PSMA-PET/MRI for Radiation Treatment Planning in Patients With Locally Metastatic Prostate Cancer: A Pilot Study

Study 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.

Official Title
-----------------
PSMA-PET/MRI for Radiation Treatment Planning in Patients With Locally Metastatic Prostate Cancer: A Pilot Study

Conditions
-----------------
Metastatic Prostate Cancer

Intervention / Treatment
-----------------
* Drug: [68Ga]PSMA-PET/MRI or PET/CT


Participation Criteria
=================
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

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
Male

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Diagnostic
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Metastatic Prostate Cancer Arm<br>[68Ga]PSMA-11 PET/MRI or PET/CT for guiding the radiation treatment plan in patients with known or suspected locally metastatic prostate cancer | Drug: [68Ga]PSMA-PET/MRI or PET/CT<br>* [68Ga]PSMA-PET/MRI or PET/CT<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The number of patients who demonstrate pelvic lymph node metastases on PSMA-PET/MRI that were not detected on MRI |  | 24 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The total number of pelvic nodal metastases detected on MRI and PSMA-PET/MRI |  | 24 months | 
| Number of patients in whom dose-escalated radiotherapy can be feasibly delivered |  | 24 months | 
| Number of patients who experience CTCAE (Common Terminology Criteria for Adverse Events) grade 3-5 GI or GU toxicities |  | 24 months |