The Role of 68Gallium PSMA-11 in Enhancing Diagnosis of Primary and Metastatic Prostate Cancer

  • End date
    Dec 15, 2022
  • participants needed
  • sponsor
    Dana Mathews
Updated on 22 March 2022
ct scan
prostate specific antigen
metastatic prostate cancer
multiparametric magnetic resonance imaging
digital rectal exam
positron emission tomography
pet/ct scan
digital rectal examination
prostate cancer metastatic


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).


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).

Condition Prostate Cancer, Prostate Cancer Metastatic
Treatment positron emission tomography/computed tomography, 68Ga PSMA-11 injection
Clinical Study IdentifierNCT04179968
SponsorDana Mathews
Last Modified on22 March 2022


Yes No Not Sure

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 TURP/BPH procedures, including steam/laser therapies
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