MRI-Guided Radiotherapy for Prostate Cancer

Age: 18+

Sex: Male

Trial Phase: Academic

Sponsor: Rush University Medical Center

Disqualifiers: Invasive malignancy, Lymph node involvement, Metastases, Prior pelvic irradiation, Chemotherapy, Severe comorbidities, others

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

Compensation: Varies

Number of Visits: 8

Duration: 5-9 weeks

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores new ways to use MRI scans to guide radiotherapy treatments for prostate cancer. The goal is to determine if different types of radiotherapy can be more effective based on the visibility of cancer lesions in MRI scans. Patients without visible lesions will receive a short course of targeted radiotherapy, while those with visible lesions will undergo a more focused and intensive treatment (IMRT followed by mpMRI-guided SBRT boost with SIB to intraprostatic lesions). Men with biopsy-confirmed prostate cancer that hasn't spread and who are in good general health might be suitable candidates. The study aims to improve treatment precision and outcomes for prostate cancer patients. As an unphased trial, it offers a unique opportunity to contribute to innovative research that could enhance future prostate cancer treatments.

Do I need to stop my current medications for the trial?

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

What prior data suggests that these radiotherapy regimens are safe for prostate cancer treatment?

Research has shown that these radiotherapy treatments are generally safe and well-tolerated for prostate cancer.

For patients with MRI-identified lesions, one study found that combining a precise form of radiation called IMRT with an SBRT boost did not cause severe side effects, and no serious adverse reactions were reported.

For SBRT treatment to the entire prostate, studies indicate it is effective with a low risk of serious side effects. Most patients did not experience severe problems, though some had mild to moderate side effects affecting the stomach and intestines.

Overall, both treatment methods are considered safe, with only minor side effects for most patients. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about MRI-guided radiotherapy for prostate cancer because it offers a more precise approach to targeting cancerous tissues. Unlike traditional methods like external beam radiotherapy, which can affect a broader area, this technique uses advanced imaging (mpMRI) to guide the delivery of radiation directly to the tumor and specific intraprostatic lesions. This precision could potentially reduce damage to surrounding healthy tissue, leading to fewer side effects and a better quality of life for patients. Additionally, by combining different types of radiation therapy—IMRT for initial treatment and SBRT for targeted boosting—this method hopes to enhance the effectiveness of cancer treatment in a shorter time frame.

What evidence suggests that this trial's treatments could be effective for prostate cancer?

Studies have shown that stereotactic body radiotherapy (SBRT) can effectively treat prostate cancer. Men who received SBRT had a low chance of cancer recurrence. This treatment is known for its safety and effectiveness, with a strong track record of disease control. In this trial, one group of participants will receive SBRT to the whole prostate. Research suggests that using MRI to guide higher doses to specific cancer spots can improve outcomes. Another group in this trial will receive IMRT followed by an SBRT boost to MRI-defined intraprostatic lesions. Adding an SBRT boost to cancer spots inside the prostate has been shown to help prevent recurrence. Overall, both treatment methods have shown promise in effectively managing prostate cancer. ^{1 6 7 8 9}

Who Is on the Research Team?

Dian Wang, MD, PhD

Principal Investigator

Rush University Medical Center

Are You a Good Fit for This Trial?

This trial is for men with prostate cancer diagnosed within the last year, who are in good physical condition (able to carry out daily activities without significant limitations). They must not have cancer spread to lymph nodes or distant sites, no history of pelvic radiation, severe illnesses like heart disease or uncontrolled infections, and they can't have had prior chemotherapy or other invasive cancers except skin cancer.

Inclusion Criteria

My prostate cancer is classified from low to high risk but not spread.

I have been mostly active and able to carry on all pre-disease activities without restriction in the last 60 days.

My prostate cancer was confirmed by a biopsy within the last year.

Exclusion Criteria

I am currently on IV antibiotics for a serious bacterial or fungal infection.

I have had chemotherapy before.

I do not have severe heart, lung, liver diseases, or AIDS.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive radiotherapy based on mpMRI results: SBRT for those without lesions and IMRT followed by SBRT boost for those with lesions

5-9 weeks

5-28 visits (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment, with assessments every 3 months for the first 2 years and then every 6 months indefinitely

Indefinite

Regular visits every 3-6 months

Long-term monitoring

Participants are monitored for late radiation-induced toxicity and disease-free survival

18 months

What Are the Treatments Tested in This Trial?

