Using PSMA-PET / MRI to Guide Cyberknife-Delivered Stereotactic Body Radiation Therapy for Favorable Risk Prostate Cancer
- Written informed consent obtained to participate in the study and Health Insurance Portability and Accountability Act (HIPAA) authorization for release of personal health information
- Histologically confirmed prostate adenocarcinoma
- Low or favorable intermediate risk, based on the National Comprehensive Cancer Network (NCCN) criteria with appropriate staging (e.g. bone scan)
- Subject has adequate performance status as defined by Eastern Cooperative Oncology Group (ECOG) performance status of 0-2
- Subject is willing and able to comply with the protocol as determined by the treating investigator
- Subject speaks English (quality of life instrument is validated in English)
- Contraindications for MRI
- Other prior or concomitant malignancies with the exception of: * Non-melanoma skin cancer * Other cancer for which the subject has been disease free for >= 5 years before the first study treatment and of low potential risk for recurrence
- Inflammatory bowel disease
- Previous transurethral prostatic resection (TURP) or surgery of the prostate
I. To determine the safety of using prostate-specific membrane antigen (PSMA)-positron emission tomography (PET)/magnetic resonance imaging (MRI) to define radiotherapy targets, while meeting all the current planning criteria.
I. To further describe the adverse events associated with using PSMA-PET/MRI to define radiotherapy target volumes in subjects with low and favorable intermediate risk prostate cancer.
II. To evaluate biochemical control after radiotherapy in subjects who have received PSMA-PET/MRI to define radiotherapy target volumes.
III. To measure patient-reported quality of life prior to radiation therapy and over time in subjects with prostate cancer who have received PSMA-PET/MRI to define radiotherapy target volumes.
IV. To determine the proportion of screened subjects who are enrolled on the study.
Patients receive gallium Ga 68-labeled PSMA-11 (68Ga-PSMA-11) intravenously (IV) and then undergo PET/MRI over 30 minutes and PET/CT. Patients may undergo a repeat 68Ga-PSMA PET scan if for whatever reason 68Ga-PSMA synthesis fails or the PET scans fail. Patients then undergo daily stereotactic body radiation therapy (SBRT) using cyberknife for 1 week.
After completion of study, patients are followed up at 1, 3, 6, 9, 12, 18, 24, 30, 36, 42, 48, 54, and 60 months.
Trial Phase Phase II
Trial Type Treatment
UNC Lineberger Comprehensive Cancer Center
- Primary ID LCCC1917
- Secondary IDs NCI-2020-08190
- Clinicaltrials.gov ID NCT04243941