de novo patients with histologically confirmed prostate cancer MedDRA version: 12.0 Level: LLT Classification code 10060862 Term: Prostate cancer
Conditions
Interventions
Product Name: 18F-fluoromethylcholine
Product Code: 18F-FCH
Pharmaceutical Form: Injection*
Sponsors
CIS bio international, member of IBA group
Eligibility
Sex/Gender
Male
Inclusion criteria
Inclusion criteria: 1. Male 2. Age > or = 18 years 3. De novo patient with histologically confirmed prostate cancer and high risk disease according to D’AMICO criteria: stages > or = T2c and/or PSA > or = 20 ng/ml and/or Gleason score > or = 8, or Gleason score = 7 with either predominance of grade 4 or percentage of positive biopsy > 50% 4. Patient who has already been imaged by contrast-enhanced thoraco-abdominal CT and bone scintigraphy 5. Patient who is able to undergo all study procedures and who has signed a written informed consent form to participate in the study Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: 1. Surgery within the last 4 weeks prior to the administration of [18F]-FCH 2. History of other malignant tumor 3. Previous radiation therapy 4. Prostate biopsy within 4 weeks before [18F]-FCH PET/CT 5. Concomitant medications containing choline 6. Severe allergic reaction to any of the ingredients of the choline formulation 7. Participation in another clinical study within one month prior to inclusion 8. Uncooperative, in the investigator's opinion 9. Linguistic or psychological inability to sign the informed consent form and/or take part in the study 10. Having already participated in this clinical trial
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: Sensitivity and specificity of [18F]-FCH PET/CT for systemic disease (i.e., lymph node metastases and/or organ metastases and/or bone metastases) on a body region basis.;Secondary Objective: • Sensitivity and specificity of [18F]-FCH PET/CT for lymph node metastases using histopathology as the SOR and CT as a comparator (per lymph node area; only lymph nodes area with histopathological analysis). Quantification using SUV (quantitative uptake in lymph nodes) will be used. • Agreement rate between [18F]-FCH PET/CT and CT for organ metastases on a region basis. Discrepant cases will be documented by MRI (except for lung metastases). For lung metastases, discrepant results will be documented by a chest CT performed within 6 monthsafter [18F]-FCH PET/CT. • Agreement rate between [18F]-FCH PET/CT and bone scintigraphy with regard to bone metastases (on a body region basis). Discrepant cases will be documented by MRI. • Sensitivity and specificity of [18F]-FCH PET/CT for systemic disease (i.e., lymph node metastases and/or organ metastases and/or bone metastases) on a patient basis. • Modification of tumor primary staging and patient management. • Safety of [18F]-FCH ;Primary end point(s): Sensitivity and specificity of [18F]-FCH PET/CT for primary staging of prostate cancer | — |
Countries
France, Spain
Outcome results
None listed