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
Curium PET France
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. Treatment with colchicine in the past 8 days or ongoing 8. Treatment with hematopoietic colony stimulating factors (CSF) in the past 5 days or ongoing 9. Unable to lie supine for imaging 10. Known allergy to investigational or reference products or to any excipients 11. Unable to provide written consent (linguistic or psychological inability) 12. Participation in another clinical study within one month prior to inclusion 13. Uncooperative, in the Investigator's opinion. 14. 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-region basis, using a composite SOR. Concordance rate between 18F-DCFPyL PET/CT and 18F-FCH PET/CT for regions 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 the independent central reading. The detection rate is defined as the ratio between the number of patients defined as positive at patient level by at least 2 independent readers, and the total number of assessed patients.;Timepoint(s) of evaluation of this end point: Last patient last tracer injection | — |
Secondary
| Measure | Time frame |
|---|---|
| Timepoint(s) of evaluation of this end point: 10 months of follow-up after last patient last tracer injection.;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-region basis, using composite SOR. • Concordance rate between 18F-DCFPyL PET/CT and 18F-FCH PET/CT for regions using composite SOR. • Safety of 18F-DCFPyL versus that of 18F-FCH. The SOR will be made of an appropriate combination of tests performed in clinical routine practice during the following 10 months after the last 18F-tracer injection including: clinical data, PSA, histopathology and follow-up imaging exams. The per-region detection rate is the ratio between the number of patients defined as positive at region level for a given region by at least 2 independent readers and the total number of assessed patients. The per-patient sensitivity is the ratio between the number of patients defined as positive at patient level by at least 2 independent readers and the total number of patients assessed as positive at patient level by the truth panel. The per-region sensitivity is the ratio between the number of patients defined as positive at region level for a given region by at least 2 independent readers and the total number of patients assessed as positive at region level for the given region by the truth panel. The per-patient specificity is the ratio between the number of patients defined as negative at patient level by at least 2 independent readers and the total number of patients assessed as negative at patient level by the truth panel. The per-region specificity is calculated for each region as the ratio between the number of patients defined as negative at region level for the considered region by at least 2 independent readers and the total number of patients assessed as negative at region level for | — |
Countries
France, Netherlands
Contacts
Public ContactD. Ekkel
Clinical Trial Service B.V.
Outcome results
None listed