CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 385 enrolled
Drug / intervention
18F-DCFPyL Injection +1 moredrug
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT02981368
NCT02981368Phase 3Completed
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A PrOspective Phase 2/3 Multi-Center Study of 18F-DCFPyL PET/CT Imaging in Patients With PRostate Cancer: Examination of Diagnostic AccuracY (OSPREY)

Progenics Pharmaceuticals, Inc.·interventional·Posted Dec 5, 2016·Updated Aug 9, 2021

In Brief

A Phase 3 clinical trial evaluating 18F-DCFPyL Injection and PET/CT imaging for Prostate Cancer. Completed, enrolled 385 participants across 10 sites in 2 countries.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsProstate Cancer
CountriesCanada, United States
Collaborators--

Timeline

Phase 3CompletedFinished
2017201820192020202120222023202420252026
First PostedDec 5, 2016
Enrollment StartNov 1, 2016
Primary CompletionJul 1, 2018
TodayJul 2, 2026
Enrollment to primary: 1.7 yearsPosted 9.6 years ago

Interventions

18F-DCFPyL Injectiondrug

A single dose of 9±1 mCi (333±37 MBq) IV injection of 18F-DCFPyL

PET/CT imagingother

PET/CT imaging will be acquired 1-2 hours post-PyL injection