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

NCT ID: NCT04086966

Last Updated: 2024-04-26

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

10 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-08-20

Study Completion Date

2022-02-23

Brief Summary

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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

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Conditions

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Metastatic Prostate Cancer

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

NONE

Study Groups

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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

Group Type EXPERIMENTAL

[68Ga]PSMA-PET/MRI or PET/CT

Intervention Type DRUG

\[68Ga\]PSMA-PET/MRI or PET/CT

Interventions

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[68Ga]PSMA-PET/MRI or PET/CT

\[68Ga\]PSMA-PET/MRI or PET/CT

Intervention Type DRUG

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

No

Sponsors

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University of Alabama at Birmingham

OTHER

Sponsor Role lead

Responsible Party

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Samuel Joseph Galgano

Program Director, Abdominal Imaging Fellowship Assistant Professor, Abdominal Imaging Section and Division of Molecular Imaging and Therapeutics

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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University of Alabama at Birmingham Medical Center

Birmingham, Alabama, United States

Site Status

Countries

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United States

Provided Documents

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Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

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R18-190 IRB-300003826

Identifier Type: -

Identifier Source: org_study_id

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