At a glance
ClinicalIndex Comparison RecordPhase 3Completed· 208 enrolled
Drug / intervention
18F-DCFPyL +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.
A Phase 3, Multi-Center, Open-Label Study to Assess the Diagnostic Performance and Clinical Impact of 18F-DCFPyL PET/CT Imaging Results in Men With Suspected Recurrence of Prostate Cancer
In Brief
A Phase 3 clinical trial evaluating 18F-DCFPyL and PET/CT Imaging for Prostate Cancer and 3 related conditions. Completed, enrolled 208 participants across 14 sites in 2 countries.
Detailed Summary
This study evaluates the diagnostic performance and safety of 18F-DCFPyL (PyL) PET/CT imaging in patients with suspected recurrence of prostate cancer who have negative or equivocal findings on conventional imaging.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsProstate Cancer, Prostate Adenocarcinoma, Prostate Cancer Recurrent, Prostate Cancer Metastatic
CountriesCanada, United States
Collaborators--
Timeline
Phase 3CompletedFinished
20192020202120222023202420252026
First PostedNov 2018
Enrollment StartNov 2018
Primary CompletionAug 2019
TodayJul 2026
First PostedNov 14, 2018
Enrollment StartNov 27, 2018
Primary CompletionAug 29, 2019
TodayJul 2, 2026
Enrollment to primary: 9 monthsPosted 7.6 years ago
Interventions
18F-DCFPyLdrug
A single dose of 9 mCi (333 MBq) IV injection of 18F-DCFPyL
PET/CT Imagingother
PET/CT imaging will be acquired 1-2 hours post-PyL injection