[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"trial:NCT06995053":3,"trial-entities:NCT06995053":157,"trial-summary:NCT06995053":161},{"id":4,"nct_id":4,"org_study_id":5,"brief_title":6,"official_title":7,"overall_status":8,"completion_date":9,"status_verified_date":10,"last_update_date":11,"start_date":12,"sponsor_name":13,"lead_sponsor_class":14,"has_dmc":15,"brief_summary":16,"detailed_description":17,"conditions":18,"keywords":23,"study_type":24,"primary_purpose":25,"phases":26,"enrollment_info":28,"interventions":31,"primary_outcomes":92,"secondary_outcomes":97,"sex":117,"minimum_age":118,"maximum_age":119,"healthy_volunteers":120,"eligibility_criteria":121,"std_ages":137,"locations":140,"central_contacts":150,"overall_officials":151,"references":155,"see_also_links":156},"NCT06995053","25-0284","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)","ACTIVE_NOT_RECRUITING","2036-09-01","2026-08","2026-08-20","2025-06-27","Jonsson Comprehensive Cancer Center","OTHER",true,"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.","PRIMARY OBJECTIVE:\n\nI. 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.\n\nSECONDARY OBJECTIVES:\n\nI. To determine the acute physician-scored GI toxicity associated with the intervention.\n\nII. To determine the late physician-scored toxicity associated with the intervention.\n\nIII. To determine the patient-reported quality of life outcomes associated with the intervention.\n\nIV. To determine the 5-year biochemical recurrence-free survival (BCRFS) associated with the intervention.\n\nV. To evaluate intrafraction prostate motion using on-board imaging data acquired during this trial in conjunction with prior data, described above.\n\nOUTLINE:\n\nPatients 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.\n\nAfter 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.",[19,20,21,22],"Localized Prostate Adenocarcinoma","Stage I Prostate Cancer AJCC v8","Stage II Prostate Cancer AJCC v8","Stage III Prostate Cancer AJCC v8",[],"INTERVENTIONAL","TREATMENT",[27],"NA",{"count":29,"type":30},91,"ESTIMATED",[32,42,57,65,68,88],{"type":33,"name":34,"description":35,"armGroupLabels":36,"otherNames":38},"PROCEDURE","Biospecimen Collection","Undergo blood sample collection",[37],"Treatment (CT-guided SBRT, intrafraction motion monitoring)",[39,40,41],"Biological Sample Collection","Biospecimen Collected","Specimen Collection",{"type":33,"name":43,"description":44,"armGroupLabels":45,"otherNames":46},"Computed Tomography","Undergo CT",[37],[47,48,49,50,51,52,53,54,55,56],"CAT","CAT Scan","Computed Axial Tomography","Computerized Axial Tomography","Computerized axial tomography (procedure)","Computerized Tomography","Computerized Tomography (CT) scan","CT","CT Scan","tomography",{"type":58,"name":59,"description":60,"armGroupLabels":61,"otherNames":62},"RADIATION","CT-guided Stereotactic Body Radiation Therapy","Undergo CT-guided SBRT with intrafraction motion monitoring",[37],[63,64],"Computed Tomography-Guided Stereotactic Body Radiation Therapy","CT-guided SBRT",{"type":14,"name":66,"description":60,"armGroupLabels":67},"Intrafraction Motion Monitoring",[37],{"type":33,"name":69,"description":70,"armGroupLabels":71,"otherNames":72},"Magnetic Resonance Imaging","Undergo MRI",[37],[73,74,75,76,77,78,79,80,81,82,83,84,85,86,87],"Magnetic Resonance","Magnetic Resonance Imaging (MRI)","Magnetic resonance imaging (procedure)","Magnetic Resonance Imaging Scan","Medical Imaging, Magnetic Resonance \u002F Nuclear Magnetic Resonance","MR","MR Imaging","MRI","MRI Scan","MRIs","NMR Imaging","NMRI","Nuclear Magnetic Resonance Imaging","sMRI","Structural MRI",{"type":14,"name":89,"description":90,"armGroupLabels":91},"Questionnaire Administration","Ancillary studies",[37],[93],{"measure":94,"description":95,"timeFrame":96},"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",[98,102,106,110,113],{"measure":99,"description":100,"timeFrame":101},"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.","From the start of SBRT to 90 days