Differences in Optimal Prostate Cancer Patient Management as Proposed by a Panel of Experts Before and After 18F-DCFPyL PET/CT
Overview
- Phase
- Phase 2
- Intervention
- Not specified
- Conditions
- Prostate Cancer
- Sponsor
- Sir Mortimer B. Davis - Jewish General Hospital
- Enrollment
- 1500
- Locations
- 1
- Primary Endpoint
- Differences in optimal clinical management
- Status
- Enrolling By Invitation
- Last Updated
- 2 years ago
Overview
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.
Investigators
Stephan Probst, MD
Chief of Nuclear Medicine
Sir Mortimer B. Davis - Jewish General Hospital
Eligibility Criteria
Inclusion Criteria
- •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
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
Outcomes
Primary Outcomes
Differences in optimal clinical management
Time Frame: 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 Outcomes
- Adverse events(2 hours)
- Scan positivity fraction in BCR by PSA.(30 days)