Radiolabeled Gallium-68 (68Ga-PSMA) for PET/CT Imaging to Detect Prostate Cancer
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|ClinicalTrials.gov Identifier: NCT03689582|
Recruitment Status : Recruiting
First Posted : September 28, 2018
Last Update Posted : November 14, 2019
|Condition or disease||Intervention/treatment||Phase|
|Prostate Cancer||Drug: 68Ga-PSMA||Phase 2|
In this study, two different imaging tests are being compared: a) 68Ga-PSMA Positron Emission Tomography (PET)/Computed Tomography (CT) and b) Magnetic Resonance Imaging (MRI) of the prostate gland. Participants already have received the MRI, and this test resulted either suspicious or definitive for prostate cancer. Both tests (MRI and 68Ga-PSMA PET/CT) are expected to show tumor tissue when more aggressive, but one test could be more accurate than the other test.
Another important question is whether these imaging tests will perform as good or better than prostate biopsies in finding all prostate cancer lesions in need for treatment. If imaging would be comparable or better than biopsies, then imaging may be able to replace invasive biopsies for some indications in the future.
To investigate these questions, participants are asked to undergo a 68Ga-PSMA PET/CT before a planned prostate biopsy procedure. After the biopsy procedure is performed, investigators will compare the imaging results from 68Ga-PSMA with those from the MRI and determine which test is more accurate.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||100 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||68GA-PSMA FUSION PET/MRI FOR IMAGE-GUIDED PROSTATE BIOPSIES|
|Actual Study Start Date :||November 13, 2018|
|Estimated Primary Completion Date :||October 15, 2022|
|Estimated Study Completion Date :||October 15, 2022|
PET/CT imaging with 68Ga-PSMA:
68Ga-PSMA is an investigational radioactive drug that binds to receptors on prostate cancer cells. The intravenously administered drug dose will be about 5 mCi (range 3-7 mCi).
- Sensitivity and specificity of multiparametric MRI (mpMRI) in combination with 68Ga-PSMA Positron Emission Tomography/Computed Tomography (PET/CT) (i.e., fusion PET/MRI) for the detection of primary Gleason score ≥ 3+4 prostate cancer. [ Time Frame: Up to ~4 weeks (after planned, standard-of-care biopsy). ]Reference standard will be pathology-defined as targeted plus standard prostate biopsy, and prostatectomy, when available. Investigators will employ mixed effects logistic regression model to estimate the positive likelihood ratio (LR) of the combination of 68Ga-PSMA-guided plus mpMRI- guided biopsy (fusion PET/MRI) for the detection of primary Gleason ≥ 3+4 cancer compared to mpMRI-guided biopsy (using Prostate Imaging - Reporting and Data System [PI-RADS] version 2) alone.
- Adverse events of 68Ga-PSMA administration [ Time Frame: 24 hours post injection ]Adverse events will be determined through clinical assessment and categorized by CTCAE 4.0.
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): NCT03689582
|Contact: Morand R Piert, M.D.||email@example.com|
|United States, Michigan|
|University of Michigan Hospital||Recruiting|
|Ann Arbor, Michigan, United States, 48109|
|Contact: James Pool 734-615-7391 firstname.lastname@example.org|
|Principal Investigator:||Morand R Piert, M.D.||University of Michigan|