Status:
COMPLETED
68Ga-PSMA-11 PET/CT in Imaging Patients With Intermediate or High Risk Prostate Cancer Before Surgery
Lead Sponsor:
Jonsson Comprehensive Cancer Center
Conditions:
Prostate Adenocarcinoma
Stage IIB Prostate Cancer AJCC v7
Eligibility:
MALE
Phase:
NA
Brief Summary
This clinical trial studies how well 68Ga-PSMA-11 positron emission tomography (PET)/computed tomography (CT) works in imaging patients with intermediate or high risk prostate cancer before surgery. D...
Detailed Description
PRIMARY OBJECTIVE: I. To assess the sensitivity and specificity of gallium Ga 68 gozetotide (68Ga-PSMA-11) PET for the detection of regional nodal metastases compared to pathology at radical prostate...
Eligibility Criteria
Inclusion
- Biopsy proven prostate adenocarcinoma
- Considered for prostatectomy with lymph node dissection
- Intermediate to high-risk disease (as determined by elevated prostate specific antigen \[PSA\] \[PSA \> 10\], tumor \[T\]-stage \[T2b or greater\], Gleason score \[Gleason score \> 6\] or other risk factors)
- Able to provide written consent
- Karnofsky performance status of \>= 50 (or Eastern Cooperative Oncology Group \[ECOG\]/World Health Organization \[WHO\] equivalent)
Exclusion
- Patients not capable of getting PET study due to weight, claustrophobia, or inability to lay still for the duration of the exam
- Neoadjuvant chemotherapy or radiation therapy prior to prostatectomy including focal ablation techniques (high-intensity focused ultrasound ablation \[HiFu\])
Key Trial Info
Start Date :
December 12 2016
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 18 2021
Estimated Enrollment :
400 Patients enrolled
Trial Details
Trial ID
NCT03368547
Start Date
December 12 2016
End Date
June 18 2021
Last Update
April 12 2023
Active Locations (1)
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1
UCLA / Jonsson Comprehensive Cancer Center
Los Angeles, California, United States, 90095