Localized Prostate AdenocarcinomaILLUSIONNCT06995053
Computed Tomography-Guided Stereotactic Body Radiation Therapy With Intrafraction Motion Monitoring for the Treatment of Localized Prostate Cancer, ILLUSION Trial
A study testing Biospecimen Collection, Computed Tomography and CT-guided Stereotactic Body Radiation Therapy in people with Localized Prostate Adenocarcinoma and Stage I Prostate Cancer AJCC v8, run by Jonsson Comprehensive Cancer Center at 1 site in United States.
Trial 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). Read more about this study
- Who is it for?
- Ages 18 years and older, men only
- Conditions the study is for
- Localized Prostate Adenocarcinoma, Stage I Prostate Cancer AJCC v8, Stage II Prostate Cancer AJCC v8
- What is being tested?
- Biospecimen Collection, Computed Tomography and CT-guided Stereotactic Body Radiation Therapy
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 91 participants
- Where
- 1 siteUnited States
- Study dates
- 27 Jun 2025to 1 Sep 2036
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Men only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
UCLA / Jonsson Comprehensive Cancer Center
Los Angeles, California, 90095
About this study
Official title: Image-Guidance With Triggered Beam Hold To Implanted Fiducial Markers or Hypersight for Stereotactic Body Radiotherapy for Prostate Cancer (ILLUSION)
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.
Read the detailed description
PRIMARY OBJECTIVE:
- 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:
- 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.
- 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
- Localized Prostate Adenocarcinoma, Stage I Prostate Cancer AJCC v8, Stage II Prostate Cancer AJCC v8, Stage III Prostate Cancer AJCC v8
- Being tested
- Biospecimen Collection, Computed Tomography, CT-guided Stereotactic Body Radiation Therapy, Intrafraction Motion Monitoring, Magnetic Resonance Imaging
- Medical subject headings
- Prostatic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Biospecimen CollectionProcedure or surgery
Also called Biological Sample Collection, Biospecimen Collected, Specimen Collection
Undergo blood sample collection
Computed TomographyProcedure or surgery
Also called CAT, CAT Scan, Computed Axial Tomography, Computerized Axial Tomography
Undergo CT
CT-guided Stereotactic Body Radiation TherapyRadiation
Also called Computed Tomography-Guided Stereotactic Body Radiation Therapy, CT-guided SBRT
Undergo CT-guided SBRT with intrafraction motion monitoring
Intrafraction Motion MonitoringOther
Undergo CT-guided SBRT with intrafraction motion monitoring
Magnetic Resonance ImagingProcedure or surgery
Also called Magnetic Resonance, Magnetic Resonance Imaging (MRI), Magnetic resonance imaging (procedure), Magnetic Resonance Imaging Scan
Undergo MRI
Questionnaire AdministrationOther
Ancillary studies
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Procedure: Biospecimen Collection; Procedure: Computed Tomography; Radiation: CT-guided Stereotactic Body Radiation Therapy; Other: Intrafraction Motion Monitoring; Procedure: Magnetic Resonance Imaging; Other: Questionnaire Administration |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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
Will determine the physician-scored GI toxicities by the CTCAE v5.0 criteria. Rates will be reported descriptively. The analysis of GI toxicity will be stratified for use of hydrogel spacers or not, as these may reduce both acute and late GI toxicity, and by use of nodal radiotherapy or not, if event rate permits this analysis. Additionally, separate analyses of these secondary endpoints stratifying patients by treatment platform and receipt of online adaptive radiotherapy will be performed.
Measured: From the start of SBRT to 90 days post-SBRT
Cumulative incidence of late grade ≥ 2 GU and GI toxicities
Will determine the physician-scored GU and GI toxicities by the CTCAE v5.0 criteria. Will be analyzed using a cumulative incidence framework. The analysis of GI toxicity will be stratified for use of hydrogel spacers or not, as these may reduce both acute and late GI toxicity, and by use of nodal radiotherapy or not, if event rate permits this analysis. Additionally, separate analyses of these secondary endpoints stratifying patients by treatment platform and receipt of online adaptive radiotherapy will be performed.
Measured: Up to 5 years post-SBRT
Change in International Prostate Symptom Score (IPSS) and Expanded Prostate Cancer Index Composite-26 (EPIC-26) score
A 15-point or greater increase in IPSS will be considered clinically relevant. Clinically relevant decrement in EPIC-26 domains will be defined as greater than 18, 14, 12, and 24 points for urinary incontinence, urinary irritative or obstructive, bowel, and sexual domains, respectively. Analysis will be performed using a restricted maximum likelihood-based mixed models repeated measures approach. The model will include the fixed categorical effects of treatment, time, and treatment-by-time interaction, as well as the other fixed baseline covariates. An unstructured covariance structure will be used to model the within-patient errors. The Kenward-Roger approximation will be used to estimate denominator degrees of freedom. The analysis of both acute and late changes in the bowel domain of the EPIC instrument will be stratified for use of hydrogel spacers or not, as these may reduce both acute and late GI bowel symptoms.
Measured: Baseline to 5 years post-SBRT
Biochemical recurrence-free survival
Biochemical recurrence will be defined as serum prostate-specific antigen (PSA) levels that are 2 ng/mL higher than the nadir PSA achieved after SBRT. Will be estimated by the Kaplan-Meier method as well as descriptively (mean, standard deviation, median, first and third quartiles, minimum, maximum).
