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

Sponsor
University of Alabama at Birmingham (Other)
Overall Status
Completed
CT.gov ID
NCT04086966
Collaborator
(none)
10
Enrollment
1
Location
1
Arm
18.1
Actual Duration (Months)
0.6
Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Drug: [68Ga]PSMA-PET/MRI or PET/CT
 Phase 1

Study Design

Study Type:
Interventional
Actual Enrollment :
10 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Masking:
None (Open Label)
Primary Purpose:
Diagnostic
Official Title:
PSMA-PET/MRI for Radiation Treatment Planning in Patients With Locally Metastatic Prostate Cancer: A Pilot Study
Actual Study Start Date :
Aug 20, 2020
Actual Primary Completion Date :
Feb 23, 2022
Actual Study Completion Date :
Feb 23, 2022

Arms and Interventions

Arm Intervention/Treatment
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

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

Outcome Measures

Primary Outcome Measures

  1. 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

  1. The total number of pelvic nodal metastases detected on MRI and PSMA-PET/MRI [24 months]

  2. Number of patients in whom dose-escalated radiotherapy can be feasibly delivered [24 months]

  3. Number of patients who experience CTCAE (Common Terminology Criteria for Adverse Events) grade 3-5 GI or GU toxicities [24 months]

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
Male
Accepts Healthy Volunteers:
No
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

Contacts and Locations

Locations

Site City State Country Postal Code
1 University of Alabama at Birmingham Medical Center Birmingham Alabama United States 35249

Sponsors and Collaborators

  • University of Alabama at Birmingham

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
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
ClinicalTrials.gov Identifier:
NCT04086966
Other Study ID Numbers:
  • R18-190 IRB-300003826
First Posted:
Sep 12, 2019
Last Update Posted:
Mar 9, 2022
Last Verified:
Mar 1, 2022
Studies a U.S. FDA-regulated Drug Product:
Yes
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:
Prostatic Neoplasms

Study Results

No Results Posted as of Mar 9, 2022