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

NCT ID: NCT06995053

Last Updated: 2025-11-10

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

80 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-06-27

Study Completion Date

2036-09-01

Brief Summary

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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.

Detailed Description

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PRIMARY OBJECTIVE:

I. To determine the acute physician-scored GU toxicity associated with CT-guided SBRT utilizing a 2mm prostate ± seminal vesicles planning target volume (PTV) margin for localized prostate cancer.

SECONDARY OBJECTIVES:

I. To determine the acute physician-scored GI toxicity associated with the intervention.

II. To determine the late physician-scored toxicity associated with the intervention.

III. To determine the patient-reported quality of life outcomes associated with the intervention.

IV. To determine the 5-year biochemical recurrence-free survival (BCRFS) associated with the intervention.

V. To evaluate intrafraction prostate motion using on-board imaging data acquired during this trial in conjunction with prior data, described above.

OUTLINE:

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.

After completion of study treatment, patients are followed up at 1 and 3 months, every 3 months for the first year, every 6 months for a minimum of 5 years, and then annually thereafter.

Conditions

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

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Treatment (CT-guided SBRT, intrafraction motion monitoring)

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.

Group Type EXPERIMENTAL

Biospecimen Collection

Intervention Type PROCEDURE

Undergo blood sample collection

Computed Tomography

Intervention Type PROCEDURE

Undergo CT

CT-guided Stereotactic Body Radiation Therapy

Intervention Type RADIATION

Undergo CT-guided SBRT with intrafraction motion monitoring

Intrafraction Motion Monitoring

Intervention Type OTHER

Undergo CT-guided SBRT with intrafraction motion monitoring

Magnetic Resonance Imaging

Intervention Type PROCEDURE

Undergo MRI

Questionnaire Administration

Intervention Type OTHER

Ancillary studies

Interventions

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Biospecimen Collection

Undergo blood sample collection

Intervention Type PROCEDURE

Computed Tomography

Undergo CT

Intervention Type PROCEDURE

CT-guided Stereotactic Body Radiation Therapy

Undergo CT-guided SBRT with intrafraction motion monitoring

Intervention Type RADIATION

Intrafraction Motion Monitoring

Undergo CT-guided SBRT with intrafraction motion monitoring

Intervention Type OTHER

Magnetic Resonance Imaging

Undergo MRI

Intervention Type PROCEDURE

Questionnaire Administration

Ancillary studies

Intervention Type OTHER

Other Intervention Names

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Biological Sample Collection Biospecimen Collected Specimen Collection CAT CAT Scan Computed Axial Tomography Computerized Axial Tomography Computerized axial tomography (procedure) Computerized Tomography Computerized Tomography (CT) scan CT CT Scan tomography Computed Tomography-Guided Stereotactic Body Radiation Therapy CT-guided SBRT 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

Eligibility Criteria

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Inclusion Criteria

* 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

Exclusion Criteria

* 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
Minimum Eligible Age

18 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

No

Sponsors

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Varian Medical Systems

INDUSTRY

Sponsor Role collaborator

Jonsson Comprehensive Cancer Center

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Amar Kishan

Role: PRINCIPAL_INVESTIGATOR

UCLA / Jonsson Comprehensive Cancer Center

Locations

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UCLA / Jonsson Comprehensive Cancer Center

Los Angeles, California, United States

Site Status RECRUITING

Countries

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United States

Central Contacts

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CHRISTY Palodichuk

Role: CONTACT

Phone: 3107942971

Email: [email protected]

Care Felix

Role: CONTACT

Phone: 3107942971

Email: [email protected]

Facility Contacts

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Carol Felix

Role: primary

CHRISTY Palodichuk

Role: backup

Other Identifiers

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NCI-2025-02120

Identifier Type: REGISTRY

Identifier Source: secondary_id

25-0284

Identifier Type: -

Identifier Source: org_study_id