Prostate Cancer
Conditions
Brief summary
This is a multi-center, single-arm, open-label, phase III trial in patients with biopsy-proven prostate cancer. Patients will receive regular standard of clinical care. The only study-specific procedures will the administration of 18F-DCFPyL followed by a PET/CT scan. Differences in theoretical optimal clinical management based on a review of clinical, biochemical and radiographic subject data before and after 18F-DCFPyL PET/CT imaging by a central panel of experts will be captured at study completion.
Detailed description
Objectives: The primary objective of this study is to assess the differences in theoretical optimal clinical management afforded by 18F-DCFPyL PET/CT in prostate cancer patients as proposed by a central panel of experts. Primary endpoint: 1\. Differences in theoretical optimal clinical management based on a review of clinical, histopathological, biochemical and radiographic subject data both before and after 18F-DCFPyL PET/CT imaging retrospectively by a central panel of experts. Secondary endpoints: 1. 18F-DCFPyL PET/CT scan positivity fraction in patients with biochemically recurrent prostate cancer, stratified by PSA. 2. Immediate AE up to 90 minutes post-administration of 18F-DCFPyL.
Interventions
DIAGNOSTIC_TEST18F-DCFPyL PET/CT
18F-DCFPyL Positron Emission Tomography/Computed Tomography Scan
Sponsors
Sir Mortimer B. Davis - Jewish General Hospital
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
DIAGNOSTIC
Masking
NONE
Eligibility
Sex/Gender
MALE
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Male sex * Age 18 years or older * Previously diagnosed with prostate cancer, under referring physician's care * ECOG performance status 0 - 3, inclusive * Able to understand and provide written informed consent * Able to tolerate the physical/logistical requirements of a PET/CT scan including lying supine (or prone) for up to 40 minutes and tolerating intravenous cannulation for injection Cohort A - High risk staging (HRS): Staging of high risk not previously treated patients as defined by any one of the following: * Gleason score \> 7 * Serum PSA \> 15 ng/ml * T stage of T3 or greater on TNM staging * Equivocal/inconclusive conventional staging such as CT, MRI or bone scan * Clinical suspicion of advance stage disease (e.g. bone pain) Cohort B - Biochemical recurrence: Restaging of biochemically recurrent prostate cancer patients as defined by increasing serum PSA on serial measurements and current PSA above 0.1 ng/ml following any treatment for prostate cancer.
Exclusion criteria
* Patients who are medically unstable (e.g. acute cardiac or respiratory distress or hypotensive) * Patients who exceed the safe weight limit of the PET/CT bed (usually approximately 400 lbs.) or who cannot fit through the PET/CT bore (usually approximately 70 cm diameter) * Patients with unmanageable claustrophobia
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Differences in optimal clinical management | 30 days | Differences in theoretical optimal clinical management based on a review of clinical, histopathological, biochemical and radiographic subject data both before and after 18F-DCFPyL PET/CT imaging retrospectively by a central panel of experts. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Scan positivity fraction in BCR by PSA. | 30 days | 18F-DCFPyL PET/CT scan positivity fraction in patients with biochemically recurrent prostate cancer, stratified by PSA. |
| Adverse events | 2 hours | Immediate AE up to 90 minutes post-administration of 18F-DCFPyL. |
Countries
Canada
Outcome results
None listed