Skip to main content
OpenTrials
Recruiting

NCT Number: NCT06171269

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

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).

Recruiting

Interested in participating?

Request Info

Key information

Conditions

Prostate Cancer Genital Diseases Genital Diseases, Male Genital Neoplasms, Male Male Urogenital Diseases Neoplasms Neoplasms by Site Prostatic Diseases Prostatic Neoplasms Urogenital Diseases Urogenital Neoplasms

Age range

18 year and older

Sex eligibility

Male

Study type

Interventional

Phase

Not applicable

Primary location

University of Chicago Medicine Comprehensive Cancer Center

Chicago, Illinois, 60637, United States

Location status: Recruiting

Location contact

Clinical Trials Intake

CONTACT

[email protected]

855-702-8222

Stanley Liauw

PRINCIPAL_INVESTIGATOR

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Radiation

Radiation

Radiation to the prostate gland will be given daily (Mon-Friday) for 4 weeks.

MRI

Radiation

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.

Androgen Deprivation Therapy

Other

Treatment of treating physician choice will be given for 6-24 months.

Primary outcomes

  1. 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.

Secondary outcomes

  1. Biochemical control

    Time frame: 2 year after start of treatment

    Number of participants that have failed ADT therapy after 2 years as shown by prostate specific antigen (PSA) levels..

  2. Relationship between Imaging findings and Pathologic (tissue) findings

    Time frame: 12 months post treatment

    Correlation between signs of cancer as seen by imaging and tissue (pathology)

  3. Treatment Side effects

    Time frame: 12 months post treatment

    Number of gastrointestinal, genitourinary, and sexual side effects that are grade 2 or above per the Common Terminology Criteria for Adverse Events (CTCAE)

  4. Patient reported quality of life

    Time frame: 12 months post treatment

    Improvement in patient reported quality of life (shown higher scores of worse symptoms) with the scale values assigned to each question ranging from 0 (best) to 4 (worst) of gastrointestinal, genitourinary, and sexual function as assess by Expanded Prostate Cancer Index (EPIC) questionnaires

Study contacts

Contact information is provided by the study sponsor or research team.

Clinical Trials Intake

CONTACT

[email protected]

1-855-702-8222

Sponsors and collaborators

Lead sponsor

University of Chicago

Other

Registry information

Official study title

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

Important dates

Study start
2024
Primary completion
2027
Study completion
2028
First posted
Dec 14, 2023
Registry last updated
Mar 4, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.