Trials / Enrolling By Invitation
Enrolling By InvitationNCT03459820
Prostate Cancer Patient Management With 18F-DCFPyL PET/CT
Differences in Optimal Prostate Cancer Patient Management as Proposed by a Panel of Experts Before and After 18F-DCFPyL PET/CT
- Status
- Enrolling By Invitation
- Phase
- Phase 2 / Phase 3
- Study type
- Interventional
- Enrollment
- 1,500 (estimated)
- Sponsor
- Sir Mortimer B. Davis - Jewish General Hospital · Academic / Other
- Sex
- Male
- Age
- 18 Years
- Healthy volunteers
- Not accepted
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.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DIAGNOSTIC_TEST | 18F-DCFPyL PET/CT | 18F-DCFPyL Positron Emission Tomography/Computed Tomography Scan |
Timeline
- Start date
- 2018-06-22
- Primary completion
- 2027-06-01
- Completion
- 2028-06-01
- First posted
- 2018-03-09
- Last updated
- 2023-11-27
Locations
1 site across 1 country: Canada
Source: ClinicalTrials.gov record NCT03459820. Inclusion in this directory is not an endorsement.