MRI-Guided Radiation for Prostate Cancer

Overseen By Clinical Trials Intake

Age: 18+

Sex: Male

Trial Phase: Academic

Sponsor: University of Chicago

Disqualifiers: Distant metastases, Prior active treatment, others

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

Approved in 1 Jurisdiction This treatment is already approved in other countries

Compensation: Varies

Number of Visits: Unknown

60 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests the safety and effectiveness of using MRI (a type of imaging scan) to guide radiation therapy for prostate cancer. The goal is to reduce radiation to non-cancerous parts of the prostate while increasing it to cancerous areas, aiming to improve treatment outcomes. The trial seeks men with prostate cancer visible on an MRI, classified as intermediate or high-risk, without cancer spread beyond the pelvis. Participants should not have undergone previous active treatments for prostate cancer, such as surgery or chemotherapy. As an unphased trial, this study provides a unique opportunity to contribute to innovative research that could enhance future prostate cancer treatments.

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 coordinators or your doctor.

What prior data suggests that this MRI-guided radiation technique is safe for prostate cancer treatment?

Research has shown that MRI-guided radiation therapy for prostate cancer is generally easy for patients to handle. Studies have found that using MRI during radiation treatment can safely increase the radiation dose to cancerous areas while reducing exposure to healthy parts of the prostate. This method can help reduce side effects and improve patients' quality of life.

For example, one study found that this technique allows for safe increases in radiation by targeting the cancer more precisely. Another study showed that the accuracy of MRI can shrink the treatment area, which may lower the risk of unwanted side effects. Overall, patients report fewer problems and better results when MRI guides radiation therapy.

These findings suggest that MRI-guided radiation is a promising and safe option for treating prostate cancer. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about MRI-guided radiation for prostate cancer because it offers a more targeted approach compared to standard treatments like external beam radiation therapy. This method uses MRI scans to precisely identify areas of the prostate that do not contain cancer cells, allowing for low doses of radiation to those areas, potentially minimizing side effects. By tailoring the radiation more accurately, this technique holds promise for reducing damage to healthy tissues and improving the overall quality of life for patients.

What evidence suggests that MRI-guided radiation is effective for prostate cancer?

Research has shown that MRI-guided radiation therapy for prostate cancer can accurately target cancer cells while protecting healthy tissue. In this trial, participants will undergo an MRI scan before starting radiation treatment to identify areas of the prostate for targeted radiation. Studies have found that this method reduces both immediate and long-term side effects, making it a promising choice. Specifically, patients in these studies experienced positive results, with fewer treatment-related issues. The precision of MRI guidance also allows higher doses of radiation to be directed at cancerous areas, potentially improving treatment success. Overall, MRI-guided radiation therapy offers significant potential for better prostate cancer care by enhancing targeting and reducing side effects. ^{1 2 6 7 8}

Who Is on the Research Team?

Stanley L. Liauw

Principal Investigator

University of Chicago

Are You a Good Fit for This Trial?

This trial is for men with prostate cancer. Participants should be suitable for radiation treatment and willing to undergo MRI scans. Specific details about inclusion and exclusion criteria are not provided, but typically these would relate to the stage of cancer, overall health, and prior treatments.

Inclusion Criteria

My prostate cancer is visible on MRI, without spread beyond the pelvic area.

Exclusion Criteria

I do not have any other active cancers except for skin cancer.

My doctor thinks I can't safely receive the specific cancer treatment due to other health issues.

My cancer has spread to distant parts of my body.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Radiation

Participants receive MRI scan to identify areas of the prostate for targeted radiation treatment

6-8 weeks

Weekly visits for radiation sessions

Follow-up

Participants are monitored for safety and effectiveness after treatment

12 months

Regular follow-up visits to assess quality of life and side effects

Long-term follow-up

Participants are monitored for biochemical control and long-term outcomes

2 years

What Are the Treatments Tested in This Trial?

Interventions

• MRI

Trial Overview The study is testing if using MRI can help target radiation more precisely in prostate cancer treatment—lowering doses to healthy areas while increasing it where the cancer is concentrated. This could improve safety and effectiveness.

How Is the Trial Designed?

Group I: Radiation therapy Experimental Treatment 3 Interventions

Participants will receive MRI scan before starting Radiation treatment. The results of this scan will be used to identify areas of the prostate to receive low doses of radiation (areas that show no cancer cells seen by the MRI scan).

Who Is Running the Clinical Trial?

University of Chicago

Lead Sponsor

Trials

1,086

Recruited

844,000+

Published Research Related to This Trial

In a study involving 9 patients with localized prostate cancer, real-time MR-guided brachytherapy successfully delivered a minimum dose of 160 Gy to 94% of the clinical target volume, demonstrating effective dose localization.

