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

Completed

• Conditions: Prostate Cancer
• Interventions: Drug: 18F DCFPyL- Radiopharmaceutica

• Registration Number: NCT02825875
• Lead Sponsor: Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2016-06-08
• Study First Submitted: 2016-06-30
• Study First Submitted QC: 2016-07-01
• Study First Posted: 2016-07-07
• Primary Completion: 2020-04
• Study Completion: 2020-04
• Status Verified: 2020-05
• Last Update Submitted: 2020-05-05
• Last Update Posted: 2020-05-07

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Male
• Target Recruitment: 200

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).

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
adenocarcinoma of the prostate	18F DCFPyL- Radiopharmaceutica	-

Primary Outcome Measures

Name	Time	Method
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.

Trial Locations

Locations (1)

Johns Hopkins University; 🇺🇸 Baltimore, Maryland, United States