Phase 1
N=10
PSMA-PET/MRI for Radiation Treatment Planning in Patients With Locally Metastatic Prostate Cancer: A Pilot Study
Metastatic Prostate Cancer
Bottom Line
View on ClinicalTrials.gov: NCT04086966 ↗Enrolled (actual)
10
Serious AEs
0.0%
Results posted
Apr 2024
Primary outcome: Primary: The Number of Patients Who Demonstrate Pelvic Lymph Node Metastases on PSMA-PET/MRI That Were Not Detected on MRI — 3 Participants
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 1
- Interventions
- [68Ga]PSMA-PET/MRI or PET/CT (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- Male
- Sponsor
- University of Alabama at Birmingham
- Primary completion
- Feb 2022
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY The Number of Patients Who Demonstrate Pelvic Lymph Node Metastases on PSMA-PET/MRI That Were Not Detected on MRI |
3 | — |
| SECONDARY The Total Number of Pelvic Nodal Metastases Detected on PSMA-PET/MRI |
19 | — |
| SECONDARY Number of Patients in Whom Dose-escalated Radiotherapy Can be Feasibly Delivered |
8 | — |
| SECONDARY Number of Patients Who Experience CTCAE (Common Terminology Criteria for Adverse Events) Grade 3-5 GI or GU Toxicities |
— | — |
| SECONDARY The Total Number of Pelvic Nodal Metastases Detected on MRI |
9 | — |
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.
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
Data sourced from ClinicalTrials.gov (NCT04086966). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.