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

NCT ID: NCT02825875

Last Updated: 2020-05-07

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 200 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2016-06-08
• Study Completion Date: 2020-04-30

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.

Conditions

Prostate Cancer

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

adenocarcinoma of the prostate

18F DCFPyL- Radiopharmaceutica

Intervention Type: DRUG

Interventions

18F DCFPyL- Radiopharmaceutica

Intervention Type: DRUG

Eligibility 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).

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 100 Years
• Eligible Sex: MALE
• Accepts Healthy Volunteers: No

Sponsors

Progenics Pharmaceuticals, Inc.

INDUSTRY

Sponsor Role: collaborator

Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Michael Gorin, MD

Role: PRINCIPAL_INVESTIGATOR

Professor of Oncology

Locations

Johns Hopkins University

Baltimore, Maryland, United States

Countries

United States

Other Identifiers

IRB00084971

Identifier Type: OTHER

Identifier Source: secondary_id

J15216

Identifier Type: -

Identifier Source: org_study_id