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

NCT06171269 | Recruiting DMC

• 1 other identifier: IRB23-1023
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief Summary

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).

Conditions

Prostate Cancer

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (4)

• Biochemical control

  2 year after start of treatment

• Relationship between Imaging findings and Pathologic (tissue) findings

  12 months post treatment

• Treatment Side effects

  12 months post treatment

• Patient reported quality of life

  12 months post treatment

Study Arms (1)

Radiation therapy

EXPERIMENTAL

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: MRI; Other: Androgen Deprivation Therapy

Interventions

Radiation RADIATION

Radiation to the prostate gland will be given daily (Mon-Friday) for 4 weeks.

Radiation therapy

MRI RADIATION

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.

Radiation therapy

Androgen Deprivation Therapy OTHER

Treatment of treating physician choice will be given for 6-24 months.

Radiation therapy

Eligibility Criteria

• Age: 18 Years+
• Gender Eligibility Details: The study will be limited to male patients given that prostate cancer does not occur in females.
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Chicago: lead

Study Sites (1)

University of Chicago Medicine Comprehensive Cancer Center

Chicago, Illinois, 60637, United States

RECRUITING

MeSH Terms

Conditions

Prostatic Neoplasms

Interventions

Radiation; Androgen Antagonists

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Physical Phenomena; Hormone Antagonists; Hormones, Hormone Substitutes, and Hormone Antagonists; Physiological Effects of Drugs; Pharmacologic Actions; Chemical Actions and Uses

Study Officials

• Stanley Liauw

  University of Chicago

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Clinical Trials Intake

CONTACT

1-855-702-8222; cancerclinicaltrials@bsd.uchicago.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 14, 2023
• First Posted: December 14, 2023
• Study Start: January 5, 2024
• Primary Completion (Estimated): February 14, 2027
• Study Completion (Estimated): October 20, 2028
• Last Updated: March 4, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)