68Ga-PSMA-11 PET / CT in Imaging Patients with Intermediate or High Risk Prostate Cancer before Surgery
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. Diagnostic procedures, such as PET / CT scans, may help find and diagnose prostate cancer and find out how far the disease has spread.
- Biopsy proven prostate adenocarcinoma
- Planned 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)
- Diagnostic CT or magnetic resonance imaging (MRI) as part of the PET study or performed within one month of PSMA PET
- 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])
Locations & Contacts
Contact: Johannes Czernin
Trial Objectives and Outline
I. To evaluate gallium Ga 68-labeled PSMA ligand Glu-urea-Lys(Ahx)-HBED-CC (68Ga-PSMA-11) PET/CT for the detection of regional nodal metastases compared to pathology at radical prostatectomy on a per patient basis.
Patients receive 68Ga-PSMA-11 intravenously (IV) and undergo a single PET/CT scan over 45-60 minutes at week 1.
After completion of study, patients are followed up at 1-3 days.
Trial Phase & Type
No phase specified
UCLA / Jonsson Comprehensive Cancer Center
Secondary IDs NCI-2016-01768
Clinicaltrials.gov ID NCT03368547