MR-Guided Radiotherapy for Prostate Cancer

Overseen By Michael Zelefsky, M.D

Age: 18+

Sex: Male

Trial Phase: Academic

Sponsor: NYU Langone Health

Must not be taking: Androgen deprivation therapy

Disqualifiers: Gleason score >7, PSA >20, others

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

Compensation: Varies

Number of Visits: 5

91 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores a new method for treating prostate cancer using advanced MRI technology to guide radiotherapy, known as Ultra-Hypofractionated MR-Guided Radiotherapy. The researchers aim to determine if this method better controls tumors by delivering a precise, high dose of radiation to the main tumor while minimizing exposure to the rest of the prostate. The trial seeks men with intermediate-risk prostate cancer who have a specific type of tumor visible on an MRI scan. This approach could result in fewer side effects and more effective treatment for eligible participants. As an unphased trial, it offers participants the chance to contribute to pioneering research that could improve 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 MR-guided radiotherapy is safe for prostate cancer patients?

Research shows that ultra-hypofractionated MR-guided radiotherapy is generally well-tolerated by patients with prostate cancer. In one study, patients experienced side effects that were usually mild and manageable, with most not experiencing severe side effects.

Another study found that using MR guidance, which involves MRI scans to direct treatment, helps focus the radiation more precisely. This precision reduces harm to healthy tissues and lessens side effects, much like having a more accurate map to aim the treatment exactly where needed.

Overall, research suggests that this treatment is safe, with side effects that are typically mild and temporary. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about ultra-hypofractionated MR-guided radiotherapy for prostate cancer because it offers a more precise and efficient treatment approach compared to traditional radiotherapy methods. Unlike standard treatments that may involve many sessions over several weeks, this technique delivers higher doses of radiation in just five sessions, potentially reducing overall treatment time and patient inconvenience. Additionally, the use of MR-guided, daily online adaptive planning allows for real-time adjustments, which helps target the tumor more accurately while sparing surrounding healthy tissue. This could lead to fewer side effects and improved outcomes for patients.

What evidence suggests that MR-guided radiotherapy is effective for prostate cancer?

Research has shown that ultra-hypofractionated MR-guided radiotherapy can effectively treat intermediate-risk prostate cancer. In this trial, all participants will receive MRI-guided Intensity Modulated Radiotherapy, which previous findings have deemed both effective and safe, with promising results in tumor control. MRI (magnetic resonance imaging) enables doctors to target the tumor precisely, delivering a high dose to the main tumor area while minimizing exposure to the rest of the prostate. This precise targeting can improve cancer control and reduce side effects, enhancing patient outcomes. ^{6 7 8 9 10}

Who Is on the Research Team?

Michael Zelefsky, M.D

Principal Investigator

NYU Langone Health

Are You a Good Fit for This Trial?

This trial is for patients with intermediate-risk prostate cancer. Participants should have a dominant lesion within the prostate visible on MRI. Key eligibility criteria include having a specific type of prostate cancer and being suitable for MR-guided radiotherapy.

Inclusion Criteria

MRI findings: Lesion may contact the capsular edge, possible extracapsular extension (ECE) permitted

I can carry out normal activities without assistance.

My prostate is smaller than 90 cubic centimeters.

Exclusion Criteria

MRI findings: suspicious for/probable ECE

I have received hormone therapy for prostate cancer.

My scans show cancer has spread to my bones.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Radiation

Participants undergo ultra-hypofractionated MR-guided radiotherapy with adaptive planning, receiving 9 Gy/fraction for five fractions to the prostate DIL

2 weeks

5 treatments (in-person, every other day)

Follow-up

Participants are monitored for safety and effectiveness after treatment, with follow-up visits at three and six months, and every six months thereafter through month 24

24 months

Regular follow-up visits at specified intervals

What Are the Treatments Tested in This Trial?

Interventions

• Ultra-Hypofractionated MR-Guided Radiotherapy

Trial Overview The study tests ultra-hypofractionated, MR-adaptive radiation therapy targeting the dominant intraprostatic lesion (DIL) using an advanced MR-Linac system, along with a hydrogel rectal spacer to minimize damage to surrounding tissues.

How Is the Trial Designed?

Group I: MRI-guided Intensity Modulated Radiotherapy Experimental Treatment 2 Interventions

All patients will undergo the injection of a hydrogel rectal spacer (SpaceOAR) 1 week before simulation. Patients will undergo ultra-hypofractionated radiation utilizing MR-guided, daily online adaptive planning. Patients will receive 9 Gy/fraction for five fractions for a total dose of 45 Gy to the prostate DIL while the rest of the prostate will be treated to a minimum dose to the rest of the prostate of 30 Gy in five fractions. Radiation will be given every other day, Monday through Friday, until 5 treatments have been completed. Patients will be followed at three and six months after treatment, and every six months thereafter through month 24 (+/- 4 weeks).

