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Study of 18F-DCFPyL PET/CT Imaging in Patients With Prostate Cancer

NCT02981368 · Status: COMPLETED · Phase: PHASE2/PHASE3 · Type: INTERVENTIONAL · Enrollment: 385

Last updated 2021-08-09

Study results available
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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

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

Sponsors & Collaborators

  • Progenics Pharmaceuticals, Inc.

    lead INDUSTRY

Principal Investigators

  • Michael J Morris, MD · Memorial Sloan Kettering Cancer Center

  • Kenneth J Pienta, MD · Johns Hopkins University

Study Design

Allocation
NA
Purpose
DIAGNOSTIC
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
MALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2016-11-30
Primary Completion
2018-07-31
Completion
2018-07-31

Countries

  • United States
  • Canada

Study Locations

More Related Trials

Entities

Diseases

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 NCT02981368 on ClinicalTrials.gov