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

NCT06995053 | Recruiting DMC FDA Device

• 2 other identifiers: 25-0284NCI-2025-02120
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 1

Brief Summary

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

Localized Prostate Adenocarcinoma; Stage I Prostate Cancer AJCC v8; Stage II Prostate Cancer AJCC v8; Stage III Prostate Cancer AJCC v8

Outcome Measures

Primary Outcomes (1)

• Incidence of acute grade ≥ 2 genitourinary (GU) toxicities

  Will determine physician-scored GU toxicities by the Common Terminology Criteria for Adverse Events, version 5 (CTCAE v5.0) criteria. Rates will be reported descriptively. Point estimates as well as the associated 95% confidence intervals will be reported.

  From the start of stereotactic body radiation therapy (SBRT) to 90 days post-SBRT

Secondary Outcomes (5)

• Incidence of acute grade ≥ 2 gastrointestinal (GI) toxicities

  From the start of SBRT to 90 days post-SBRT

• Cumulative incidence of late grade ≥ 2 GU and GI toxicities

  Up to 5 years post-SBRT

• Change in International Prostate Symptom Score (IPSS) and Expanded Prostate Cancer Index Composite-26 (EPIC-26) score

  Baseline to 5 years post-SBRT

• Biochemical recurrence-free survival

  Up to 5 years post-SBRT

• Intrafraction prostate motion

  Baseline, at time of SBRT

Study Arms (1)

Treatment (CT-guided SBRT, intrafraction motion monitoring)

EXPERIMENTAL

Patients undergo CT-guided SBRT with intrafraction motion monitoring over 5 fractions every other day, or on consecutive days, if necessary, in the absence of disease progression or unacceptable toxicity. Patients also undergo CT and MRI on study and blood sample collection throughout the study.

Procedure: Biospecimen Collection; Procedure: Computed Tomography; Radiation: CT-guided Stereotactic Body Radiation Therapy; Other: Intrafraction Motion Monitoring; Procedure: Magnetic Resonance Imaging; Other: Questionnaire Administration

Interventions

Biospecimen Collection PROCEDURE

Undergo blood sample collection

Also known as: Biological Sample Collection, Biospecimen Collected, Specimen Collection

Treatment (CT-guided SBRT, intrafraction motion monitoring)

Computed Tomography PROCEDURE

Undergo CT

Also known as: CAT, CAT Scan, Computed Axial Tomography, Computerized Axial Tomography, Computerized axial tomography (procedure), Computerized Tomography, Computerized Tomography (CT) scan, CT, CT Scan, tomography

Treatment (CT-guided SBRT, intrafraction motion monitoring)

CT-guided Stereotactic Body Radiation Therapy RADIATION

Undergo CT-guided SBRT with intrafraction motion monitoring

Also known as: Computed Tomography-Guided Stereotactic Body Radiation Therapy, CT-guided SBRT

Treatment (CT-guided SBRT, intrafraction motion monitoring)

Intrafraction Motion Monitoring OTHER

Undergo CT-guided SBRT with intrafraction motion monitoring

Treatment (CT-guided SBRT, intrafraction motion monitoring)

Magnetic Resonance Imaging PROCEDURE

Undergo MRI

Also known as: Magnetic Resonance, Magnetic Resonance Imaging (MRI), Magnetic resonance imaging (procedure), Magnetic Resonance Imaging Scan, Medical Imaging, Magnetic Resonance / Nuclear Magnetic Resonance, MR, MR Imaging, MRI, MRI Scan, MRIs, NMR Imaging, NMRI, Nuclear Magnetic Resonance Imaging, sMRI, Structural MRI

Treatment (CT-guided SBRT, intrafraction motion monitoring)

Questionnaire Administration OTHER

Ancillary studies

Treatment (CT-guided SBRT, intrafraction motion monitoring)

Eligibility Criteria

• Age: 18 Years+
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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
• 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
• 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

Sponsors & Collaborators

• Jonsson Comprehensive Cancer Center: lead
• Varian Medical Systems: collaborator

Study Sites (1)

UCLA / Jonsson Comprehensive Cancer Center

Los Angeles, California, 90095, United States

RECRUITING

MeSH Terms

Conditions

Prostatic Neoplasms

Interventions

Specimen Handling; Magnetic Resonance Spectroscopy

Condition Hierarchy (Ancestors)

Genital Neoplasms, Male; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Prostatic Diseases; Male Urogenital Diseases

Intervention Hierarchy (Ancestors)

Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Investigative Techniques; Spectrum Analysis; Chemistry Techniques, Analytical

Study Officials

• Amar Kishan

  UCLA / Jonsson Comprehensive Cancer Center

  PRINCIPAL INVESTIGATOR

Central Study Contacts

CHRISTY Palodichuk

CONTACT

3107942971; cpalodichuk@mednet.ucla.edu

Care Felix

CONTACT

3107942971; cfelix@mednet.ucla.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 20, 2025
• First Posted: May 29, 2025
• Study Start: June 27, 2025
• Primary Completion (Estimated): September 1, 2035
• Study Completion (Estimated): September 1, 2036
• Last Updated: November 10, 2025

Record last verified: 2025-06

Locations

US (1)