Who Is Running the Clinical Trial?

NYU Langone Health

Lead Sponsor

Trials

1,431

Recruited

838,000+

Published Research Related to This Trial

Moderate hypofractionated radiotherapy for prostate cancer is associated with a 6.3% increase in acute grade ≥ 2 gastrointestinal toxicity compared to standard fractionation, indicating a need for careful monitoring and management of these symptoms.

There was no significant increase in acute genitourinary toxicity or late toxicity levels between moderate hypofractionation and standard fractionation, suggesting that while acute GI symptoms may be more common, overall safety profiles for late effects are similar.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Acute and late toxicity patterns of moderate hypo-fractionated radiotherapy for prostate cancer: A systematic review and meta-analysis. Sinzabakira, F., Brand, V., Heemsbergen, WD., et al.[2023]

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]

In a study of 50 prostate cancer patients treated with MRI-guided adaptive radiotherapy (MRgRT) using ultra-hypofractionation, the treatment was well tolerated, with manageable acute genitourinary toxicity rates of 28% for Grade 1 and 36% for Grade 2, and very low gastrointestinal toxicity.

MRgRT allows for real-time tracking and adaptive planning during stereotactic body radiotherapy (SBRT), suggesting it is a promising method for delivering effective treatment with an acceptable safety profile for localized prostate cancer.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Magnetic resonance image-guided adaptive stereotactic body radiotherapy for prostate cancer: preliminary results of outcome and toxicity. Ugurluer, G., Atalar, B., Zoto Mustafayev, T., et al.[2022]

The study involving 12 patients with lymph node oligometastases demonstrated that hypofractionated radiotherapy using the 1.5T MR-linac system is feasible, with most pre-treatment plans meeting clinical dose criteria for different fractionation schemes.

However, the quality of treatment plans varied, with single fraction treatments (1x20 Gy) generally being of lesser quality compared to multiple fractions (5x7 Gy and 3x10 Gy), highlighting the importance of considering the target's location relative to critical structures when selecting a treatment plan.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Dosimetric feasibility of hypofractionation for SBRT treatment of lymph node oligometastases on the 1.5T MR-linac. Winkel, D., Werensteijn-Honingh, AM., Eppinga, WSC., et al.[2021]

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11120184/

Online Adaptive MR-Guided Ultrahypofractionated ... This prospective study reports on the first results of all consecutive patients with intermediate-risk prostate cancer treated with MR-guided ...

2. sciencedirect.com sciencedirect.com/science/article/pii/S2405630825000771

The impact of daily MRI-guided adaptive radiotherapy on ... This is the first study to examine the dosimetric impact of MRIgART for ultrahypofractionated prostate cancer treatment, compared to standard-of-care image- ...

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

Magnetic Resonance-Guided Adaptive Radiation Therapy ... Ultrahypofractionated MR-guided radiation therapy for localized PCa using a 1.5T MR-Linac is effective and safe. The peak of CTCAE genitourinary ...

4. ctro.science ctro.science/article/S2405-6308%2824%2900019-3/fulltext

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 ...

5. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC7674276/

Feasibility of MR-guided ultrahypofractionated ... Conventional versus hypofractionated high-dose intensity-modulated radiotherapy for prostate cancer: 5-year outcomes of the randomised, non-inferiority ...

6. redjournal.org redjournal.org/article/S0360-3016(23)08006-9/abstract

Safety of Ultrahypofractionated Pelvic Nodal Irradiation in ... We identified 16 publications that reported the use of ultrahypofractionated radiation therapy to treat the pelvis in prostate cancer. Seven publications met ...

7. ctro.science ctro.science/article/S2405-6308(25)00077-1/fulltext

The impact of daily MRI-guided adaptive radiotherapy on ... This is the first study to examine the dosimetric impact of MRIgART for ultrahypofractionated prostate cancer treatment, compared to standard-of ...

8. sciencedirect.com sciencedirect.com/science/article/pii/S240563082400048X

Stereotactic ultrahypofractionated MR-guided radiotherapy ... This study reports on acute toxicity rates and patient-reported outcomes after MR-guided adaptive ultrahypofractionated radiotherapy for localized prostate ...

9. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC12173759/

The impact of daily MRI-guided adaptive radiotherapy ... MRIgART offers significant dosimetric benefit for ultrahypofractionated prostate cancer compared to non-adapted strategies.

10. mdpi.com mdpi.com/1718-7729/31/5/203

Online Adaptive MR-Guided Ultrahypofractionated ... This prospective study reports on the first results of all consecutive patients with intermediate-risk prostate cancer treated with MR-guided ...