NCT06171269 · University of Chicago
Using MRI to Identify Areas to Receive Lower Doses of Radiation Treatment in Men With Prostate Cancerdose Mapping to Preserve Quality of Life
What this study is about
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).
View original scientific description
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).
Interventions
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.
Primary outcome measures
Improvement in bowel related quality of life
Time frame: 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.
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
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.
Where
- Chicago, Illinois
Related conditions & keywords
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced Mar 4, 2026 · Source of record for eligibility and locations