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

NCT04086966 | Completed Phase 1 Results DMC FDA Drug

• 1 other identifier: R18-190 IRB-300003826
• Study Type: interventional
• Target: 10
• Locations: 1 country
• Sites: 1

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.

Conditions

Metastatic Prostate Cancer

Outcome Measures

Primary Outcomes (1)

• The Number of Patients Who Demonstrate Pelvic Lymph Node Metastases on PSMA-PET/MRI That Were Not Detected on MRI

  1 scan

Secondary Outcomes (4)

• The Total Number of Pelvic Nodal Metastases Detected on PSMA-PET/MRI

  1 scan

• Number of Patients in Whom Dose-escalated Radiotherapy Can be Feasibly Delivered

  1 simulation scan

• Number of Patients Who Experience CTCAE (Common Terminology Criteria for Adverse Events) Grade 3-5 GI or GU Toxicities

  18 months

• The Total Number of Pelvic Nodal Metastases Detected on MRI

  1 scan

Study Arms (1)

Metastatic Prostate Cancer Arm

EXPERIMENTAL

\[68Ga\]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

Interventions

[68Ga]PSMA-PET/MRI or PET/CT DRUG

\[68Ga\]PSMA-PET/MRI or PET/CT

Metastatic Prostate Cancer Arm

Eligibility Criteria

• Age: 18 Years+
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Alabama at Birmingham: lead

Study Sites (1)

University of Alabama at Birmingham Medical Center

Birmingham, Alabama, 35249, United States

Location

MeSH Terms

Conditions

Prostatic Neoplasms

Condition Hierarchy (Ancestors)

Genital Neoplasms, Male; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Prostatic Diseases; Male Urogenital Diseases

Results Point of Contact

• Title: April Riddle
• Organization: University of Alabama at Birmingham

ariddle@uabmc.edu

(205)934-6504

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Program Director, Abdominal Imaging Fellowship Assistant Professor, Abdominal Imaging Section and Division of Molecular Imaging and Therapeutics

Study Record Dates

• First Submitted: September 9, 2019
• First Posted: September 12, 2019
• Study Start: August 20, 2020
• Primary Completion: February 23, 2022
• Study Completion: February 23, 2022
• Last Updated: April 26, 2024
• Results First Posted: April 26, 2024

Record last verified: 2023-11

Locations

US (1)