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

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.

Study Overview

• Status: Completed
• Conditions: Prostate Cancer
• Intervention / Treatment: Drug: 18F DCFPyL- Radiopharmaceutica

• Study Type: Observational
• Enrollment (Actual): 200

Contacts and Locations

Study Locations

• United States
  • Maryland
    • Baltimore, Maryland, United States, 21287
      • Johns Hopkins University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 100 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Male

• Sampling Method: Non-Probability Sample

Study Population

Adenocarcinoma of the prostate

Description

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 Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
adenocarcinoma of the prostate	Drug: 18F DCFPyL- Radiopharmaceutica

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Physician responses to a questionnaire	The Post-PET/CT questionnaire will determine if the PET/CT scan results in changes to clinical management of patient illness.	less than 1 year

Collaborators and Investigators

• Sponsor: Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
• Collaborators: Progenics Pharmaceuticals, Inc.
• Investigators: Principal Investigator: Michael Gorin, MD, Professor of Oncology

Study record dates

Study Major Dates

• Study Start (Actual): June 8, 2016
• Primary Completion (Actual): April 1, 2020
• Study Completion (Actual): April 1, 2020

Study Registration Dates

• First Submitted: June 30, 2016
• First Submitted That Met QC Criteria: July 1, 2016
• First Posted (Estimate): July 7, 2016

Study Record Updates

• Last Update Posted (Actual): May 7, 2020
• Last Update Submitted That Met QC Criteria: May 5, 2020
• Last Verified: May 1, 2020

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Neoplasms; Urogenital Neoplasms; Neoplasms by Site; Genital Neoplasms, Male; Prostatic Diseases; Prostatic Neoplasms
• Other Study ID Numbers: J15216; IRB00084971 (Other Identifier: JHM IRB)