Gallium Ga 68-labeled PSMA-11 PET in Detecting Prostate Cancer Metastasis
This phase III trial studies how well gallium Ga 68-labeled prostate specific membrane antigen (PSMA)-11 positron emission tomography (PET) works in detecting prostate cancer that has spread to other places in the body. PSMA is a protein found on most prostate cancers. Gallium Ga 68-labeled PSMA-11 is an imaging agent that binds to prostate cancer cells and can be imaged using PET scan. A PET scan uses a special camera to detect energy given off from radioactive material to make detailed pictures of areas where the Ga-68 accumulates in the body. The PET scan if often combined with a magnetic resonance imaging (MRI) or computed tomography (CT) scan may help to more accurately map the location of where in the body the radioactive material has collected. Gallium Ga 68-labeled PSMA-11 may help to detect the presence of prostate cancer that has spread to other places in the body (metastasis).
- Histopathologically proven prostate adenocarcinoma
- Concern for metastatic disease in the following settings: * Initial staging with intermediate to high risk prostate cancer * Biochemical recurrence after initial therapy
- Karnofsky performance status of >= 50 (or Eastern Cooperative Oncology Group [ECOG]/World Health Organization [WHO] equivalent)
- Ability to understand a written informed consent document, and the willingness to sign it
- Unable to lie flat, still or tolerate a PET scan
Locations & Contacts
Contact: Thomas A. Hope
Trial Objectives and Outline
I. Sensitivity on a per-patient and per-region-basis of gallium Ga 68-labeled PSMA-11 (68Ga-PSMA-11) PET for detection of tumor location confirmed by histopathology/biopsy, clinical and conventional imaging follow-up.
Patients receive gallium Ga 68-labeled PSMA-11 intravenously (IV) over 1-2 minutes. Beginning 50-100 minutes after injection, patients undergo PET/CT scan over 30-60 minutes or PET/MRI scan over 50-60 minutes.
Trial Phase & Type
UCSF Medical Center-Mount Zion
Thomas A. Hope
Secondary IDs NCI-2019-01394, 15-17570
Clinicaltrials.gov ID NCT03803475