The Role of 68Gallium PSMA-11 in Enhancing Diagnosis of Primary and Metastatic Prostate Cancer
March 16, 2023 updated by: Dana Mathews
To goal of this research is to assess the ability of Gallium-68 (68Ga) Prostate-Specific Membrane Antigen-11 (PSMA-11) positron emission tomography/computed tomography (PET/CT) to increase diagnostic accuracy in localizing primary and metastatic lesions in patients with suspected prostate cancer and elevated Prostate Imaging Reporting and Data System (PI-RADS) scores and Prostate-Specific Antigen (PSA).
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Detailed Description
This study is designed to evaluate the added value of 68Ga PSMA-11 PET/CT for detection of additional primary prostate cancer lesions compared to multiparametric magnetic resonance imaging (mpMRI) in a group of patients with elevated PI-RADS scores and PSA. We propose that the addition of early dynamic 68Ga PSMA-11 PET/CT imaging to the more usual delayed imaging will enhance detection of primary lesions and additional lesions not detected on the mpMRI. In addition, the dynamic imaging will allow us to evaluate the kinetics of uptake in the prostate gland. It is possible that even in the absence of focal uptake, hyperemia of the gland could indicate the presence of an occult primary.
A second purpose of this research is to examine the value of 68Ga PSMA-11 PET/CT in this same group of patients in detecting metastatic disease at initial staging in comparison with current standard of care imaging such as computed tomography (CT) and magnetic resonance imaging (MRI).
Study Type
Interventional
Enrollment (Actual)
20
Phase
- Phase 2
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
-
-
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
No
Genders Eligible for Study
Male
Description
Inclusion Criteria:
- Patients with suspected prostate cancer (e.g., abnormal digital rectal exam, elevated and/or rising PSA) as determined by referring physician
- Patients must have had a diagnostic, standard of care mpMRI of the prostate with at least one lesion with a PI-RADS v2.1 score ≥ 4
- In men with PI-RADS v2.1 score 4, PSA should be ≥ 10 ng/mL. In men with at least one PI-RADS v2.1 score 5 lesion, there is no restriction on PSA level.
- Patients must be scheduled for biopsy or radical prostatectomy
- Patients should not have had any type of curative or palliative therapy for prostate cancer before enrolling in the study
- Patients must be medically stable as judged by the patient's physician
- Patients must be able to lie still for a total of 60 minutes for the PET/CT scans
- Ability to understand and the willingness to sign a written informed consent
Exclusion Criteria:
- Patients who have had a prior prostatectomy or radiotherapy for prostate cancer cannot participate in the study
- Patients who have had a prior biopsy for prostate cancer cannot participate in the study
- Patients who have been treated for cancers other than skin cancers
- Subjects may not be receiving any other investigational agents for the treatment of the cancer under study
- Patients may not weigh more than the maximum weight limit for the PET/CT scanner table (>200 kilograms or 440 pounds)
- History of allergic reactions attributed to compounds of similar chemical or biologic composition to 68Ga PSMA-11 or other agents used in the study such as gadolinium-based intravenous contrast agent used during the mpMRI
- Prior transurethral resection of the prostate (TURP)/benign prostatic hyperplasia (BPH) procedures, including steam/laser therapies
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: Patients with suspected prostate cancer
Patients with suspected prostate cancer who have at least one PI-RADS 5 lesion, or at least one PI-RADS 4 lesion and PSA ≥10 nanograms/milliliter (ng/mL), on standard of care mpMRI of the prostate, who are scheduled for biopsy or radical prostatectomy
|
PET/CT scan after 68Ga PSMA-11 injection
Other Names:
Injection of 68Ga PSMA-11
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Number of Primary Prostate Lesions Detected on Early Dynamic 68Ga-PSMA-11 PET/CT Imaging
Time Frame: During PET/CT imaging, up to 2 hours
|
Number of primary prostate lesions will be detected using early dynamic 68Ga-PSMA-11 PET/CT imaging.
PSMA is a protein expressed on prostate cancer cells that can be imaged using small molecules that target this protein.
|
During PET/CT imaging, up to 2 hours
|
|
Number of Primary Prostate Lesions Detected by mpMRI
Time Frame: During mpMRI, up to 2 hours
|
Number of primary prostate lesions will be detected by using mpMRI.
|
During mpMRI, up to 2 hours
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Number of Sites of Metastatic Prostate Lesions Detected on 68Ga-PSMA-11 PET/CT
Time Frame: During PET/CT imaging, up to 2 hours
|
Number of sites of metastatic prostate lesions will be detected using 68Ga-PSMA-11 PET/CT.
PSMA is a protein expressed on prostate cancer cells that can be imaged using small molecules that target this protein.
|
During PET/CT imaging, up to 2 hours
|
|
Number of Sites of Metastatic Prostate Lesions Detected by Current Standard of Care Imaging (CT/MRI)
Time Frame: During CT/MRI imaging, up to 2 hours
|
Patients with metastatic prostate lesions were imaged using current standard of care imaging (CT/MRI).
|
During CT/MRI imaging, up to 2 hours
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
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 Major Dates
Study Start (Actual)
January 27, 2020
Primary Completion (Actual)
September 9, 2021
Study Completion (Actual)
July 15, 2022
Study Registration Dates
First Submitted
November 25, 2019
First Submitted That Met QC Criteria
November 25, 2019
First Posted (Actual)
November 27, 2019
Study Record Updates
Last Update Posted (Actual)
March 20, 2023
Last Update Submitted That Met QC Criteria
March 16, 2023
Last Verified
March 1, 2023
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- STU-2019-1198
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.