Clinical trial NCT04179968: The Role of 68Gallium PSMA-11 in Enhancing Diagnosis of Primary and Metastatic Prostate Cancer
Official title: The Role of 68Gallium PSMA-11 in Enhancing Diagnosis of Primary and Metastatic Prostate Cancer
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Prostate Cancer
Prostate Cancer Metastatic
Keywords: PET/CT
prostate cancer
Gallium-68
PSMA-11
Lead sponsor: University of Texas Southwestern Medical Center
Sponsor class: OTHER
First posted: 2019-11-27
Enrollment: 20
Sex: MALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: Unblinded, single arm imaging study
Primary purpose: DIAGNOSTIC

Brief summary: 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).

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).

Eligibility criteria: 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

Primary outcomes:
measure: Number of Primary Prostate Lesions Detected on Early Dynamic 68Ga-PSMA-11 PET/CT Imaging
timeFrame: During PET/CT imaging, up to 2 hours
measure: Number of Primary Prostate Lesions Detected by mpMRI
timeFrame: During mpMRI, up to 2 hours
Secondary outcomes:
measure: Number of Sites of Metastatic Prostate Lesions Detected on 68Ga-PSMA-11 PET/CT
timeFrame: During PET/CT imaging, up to 2 hours
measure: Number of Sites of Metastatic Prostate Lesions Detected by Current Standard of Care Imaging (CT/MRI)
timeFrame: During CT/MRI imaging, up to 2 hours
Other outcomes:
Locations:
city: Dallas
country: United States
facility: UT Southwestern Medical Center
state: Texas
Study officials:
affiliation: UT Southwestern Medical Center
name: Orhan K Oz, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References: