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Recruiting NCT06171269

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

No phase Interventional Prostate Cancer

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Radiation, MRI, Androgen Deprivation Therapy.
Who it may be relevant to
Registry conditions: Prostate Cancer. Basic parameters: from 18 years · Male.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
United States
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

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

Overview

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]
Secondary outcome measures (4)
  • Biochemical control [Time frame: 2 year after start of treatment]
  • Relationship between Imaging findings and Pathologic (tissue) findings [Time frame: 12 months post treatment]
  • Treatment Side effects [Time frame: 12 months post treatment]
  • Patient reported quality of life [Time frame: 12 months post treatment]

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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
N/A
Model
Single group
Masking
Open label
Primary purpose
Treatment

Study locations

United States · 1 center
  • University of Chicago Medicine Comprehensive Cancer Center — Chicago

Identifiers

NCT: NCT06171269 · IRB23-1023

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