Gallium-68 PSMA-11 PET Imaging in Prostate Cancer Patients

July 31, 2021 updated by: Thomas Hope
The investigators are imaging patients with prostate cancer using a new Positron Emission Tomography (PET) imaging agent (Ga-68-PSMA-11) in order to evaluate its ability to detect prostate cancer.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Patients will be imaged using Ga-68 labeled PSMA-11 PET to determine if there is presence of metastatic disease. Prostate Specific Membrane Antigen (PSMA) is a protein expressed on prostate cancer cells that can be imaged using small molecules that target this protocol. PET imaging will begin 50-100 minutes after injection, but may be possible in certain circumstances for imaging to be delayed due to patient workflow or equipment issues

Primary Objective:

Sensitivity on a per-patient and per-region-basis (Table 1) of 68Ga-PSMA-11 PET for detection of tumor location confirmed by histopathology/biopsy, clinical and conventional imaging follow-up.

Study Type

Interventional

Enrollment (Actual)

485

Phase

  • Phase 3

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
    • California
      • San Francisco, California, United States, 94143
        • University of California, San Francisco

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

16 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Male

Description

Inclusion Criteria:

  1. Male, age >= 18.
  2. Histopathologically proven prostate adenocarcinoma.

  3. Concern for metastatic disease in one of the following settings:

    1. Initial staging with intermediate to high risk prostate cancer.
    2. Biochemical recurrence after initial therapy.
  4. Ability to understand a written informed consent document, and the willingness to sign it.

Exclusion Criteria:

1. Patient unlikely to comply with study procedures, restrictions and requirements and judged by the Investigator to be unsuitable for study participation.

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?

Design Details

  • Primary Purpose: Diagnostic
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Ga-68 labeled PSMA-11 PET PSMA
The imaging agent (Ga-68 PSMA-11 or PSMA-HBED-CC) will be administered on an outpatient basis. It will be administered a single time intravenously prior to the PET imaging. The injected dose will be 3 to 7 millicurie (mCi) +/- 10% of 68Ga-PSMA-11.
Drug: Ga-68 labeled PSMA-11
Patients will be imaged using Ga-68 labeled PSMA-11 PET to determine if there is presence of metastatic disease. Prostate Specific Membrane Antigen (PSMA) is a protein expressed on prostate cancer cells that can be imaged using small molecules that target this protocol.
Other Names:
  • Ga-68 labeled DKFZ-PSMA-11
  • Ga-68 labeled Glu-NH-CO-NH- Lys(Ahx)-HBED- CC
  • Ga-68 labeled Glu-urea- Lys(Ahx)-HBED-CC
  • Ga-68 labeled HBED-CC PSMA
Device: Positron emission tomography-computed tomography (PET/CT)
Positron emission tomography-computed tomography (PET/CT) is a nuclear medicine technique which combines, in a single gantry, a positron emission tomography (PET) scanner and an x-ray computed tomography (CT) scanner, to acquire sequential images from both devices in the same session
Other Names:
  • PET-CT
Device: Positron emission tomography-magnetic resonance imaging (PET/MRI)
A PET/MRI scan is a two-in-one test that combines images from a positron emission tomography (PET) scan and a magnetic resonance imaging (MRI) scan in a single session
Other Names:
  • PET-MRI

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Detection Rate of PSMA-11 PET for Positive Disease by Prostate Specific Antigen (PSA) Group
Time Frame: 1 day
Detection rate is defined as the proportion of all patients who have prostate cancer and are true-positives confirmed by the imaging based on local reads for the detection of metastatic disease. Detection rates will be stratified based upon the PSA group at time of imaging.
1 day
Detection Rate of PSMA-11 PET for Positive Disease in Prostate Bed by PSA Group
Time Frame: 1 day
Detection rate is defined as the proportion of all patients who have prostate cancer located in the prostate bed and are true-positives confirmed by the imaging based on local reads for the detection of metastatic disease. Detection rates will be stratified based upon the PSA group at time of imaging.
1 day
Detection Rate of PSMA-11 PET for Positive Disease in Pelvic Nodes by PSA Group
Time Frame: 1 day
Detection rate is defined as the proportion of all patients who have prostate cancer located in the pelvic nodes and are true-positives confirmed by the imaging based on local reads for the detection of metastatic disease. Detection rates will be stratified based upon the PSA group at time of imaging.
1 day
Detection Rate of PSMA-11 PET for Positive Disease in Distant Soft Tissues by PSA Group
Time Frame: 1 day
Detection rate is defined as the proportion of all patients who have prostate cancer located in the distant soft tissues and are true-positives confirmed by the imaging based on local reads for the detection of metastatic disease. Detection rates will be stratified based upon the PSA group at time of imaging.
1 day
Detection Rate of PSMA-11 PET for Positive Disease in Bones (Osseous Lesions) by PSA Group
Time Frame: 1 day
Detection rate is defined as the proportion of all patients who have prostate cancer located in the bone (osseous lesions) and are true-positives confirmed by the imaging based on local reads for the detection of metastatic disease. Detection rates will be stratified based upon the PSA group at time of imaging.
1 day

Collaborators and Investigators

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

Sponsor

Thomas Hope

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 Major Dates

Study Start (Actual)

October 11, 2018

Primary Completion (Actual)

August 25, 2020

Study Completion (Actual)

August 25, 2020

Study Registration Dates

First Submitted

January 10, 2019

First Submitted That Met QC Criteria

January 10, 2019

First Posted (Actual)

January 14, 2019

Study Record Updates

Last Update Posted (Actual)

August 24, 2021

Last Update Submitted That Met QC Criteria

July 31, 2021

Last Verified

July 1, 2021

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 185513
  • NCI-2019-01394 (Registry Identifier: NCI Clinical Trials Reporting Program (CTRP))

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

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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