Recruiting

Radiation Treatment

Sponsor:

University of Chicago

Code:

NCT06171269

Conditions

Prostate Cancer

Eligibility Criteria

Sex: Male

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Radiation

MRI

Androgen Deprivation Therapy

Study Details

Brief summary:

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).

Conditions

Prostate Cancer

Study ID

NCT06171269

Start date

Jan 5, 2024

Status verified date

Mar, 2026

Completion date

Oct 20, 2028

Anticipated

Primary completion date

Feb 14, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: Male

Age: 18+

Healthy Volunteers: Not accepted

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 Design

Enrollment

60 participants

Anticipated

Intervention Model

Single group

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Radiation therapy

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).

Interventions

Radiation

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

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.

Androgen Deprivation Therapy

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

Primary outcome measure

  • Improvement in bowel related quality of life [ Time Frame: 12 months after treatment ]

Central Contacts and Locations

Central contacts

Clinical Trials Intake

1-855-702-8222cancerclinicaltrials@bsd.uchicago.edu

Locations

University of Chicago Medicine Comprehensive Cancer Center

Recruiting

Chicago, Illinois, United States, 60637

Contacts

Clinical Trials Intake

855-702-8222cancerclinicaltrials@bsd.uchicago.edu

Principal Investigator:

Stanley Liauw

More Information

Sponsor

University of Chicago

Last update posted

Mar 4, 2026

Last verified

Mar, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-08. This information was provided to ClinicalTrials.gov by University of Chicago on 2026-03-04.