RECRUITINGINTERVENTIONAL

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

About This Trial

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).

Who May Be Eligible (Plain English)

Who May Qualify: - Adult (≥ 18 years old) male patients with an You should be able to carry out daily activities with 0 level of ability (ECOG 0)-2 - Histologically-confirmed, MRI-visible prostate adenocarcinoma with NCCN intermediate- or high-risk disease1 without extra-pelvic metastasis. Who Should NOT Join This Trial: - 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 willing to sign a consent form. - Patients who are unable to adhere to the experimental protocols for any reason. Always talk to your doctor about whether this trial is right for you.

Original Eligibility Criteria

View original clinical language

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.

Treatments Being Tested

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.

Locations (1)

University of Chicago Medicine Comprehensive Cancer Center

Chicago, Illinois, United States