Trials / Completed
CompletedNCT02981368
Study of 18F-DCFPyL PET/CT Imaging in Patients With Prostate Cancer
A PrOspective Phase 2/3 Multi-Center Study of 18F-DCFPyL PET/CT Imaging in Patients With PRostate Cancer: Examination of Diagnostic AccuracY (OSPREY)
- Status
- Completed
- Phase
- Phase 2 / Phase 3
- Study type
- Interventional
- Enrollment
- 385 (actual)
- Sponsor
- Progenics Pharmaceuticals, Inc. · Industry
- Sex
- Male
- Age
- 18 Years
- Healthy volunteers
- Not accepted
Summary
This study evaluates the safety and diagnostic performance of 18F-DCFPyL Injection in patients with at least high risk prostate cancer who are planned for radical prostatectomy with lymphadenectomy (Cohort A) or in patients with locally recurrent or metastatic disease willing to undergo biopsy (Cohort B). Cohort B is complete and no longer recruiting subjects.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | 18F-DCFPyL Injection | A single dose of 9±1 mCi (333±37 MBq) IV injection of 18F-DCFPyL |
| DIAGNOSTIC_TEST | PET/CT imaging | PET/CT imaging will be acquired 1-2 hours post-PyL injection |
Timeline
- Start date
- 2016-11-01
- Primary completion
- 2018-07-01
- Completion
- 2018-07-01
- First posted
- 2016-12-05
- Last updated
- 2021-08-09
- Results posted
- 2021-08-09
Locations
10 sites across 2 countries: United States, Canada
Source: ClinicalTrials.gov record NCT02981368. Inclusion in this directory is not an endorsement.