Actively Recruiting
Image-Guidance With Triggered Beam Hold To Implanted Fiducial Markers or Hypersight for Stereotactic Body Radiotherapy for Prostate Cancer (ILLUSION)
Led by Jonsson Comprehensive Cancer Center · Updated on 2025-11-10
80
Participants Needed
1
Research Sites
52 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
Researchers are evaluating the side effects and effectiveness of computed tomography (CT)-guided stereotactic body radiation therapy (SBRT) with intrafraction motion monitoring for treating men with localized prostate cancer that has not spread. This study aims to determine the acute and late urinary and bowel side effects, patient-reported quality of life, and 5-year biochemical recurrence-free survival. The trial also assesses prostate motion during treatment to improve targeting precision. Participants receive CT-guided SBRT with intrafraction motion monitoring over 5 treatment sessions, typically given every other day or on consecutive days if needed. Imaging such as CT and MRI, along with blood sample collection, are performed throughout the study. The intrafraction motion monitoring helps track prostate movement during radiation to target the tumor more precisely and potentially reduce side effects. During the study, participants undergo regular follow-up visits at 1 and 3 months after treatment, then every 3 months for the first year, every 6 months for at least 5 years, and annually thereafter. Assessments include physician-scored urinary and gastrointestinal toxicities, patient questionnaires on quality of life, imaging scans, and blood tests. The main outcome measures focus on acute and late side effects, quality of life changes, cancer recurrence, and prostate motion during treatment.
CONDITIONS
Brief 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 above the renal arteries or in bones or visceral organs
- Lymph node disease below the renal arteries may be allowed if deemed locoregional
- Staging workup as per NCCN risk grouping recommendations
- Advanced imaging (PSMA PET/CT or fluciclovine PET/CT) can replace bone scan if done first
- Age 18 years or older
- Able to give written informed consent and comply with study requirements
You will not qualify if you...
- Neuroendocrine or small cell carcinoma of the prostate
- Evidence of distant metastases except nodal disease below renal arteries
- 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 that may compromise participant safety or data quality as judged by the investigator
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Approximately 2 weeks
Participants undergo CT-guided stereotactic body radiation therapy with intrafraction motion monitoring over 5 fractions every other day or consecutive days if needed. They also undergo CT, MRI, and blood sample collection during the treatment period.
5 treatment sessions and additional imaging and blood sample visits
Duration - Up to 5 years and beyond
After treatment completion, participants are followed up at 1 and 3 months, every 3 months for the first year, every 6 months for at least 5 years, and annually thereafter to monitor toxicity, quality of life, and disease status.
Multiple follow-up visits starting at 1 month post-treatment with decreasing frequency over time
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
C
Care Felix
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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