Expanded Access [Ga-68] PSMA-11 PET Imaging

January 5, 2022 updated by: Geoffrey Johnson, Mayo Clinic
In this expanded access IND study, Mayo Clinic in Rochester MN offers [Ga-68] PSMA-11 PET/CT or PET/MR imaging to patients who meet criteria.

Study Overview

Status

No longer available

Conditions

Intervention / Treatment

Detailed Description

[Ga-68] PSMA-11 PET/CT and PET/MR imaging has been shown to allow for accurate detection of metastatic prostate cancer at the time of initial diagnosis and staging of patients with high-risk prostate cancer and at the time of biochemical recurrence. In addition, available data show superiority of metastatic lesion detection with [Ga-68] PSMA-11 PET over conventional imaging. This improved lesion detection has a direct impact on selection of anti-cancer therapy and thus may improve patient outcomes.

Under expanded access IND, enrolled patients will receive a clinical [68Ga] PSMA-11 PET/CT or PET/MR for evaluation of their cancer. Imaging exams must be deemed clinically indicated by a referring provider. Patients will be responsible for the cost of the imaging exam. Access is limited.

Study Type

Expanded Access

Expanded Access Type

  • Individual Patients
  • Treatment IND/Protocol

Contacts and Locations

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

Study Locations

  • United States
    • Minnesota
      • Rochester, Minnesota, United States, 55905
        • Mayo Clinic

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

Genders Eligible for Study

Male

Description

Participant Groups

There are two participant groups; please refer to the inclusion details below:

Group 1: Untreated High-Risk prostate cancer group (must meet at least one of the following inclusion criteria):

  1. Serum prostate-specific antigen (PSA) concentration of 20 ng/mL or more
  2. Pathologic criteria of International Society of Uropathology (ISUP) grade group 3-5 (ISUP grades 3-5 are equivalent to pathologic Gleason scores of 4+3, 8, 9 or 10)
  3. Local staging of T3 or worse (Indicating that cancer has invaded into tissues outside of the prostate gland, as seen at either CT or MRI)

Biochemically Recurrent prostate cancer group (must meet one of the criteria):

  1. In patients who have undergone a prostatectomy, PSA > 0.2 ng/ml on 2 consecutive tests
  2. In patients who have undergone definitive prostate radiation, PSA rise ≥ 2 ng/mL above the nadir PSA

Exclusion Criteria: Current exclusion criteria for both groups includes:

  1. Patients unable to sign informed consent
  2. Patient with a life expectancy less than 6 months
  3. Additional exclusion criteria may be added based on demand

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

Mayo Clinic

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

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

March 12, 2021

First Submitted That Met QC Criteria

March 12, 2021

First Posted (ACTUAL)

March 16, 2021

Study Record Updates

Last Update Posted (ACTUAL)

January 21, 2022

Last Update Submitted That Met QC Criteria

January 5, 2022

Last Verified

January 1, 2022

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 20-013358

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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