Evaluation of Prostate-specific Membrane Antigen (PSMA)-Based PET Imaging of Primary Prostate Cancer
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|ClinicalTrials.gov Identifier: NCT01496157|
Recruitment Status : Completed
First Posted : December 21, 2011
Results First Posted : August 28, 2018
Last Update Posted : August 28, 2018
|Condition or disease||Intervention/treatment||Phase|
|Prostate Cancer||Drug: 18F-DCFBC||Phase 1 Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||15 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Evaluation of PSMA-based PET as an Imaging Biomarker of Primary Prostate Cancer|
|Actual Study Start Date :||September 11, 2012|
|Actual Primary Completion Date :||January 2015|
|Actual Study Completion Date :||September 17, 2017|
Experimental: Patients with Primary Prostate Cancer
Patients will be imaged with 18F-DCFBC
A bolus of 10 mCi (370 MBq) [9-11 mCi (333-407 MBq)] of 18F-DCFBC will be injected into the IV line by slow IV push.
- PET Detection of Primary Prostate Cancer [ Time Frame: 24 months ]To compare number of participants with positive or negative uptake of 18F-DCFBC in primary prostate cancer by DCFBC PET to prostatectomy pathology as determined by tissue step-section analysis in men with biopsy-positive prostate cancer (Gleason score > 4+3=7).
- PET Detection of Metastatic Disease at Initial Staging [ Time Frame: 24 months ]To compare the detection of bone and nodal metastatic disease by DCFBC PET at initial staging to detection by available conventional imaging modalities (bone scan, CT, MRI) and biopsy pathology.
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): NCT01496157
|United States, Maryland|
|Johns Hopkins University|
|Baltimore, Maryland, United States, 21287|
|Principal Investigator:||Steven P Rowe, MD, PhD||Johns Hopkins University|