The procedure resulted in minimal acute toxicity, with all patients voiding spontaneously within 3 hours post-treatment and only requiring a short course of medication for post-implant urethritis, indicating a safe intervention.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Real-time magnetic resonance image-guided interstitial brachytherapy in the treatment of select patients with clinically localized prostate cancer. D'Amico, AV., Cormack, R., Tempany, CM., et al.[2022]

MRI-guided radiotherapy (MR-IGRT) for localized prostate cancer can be cost-effective if it achieves a relative reduction in toxicity, requiring only a 7-14% reduction for stereotactic body radiotherapy (SBRT) to justify its added costs.

In contrast, conventional radiotherapy would need a much larger reduction in toxicity (50-94%) to be considered cost-effective, highlighting that MR-IGRT is particularly beneficial in hypofractionated treatment schedules.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Toxicity reduction required for MRI-guided radiotherapy to be cost-effective in the treatment of localized prostate cancer. Schumacher, LD., Dal Pra, A., Hoffe, SE., et al.[2022]

This study involving 20 patients demonstrated that MRI-guided radiation therapy for isolated prostate cancer recurrence is feasible and safe, with acute toxicities being minimal and manageable after treatment.

The treatment plans effectively covered the tumor while adhering to safety constraints for surrounding organs, achieving a biochemical control rate of 75%, indicating promising efficacy in managing localized recurrences.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Magnetic Resonance-Guided Reirradiation for Local Recurrence Within the Prostate or in the Prostate Bed: Preliminary Results of a Prospective Registry Study. Michalet, M., Riou, O., Valdenaire, S., et al.[2022]

External beam radiotherapy is the main treatment for localized prostate cancer, and recent studies suggest that hypofractionation (shorter treatment schedules) can lead to good outcomes.

Magnetic resonance-guided radiotherapy (MR-guided treatment) shows promise for improving the accuracy of radiotherapy delivery, potentially enhancing treatment effectiveness, although current image-guidance techniques have limitations.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

MR-Guided Radiotherapy for Prostate Cancer. Tocco, BR., Kishan, AU., Ma, TM., et al.[2020]

Out of 585 patients with prostate cancer, 93.2% successfully underwent MR-only simulation for radiotherapy, indicating a high success rate for this method.

Challenges such as synthetic-CT reconstruction failures and motion artifacts led to a small percentage of patients (4.1%) requiring backup CT scans, suggesting that while MR-only workflows are effective, they may not be suitable for all patients, particularly those with specific contraindications.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Clinical experience and workflow challenges with magnetic resonance-only radiation therapy simulation and planning for prostate cancer. Tyagi, N., Zelefsky, MJ., Wibmer, A., et al.[2022]

MRI-guided radiation therapy (RT) for localized prostate cancer shows promise, but the precise benefits compared to traditional CT-based guidance are still unclear, necessitating further investigation.

The review identified multiple ongoing trials and proposed eight clinical trial design strategies to explore the potential advantages of MRI guidance in improving treatment outcomes for prostate cancer patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Adaptive magnetic resonance image guided radiation for intact localized prostate cancer how to optimally test a rapidly emerging technology. Hall, WA., Kishan, AU., Hall, E., et al.[2022]

Magnetic resonance imaging (MRI) has a significant diagnostic performance for detecting prostate cancer in patients with prior negative biopsies and elevated PSA levels, with a mean detection rate of 37.5% across 14 studies involving 698 patients.

MRI combined with magnetic resonance spectroscopy imaging (MRSI) shows the highest accuracy, achieving a pooled sensitivity of 91% and specificity of 73%, indicating it is a valuable tool for targeting prostate cancer in challenging cases.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The value of magnetic resonance imaging in the detection of prostate cancer in patients with previous negative biopsies and elevated prostate-specific antigen levels: a meta-analysis. Zhang, ZX., Yang, J., Zhang, CZ., et al.[2022]

The study developed a robotic system for MRI-guided prostate biopsy that achieved an average targeting accuracy of 2.5 mm, which is promising for improving biopsy precision and patient comfort.

The addition of a teleoperated needle driver demonstrated excellent position tracking with errors below 0.1 mm, indicating that this robotic system can enhance the accuracy of needle placement while allowing clinician oversight.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Robotic system for MRI-guided prostate biopsy: feasibility of teleoperated needle insertion and ex vivo phantom study. Seifabadi, R., Song, SE., Krieger, A., et al.[2023]

This pilot study demonstrated that MRI-guided high-dose-rate prostate brachytherapy is feasible and can achieve high dosimetric quality, with 94% of the prescribed dose delivered to the target volume in 5 patients.