Interventions

• IMRT followed by mpMRI guided SBRT boost with SIB to intraprostatic lesions
• SBRT to whole prostate

Trial Overview The study tests two radiotherapy approaches using MRI guidance. Men without visible lesions get a short course of SBRT to the whole prostate. Those with lesions receive longer IMRT treatment followed by an intense SBRT boost specifically targeting the identified lesions.

How Is the Trial Designed?

Group I: Positive mpMRI Prostate Scan Experimental Treatment 1 Intervention

IMRT to the prostate + seminal vesicles followed by SBRT boost to the whole prostate with SIB to MRI defined intraprostatic lesions

Group II: Negative mpMRI Prostate Scan Experimental Treatment 1 Intervention

SBRT to the whole prostate

Who Is Running the Clinical Trial?

Rush University Medical Center

Lead Sponsor

Trials

448

Recruited

247,000+

Published Research Related to This Trial

Using MR-guided stereotactic body radiotherapy (SBRT) for prostate cancer showed that daily changes in patient anatomy had minimal impact on the radiation dose delivered, with prostate doses varying by only 0.5%.

The study analyzed data from four patients, indicating that the rectum and bladder also received minimal dose changes, mostly less than 0.5 Gy, which can inform strategies for daily online plan adaptation in MR-guided radiotherapy.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Online adaptive planning for prostate stereotactic body radiotherapy using a 1.5 Tesla magnetic resonance imaging-guided linear accelerator. Yang, J., Vedam, S., Lee, B., et al.[2021]

Citations

1. clinicaltrials.gov clinicaltrials.gov/study/NCT03778112

MRI Guided SBRT for Localized Prostate Cancer In patients with MRI-identified lesion(s), pelvic IMRT in 25 fractions will be administered followed by an SBRT prostate boost while simultaneously treating the ...

2. clinicaltrials.gov clinicaltrials.gov/study/NCT03778112

MRI Guided SBRT for Localized Prostate Cancer In patients with MRI-identified lesion(s), pelvic IMRT in 25 fractions will be administered followed by an SBRT prostate boost while simultaneously treating the ...

3. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10526919/

MRI-Guided Radiation Therapy for Prostate Cancer In this review, we discuss the advantages and limitations of MRIgRT for prostate cancer, as well as clinical trials testing the efficacy and ...

4. cureus.com cureus.com/articles/399115-assessment-of-online-adaptive-mri-guided-stereotactic-body-radiotherapy-sbrt-with-an-integrated-boost-to-the-dominant-lesion-in-prostate-cancer

Assessment of Online Adaptive MRI-Guided Stereotactic ... The purpose of this study is to evaluate the potential dosimetric benefits of daily ART with SIB to the dominant intraprostatic lesion and other ...

5. sciencedirect.com sciencedirect.com/science/article/pii/S0360301625063990?dgcid=rss_sd_all

Stereotactic body radiotherapy to the prostate with focal boost It has been shown that focal dose escalation to the area of multiparametric MRI (mpMRI) defined dominant disease improves biochemical relapse- ...

6. redjournal.org redjournal.org/article/S0360-3016(23)05955-2/fulltext

Multifocal MRI-Directed Simultaneous Integrated Boost ... We demonstrate that multifocal MRI-directed intraprostatic SBRT SIB yields no acute high-grade toxicity and is not associated with a higher risk of low-grade ...

7. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC6349624/

Prostate Stereotactic Body Radiation Therapy With a Focal ... This study aimed to report the early toxicity results of a prospective clinical trial of prostate stereotactic body radiation therapy (SBRT) to the entire ...

8. onclive.com onclive.com/view/addition-of-multifocal-mri-directed-sib-to-sbrt-shows-acceptable-toxicity-profile-in-prostate-cancer

Addition of Multifocal MRI-Directed SIB to SBRT Shows ... Joshua Hurwitz, MD, shares how multifocal MRI-directed SIB plus SBRT was not linked with added toxicity vs unifocal SIB in patients with ...

9. ascopubs.org ascopubs.org/doi/10.1200/JCO.2023.41.6_suppl.121

Simultaneous integrated boost (SIB) stereotactic body ... SIB-SBRT for HR, N+ and OM prostate cancers is safe and effective, with good QOL. The encouraging PSA control and minimal grade 3 toxicity and favorable ...