Back to resultsPSMA-PET/MRI for Radiation Treatment Planning in Patients With Locally Metastatic Prostate Cancer: A Pilot Study
Primary Purpose
Metastatic Prostate Cancer
Status
Completed
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
[68Ga]PSMA-PET/MRI or PET/CT
Sponsored by
About this trial
This is an interventional diagnostic trial for Metastatic Prostate Cancer
Eligibility Criteria
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
Sites / Locations
- University of Alabama at Birmingham Medical Center
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Metastatic Prostate Cancer Arm
Arm Description
[68Ga]PSMA-11 PET/MRI or PET/CT for guiding the radiation treatment plan in patients with known or suspected locally metastatic prostate cancer
Outcomes
Primary Outcome Measures
The number of patients who demonstrate pelvic lymph node metastases on PSMA-PET/MRI that were not detected on MRI
Secondary Outcome Measures
The total number of pelvic nodal metastases detected on MRI and PSMA-PET/MRI
Number of patients in whom dose-escalated radiotherapy can be feasibly delivered
Number of patients who experience CTCAE (Common Terminology Criteria for Adverse Events) grade 3-5 GI or GU toxicities
Full Information
NCT ID
NCT04086966
First Posted
September 9, 2019
Last Updated
March 7, 2022
Sponsor
University of Alabama at Birmingham
1. Study Identification
Unique Protocol Identification Number
NCT04086966
Brief Title
PSMA-PET/MRI for Radiation Treatment Planning in Patients With Locally Metastatic Prostate Cancer: A Pilot Study
Official Title
PSMA-PET/MRI for Radiation Treatment Planning in Patients With Locally Metastatic Prostate Cancer: A Pilot Study
Study Type
Interventional
2. Study Status
Record Verification Date
March 2022
Overall Recruitment Status
Completed
Study Start Date
August 20, 2020 (Actual)
Primary Completion Date
February 23, 2022 (Actual)
Study Completion Date
February 23, 2022 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Alabama at Birmingham
4. Oversight
Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Metastatic Prostate Cancer
7. Study Design
Primary Purpose
Diagnostic
Study Phase
Phase 1
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
10 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Metastatic Prostate Cancer Arm
Arm Type
Experimental
Arm Description
[68Ga]PSMA-11 PET/MRI or PET/CT for guiding the radiation treatment plan in patients with known or suspected locally metastatic prostate cancer
Intervention Type
Drug
Intervention Name(s)
[68Ga]PSMA-PET/MRI or PET/CT
Intervention Description
[68Ga]PSMA-PET/MRI or PET/CT
Primary Outcome Measure Information:
Title
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 Outcome Measure Information:
Title
The total number of pelvic nodal metastases detected on MRI and PSMA-PET/MRI
Time Frame
24 months
Title
Number of patients in whom dose-escalated radiotherapy can be feasibly delivered
Time Frame
24 months
Title
Number of patients who experience CTCAE (Common Terminology Criteria for Adverse Events) grade 3-5 GI or GU toxicities
Time Frame
24 months
10. Eligibility
Sex
Male
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Facility Information:
Facility Name
University of Alabama at Birmingham Medical Center
City
Birmingham
State/Province
Alabama
ZIP/Postal Code
35249
Country
United States
12. IPD Sharing Statement
Learn more about this trial
PSMA-PET/MRI for Radiation Treatment Planning in Patients With Locally Metastatic Prostate Cancer: A Pilot Study
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