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



Status:Recruiting
Conditions:Prostate Cancer, Cancer
Therapuetic Areas:Oncology
Healthy:No
Age Range:18 - 100
Updated:2/10/2019
Start Date:June 8, 2016
End Date:May 2020
Contact:Kenneth Pienta, MD
Email:kpienta1@jhmi.edu
Phone:(410)502-3137

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Trial Summary
Trial Overview
Inclusion Criteria
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.


Inclusion Criteria:

1. Age ≥18 years

2. Willingness to signed informed consent

3. Histologically confirmed adenocarcinoma of the prostate

4. PSA measurement ≤60 days prior to study enrollment

5. 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:

1. Administered a radioisotope within 5 physical half-lives prior to study enrollment

2. 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).
We found this trial at
1
site
Johns Hopkins University
3400 N Charles St
Baltimore, Maryland 21205
410-516-8000
Phone: 410-502-1040
Johns Hopkins University The Johns Hopkins University opened in 1876, with the inauguration of its...
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from
Baltimore, MD
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