NCT06995053Active, not recruiting
Computed Tomography-Guided Stereotactic Body Radiation Therapy With Intrafraction Motion Monitoring for the Treatment of Localized Prostate Cancer, ILLUSION Trial
Image-Guidance With Triggered Beam Hold To Implanted Fiducial Markers or Hypersight for Stereotactic Body Radiotherapy for Prostate Cancer (ILLUSION)
Source: ClinicalTrials.gov · Last updated 20 Aug 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Active, not recruiting
- Study type
- Interventional
- Enrollment
- 91 (estimated)
- First submitted
- 20 May 2025
- Start date
- 27 Jun 2025
- Primary completion date
- 1 Sept 2035
- Lead sponsor
- Jonsson Comprehensive Cancer Center
- Diseases
- Prostate cancer
- NCT number
- NCT06995053
What you commit to
- Study type: Interventional
- Planned participants: 91
- From 27 Jun 2025 to the primary completion date, 1 Sept 2035
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Prior whole gland cryosurgery, high-intensity focused ultrasound (HIFU) or brachytherapy of the prostate
- Prior pelvic radiotherapy
Other illness
- History of Crohn's Disease, ulcerative colitis, or ataxia telangiectasia
- Presence of a condition or abnormality that in the opinion of the investigator would compromise the safety of the participant or the quality of the data
Other
- Patients with neuroendocrine or small cell carcinoma of the prostate
- Patients with any evidence of distant metastases except that evidence of lymphadenopathy below the level of the renal arteries can be deemed locoregional per the discretion of the investigator
Who the study is looking for
- 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 a prostate-specific membrane antigen \[PSMA\] positron emission tomography \[PET\]/CT scan below the bifurcation of the renal arteries are amenable)
- Staging workup as recommended by the National Comprehensive Cancer Network (NCCN) on the basis of risk grouping
- Advanced imaging studies (i.e. PSMA PET/CT and fluciclovine PET/CT scan) can supplant a bone scan if performed first
- Age ≥ 18
- Written informed consent obtained from participant or participant's legal representative and ability for participant to comply with the requirements of the study
Age in the registry: 18 years to - · Sex: Male · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| UCLA / Jonsson Comprehensive Cancer Center Coordinator of this site? Confirm its status | Los Angeles | United States | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.