The Role of 68Gallium PSMA-11 in Enhancing Diagnosis of Primary and Metastatic Prostate Cancer
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|ClinicalTrials.gov Identifier: NCT04179968|
Recruitment Status : Recruiting
First Posted : November 27, 2019
Last Update Posted : January 30, 2020
|Condition or disease||Intervention/treatment||Phase|
|Prostate Cancer Prostate Cancer Metastatic||Drug: 68Ga PSMA-11 injection Procedure: Positron Emission Tomography/Computed Tomography||Phase 2|
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 (Clinical Trial)|
|Estimated Enrollment :||20 participants|
|Intervention Model:||Single Group Assignment|
|Intervention Model Description:||Unblinded, single arm imaging study|
|Masking:||None (Open Label)|
|Official Title:||The Role of 68Gallium PSMA-11 in Enhancing Diagnosis of Primary and Metastatic Prostate Cancer|
|Actual Study Start Date :||January 27, 2020|
|Estimated Primary Completion Date :||December 15, 2021|
|Estimated Study Completion Date :||December 15, 2022|
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
Drug: 68Ga PSMA-11 injection
Injection of 68Ga PSMA-11
Procedure: Positron Emission Tomography/Computed Tomography
PET/CT scan after 68Ga PSMA-11 injection
Other Name: PET/CT
- Focus of Uptake in Prostate [ Time Frame: Up to 3 years ]Correlation between foci of update detected on PET/CT to detected abnormalities on standard of care mpMRI and pathology specimens.
- Focus of Update Outside Prostate [ Time Frame: Up to 3 years ]Correlation between foci of update detected on PET/CT to lesions seen on conventional standard of care imaging, including pelvic CT or MRI and bone scintigraphy.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04179968
|Contact: Kelli Key, PhD||214-648-8152||Kelli.Key@UTSouthwestern.edu|
|United States, Texas|
|UT Southwestern Medical Center||Recruiting|
|Dallas, Texas, United States, 75390|
|Contact: Kelli Key, PhD 214-648-8152 Kelli.Key@UTSouthwestern.edu|
|Principal Investigator: Neil Rofsky, MD, MHA|
|Principal Investigator:||Neil Rofsky, MD, MHA||UT Southwestern Medical Center|