post-SBRT",{"measure":103,"description":104,"timeFrame":105},"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.","Up to 5 years post-SBRT",{"measure":107,"description":108,"timeFrame":109},"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.","Baseline to 5 years post-SBRT",{"measure":111,"description":112,"timeFrame":105},"Biochemical recurrence-free survival","Biochemical recurrence will be defined as serum prostate-specific antigen (PSA) levels that are 2 ng\u002FmL 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).",{"measure":114,"description":115,"timeFrame":116},"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.","Baseline, at time of SBRT","MALE","18 Years",null,false,{"inclusion":122,"exclusion":129,"raw_text":136},[123,124,125,126,127,128],"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\\]\u002FCT 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\u002FCT and fluciclovine PET\u002FCT 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",[130,131,132,133,134,135],"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","Inclusion Criteria:\n\n* Histologically confirmed, clinically localized adenocarcinoma of the prostate\n* 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\\]\u002FCT scan below the bifurcation of the renal arteries are amenable)\n* Staging workup as recommended by the National Comprehensive Cancer Network (NCCN) on the basis of risk grouping\n* Advanced imaging studies (i.e. PSMA PET\u002FCT and fluciclovine PET\u002FCT scan) can supplant a bone scan if performed first\n* Age ≥ 18\n* Written informed consent obtained from participant or participant's legal representative and ability for participant to comply with the requirements of the study\n\nExclusion Criteria:\n\n* Patients with neuroendocrine or small cell carcinoma of the prostate\n* 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\n* Prior whole gland cryosurgery, high-intensity focused ultrasound (HIFU) or brachytherapy of the prostate\n* Prior pelvic radiotherapy\n* History of Crohn's Disease, ulcerative colitis, or ataxia telangiectasia\n* 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",[138,139],"ADULT","OLDER_ADULT",[141],{"facility":142,"city":143,"state":144,"zip":145,"country":146,"geoPoint":147},"UCLA \u002F Jonsson Comprehensive Cancer Center","Los Angeles","California","90095","United States",{"lat":148,"lon":149},34.05223,-118.24368,[],[152],{"name":153,"affiliation":142,"role":154},"Amar Kishan","PRINCIPAL_INVESTIGATOR",[],[],{"nct_id":4,"conditions":158,"biomarkers":160},[159],"Prostate Carcinoma",[],{"nct_id":4,"found":15,"summary":162,"prompt_version":172},{"design":163,"status":164,"heading":165,"summary":166,"follow_up":167,"word_count":168,"commitments":169,"compensation":170,"drugs_mentioned":171},"This is an interventional study planning to enroll 80 men. It is not specified if it is randomized or blinded.","completed","ILLUSION Trial: CT-Guided SBRT for Localized Prostate Cancer","This study, called the ILLUSION Trial, is looking at a type of radiation treatment called CT-guided stereotactic body radiation therapy (SBRT) with intrafraction motion monitoring for men with prostate cancer that hasn't spread. SBRT uses special equipment to precisely deliver radiation to tumors, helping to protect healthy tissues. Researchers want to understand the side effects, especially those affecting the urinary and digestive systems, and how this treatment impacts your quality of life. They will also track how well the treatment prevents the cancer from returning over five years. You would receive SBRT over several days, along with CT and MRI scans and blood tests. The study aims to enroll 80 participants.","Participants will be followed up for at least 5 years after treatment, then annually thereafter.",111,"You would undergo CT-guided SBRT over 5 sessions, along with CT and MRI scans and blood sample collection. After treatment, you will have follow-up visits for at least 5 years, then annually.","Not stated in the trial record.",[59,66],"v2"]