Actively Recruiting

Phase Not Applicable
Age: 18Years +
MALE
NCT06995053

Computed Tomography-Guided Stereotactic Body Radiation Therapy With Intrafraction Motion Monitoring for the Treatment of Localized Prostate Cancer, ILLUSION Trial

Led by Jonsson Comprehensive Cancer Center · Updated on 2025-11-10

80

Participants Needed

1

Research Sites

583 weeks

Total Duration

On this page

Sponsors

J

Jonsson Comprehensive Cancer Center

Lead Sponsor

V

Varian Medical Systems

Collaborating Sponsor

AI-Summary

What this Trial Is About

This clinical trial studies the side effects of computed tomography (CT)-guided stereotactic body radiation therapy (SBRT) with intrafraction motion monitoring and to see how well it works in treating patients with prostate cancer that has not spread to other parts of the body (localized). In CT-guided SBRT, x-ray-based imaging and cone-beam CTs are used to define and localize the area to be treated with SBRT. SBRT is a type of external radiation therapy that uses special equipment to position a patient and precisely deliver radiation to tumors in the body (except the brain). The total dose of radiation is divided into smaller doses given over several days. This type of radiation therapy helps spare normal tissue. A recent randomized trial showed that while SBRT is associated with less urinary incontinence and erectile dysfunction than complete surgical removal of the prostate, there are more urinary irritative side effects and more bowel side effects than with surgery. One source of uncertainty in SBRT that may contribute to genitourinary (GU) and gastrointestinal (GI) side effects is the necessity of treating a "margin" of volume around the prostate to account for its movement during SBRT. Intrafraction motion monitoring is any technique or system designed to track the movement of the body and target during fractions of external beam radiation to keep the beam on target. This allows for the patient to be repositioned, if needed, to ensure delivery of the SBRT to only the planned treatment area. CT-guided SBRT with intrafraction motion monitoring may lower GU and GI side effects by allowing tighter margins, as has been demonstrated with magnetic resonance imaging (MRI)-guided SBRT.

CONDITIONS

Official Title

Computed Tomography-Guided Stereotactic Body Radiation Therapy With Intrafraction Motion Monitoring for the Treatment of Localized Prostate Cancer, ILLUSION Trial

Who Can Participate

Age: 18Years +
MALE

Eligibility Criteria

Eligible

You may qualify if you...

  • Histologically confirmed, clinically localized adenocarcinoma of the prostate
  • No evidence of metastatic disease in lymph nodes above the bifurcation of the renal arteries, or in bones or visceral organs (nodal disease identified on PSMA PET/CT scan below the bifurcation of the renal arteries are allowed)
  • Staging workup as recommended by the National Comprehensive Cancer Network (NCCN) based on risk grouping
  • Advanced imaging studies like PSMA PET/CT or fluciclovine PET/CT can replace a bone scan if done first
  • Age 18 years or older
  • Written informed consent and ability to comply with study requirements
Not Eligible

You will not qualify if you...

  • Neuroendocrine or small cell carcinoma of the prostate
  • Any evidence of distant metastases except lymphadenopathy below the renal arteries as deemed locoregional by investigator
  • Prior whole gland cryosurgery, high-intensity focused ultrasound (HIFU), or brachytherapy of the prostate
  • Prior pelvic radiotherapy
  • History of Crohn's Disease, ulcerative colitis, or ataxia telangiectasia
  • Any condition or abnormality that could compromise participant safety or data quality according to the investigator

AI-Screening

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Trial Site Locations

Total: 1 location

1

UCLA / Jonsson Comprehensive Cancer Center

Los Angeles, California, United States, 90095

Actively Recruiting

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Research Team

C

CHRISTY Palodichuk

CONTACT

C

Care Felix

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

NA

Model

SINGLE_GROUP

Primary Purpose

TREATMENT

Number of Arms

1

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