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

Study results available
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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

More Related Trials

Entities

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03739684 on ClinicalTrials.gov