Status:
RECRUITING
Computed Tomography-Guided Stereotactic Body Radiation Therapy With Intrafraction Motion Monitoring for the Treatment of Localized Prostate Cancer, ILLUSION Trial
Lead Sponsor:
Jonsson Comprehensive Cancer Center
Collaborating Sponsors:
Varian Medical Systems
Conditions:
Localized Prostate Adenocarcinoma
Stage I Prostate Cancer AJCC v8
Eligibility:
MALE
18+ years
Phase:
NA
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...
Detailed Description
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 ...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
June 27 2025
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
September 1 2036
Estimated Enrollment :
80 Patients enrolled
Trial Details
Trial ID
NCT06995053
Start Date
June 27 2025
End Date
September 1 2036
Last Update
November 10 2025
Active Locations (1)
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1
UCLA / Jonsson Comprehensive Cancer Center
Los Angeles, California, United States, 90095