CT-Guided Stereotactic Body Radiation Therapy for Prostate Cancer

(ILLUSION Trial)

Overseen By Care Felix

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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new radiation therapy method for men with prostate cancer that remains confined to the prostate. The treatment employs advanced imaging and tracking techniques to precisely target the tumor, aiming to reduce side effects such as urinary and bowel issues. This trial may suit men diagnosed with prostate cancer who show no signs of the disease spreading to distant parts of the body. As an unphased trial, it provides patients the opportunity to access cutting-edge treatment techniques that could enhance their quality of life.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial team or your doctor.

What prior data suggests that this CT-guided stereotactic body radiation therapy is safe for prostate cancer patients?

Research has shown that CT-guided Stereotactic Body Radiation Therapy (SBRT) is generally safe for treating localized prostate cancer. One study found that SBRT achieved high success rates five years post-treatment, with side effects deemed acceptable by patients. Another study noted that side effects remained manageable even two years after treatment.

Patients often report that SBRT is easy to tolerate, even shortly after treatment. Common side effects can include some urinary and bowel issues, but these are usually less severe than those from surgery. CT-guided SBRT may help reduce these side effects by using precise imaging to target the cancer, minimizing harm to healthy tissue. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about CT-guided Stereotactic Body Radiation Therapy (SBRT) for prostate cancer because it offers a precise and potentially more effective way to target tumors. Unlike traditional radiation therapy, which can take several weeks, this method delivers high doses of radiation in just five sessions, either every other day or consecutively, which may lead to faster results. The use of CT-guidance with intrafraction motion monitoring ensures accuracy by tracking the tumor's position in real-time, potentially reducing damage to surrounding healthy tissue. This approach could improve patient outcomes by minimizing side effects while maintaining or enhancing treatment effectiveness.

What evidence suggests that CT-guided SBRT with intrafraction motion monitoring is effective for prostate cancer?

Research has shown that CT-guided stereotactic body radiation therapy (SBRT), the treatment under study in this trial, is a promising option for localized prostate cancer. One study found it safe and effective, with good cancer control and manageable side effects, particularly for patients with lower Gleason scores, which indicate cancer aggressiveness. Another study compared CT-guided and MRI-guided SBRT, revealing a 27% rate of significant side effects after two years with CT-guided SBRT, higher than the MRI-guided method. Despite this, CT-guided SBRT effectively targets prostate cancer while minimizing harm to healthy tissue. In this trial, intrafraction motion monitoring, which tracks body movement to keep the radiation beam on target, may reduce side effects related to urinary and bowel functions by allowing more precise treatment. ^{1 3 5 6 7}

Who Is on the Research Team?

Amar Kishan

Principal Investigator

UCLA / Jonsson Comprehensive Cancer Center

Are You a Good Fit for This Trial?

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 for a Trial Participant

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

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

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

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC8557180/

Five-year outcomes of stereotactic body radiation therapy ... SBRT is a safe and effective treatment with an encouraging bPFS rate and tolerable toxicity for localized PCa patients. Patients with a Gleason score < 8 and ...

2. europeanurology.com europeanurology.com/article/S0302-2838(24)02688-5/fulltext

2-year Outcomes from the MIRAGE Randomized Clinical ... Cumulative incidence rates of late grade ≥2 toxicity at 2 yr with MRI-guided versus CT-guided SBRT were 27% (95% confidence interval [CI] 19–39 ...

3. asco.org asco.org/abstracts-presentations/ABSTRACT356139

Interim analysis of a phase III randomized trial. Conclusions: This interim analysis demonstrates a statistically significant reduction in acute grade ≥2 GU toxicity with MRI-guidance versus CT-guidance in the ...

4. sciencedirect.com sciencedirect.com/science/article/pii/S0360301622031601

Quality-of-Life Outcomes and Toxicity Profile Among ... In this multicenter phase 2 trial, postprostatectomy SBRT was well tolerated within the first 6 months as evaluated by both physician-scored toxicity and ...

5. clinicaltrials.gov clinicaltrials.gov/study/NCT04384770

CT-guided Stereotactic Body Radiation Therapy and MRI ... This phase III trial studies compares CT-guided stereotactic body radiation therapy and MRI-guided stereotactic body radiation therapy (SBRT) in treating ...

6. advancesradonc.com advancesradonc.com/article/S2452-1094(24)00137-4/fulltext

Acute and Late Patient-Reported Toxicity Outcomes Our study is one the largest patient-reported outcomes study after prostate SMART. It shows acceptable levels of toxicity even up to 2 years after treatment.

7. practicalradonc.org practicalradonc.org/article/S1879-8500(23)00237-0/fulltext

Stereotactic Body Radiation Therapy: A Radiosurgery ... External beam radiation therapy (RT) is a safe and effective curative treatment modality for men with localized prostate cancer (PCa). While ...