Study of 18F-DCFPyL PET/CT Imaging in Patients With Suspected Recurrence of Prostate Cancer
NCT03739684 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 208
Last updated 2021-06-14
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.
Conditions
- Prostate Cancer
- Prostate Adenocarcinoma
- Prostate Cancer Recurrent
- Prostate Cancer Metastatic
Interventions
- DRUG
-
18F-DCFPyL
A single dose of 9 mCi (333 MBq) IV injection of 18F-DCFPyL
- DIAGNOSTIC_TEST
-
PET/CT Imaging
PET/CT imaging will be acquired 1-2 hours post-PyL injection
Sponsors & Collaborators
-
Progenics Pharmaceuticals, Inc.
lead INDUSTRY
Principal Investigators
-
Jessica D Jensen · Progenics Pharmaceuticals, Inc.
Study Design
- Allocation
- NA
- Purpose
- DIAGNOSTIC
- Masking
- NONE
- Model
- SINGLE_GROUP
Eligibility
- Min Age
- 18 Years
- Sex
- MALE
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2018-11-27
- Primary Completion
- 2019-08-29
- Completion
- 2019-08-29
- FDA Drug
- Yes
Countries
- United States
- Canada
Study Locations
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