Actively Recruiting
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
Eligibility Criteria
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
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
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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