The procedure allowed for excellent visualization of prostate lesions and surrounding anatomy, identifying extracapsular disease in 2 patients, although further follow-up is needed to assess long-term safety and efficacy.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

MRI-guided HDR prostate brachytherapy in standard 1.5T scanner. Ménard, C., Susil, RC., Choyke, P., et al.[2019]

In a study of 425 localized prostate cancer patients treated with MR-guided ultrahypofractionated radiation therapy, significant declines in prostate-specific antigen levels were observed, indicating effective treatment outcomes over 12 months.

While the therapy was generally safe, with peak toxicity reported at 3 months, patients not receiving androgen deprivation therapy experienced significant worsening of erectile function by 12 months, highlighting the need for patient education on potential side effects.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Magnetic Resonance-Guided Adaptive Radiation Therapy for Prostate Cancer: The First Results from the MOMENTUM study-An International Registry for the Evidence-Based Introduction of Magnetic Resonance-Guided Adaptive Radiation Therapy. Teunissen, FR., Willigenburg, T., Tree, AC., et al.[2023]

In a study of 100 prostate cancer patients treated with 1.5T MR-guided stereotactic body radiotherapy (SBRT), the treatment showed promising safety outcomes with manageable acute and late toxicity, including only a few cases of significant urinary and gastrointestinal side effects.

Quality of life assessments indicated substantial improvement in overall health and comfort after treatment, although sexual function remained a concern, highlighting the need for further long-term studies to confirm these benefits.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

1.5T MR-Guided Daily-Adaptive SBRT for Prostate Cancer: Preliminary Report of Toxicity and Quality of Life of the First 100 Patients. Alongi, F., Rigo, M., Figlia, V., et al.[2022]

The MRI-only planning procedure for radiation therapy in localized prostate cancer was technically suitable for 92% of the 200 patients studied, indicating its high applicability in clinical settings.

Early results showed that patients receiving MRI-only planned radiation therapy had similar prostate-specific antigen (PSA) responses and toxicity levels compared to those planned with traditional CT imaging, suggesting that MRI-only planning is both effective and safe.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

MRI-only based radiation therapy of prostate cancer: workflow and early clinical experience. Tenhunen, M., Korhonen, J., Kapanen, M., et al.[2019]

Citations

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

MRI-Guided Radiation Therapy for Prostate Cancer MRI-guided radiation therapy provides a potential avenue to reduce toxicity while maintaining high efficacy.

2. sciencedirect.com sciencedirect.com/science/article/pii/S2405630824000193

MRI-guided radiotherapy in twenty fractions for localised ... This study examines the potential clinical benefits of MRIgRT for men with localised prostate cancer, in the setting of moderately hypofractionated radiotherapy ...

3. northside.com northside.com/about/news-center/article-details/mri-guided-radiation-improves-prostate-cancer-care

MRI-guided radiation improves prostate cancer care These results demonstrate that MRI-guided therapy can translate into meaningful reductions in both short- and long-term treatment-related ...

4. redjournal.org redjournal.org/article/S0360-3016(24)00691-6/fulltext

Patient-Reported Outcomes Following Magnetic ... Patient-reported outcomes following magnetic resonance-guided radiation therapy for prostate cancer: a systematic review and meta-analysis.

5. zerocancer.org zerocancer.org/blog/not-just-mirage-benefit-mri-guided-radiotherapy-prostate-cancer

Not just a MIRAGE: The benefit of MRI-guided radiotherapy ... MRIdian MRI-guided radiation therapy offers several theoretical advantages in the context of prostate SBRT, where high accuracy and precision are required.

6. sciencedirect.com sciencedirect.com/science/article/pii/S266616832401423X

Prostate Cancer Salvage Magnetic Resonance Imaging ... This phase 2 study evaluates the outcomes of salvage magnetic resonance imaging (MRI)-guided transurethral ultrasound ablation (sTULSA).

7. clinicaltrials.gov clinicaltrials.gov/study/NCT05676463

MRI Guided Radiation Therapy for the Treatment of High ... This phase II trial tests whether magnetic resonance imaging (MRI)-guided hypofractionated radiation therapy works to reduce treatment time and side effects ...

8. practicalradonc.org practicalradonc.org/article/S1879-8500(22)00363-0/fulltext

Magnetic Resonance-Guided Adaptive Radiation Therapy ... We report the 12-month outcomes for the first PCa patients treated within an international consortium (the MOMENTUM study) on a 1.5T MR-Linac ...