- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02825875
Study of the Clinical Utility of PSMA Imaging in the Evaluation of Men With Prostate Cancer
May 5, 2020 updated by: Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Observational
Enrollment (Actual)
200
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
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Maryland
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Baltimore, Maryland, United States, 21287
- Johns Hopkins University
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 100 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
Male
Sampling Method
Non-Probability Sample
Study Population
Adenocarcinoma of the prostate
Description
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).
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
---|---|
adenocarcinoma of the prostate
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Physician responses to a questionnaire
Time Frame: less than 1 year
|
The Post-PET/CT questionnaire will determine if the PET/CT scan results in changes to clinical management of patient illness.
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less than 1 year
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Collaborators
Investigators
- Principal Investigator: Michael Gorin, MD, Professor of Oncology
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
June 8, 2016
Primary Completion (Actual)
April 1, 2020
Study Completion (Actual)
April 1, 2020
Study Registration Dates
First Submitted
June 30, 2016
First Submitted That Met QC Criteria
July 1, 2016
First Posted (Estimate)
July 7, 2016
Study Record Updates
Last Update Posted (Actual)
May 7, 2020
Last Update Submitted That Met QC Criteria
May 5, 2020
Last Verified
May 1, 2020
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- J15216
- IRB00084971 (Other Identifier: JHM IRB)
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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