Clinical Use of 68Ga PSMA-11 PET/CT in Diagnosing, Staging and Restaging Prostate Cancer

September 6, 2023 updated by: Dana Mathews

Clinical Use of 68Ga Prostate Specific Membrane Antigen-11 Positron Emission Tomography With Computed Tomography in Diagnosing, Staging and Restaging Prostate Cancer

The purpose of this protocol is to provide 68Ga Prostate Specific Membrane Antigen-11 (68Ga PSMA-11) for clinical use in the diagnosis, staging and restaging of prostate cancer using Positron Emission Tomography with Computed Tomography (PET/CT) prior to its full local Federal Drug Administration (FDA) approval. Extensive research has shown that 68Ga PSMA-11 PET/CT offers higher detection rate of metastatic disease in prostate cancer than the current standard of care usually used in staging and restaging prostate cancer.

Study Overview

Status

No longer available

Conditions

Intervention / Treatment

Detailed Description

68Ga PSMA-11 PET/CT offers higher detection rate of metastatic disease in prostate cancer than the current standard of care of computed tomography (CT), magnetic resonance imaging (MRI), and bone scintigraphy usually used in staging and restaging prostate cancer. Furthermore, 68Ga PSMA-11 PET/CT offers a higher detection rate of primary and metastatic prostate cancer compared to other available radiotracers used for prostate cancer. It additionally offers enhanced imaging characteristics of greater sensitivity at lower prostate specific antigen (PSA) values and higher target to background ratios than currently available radiotracers. For these reasons, we feel that expanded access to 68Ga PSMA-11 offers better patient care at comparable cost to standard imaging.

The population to be treated consists of men in whom metastatic or recurrent prostate cancer is suspected. Patients will be recruited primarily from the clinical practices of the University of Texas Southwestern Medical Center (UTSW) and Parkland Health and Hospital System. Additional patients may be referred for recruitment from physicians outside UTSW.

Each patient will receive an IV injection of 68Ga PSMA-11 as a bolus intravenous injection. Depending on patient medical history and Radiology physician preference, the patient may also be injected with 20 milligrams (mg) of furosemide to encourage urination, and the patient will void immediately prior to getting on the scan table. Patients will be scanned on a PET/CT scanner. The patient will be positioned with arms elevated above the head.

Study Type

Expanded Access

Expanded Access Type

  • Intermediate-size Population

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • United States
    • Texas
      • Dallas, Texas, United States, 75390
        • UT Southwestern Medical Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

N/A

Description

Inclusion Criteria:

  • One of the following:

    1. Patients with suspected recurrence based on elevated serum prostate specific antigen (PSA) level.
    2. Patients with suspected metastasis who are candidates for initial definitive therapy.
    3. Patients with metastatic prostate cancer, for whom Lutetium-177 vipivotide tetraxetan PSMA-directed therapy is indicated.
  • Patients must be able to lie still for approximately 20 - 40 minutes for the PET/CT scans.
  • Patients must be deemed medically stable by their treating physician.
  • Patients must have the ability and willingness to sign a written informed consent.

Exclusion Criteria:

  • Patients must not weigh more than the maximum weight limit for the PET/CT scanner table (> 225 kilograms or 500 pounds).
  • Patients must not have history of allergic reactions attributed to compounds of similar chemical or biologic composition to 68Ga PSMA-11.
  • Patients must not be claustrophobic.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Dana Mathews

Investigators

  • Principal Investigator: Orhan K Oz, MD, PhD, UT Southwestern Medical Center

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

First Submitted

July 27, 2021

First Submitted That Met QC Criteria

August 11, 2021

First Posted (Actual)

August 12, 2021

Study Record Updates

Last Update Posted (Actual)

September 11, 2023

Last Update Submitted That Met QC Criteria

September 6, 2023

Last Verified

September 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • STU-2021-0291

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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