GENH01
Identifier Type: -
Identifier Source: org_study_id
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