54 Participants NeededMy employer runs this trial

Lower Dose Radiation Therapy for Prostate Cancer

Recruiting at 6 trial locations
VB
ZM
Overseen ByZachary Moore, MD, PhD
Age: 18+
Sex: Male
Trial Phase: Phase 2
Sponsor: Memorial Sloan Kettering Cancer Center
Must be taking: LHRH analogues, LHRH agonists
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)
Prior Safety DataThis treatment has passed at least one previous human trial

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial examines whether a lower dose of radiation therapy can reduce side effects for men with prostate cancer while maintaining effectiveness. Participants will undergo MR-guided Stereotactic Body Radiation Therapy, a precise radiation treatment. Some will receive a uniform dose, while others will receive a lower dose to specific areas. Men with confirmed prostate cancer, a visible tumor on MRI, and no previous prostate treatments qualify for this study. As a Phase 2 trial, this research measures the treatment's effectiveness in an initial, smaller group.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Research has shown that MRI-guided stereotactic body radiation therapy (SBRT) for prostate cancer is safe for patients. Studies indicate that this type of radiation therapy reduces long-term side effects, improving quality of life after treatment.

Other studies have demonstrated that the treatment has manageable side effects even up to two years post-treatment. Specifically, MRI-guided SBRT appears to cause fewer urinary and digestive problems, common concerns with prostate treatments.

Overall, MRI-guided SBRT is both safe and effective. It provides precise treatment, protecting nearby sensitive tissues from harm. This makes it a promising option for those considering joining a clinical trial.12345

Why are researchers excited about this trial's treatment for prostate cancer?

Researchers are excited about MR-guided Stereotactic Body Radiation Therapy (SBRT) for prostate cancer because it offers a more precise and potentially safer way to deliver radiation. Unlike traditional radiation therapy, which can affect surrounding healthy tissues, this method uses MRI guidance to target cancer cells more accurately. The trial is exploring two approaches: one that maintains a uniform radiation dose and another that uses a de-escalated dose, which could reduce side effects while maintaining effectiveness. This precision and potential for fewer side effects are what make this treatment approach promising.

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

This trial will compare two approaches to MRI-guided stereotactic body radiation therapy (SBRT) for prostate cancer: a uniform dose and a de-escalated dose. Research has shown that MRI-guided SBRT effectively treats prostate cancer. Studies have found that this method significantly reduces long-term side effects and enhances patients' quality of life. Compared to traditional CT-guided methods, MRI-guided SBRT better reduces short-term urinary and digestive issues. Its high accuracy and precision are crucial for effectively treating prostate cancer. Overall, MRI-guided SBRT is emerging as a safe and effective option for treating localized prostate cancer.12346

Who Is on the Research Team?

VB

Victoria Brennan, MBBCH BAO

Principal Investigator

Memorial Sloan Kettering Cancer Center

Are You a Good Fit for This Trial?

This trial is for people with confirmed prostate adenocarcinoma (prostate cancer) that is low to intermediate risk, visible on MRI, and not too large. Participants must have a PSA under 20 ng/mL if using hormone therapy and should not need more than 6 months of hormone treatment.

Inclusion Criteria

My disease has been confirmed by medical records.
My tumor nodule is less than 2.5 cm and can be safely targeted for treatment.
My MRI lesion was confirmed as cancer by biopsy (grade group 1, 2, or 3).
See 7 more

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Radiation

Participants receive either a uniform or de-escalated dose of SBRT to the prostate

2 weeks

Follow-up

Participants are monitored for acute GU toxicities and other side effects

12 weeks

What Are the Treatments Tested in This Trial?

Interventions

  • MR-guided Stereotactic Body Radiation Therapy

Trial Overview

The study compares two types of MR-guided radiation therapy: one uses a lower dose targeted at certain parts of the prostate, while the other gives an even dose to the whole prostate. The goal is to see if lowering the dose in some areas reduces side effects.

How Is the Trial Designed?

2

Treatment groups

Experimental Treatment

Active Control

Group I: Group 2: De-escalated dose SBRTExperimental Treatment1 Intervention
Group II: Group 1: Uniform dose SBRTActive Control1 Intervention

Find a Clinic Near You

Who Is Running the Clinical Trial?

Memorial Sloan Kettering Cancer Center

Lead Sponsor

Trials
1,998
Recruited
602,000+

Citations

Stereotactic Magnetic Resonance-Guided Adaptive and Non ...

Stereotactic body radiotherapy (SBRT) is an effective radiation therapy technique that has allowed for shorter treatment courses, as compared to conventionally ...

MRI-guided radiation therapy reduces long-term side ...

MRI-guided stereotactic body radiotherapy (SBRT) for prostate cancer significantly reduced long-term side effects and improved quality of life.

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.

Acute and Late Patient-Reported Toxicity Outcomes

Our study is one the largest patient-reported outcomes study after prostate SMART. It shows acceptable levels of toxicity even up to 2 years after treatment.

Magnetic Resonance-Guided Adaptive Radiation Therapy ...

Ultrahypofractionated MR-guided radiation therapy for localized PCa using a 1.5T MR-Linac is effective and safe.

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 ...