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

Study Overview
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Brief Summary
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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).

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

Conditions
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Prostate Cancer

Intervention / Treatment
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* Radiation: Radiation
* Radiation: MRI
* Other: Androgen Deprivation Therapy


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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Male

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Radiation therapy<br>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<br>* Radiation to the prostate gland will be given daily (Mon-Friday) for 4 weeks.<br>Radiation: MRI<br>* 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.<br>Other: Androgen Deprivation Therapy<br>* Treatment of treating physician choice will be given for 6-24 months.<br>|

What is the study measuring?
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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 |