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

NCT02825875 | Completed

• 2 other identifiers: J15216IRB00084971
• Study Type: observational
• Target: 200
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (1)

adenocarcinoma of the prostate

Drug: 18F DCFPyL- Radiopharmaceutica

Interventions

18F DCFPyL- Radiopharmaceutica DRUG

adenocarcinoma of the prostate

Eligibility Criteria

• Age: 18 Years - 100 Years
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Adenocarcinoma of the prostate

You may qualify if:

• Age ≥18 years
• Willingness to signed informed consent
• Histologically confirmed adenocarcinoma of the prostate
• PSA measurement ≤60 days prior to study enrollment
• 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

You may not qualify if:

• Administered a radioisotope within 5 physical half-lives prior to study enrollment
• 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).

Sponsors & Collaborators

• Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins: lead
• Progenics Pharmaceuticals, Inc.: collaborator

Study Sites (1)

Johns Hopkins University

Baltimore, Maryland, 21287, United States

Location

MeSH Terms

Conditions

Prostatic Neoplasms

Condition Hierarchy (Ancestors)

Genital Neoplasms, Male; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Prostatic Diseases; Male Urogenital Diseases

Study Officials

• Michael Gorin, MD

  Professor of Oncology

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 30, 2016
• First Posted: July 7, 2016
• Study Start: June 8, 2016
• Primary Completion: April 1, 2020
• Study Completion: April 1, 2020
• Last Updated: May 7, 2020

Record last verified: 2020-05

Locations

US (1)