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

Phase 1

Completed

• Conditions: Metastatic Prostate Cancer
• Interventions: Drug: [68Ga]PSMA-PET/MRI or PET/CT

• Registration Number: NCT04086966
• Lead Sponsor: University of Alabama at Birmingham

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2019-09-09
• Study First Submitted QC: 2019-09-10
• Study First Posted: 2019-09-12
• Study Start: 2020-08-20
• Primary Completion: 2022-02-23
• Study Completion: 2022-02-23
• Results First Submitted: 2023-01-17
• Status Verified: 2023-11
• Results First Submitted QC: 2023-11-18
• Last Update Submitted: 2023-11-18
• Results First Posted: 2024-04-26
• Last Update Posted: 2024-04-26

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Male
• Target Recruitment: 10

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

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Metastatic Prostate Cancer Arm	[68Ga]PSMA-PET/MRI or PET/CT	\[68Ga\]PSMA-11 PET/MRI or PET/CT for guiding the radiation treatment plan in patients with known or suspected locally metastatic prostate cancer

Primary Outcome Measures

Name	Time	Method
The Number of Patients Who Demonstrate Pelvic Lymph Node Metastases on PSMA-PET/MRI That Were Not Detected on MRI	1 scan

Secondary Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (1)

University of Alabama at Birmingham Medical Center; 🇺🇸 Birmingham, Alabama, United States