Gallium-68 PSMA-11 PET in Patients With Biochemical Recurrence (PSMA BCR)
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT02918357|
Recruitment Status : Completed
First Posted : September 28, 2016
Last Update Posted : July 25, 2018
|Condition or disease||Intervention/treatment||Phase|
|Prostate Cancer||Drug: Ga-68 labeled PSMA-11 PET||Phase 2 Phase 3|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||375 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Gallium-68 PSMA-11 PET in Patients With Biochemical Recurrence|
|Actual Study Start Date :||October 2016|
|Actual Primary Completion Date :||October 2017|
|Actual Study Completion Date :||October 2017|
Experimental: Ga-68 labeled PSMA-11 PET
PSMA PET imaging: Patients will receive Ga-68 labeled PSMA-11 PET and then undergo PET/CT or PET/MRI approximately 55-70 minutes later.
Drug: Ga-68 labeled PSMA-11 PET
Patients will be imaged using Ga-68 labeled PSMA-11 PET to determine if the presence of metastatic disease. Prostate Specific Membrane Antigen (PSMA) is a protein expressed on prostate cancer cells that can be imaged using small molecules that target this protocol.
- Sensitivity of PSMA PET for the detection of metastases a per-patient and per-region-basis confirmed by histopathology/biopsy. [ Time Frame: one month ]Point estimate of the sensitivity will be calculated with the corresponding 95% confidence interval.
- Positive predictive value of PSMA PET for the detection of metastases a per-patient and per-region-basis confirmed by histopathology/biopsy. [ Time Frame: one month ]Point estimate of the positive predictive value will be calculated with the corresponding 95% confidence interval.
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): NCT02918357
|United States, California|
|UCSF Imaging Center at China Basin|
|San Francisco, California, United States, 94107|