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

Trial Summary

What is the purpose of this trial?

The purpose of this study is to assess the impact of this MR-guided radiotherapy on tumor control of the dominant intraprostatic lesion among patients with intermediate risk prostate cancer. This study of Radiotherapy to the Prostate and Dominant Lesion Using Ultra-Hypofractionated, MR-adaptive Radiation Therapy aims to evaluate tumor control after definitive ultra-hypofractionated external beam radiation therapy (including a simultaneously delivered high-dose boost to a dominant lesion as detected on prostate magnetic resonance imaging (MRI)) in patients with intermediate-risk prostate cancer. This will incorporate the use of multiparametric MRI for target segmentation and the use of the MR-linac with adaptive radiation planning to treat the prostate gland, incorporating a dose boost to the dominant intraprostatic lesion (DIL) that is visible on T2-weighted and diffusion-weighted imaging and de-escalation of dose to the remainder of the prostate.

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 data supports the effectiveness of the treatment Ultra-Hypofractionated MR-Guided Radiotherapy for prostate cancer?

Research shows that using MRI-guided radiotherapy for prostate cancer allows for better targeting of the cancer while reducing harm to nearby healthy tissues. This approach has shown promising results in delivering effective treatment with fewer side effects, thanks to improved visualization and real-time tracking during therapy. ^{1 2 3 4 5}

Is MR-guided radiotherapy safe for prostate cancer treatment?

MR-guided radiotherapy for prostate cancer has shown promising safety results, with studies indicating good tolerability and manageable side effects. Early evidence suggests that it can be delivered safely with reduced toxicity to surrounding tissues, especially when using ultra-hypofractionated doses. ^{2 4 6 7 8}

How is Ultra-Hypofractionated MR-Guided Radiotherapy different from other prostate cancer treatments?

Ultra-Hypofractionated MR-Guided Radiotherapy is unique because it uses MRI to guide the treatment, allowing for better visualization and real-time tracking of the prostate and surrounding tissues. This approach can improve targeting and reduce side effects by adapting the treatment plan as needed, which is not typically possible with standard radiotherapy methods. ^{2 3 4 9 10}

Research Team

Michael Zelefsky, M.D

Principal Investigator

NYU Langone Health

Eligibility Criteria

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

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

Treatment Details

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.

Participant Groups

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+

Findings from Research

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]

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]

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]

References

1. Switzerland pubmed.ncbi.nlm.nih.gov

MR-Guided Radiotherapy for Prostate Cancer. [2020]

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

Magnetic resonance image-guided adaptive stereotactic body radiotherapy for prostate cancer: preliminary results of outcome and toxicity. [2022]

3. Switzerland pubmed.ncbi.nlm.nih.gov

Assessment of delivered dose in prostate cancer patients treated with ultra-hypofractionated radiotherapy on 1.5-Tesla MR-Linac. [2023]

4. England pubmed.ncbi.nlm.nih.gov

Randomized phase II trial of MRI-guided salvage radiotherapy for prostate cancer in 4 weeks versus 2 weeks (SHORTER). [2023]

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

Magnetic Resonance Imaging-Guided Adaptive Radiation Therapy: A "Game Changer" for Prostate Treatment? [2019]

6. Ireland pubmed.ncbi.nlm.nih.gov

Feasibility of MR-guided ultrahypofractionated radiotherapy in 5, 2 or 1 fractions for prostate cancer. [2020]

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

Acute and late toxicity patterns of moderate hypo-fractionated radiotherapy for prostate cancer: A systematic review and meta-analysis. [2023]

8. England pubmed.ncbi.nlm.nih.gov

Stereotactic MRI-guided radiation therapy for localized prostate cancer (SMILE): a prospective, multicentric phase-II-trial. [2022]

9. Ireland pubmed.ncbi.nlm.nih.gov

Dosimetric feasibility of hypofractionation for SBRT treatment of lymph node oligometastases on the 1.5T MR-linac. [2021]

10. Ireland pubmed.ncbi.nlm.nih.gov

Prostate intrafraction motion during the preparation and delivery of MR-guided radiotherapy sessions on a 1.5T MR-Linac. [2021]