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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02825875
Recruitment Status : Completed
First Posted : July 7, 2016
Last Update Posted : May 7, 2020
Sponsor:
Collaborator:
Progenics Pharmaceuticals, Inc.
Information provided by (Responsible Party):
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins

Study Description
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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.

Condition or disease Intervention/treatment
Prostate Cancer Drug: 18F DCFPyL- Radiopharmaceutica

Study Design
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Study Type : Observational
Actual Enrollment : 200 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Study of the Clinical Utility of PSMA Imaging in the Evaluation of Men With Prostate Cancer
Actual Study Start Date : June 8, 2016
Actual Primary Completion Date : April 2020
Actual Study Completion Date : April 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Prostate Cancer

Groups and Cohorts
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Group/Cohort Intervention/treatment
adenocarcinoma of the prostate Drug: 18F DCFPyL- Radiopharmaceutica


Outcome Measures
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Primary Outcome Measures :
  1. 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.


Eligibility Criteria
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Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years to 100 Years   (Adult, Older Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Adenocarcinoma of the prostate
Criteria

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).
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02825875


Locations
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United States, Maryland
Johns Hopkins University
Baltimore, Maryland, United States, 21287
Sponsors and Collaborators
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
Progenics Pharmaceuticals, Inc.
Investigators
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Principal Investigator: Michael Gorin, MD Professor of Oncology
More Information
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Responsible Party: Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
ClinicalTrials.gov Identifier: NCT02825875    
Other Study ID Numbers: J15216
IRB00084971 ( Other Identifier: JHM IRB )
First Posted: July 7, 2016    Key Record Dates
Last Update Posted: May 7, 2020
Last Verified: May 2020
Additional relevant MeSH terms:
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Prostatic Neoplasms
Genital Neoplasms, Male
Urogenital Neoplasms
Neoplasms by Site
Neoplasms
 Genital Diseases, Male
Genital Diseases
Urogenital Diseases
Prostatic Diseases
Male Urogenital Diseases