68Ga-PSMA-11 PET/CT in Detecting Recurrent Prostate Cancer in Patients After Initial Therapy
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|ClinicalTrials.gov Identifier: NCT02940262|
Recruitment Status : Recruiting
First Posted : October 20, 2016
Last Update Posted : November 14, 2017
|Condition or disease||Intervention/treatment||Phase|
|Prostate Adenocarcinoma Recurrent Prostate Carcinoma||Device: Computed Tomography Radiation: Gallium Ga 68-labeled PSMA Ligand Glu-urea-Lys(Ahx)-HBED-CC Other: Laboratory Biomarker Analysis Device: Positron Emission Tomography||Not Applicable|
I. To evaluate 68gallium (Ga)-prostate-specific membrane antigen (PSMA) PET/CT for detection of recurrent prostate cancer after initial therapy in patients with elevated PSA and non-contributory bone scintigraphy, computed tomography (CT) or magnetic resonance imaging (MRI).
Patients receive gallium Ga 68-labeled PSMA ligand glutamic acid (Glu)-urea-lysine (Lys)(Ahx) intravenously (IV) and after 45-60 minutes undergo PET/CT.
After completion of study, patients are followed up every 3-6 months for up to 1 year.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||200 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||68Ga-PSMA PET/CT for Detection of Recurrent Prostate Cancer After Initial Therapy|
|Actual Study Start Date :||September 5, 2016|
|Estimated Primary Completion Date :||August 2021|
|Estimated Study Completion Date :||August 2022|
Experimental: Treatment (68Ga-PSMA-11)
Patients receive gallium Ga 68-labeled PSMA ligand Glu-urea-Lys(Ahx) IV and after 45-60 minutes undergo PET/CT.
Device: Computed Tomography
Other Names:Radiation: Gallium Ga 68-labeled PSMA Ligand Glu-urea-Lys(Ahx)-HBED-CC
Other Names:Other: Laboratory Biomarker Analysis
Correlative studiesDevice: Positron Emission Tomography
- Diagnostic performance of 68Ga-PSMA-11 PET/CT assessed by detected lesion [ Time Frame: Up to 1 year ]Patients receive gallium Ga 68-labeled PSMA ligand glutamic acid (Glu)-urea-lysine (Lys)(Ahx) intravenously (IV) and after 45-60 minutes undergo PET/CT. After completion of study, patients are followed up every 3-6 months for up to 1 year.
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): NCT02940262
|United States, California|
|UCLA / Jonsson Comprehensive Cancer Center||Recruiting|
|Los Angeles, California, United States, 90095|
|Contact: Johannes Czernin 310-206-3226|
|Principal Investigator: Johannes Czernin|
|Principal Investigator:||Johannes Czernin||UCLA / Jonsson Comprehensive Cancer Center|