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

54 Participants Needed

Trial Summary

What is the purpose of this trial?

This study utilizes advanced imaging techniques (mpMRI prostate scan) to select and stratify patients for two different radiotherapy regimens based on the presence/absence of identifiable intraprostatic lesions. In patients without identifiable prostate cancer lesions, SBRT to the prostate in 5 sessions (fractions) will be administered. 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 prostate cancer lesion(s) to a higher dose in 3 fractions.

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 data supports the effectiveness of the treatment MRI-Guided Radiotherapy for Prostate Cancer?

Research shows that using MRI to guide radiotherapy, like IMRT and SBRT, can effectively target prostate cancer lesions with high precision. This approach has been proven safe and effective for patients with low and intermediate-risk prostate cancer, improving detection and treatment accuracy. ^{1 2 3 4 5}

Is MRI-guided radiotherapy for prostate cancer safe for humans?

Research shows that MRI-guided radiotherapy for prostate cancer, including techniques like IMRT and SBRT, has been studied for safety. Studies have reported on the feasibility and early toxicity, indicating that while there may be some side effects, the treatment is generally considered safe for humans. ^{1 3 6 7 8}

How is the MRI-Guided Radiotherapy treatment for prostate cancer different from other treatments?

This treatment is unique because it uses MRI (magnetic resonance imaging) to guide radiotherapy, allowing for precise targeting of prostate cancer lesions with a higher dose of radiation, known as a boost, while minimizing exposure to surrounding healthy tissue. It combines IMRT (intensity-modulated radiotherapy) with SBRT (stereotactic body radiotherapy) to deliver a focused and adaptive treatment plan, which is not commonly used in standard prostate cancer treatments. ^{2 4 5 7 9}

Research Team

Dian Wang, MD, PhD

Principal Investigator

Rush University Medical Center

Eligibility Criteria

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

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

Treatment Details

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.

Participant Groups

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+

Findings from Research

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]

References

1. England pubmed.ncbi.nlm.nih.gov

The feasibility of a dose painting procedure to treat prostate cancer based on mpMR images and hierarchical clustering. [2023]

2. England pubmed.ncbi.nlm.nih.gov

Effect on therapeutic ratio of planning a boosted radiotherapy dose to the dominant intraprostatic tumour lesion within the prostate based on multifunctional MR parameters. [2022]

3. England pubmed.ncbi.nlm.nih.gov

Simultaneous integrated boost of biopsy proven, MRI defined dominant intra-prostatic lesions to 95 Gray with IMRT: early results of a phase I NCI study. [2018]

4. Ireland pubmed.ncbi.nlm.nih.gov

Validation of T2- and diffusion-weighted magnetic resonance imaging for mapping intra-prostatic tumour prior to focal boost dose-escalation using intensity-modulated radiotherapy (IMRT). [2023]

5. United States pubmed.ncbi.nlm.nih.gov

Stereotactic Radiosurgery for Prostate Cancer Following Magnetic Resonance Imaging Directed Biopsy: A Multidisciplinary Approach with Case Examples. [2020]

6. United States pubmed.ncbi.nlm.nih.gov

Impact of magnetic resonance imaging on computed tomography-based treatment planning and acute toxicity for prostate cancer patients treated with intensity modulated radiation therapy. [2018]

7. Ireland pubmed.ncbi.nlm.nih.gov

Dosimetric feasibility of ablative dose escalated focal monotherapy with MRI-guided high-dose-rate (HDR) brachytherapy for prostate cancer. [2018]

8. United States pubmed.ncbi.nlm.nih.gov

Toxicity and Patient-Reported Quality-of-Life Outcomes After Prostate Stereotactic Body Radiation Therapy With Focal Boost to Magnetic Resonance Imaging-Identified Prostate Cancer Lesions: Results of a Phase 2 Trial. [2023]

9. Netherlands pubmed.ncbi.nlm.nih.gov

Online adaptive planning for prostate stereotactic body radiotherapy using a 1.5 Tesla magnetic resonance imaging-guided linear accelerator. [2021]