PSMA-PET/MRI for Radiation Treatment Planning in Patients With Locally Metastatic Prostate Cancer: A Pilot Study
Overview
- Phase
- Phase 1
- Intervention
- [68Ga]PSMA-PET/MRI or PET/CT
- Conditions
- Metastatic Prostate Cancer
- Sponsor
- University of Alabama at Birmingham
- Enrollment
- 10
- Locations
- 1
- Primary Endpoint
- The Number of Patients Who Demonstrate Pelvic Lymph Node Metastases on PSMA-PET/MRI That Were Not Detected on MRI
- Status
- Completed
- Last Updated
- 2 years ago
Overview
Brief Summary
This pilot study will investigate the use of PSMA-PET/MRI (Positron Emission Tomography/ Magnetic Resonance Imaging)to guide radiation treatment planning in patients with known or suspected locally metastatic prostate cancer at the time of diagnosis. Patients will undergo a single PSMA-PET/MRI (or PET/CT (Computed Tomography) in some circumstances) prior to initiation of treatment. Following development of a PSMA-PET guided radiation treatment plan, therapeutic radiation will be delivered per standard-of-care parameters and assessments of feasibility and tolerability will be performed.
Investigators
Samuel Joseph Galgano
Program Director, Abdominal Imaging Fellowship Assistant Professor, Abdominal Imaging Section and Division of Molecular Imaging and Therapeutics
University of Alabama at Birmingham
Eligibility Criteria
Inclusion Criteria
- •Biopsy-proven treatment-naïve prostate adenocarcinoma with pelvic metastases known to suspected on standard-of-care staging imaging
- •Eligibility and plan to undergo definitive radiation therapy for prostate cancer per established standard-of-care radiation oncology clinical guidelines
- •Be at least 18 years of age
Exclusion Criteria
- •Inability to tolerate or undergo PET/MRI or PET/CT
- •Previous or current hematologic or lymphatic disorder (including leukemia, lymphoma, Castleman's disease, etc.)
- •Recurrent prostate adenocarcinoma
- •Known distant metastatic disease
- •Current or prior treatment for prostate cancer
- •Known allergy to glucagon
- •Previous diagnosis of insulinoma or pheochromocytoma
Arms & Interventions
Metastatic Prostate Cancer Arm
\[68Ga\]PSMA-11 PET/MRI or PET/CT for guiding the radiation treatment plan in patients with known or suspected locally metastatic prostate cancer
Intervention: [68Ga]PSMA-PET/MRI or PET/CT
Outcomes
Primary Outcomes
The Number of Patients Who Demonstrate Pelvic Lymph Node Metastases on PSMA-PET/MRI That Were Not Detected on MRI
Time Frame: 1 scan
Secondary Outcomes
- Number of Patients Who Experience CTCAE (Common Terminology Criteria for Adverse Events) Grade 3-5 GI or GU Toxicities(18 months)
- The Total Number of Pelvic Nodal Metastases Detected on PSMA-PET/MRI(1 scan)
- Number of Patients in Whom Dose-escalated Radiotherapy Can be Feasibly Delivered(1 simulation scan)
- The Total Number of Pelvic Nodal Metastases Detected on MRI(1 scan)