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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

Who can join

As published by the study on ClinicalTrials.gov. "Not stated" means the study hasn't said — ask the study team.

Age
18 Years and older
Sex
Male only
Healthy volunteers
Not accepted
Compensation
Not stated

Other requirements are listed under Eligibility below. Only the study team can confirm whether you can join.

What to expect

No one can promise a trial will help you personally — that is what the research is trying to find out.

What participation involves

Not stated in the study description — ask the study team about visits and procedures.

Compensation
Not stated
  • Study-related exams and procedures are typically provided at no cost. This is how many trials work in general — confirm the details for this study with the study team.
  • Participants are monitored closely by the research team throughout the study.
  • Some participants may receive access to an investigational treatment, which is still being studied.
  • Your participation helps researchers learn whether this approach could help future patients.

About this study

In plain language

This study tests whether MRI scans can safely guide radiation treatment for men with prostate cancer. It uses lower radiation doses in areas that do not clearly have cancer and higher doses in areas that have cancer. It is for men whose cancer has a medium or high risk level and has not spread outside the pelvis.

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).

Compensation is read from the study's own description and may be missing — always confirm with the study team.

Eligibility

Who can join

  • Men age 18 or older who can care for themselves and are up and about at least half of their waking hours.
  • Prostate adenocarcinoma, a type of prostate cancer, confirmed by a tissue test and visible on MRI.
  • Cancer rated as medium or high risk, with no spread outside the pelvis.

Who can't join

  • Cancer that has spread to distant parts of the body.
  • Past prostate cancer treatment, such as prostate removal, focused ultrasound, freezing treatment, hormone treatment (ADT), or chemotherapy. Watching the cancer without treating it does not rule you out.
  • Past radiation to the pelvis, including radiation placed inside the body.
  • Another active cancer, except certain skin cancers (squamous or basal cell) that have not spread.
  • Other health problems that your radiation doctor believes would make the study's radiation or hormone treatment unsafe.
  • Unable to safely have or tolerate MRI. Reasons include metal in the body that is affected by magnets, contrast dye allergy, very poor kidney function, or a strong fear of enclosed spaces.
  • Plans to have a hydrogel or hyaluronic acid spacer placed—a gel used to create space between tissues.
  • Unable to give informed consent (understand and agree to join) or follow the study's requirements.

Simplified for readability. The official criteria below are what the study team uses.

Official eligibility criteria

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 sites (1)

IL