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

Metastatic Prostate Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04086966
• Other study ID #: R18-190 IRB-300003826
• Status: Completed
• Phase: Phase 1
• Start date: August 20, 2020
• Est. completion date: February 23, 2022

Study information

• Verified date: November 2023
• Source: University of Alabama at Birmingham
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 10
• Est. completion date: February 23, 2022
• Est. primary completion date: February 23, 2022
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Metastatic Prostate Cancer
• Prostatic Neoplasms

Intervention

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

Locations

Country	Name	City	State
United States	University of Alabama at Birmingham Medical Center	Birmingham	Alabama

Sponsors (1)

Lead Sponsor	Collaborator
University of Alabama at Birmingham

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The Number of Patients Who Demonstrate Pelvic Lymph Node Metastases on PSMA-PET/MRI That Were Not Detected on MRI		1 scan
Secondary	The Total Number of Pelvic Nodal Metastases Detected on PSMA-PET/MRI		1 scan
Secondary	Number of Patients in Whom Dose-escalated Radiotherapy Can be Feasibly Delivered		1 simulation scan
Secondary	Number of Patients Who Experience CTCAE (Common Terminology Criteria for Adverse Events) Grade 3-5 GI or GU Toxicities		18 months
Secondary	The Total Number of Pelvic Nodal Metastases Detected on MRI		1 scan