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

Not Applicable

Recruiting

• Conditions: Prostate Cancer
• Interventions: Radiation: Radiation; Radiation: MRI; Other: Androgen Deprivation Therapy

• Registration Number: NCT06171269
• Lead Sponsor: University of Chicago

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).

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2023-11-14
• Study First Submitted QC: 2023-12-06
• Study First Posted: 2023-12-14
• Study Start: 2024-01-05
• Status Verified: 2024-12
• Last Update Submitted: 2025-01-06
• Last Update Posted: 2025-01-08
• Primary Completion: 2027-02-14
• Study Completion: 2028-10-20

Recruitment & Eligibility

• Status: RECRUITING
• Sex: Male
• Target Recruitment: 60

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Radiation therapy	Radiation	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 therapy	MRI	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 therapy	Androgen Deprivation 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).

Primary Outcome Measures

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

Secondary Outcome Measures

Name	Time	Method
Biochemical control	2 year after start of treatment	Number of participants that have failed ADT therapy after 2 years as shown by prostate specific antigen (PSA) levels..
Patient reported quality of life	12 months post treatment	Improvement in patient reported quality of life (shown higher scores of worse symptoms) with the scale values assigned to each question ranging from 0 (best) to 4 (worst) of gastrointestinal, genitourinary, and sexual function as assess by Expanded Prostate Cancer Index (EPIC) questionnaires
Relationship between Imaging findings and Pathologic (tissue) findings	12 months post treatment	Correlation between signs of cancer as seen by imaging and tissue (pathology)
Treatment Side effects	12 months post treatment	Number of gastrointestinal, genitourinary, and sexual side effects that are grade 2 or above per the Common Terminology Criteria for Adverse Events (CTCAE)

Trial Locations

Locations (1)

University of Chicago Medicine Comprehensive Cancer Center; 🇺🇸 Chicago, Illinois, United States