Patients with histopathologically confirmed prostate adenocarcinoma per original diagnosis and subsequent definitive therapy, with first biochemical recurrence MedDRA version: 21.0 Level: PT Classification code 10036911 Term: Prostate cancer recurrent System Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Conditions
Sponsors
CYCLOPHARMA
Eligibility
Sex/Gender
Male
Inclusion criteria
Inclusion criteria: 1. Male. 2. Age superior or equal to 18 years. 3. Histopathological proven prostate adenocarcinoma per original diagnosis. 4. First suspected recurrence of prostate cancer based on rising prostate-specific antigen (PSA) after initial curative therapy with radical prostatectomy of PSA = 0.2 ng/mL confirmed by a subsequent PSA value of =0.2 ng/mL or with radiation therapy (external beam or brachytherapy) of PSA > 2 ng/mL above the nadir after therapy regardless of the serum concentration of the nadir. 5. Able and willing to provide informed consent and comply with protocol requirements 6. Patient who can undergo all study procedures per Investigator’s point of view 7. Patient with social insurance cover. 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 43 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 174
Exclusion criteria
Exclusion criteria: 1. ECOG > 2 2. History of previous salvage therapies (including salvage radiotherapy or salvage lymph node dissection) 3. History of adjuvant radiotherapy 4. History of cryotherapy, high-intensity focused ultrasound (HIFU) 5. Other active malignant tumour 6. Treatment with Androgen Deprivation Therapy (ADT) in the past 30 days or ongoing 7. Unable to lie supine for imaging 8. Known allergy to investigational or reference products or to any excipients 9. Unable to provide written consent (linguistic or psychological inability) 10. Participation in another clinical study within one month prior to inclusion 11. Uncooperative, in the Investigator's opinion. 12. Subjects deprived of their freedom by administrative or legal decision or who are under guardianship
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: Per-patient detection rate of 18F-DCFPyL PET/CT versus that of 18F-FCH PET/CT;Secondary Objective: Impact on patient treatment/management. Per-region detection rate of 18F-DCFPyL PET/CT versus that of 18F-FCH PET/CT. Sensitivity and specificity of 18F-DCFPyL PET/CT versus that of 18F-FCH PET/CT on a per-patient and per-lesion basis, using a composite SOR. Concordance rate between 18F-DCFPyL PET/CT and 18F-FCH PET/CT for lesions using a composite SOR. Safety of 18F-DCFPyL versus that of 18F-FCH ;Primary end point(s): Per-patient detection rate of 18F-DCFPyL PET/CT and 18F-FCH PET/CT for recurrence (either local, regional or distant), based on a surrogate SOR. The SOR will be made of an appropriate combination of tests performed in clinical routine practice during the following 6 to 7 months after the last 18F-tracer injection including: clinical data, PSA, histopathology and follow-up imaging exams.;Timepoint(s) of evaluation of this end point: 6 to 7 months of follow-up after the last tracer administration | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): • Impact on patient treatment/management. • Per-region detection rate of 18F-DCFPyL PET/CT versus that of 18F-FCH PET/CT. • Sensitivity and specificity of 18F-DCFPyL PET/CT versus that of 18F-FCH PET/CT on a per-patient and per-lesion basis, using composite SOR. • Concordance rate between 18F-DCFPyL PET/CT and 18F-FCH PET/CT for lesions using composite SOR. • Safety of 18F-DCFPyL versus that of 18F-FCH ;Timepoint(s) of evaluation of this end point: 6 to 7 months of follow-up after the last tracer administration | — |
Countries
France, Netherlands
Contacts
Public ContactAurélie ETRINGER
ICTA PM
Outcome results
None listed