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

Overview

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.

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: N/A
    • Intervention Model: Single Group Assignment
    • Primary Purpose: Diagnostic
    • Masking: None (Open Label)
  • Study Primary Completion Date: February 2, 2022

Interventions

  • Drug: [68Ga]PSMA-PET/MRI or PET/CT
    • [68Ga]PSMA-PET/MRI or PET/CT

Arms, Groups and Cohorts

  • Experimental: 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

Clinical Trial Outcome Measures

Primary Measures

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

Secondary Measures

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

Participating in This Clinical Trial

Inclusion Criteria

  • Biopsy-proven treatment-na├»ve 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

Gender Eligibility: Male

Minimum Age: 18 Years

Maximum Age: N/A

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • University of Alabama at Birmingham
  • Provider of Information About this Clinical Study
    • Principal Investigator: 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
  • Overall Contact(s)
    • Samuel Galgano, MD, 205-934-1388, samuelgalgano@uabmc.edu

Clinical trials entries are delivered from the US National Institutes of Health and are not reviewed separately by this site. Please see the identifier information above for retrieving further details from the government database.

At TrialBulletin.com, we keep tabs on over 200,000 clinical trials in the US and abroad, using medical data supplied directly by the US National Institutes of Health. Please see the About and Contact page for details.