Measured: Up to 5 years post-SBRT
Intrafraction prostate motion
Will evaluate intrafraction prostate motion using on-board imaging data acquired during this trial, as well as imaging data from previously treated patients who received computed tomography-guided SBRT. Analysis of imaging data acquired during this study will be descriptive and exploratory.
Measured: Baseline, at time of SBRT
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 May 2025
- Study start27 Jun 2025
- Primary completion1 Sep 2035 (estimated)
- Study completion1 Sep 2036 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Localized Prostate AdenocarcinomaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 91 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Jonsson Comprehensive Cancer Center
- Sponsor type
- University, hospital or other
- Collaborators
- Varian Medical Systems
- Responsible party
- Sponsor
- Investigators
- Amar Kishan, Principal investigator, UCLA / Jonsson Comprehensive Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06995053
- Sponsor's protocol ID
- 25-0284
- Other IDs
- NCI-2025-02120
- Acronym
- ILLUSION
- Status last verified
- Aug 2026
- First submitted
- 20 May 2025
- Last updated
- 20 Aug 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 20 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Image-Guidance With Triggered Beam Hold To Implanted Fiducial Markers or Hypersight for Stereotactic Body Radiotherapy for Prostate Cancer (ILLUSION)
- ClinicalTrials.gov ID
- NCT06995053
- Acronym / sponsor ID
- ILLUSION / 25-0284
- Conditions
- Localized Prostate Adenocarcinoma, Stage I Prostate Cancer AJCC v8, Stage II Prostate Cancer AJCC v8, Stage III Prostate Cancer AJCC v8
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 91 participants (estimated)
- Lead sponsor
- Jonsson Comprehensive Cancer CenterUniversity, hospital or other
- Collaborators
- Varian Medical Systems
- Study start
- 27 Jun 2025 (actual)
- Primary completion
- 1 Sep 2035 (estimated)
- Study completion
- 1 Sep 2036 (estimated)
- First posted
- 29 May 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
PRIMARY OBJECTIVE:
- 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:
- 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.
- 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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Treatment (CT-guided SBRT, intrafraction motion monitoring) | Experimental | Procedure: Biospecimen Collection, Procedure: Computed Tomography, Radiation: CT-guided Stereotactic Body Radiation Therapy, Other: Intrafraction Motion Monitoring, Procedure: Magnetic Resonance Imaging, Other: Questionnaire AdministrationPatients 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Biospecimen CollectionAlso: Biological Sample Collection, Biospecimen Collected, Specimen CollectionUndergo blood sample collection | Procedure or surgery | Treatment (CT-guided SBRT, intrafraction motion monitoring) |
| Computed TomographyAlso: CAT, CAT Scan, Computed Axial Tomography, Computerized Axial TomographyUndergo CT | Procedure or surgery | Treatment (CT-guided SBRT, intrafraction motion monitoring) |
| CT-guided Stereotactic Body Radiation TherapyAlso: Computed Tomography-Guided Stereotactic Body Radiation Therapy, CT-guided SBRTUndergo CT-guided SBRT with intrafraction motion monitoring | Radiation | Treatment (CT-guided SBRT, intrafraction motion monitoring) |
| Intrafraction Motion MonitoringUndergo CT-guided SBRT with intrafraction motion monitoring | Other | Treatment (CT-guided SBRT, intrafraction motion monitoring) |
| Magnetic Resonance ImagingAlso: Magnetic Resonance, Magnetic Resonance Imaging (MRI), Magnetic resonance imaging (procedure), Magnetic Resonance Imaging ScanUndergo MRI | Procedure or surgery | Treatment (CT-guided SBRT, intrafraction motion monitoring) |
| Questionnaire AdministrationAncillary studies | Other | Treatment (CT-guided SBRT, intrafraction motion monitoring) |
Primary outcome
Incidence of acute grade ≥ 2 genitourinary (GU) toxicities
Time frame: From the start of stereotactic body radiation therapy (SBRT) to 90 days post-SBRT
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.
5 secondary outcomes
Incidence of acute grade ≥ 2 gastrointestinal (GI) toxicities
Time frame: From the start of SBRT to 90 days post-SBRT
Cumulative incidence of late grade ≥ 2 GU and GI toxicities
Time frame: Up to 5 years post-SBRT
Change in International Prostate Symptom Score (IPSS) and Expanded Prostate Cancer Index Composite-26 (EPIC-26) score
Time frame: Baseline to 5 years post-SBRT
Biochemical recurrence-free survival
Time frame: Up to 5 years post-SBRT
Intrafraction prostate motion
Time frame: Baseline, at time of SBRT
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Aug 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Amar Kishan principal investigator
UCLA / Jonsson Comprehensive Cancer Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Biospecimen Collection, Computed Tomography and CT-guided Stereotactic Body Radiation Therapy in people with Localized Prostate Adenocarcinoma and Stage I Prostate Cancer AJCC v8, run by Jonsson Comprehensive Cancer Center at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 20 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of acute grade ≥ 2 genitourinary (GU) toxicities (time frame: From the start of stereotactic body radiation therapy (SBRT) to 90 days post-SBRT). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Aug 2026.