CT-Guided Stereotactic Body Radiation Therapy for Prostate Cancer

(ILLUSION Trial)

Age: 18+

Sex: Male

Trial Phase: Academic

Sponsor: Jonsson Comprehensive Cancer Center

Disqualifiers: Neuroendocrine carcinoma, Small cell carcinoma, Prior pelvic radiotherapy, Crohn's disease, Ulcerative colitis, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 6

Duration: 1-2 weeks

80 Participants Needed

Trial Summary

What is the purpose of this trial?

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.

Research Team

Amar Kishan

Principal Investigator

UCLA / Jonsson Comprehensive Cancer Center

Eligibility Criteria

This trial is for patients with localized prostate cancer, meaning the cancer hasn't spread. Participants should be suitable for CT-guided SBRT and willing to undergo various monitoring procedures like MRI and questionnaires.

Inclusion Criteria

Written informed consent obtained from participant or participant's legal representative and ability for participant to comply with the requirements of the study

Advanced imaging studies (i.e. PSMA PET/CT and fluciclovine PET/CT scan) can supplant a bone scan if performed first

My cancer has not spread to lymph nodes above my kidneys or to bones or organs.

Exclusion Criteria

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

I have a history of Crohn's Disease, ulcerative colitis, or ataxia telangiectasia.

I have had cryosurgery, HIFU, or brachytherapy on my prostate.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Patients undergo CT-guided SBRT with intrafraction motion monitoring over 5 fractions every other day, or on consecutive days, if necessary

1-2 weeks

5 visits (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment

5 years

1 and 3 months, every 3 months for the first year, every 6 months for a minimum of 5 years, and then annually thereafter

Treatment Details

Interventions

• CT-guided Stereotactic Body Radiation Therapy

Trial Overview The trial tests CT-guided Stereotactic Body Radiation Therapy (SBRT) with intrafraction motion monitoring on prostate cancer. It aims to deliver precise radiation doses while minimizing side effects by tracking and adjusting for organ movement during treatment.

Participant Groups

Group I: Treatment (CT-guided SBRT, intrafraction motion monitoring) Experimental Treatment 6 Interventions

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.

Who Is Running the Clinical Trial?

Jonsson Comprehensive Cancer Center

Lead Sponsor

Trials

373

Recruited

35,200+

Varian Medical Systems

Industry Sponsor

Trials

63

Recruited

3,700+

Dow R. Wilson

Varian Medical Systems

Chief Executive Officer since 2012

MBA from Dartmouth's Amos Tuck School of Business, BA from Brigham Young University

Dr. Deepak Khuntia

Varian Medical Systems

Chief Medical Officer since 2020

MD from the University of Cambridge, PhD from the University of Leicester