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

• Status: Completed
• Trial end date: 2020-04-01
• Target enrollment: 0
• Participant gender: Male

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.

• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Sidney Kimmel Comprehensive Cancer Center; Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
• Collaborator: Progenics Pharmaceuticals, Inc.

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).