68Ga PSMA-HBED-CC PET / CT in Imaging Patients with Metastatic Prostate Cancer
This pilot clinical trial studies how well 68Ga PSMA-HBED-CC positron emission tomography / computed tomography (PET / CT) works in imaging patients with prostate cancer that has spread to other parts of the body. Diagnostic procedures, such as 68Ga PSMA-HBED-CC PET / CT, may help find and diagnose metastatic prostate cancer and find out how far the disease has spread.
- Histological diagnosis of adenocarcinoma of the prostate OR has a clinical diagnosis of prostate cancer and on active therapy or has received treatment for prostate cancer
- Multifocal metastatic disease in either castrate sensitive or castrate resistant patients
- May or may not be on hormonal therapy, chemotherapy, or radium therapy; if on hormonal therapy or chemotherapy, must be on it for at least 3 months
- No plans to undergo prostate cancer (PCa) therapy (with hormone therapy, chemotherapy, radium therapy, or external radiation) between the two study exams
- At least 2 metastatic soft tissue or osseous lesions identified on conventional imaging (CT, magnetic resonance imaging [MRI] or bone scan)
- Karnofsky performance status of 50 or greater (or Eastern Cooperative Oncology Group [ECOG]/World Health Organization [WHO] equivalent)
- Ability to understand and willingness to sign a consent document
- Uncontrolled intercurrent illness including, but not limited to ongoing or active infection requiring hospitalization, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements
- Physical limitation that would limit compliance with the study requirements
- Current enrollment in a therapeutic clinical trial
Locations & Contacts
Contact: Janet Pollard
Trial Objectives and Outline
I. Determine the biodistribution, quantitative time course, and the range of uptake in normal organs using gallium Ga 68-labeled PSMA ligand Glu-urea-Lys[Ahx] ([68Ga]Glu-urea-Lys(Ahx)-HBED-CC) (68Ga prostate specific membrane antigen [PSMA]-HBED-CC) positron emission tomography (PET) in patients with metastatic castrate resistant prostate cancer.
II. Analyze reproducibility of 68Ga PSMA-HBED-CC PET uptake in target tumors and normal tissues.
I. To corroborate radiopharmaceutical radiation dosimetry estimates found in the literature.
Patients receive gallium Ga 68-labeled PSMA ligand Glu-urea-Lys(Ahx) intravenously (IV) on day 0. Beginning 60 minutes after injection, patients undergo PET/CT for about 30-40 minutes on day 0. Within 1-15 days, patients undergo a second gallium Ga 68-labeled PSMA ligand Glu-urea-Lys(Ahx) PET/CT.
After completion of study, patients are followed at 24 hours and and then within 3 days.
Trial Phase & Type
No phase specified
University of Iowa / Holden Comprehensive Cancer Center
Secondary IDs NCI-2016-01204
Clinicaltrials.gov ID NCT02952469