Study of the Clinical Utility of PSMA Imaging in the Evaluation of Men With Prostate Cancer

Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins1 site in 1 country200 target enrollmentJune 8, 2016

ConditionsProstate Cancer

Interventions18F DCFPyL- Radiopharmaceutica

Drugs18F DCFPyL- Radiopharmaceutica

Overview

Phase: Not Applicable
Intervention: 18F DCFPyL- Radiopharmaceutica
Conditions: Prostate Cancer
Sponsor: Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
Enrollment: 200
Locations: 1
Primary Endpoint: Physician responses to a questionnaire
Status: Completed
Last Updated: 5 years ago

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Sites Similar Trials

Overview

Brief Summary

In this study we aim to more precisely define the clinical utility of PSMA imaging across a range of clinical indications in men with prostate cancer. To accomplish this, we will make the 18F-DCFPyL PET/CT scan available to urologists, medical oncologists, and radiation oncologists at Johns Hopkins and survey physicians as to the indication for ordering the PET/CT and if a change in management occurred as the result of new information gained from the scan. We believe these data will prove critical for planning future studies aimed at evaluating the efficacy of this test for improving patient outcomes.

Registry

clinicaltrials.gov

Start Date

June 8, 2016

End Date

April 2020

Last Updated

5 years ago

Study Type

Observational

Sex

Male

Investigators

Sponsor

Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins

Responsible Party

Sponsor

Eligibility Criteria

Inclusion Criteria

•Age ≥18 years
•Willingness to signed informed consent
•Histologically confirmed adenocarcinoma of the prostate
•PSA measurement ≤60 days prior to study enrollment
•Completed radiographic evaluation with whole-body bone scan (99mTc-MDP or Na18F) and cross-sectional imaging (CT or MRI) of the abdomen and pelvis ≤60 days prior to study enrollment

Exclusion Criteria

•Administered a radioisotope within 5 physical half-lives prior to study enrollment
•History of other malignancy diagnosed within the last 5 years (exceptions: low grade urothelial carcinoma of the bladder, squamous cell carcinoma or basal cell carcinoma of the skin).