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Completed

NCT Number: NCT02825875

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.

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Key information

Conditions

Prostate Cancer Genital Diseases Genital Diseases, Male Genital Neoplasms, Male Male Urogenital Diseases Neoplasms Neoplasms by Site Prostatic Diseases Prostatic Neoplasms Urogenital Diseases Urogenital Neoplasms

Age range

18 year–100 year

Sex eligibility

Male

Study type

Observational

Primary location

Johns Hopkins University

Baltimore, Maryland, 21287, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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

Exclusion criteria

  • 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).

Treatment and study plan

18F DCFPyL- Radiopharmaceutica

Drug

Primary outcomes

  1. Physician responses to a questionnaire

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins

Other

Collaborators

  • Progenics Pharmaceuticals, Inc.

Registry information

Important dates

Study start
2016
Primary completion
2020
Study completion
2020
First posted
Jul 7, 2016
Registry last updated
May 7, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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