Using MRI to Identify Areas to Receive Lower Doses of Radiation Treatment in Men With Prostate Cancerdose Mapping to Preserve Quality of Life

A Prospective Study of Lower Dose Radiation (LO-RADS) for Prostate Cancer Using MRI Dose Mapping to Preserve Quality of Life

The purpose of this research is to gather information on the safety and effectiveness of using an imaging technique called magnetic resonance imaging (MRI) to decrease radiation dose to the uninvolved prostate (areas of the prostate that do not clearly have cancer cells) while increasing radiation dose to the nodules (hardened areas of the prostate that have cancer cells).

Study Overview

• Status: Not yet recruiting
• Conditions: Prostate Cancer
• Intervention / Treatment: Radiation: Radiation; Radiation: MRI; Other: Androgen Deprivation Therapy

• Study Type: Interventional
• Enrollment (Estimated): 60
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Clinical Trials Intake; Phone Number: 1-855-702-8222; Email: cancerclinicaltrials@bsd.uchicago.edu

Study Locations

• United States
  • Illinois
    • Chicago, Illinois, United States, 60637
      • University of Chicago Medicine Comprehensive Cancer Center
      • Contact: Clinical Trials Intake; Phone Number: 855-702-8222; Email: cancerclinicaltrials@bsd.uchicago.edu
      • Principal Investigator: Stanley Liauw

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• Adult (≥ 18 years old) male patients with an ECOG Performance Status 0-2
• Histologically-confirmed, MRI-visible prostate adenocarcinoma with NCCN intermediate- or high-risk disease1 without extra-pelvic metastasis.

Exclusion Criteria:

• Distant metastases
• Prior active treatment for prostate cancer including radical prostatectomy, high-intensity focused ultrasound (HIFU), cryosurgery, ADT, or cytotoxic chemotherapy for treatment of prostate cancer. Patients with prostate cancer on active surveillance prior to the study are not excluded if they have not received active treatment.
• Prior pelvic radiotherapy including brachytherapy.
• Additional active concurrent malignancies (except localized cutaneous squamous or basal cell carcinomas).
• Comorbid conditions that, in the opinion of the treating radiation oncologist, preclude the patient from safely receiving the protocol-specified treatment including RT and/or ADT.
• Patients with contraindications to MRI including patients with ferromagnetic materials in their body (e.g. bioimplants, surgical hardware, shrapnel), patients who are unable to receive contrast due to history of allergy or impaired renal function (glomerular filtration rate < 30 mil/min), and patients unable to tolerate MRI for other reasons (e.g. significant claustrophobia).
• Patients for whom hydrogel or hyaluronic acid spacer will be placed.
• Patients incapable of giving informed consent.
• Patients who are unable to adhere to the experimental protocols for any reason.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

Experimental: Radiation therapy; Participants will receive MRI scan before starting Radiation treatment. The results of this scan will be used to identify areas of the prostate to receive low doses of radiation (areas that show no cancer cells seen by the MRI scan).

Radiation: Radiation; Radiation to the prostate gland will be given daily (Mon-Friday) for 4 weeks.; Radiation: MRI; The study doctor will use an MRI scan to take pictures of the prostate gland. These images of the prostate gland will let the study doctor know which areas of the prostate contain cancer cells that need to be targeted with higher doses of radiation and which uninvolved areas to target with lower doses of radiation.; Other: Androgen Deprivation Therapy; Treatment of treating physician choice will be given for 6-24 months.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Improvement in bowel related quality of life	Decrease by at least 5 points in bowel related endpoints as measured by Expanded Prostate Cancer Index Composite 26 (EPIC-26) questionnaire.	12 months after treatment

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Biochemical control	Number of participants that have failed ADT therapy after 2 years as shown by prostate specific antigen (PSA) levels..	2 year after start of treatment
Relationship between Imaging findings and Pathologic (tissue) findings	Correlation between signs of cancer as seen by imaging and tissue (pathology)	12 months post treatment
Treatment Side effects	Number of gastrointestinal, genitourinary, and sexual side effects that are grade 2 or above per the Common Terminology Criteria for Adverse Events (CTCAE)	12 months post treatment
Patient reported quality of life	improvement in patient reported quality of life (shown higher scores of worse symptoms) of gastrointestinal, genitourinary, and sexual function as assess by Expanded Prostate Cancer Index (EPIC) questionnaires	12 months post treatment

Collaborators and Investigators

• Sponsor: University of Chicago
• Investigators: Principal Investigator: Stanley Liauw, University Of Chicago

Study record dates

Study Major Dates

• Study Start (Estimated): February 14, 2024
• Primary Completion (Estimated): February 14, 2027
• Study Completion (Estimated): October 20, 2028

Study Registration Dates

• First Submitted: November 14, 2023
• First Submitted That Met QC Criteria: December 6, 2023
• First Posted (Actual): December 14, 2023

Study Record Updates

• Last Update Posted (Actual): December 20, 2023
• Last Update Submitted That Met QC Criteria: December 13, 2023
• Last Verified: December 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Neoplasms; Urogenital Neoplasms; Neoplasms by Site; Genital Neoplasms, Male; Prostatic Diseases; Urogenital Diseases; Male Urogenital Diseases; Genital Diseases, Male; Genital Diseases; Prostatic Neoplasms; Physiological Effects of Drugs; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Androgens
• Other Study ID Numbers: IRB23-1023

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No