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

Johns Hopkins Medicine

Status: Completed

Conditions: Prostate Cancer

Treatments: Drug: 18F DCFPyL- Radiopharmaceutica

Study type: Observational

Funder types: Other; Industry

Identifiers

NCT02825875

J15216

IRB00084971 (Other Identifier)

Details and patient eligibility

About

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.

Enrollment: 200 patients

Sex: Male

Ages: 18 to 100 years old

Volunteers: No Healthy Volunteers

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).

Trial design

200 participants in 1 patient group

adenocarcinoma of the prostate

Treatment:

Drug: 18F DCFPyL- Radiopharmaceutica