This phase II trial studies the effect of 68Ga-HBED-CC PSMA-PET/MRI in defining the best placement of radiation in patients with prostate cancer undergoing radiation therapy. Diagnostic procedures, such as 68Ga-HBED-CC PSMA-PET/MRI, may help design the radiation treatment plan so that the entire prostate receives the prescribed dose of radiation and, in addition, the visible tumor as defined by the scans receives hot spots. Hot spots are the areas that receive above the dose of prescription simply due to the nature of radiation therapy. All radiation plans have hot spots. This trial focuses the hot spots on certain regions determined by the scans where the visible tumor is located as opposed to the current practice where hot spot regions are randomly located in the target area.
Study sponsor and potential other locations can be found on ClinicalTrials.gov for NCT04176497.
PRIMARY OBJECTIVE:
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.
SECONDARY OBJECTIVES:
I. To further describe the adverse events associated with using PSMA-PET/MRI to define radiotherapy target volumes in subjects with unfavorable-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.
EXPLORATORY OBJECTIVES:
I. To determine the feasibility of meeting dose constraints of the organs at risk in subjects who have received PSMA-PET/MRI to define radiotherapy target volumes.
II. To measure the proportion of patients who have the pelvic lymph nodes included in the radiation field due to PSMA-PET/MRI findings.
OUTLINE:
Patients receive Gallium Ga 68-labeled 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. Within 8 weeks, patients undergo standard of care external beam radiation therapy (EBRT), brachytherapy, and androgen deprivation therapy (ADT). Patients also undergo tissue biopsy on study.
After completion of study treatment, patients are followed up at 1, 3, 6, 9, 12, 18, 24, 30, 36, 42, 48, 54 and 60 months.
Lead OrganizationUNC Lineberger Comprehensive Cancer Center
Principal InvestigatorMichael C Repka
