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

Overview

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).

Interventions

• Other 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 Spon

Primary outcome measures

• The rate of patients presenting at least one (i.e >0) CTC-PSMA positive. [Time frame: 1 day for each patient]

Secondary outcome measures (4)

• The number of CTC-PSMA positive will be evaluated at inclusion for each group and just before the 2nd and 4th course of 177LuPSMA (C2/C4). [Time frame: 18 weeks for each patient]
• CTC-PSMA change will be defined as the number of CTC-PSMA positive at C2/C4 minus the number of CTC-PSMA positive at inclusion, if feasible. [Time frame: 18 weeks for each patient]
• The total number of CTC will be evaluated. [Time frame: 18 weeks for each patient]
• The response to 177LuPSMA [Time frame: 15 months]

Eligibility criteria

Inclusion criteria

• 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.

Exclusion criteria

• Patients with a contraindication to 18F-PET-PSMA
• Patient with an established neuro endocrine prostate cancer
• Concurrent malignancy known to express a significant amount of PSMA (renal cancer, salivary gland tumors)
• 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).

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation

N/A

Model

Single group

Masking

Open label

Primary purpose

Other

Study locations

France · 1 center

• IUCT-O — Toulouse

Identifiers

NCT: NCT06917781 · 25GENH01

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