CT-guided stereotactic body radiation with motion monitoring for localized prostate cancer
Image-Guidance With Triggered Beam Hold To Implanted Fiducial Markers or Hypersight for Stereotactic Body Radiotherapy for Prostate Cancer (ILLUSION)
NA · Jonsson Comprehensive Cancer Center · NCT06995053
This trial tests CT-guided SBRT with intrafraction motion monitoring for men with localized prostate cancer to see if it reduces urinary and bowel side effects while keeping the cancer controlled.
Quick facts
| Phase | NA |
|---|---|
| Study type | Interventional |
| Enrollment | 80 (estimated) |
| Ages | 18 Years and up |
| Sex | Male |
| Sponsor | Jonsson Comprehensive Cancer Center (other) |
| Drugs / interventions | radiation |
| Locations | 1 site (Los Angeles, California) |
| Trial ID | NCT06995053 on ClinicalTrials.gov |
What this trial studies
Patients with localized prostate adenocarcinoma receive CT-guided stereotactic body radiation therapy (SBRT) delivered in five fractions with intrafraction motion monitoring using on-board imaging and cone-beam CT. A 2 mm planning target volume margin around the prostate (and seminal vesicles when indicated) is used to enable highly precise dose delivery and spare adjacent normal tissues. The trial records physician-scored acute and late genitourinary (GU) and gastrointestinal (GI) toxicities, patient-reported quality of life, and five-year biochemical recurrence-free survival. Imaging and biospecimens are collected and intrafraction prostate motion data are analyzed to correlate motion management with toxicity and control outcomes.
Who should consider this trial
Good fit: Men aged 18 or older with histologically confirmed, clinically localized prostate adenocarcinoma without distant metastases who can undergo CT/MRI imaging and provide informed consent are appropriate candidates.
Not a fit: Patients with neuroendocrine or small cell prostate cancer, evidence of distant metastases, or those unable to tolerate on‑table imaging or follow-up are unlikely to benefit from this protocol.
Why it matters
Potential benefit: If successful, the approach could reduce urinary and bowel side effects by enabling more precise radiation delivery while maintaining cancer control.
How similar studies have performed: Prior randomized and observational studies show SBRT achieves comparable cancer control and less incontinence and erectile dysfunction than surgery but can cause more urinary irritative and bowel symptoms, making motion-management refinements plausible though not fully proven.
Eligibility criteria
Show full inclusion / exclusion criteria
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
Where this trial is running
Los Angeles, California
- UCLA / Jonsson Comprehensive Cancer Center — Los Angeles, California, United States (RECRUITING)
Study contacts
- Principal investigator: Amar Kishan — UCLA / Jonsson Comprehensive Cancer Center
- Study coordinator: CHRISTY Palodichuk
- Email: cpalodichuk@mednet.ucla.edu
- Phone: 3107942971
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Localized Prostate Adenocarcinoma, Stage I Prostate Cancer AJCC v8, Stage II Prostate Cancer AJCC v8, Stage III Prostate Cancer AJCC v8