Prostate Cancer
Conditions
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.
Interventions
DRUG18F DCFPyL- Radiopharmaceutica
Sponsors
Progenics Pharmaceuticals, Inc.
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
MALE
Age
18 Years to 100 Years
Healthy volunteers
No
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).
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Physician responses to a questionnaire | 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. |
Countries
United States
Outcome results
None listed