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


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


  • 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,

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