Prostate cancer 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
Interventions
Product Name: DCFPyL
Product Code: DCFPyL
Pharmaceutical Form: Solution for infusion
Sponsors
Amsterdam UMC, VU University Medical Center
Eligibility
Sex/Gender
Male
Inclusion criteria
Inclusion criteria: Male. Age = 18 years. Histopathological confirmed prostate adenocarcinoma per original diagnosis. History of RARP. Biochemical recurrence of prostate cancer based on two consecutive measurable PSA levels of 0.2 -2.0 ng/mL. Ability to understand and sign the written informed consent form. Patients who can undergo all study procedures per investigator’s point of view. 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 20 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 30
Exclusion criteria
Exclusion criteria: Another active malignant tumor, except skin basal cell carcinoma. pN1 disease after ePLND. Any change in prostate cancer treatment between both PET/CT scans. History of previous salvage therapies (including salvage radiotherapy or salvage lymph node dissection). History of salvage radiotherapy of the prostate bed. History of cryotherapy, high-intensity focused ultrasound (HIFU). Treatment with androgen deprivation therapy (ADT) in the past 30 days or ongoing. Unable to lie supine or still for imaging. Known allergy to investigational or reference products or to any excipients. Unable to provide written consent (linguistic or psychological inability). Uncooperative, in the Investigator’s opinion.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To head-to-head compare the imaging performance of 18F-fluciclovine PET/low-dose CT and 18F-DCFPyL PET/low-dose CT in patients with BCR of PCa after radical prostatectomy.;Primary end point(s): 1.To compare the per patient detection rates (i.e., the proportion of patients with PET-positive findings) of 18F-fluciclovine (reference test) versus 18F-DCFPyL PET/CT (index test) for the identification of tumour location(s) patients with BCR of disease after RARP (PSA <0.2). ;Timepoint(s) of evaluation of this end point: We expect to complete the patient inclusion in 9 months. Data analysis and document writing will require 2-3 months. ;Secondary Objective: 1.the detection rates on a patient-based analysis of 18F-DCFPyL and 18F-fluciclovine PET/CT stratified by PSA level (0.2-0.5; 0.51-1.0; 1.01-2.0 ng/mL); 2.the per-region detection rate of 18F-fluciclovine versus 18F-DCFPyL; 3.the side-effects of 18F-DCFPyL; 4.the inter-observer agreement. | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): 2. the detection rates on a patient-based analysis of 18F-DCFPyL and 18F-fluciclovine PET/CT stratified by PSA level (0.2-0.5; 0.51-1.0; 1.01-2.0 ng/mL); 3. the per-region detection rate of 18F-fluciclovine versus 18F-DCFPyL; 4. the side-effects of 18F-DCFPyL; 5. the inter-observer agreement. ;Timepoint(s) of evaluation of this end point: Please see above. | — |
Countries
Netherlands
Contacts
Public ContactDepartment of Nuclear Medicine
Amsterdam UMC, VU University Medical Center
Outcome results
None listed