NCT05002465

Brief Summary

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.

Trial Health

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Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

July 27, 2021

Completed
16 days until next milestone

First Posted

Study publicly available on registry

August 12, 2021

Completed
Last Updated

September 11, 2023

Status Verified

September 1, 2023

First QC Date

July 27, 2021

Last Update Submit

September 6, 2023

Conditions

Prostate CancerProstate Cancer MetastaticProstate Cancer Recurrent

Keywords

Gallium-68PSMA-11PET/CT

Interventions

68Ga-PSMA-11DRUG

Injection of 68Ga PSMA-11

Positron Emission Tomography/Computed TomographyPROCEDURE

PET/CT scan after 68Ga PSMA-11 injection

Also known as: PET/CT

Eligibility Criteria

Age18 Years+
Sexmale(Gender-based eligibility)
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • One of the following:
  • Patients with suspected recurrence based on elevated serum prostate specific antigen (PSA) level.
  • Patients with suspected metastasis who are candidates for initial definitive therapy.
  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

UT Southwestern Medical Center

Dallas, Texas, 75390, United States

Location

MeSH Terms

Conditions

Prostatic Neoplasms

Interventions

gallium 68 PSMA-11Magnetic Resonance Spectroscopy

Condition Hierarchy (Ancestors)

Genital Neoplasms, MaleUrogenital NeoplasmsNeoplasms by SiteNeoplasmsGenital Diseases, MaleGenital DiseasesUrogenital DiseasesProstatic DiseasesMale Urogenital Diseases

Intervention Hierarchy (Ancestors)

Spectrum AnalysisChemistry Techniques, AnalyticalInvestigative Techniques

Study Officials

  • Orhan K Oz, MD, PhD

    University of Texas Southwestern Medical Center

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
expanded access
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

July 27, 2021

First Posted

August 12, 2021

Last Updated

September 11, 2023

Record last verified: 2023-09

Locations

US(1)