Microboost SBRT for Prostate Cancer
(MIDAS Trial)
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial tests a new radiation technique called microboost SBRT (stereotactic body radiation therapy) to determine its safety and effectiveness for treating low to intermediate-risk prostate cancer. The focus is on managing cancer while minimizing side effects. Participants will be divided into two groups based on specific cancer characteristics and will receive different radiation doses. Men with localized prostate cancer who have not undergone previous radiation or surgery may be suitable for this study. As a Phase 2 trial, this research measures the treatment's effectiveness in an initial, smaller group, offering participants an opportunity to contribute to significant advancements in cancer care.
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.
Is there any evidence suggesting that this trial's treatments are likely to be safe?
Research has shown that stereotactic body radiation therapy (SBRT) is a safe treatment for prostate cancer, particularly for men with low to intermediate risk. Previous studies found that severe side effects are rare, with most being mild and manageable.
For whole gland treatment at 30 Gy, studies reported no severe side effects. Some men might notice changes in urinary function, but these are usually not serious. At the 35 Gy dose, patients reported recovering over time without major side effects.
Overall, previous research has demonstrated the safety of the treatments in this trial. This should reassure potential participants about the low risk of serious side effects.12345Why are researchers excited about this trial's treatments?
Researchers are excited about Microboost SBRT for prostate cancer because it offers a highly targeted approach that differs from traditional therapies like surgery, hormone therapy, or conventional radiation. This treatment involves Stereotactic Body Radiation Therapy (SBRT) which delivers precise, high doses of radiation to just the tumor spots identified by MRI, sparing the rest of the prostate and surrounding tissues. This precision can potentially reduce side effects and improve quality of life compared to standard treatments, which often affect the entire prostate gland and have more widespread impacts. Moreover, the treatment is delivered in fewer sessions, which could make it more convenient for patients.
What evidence suggests that this trial's treatments could be effective for prostate cancer?
Research has shown that microboost SBRT, a type of targeted radiation therapy, is a promising treatment for prostate cancer. Studies have found that about 95% of men who received this treatment remained cancer-free for at least five years. It effectively controls the disease with few serious side effects. Administering a higher dose to specific tumor areas in the prostate might enhance its effectiveness.
In this trial, participants in Arm 1, who have low-risk prostate cancer, will receive microboost SBRT at a dose of 45 Gy along with whole gland de-escalation at a dose of 30 Gy. This 30 Gy dose has been safe and effective, maintaining cancer control with fewer side effects. Participants in Arm 2, with intermediate-risk prostate cancer, will receive the same microboost SBRT dose but with whole gland de-escalation at a dose of 35 Gy. The 35 Gy dose has shown very good results for urinary and bowel health. Overall, these treatments have demonstrated positive outcomes in managing prostate cancer.12567Are You a Good Fit for This Trial?
This trial is for men age 18 or older with low to intermediate risk prostate cancer that has not spread, who have not had prior pelvic radiation or prostate removal surgery. Participants must be in generally good health and able to perform daily activities.Inclusion Criteria
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants receive microboost SBRT at a dose of 45 Gy delivered in 5 fractions in up to 4 MRI-defined lesions, with whole gland de-escalation at a dose of 30 Gy or 35 Gy delivered in 5 fractions depending on risk group
Follow-up
Participants are monitored for safety and effectiveness after radiation treatment, including assessments of genitourinary and gastrointestinal toxicity, and quality of life measures
What Are the Treatments Tested in This Trial?
Interventions
- Microboost SBRT
- Whole gland de-escalation 30 Gy
- Whole gland de-escalation 35 Gy
Trial Overview
The study tests a focused high-dose SBRT (microboost) to MRI-identified tumor spots in the prostate, combined with lower dose whole gland radiation. Two dosing strategies are compared based on where the highest grade cancer is located. All treatment is given over two weeks.
How Is the Trial Designed?
2
Treatment groups
Experimental Treatment
Patients enrolled to arm 2 will have intermidiate risk prostate cancer with grade group 2-3 disease outside of the microboost target(s). Patients in arm 2 will receive microboost SBRT at a dose of 45 Gy delivered in 5 fractions in up to 4 MRI-defined lesions plus whole gland de-escalation at a dose of 35 Gy delivered in 5 fractions.
Patients enrolled to arm 1 will have low risk prostate cancer without Grade Group 2-3 (GG2-3) outside of the microboost target(s). Patients in arm 1 will receive microboost SBRT at a dose of 45 Gy delivered in 5 fractions in up to 4 MRI-defined lesions plus whole gland de-escalation at a dose of 30 Gy delivered in 5 fractions.
Find a Clinic Near You
Who Is Running the Clinical Trial?
Georgetown University
Lead Sponsor
Citations
Shorter radiation improves patient experience but not ...
88.6% of patients in the SBRT group were free from disease progression after three years, compared to 92.1% receiving longer courses of ...
Microboost in Localized Prostate Cancer: Analysis of a ...
Median boost volume was 20.7cc, and median boost D98% was 94.4 EQD2Gy. Only approximately 10% of patients treated with EBRT received microboost.
Stereotactic Body Radiation Therapy for Localized Prostate ...
We demonstrate that prostate SBRT provides excellent disease control, favorable patient-reported quality of life and results in minimal serious acute or late ...
SBRT Proves Effective for Some Prostate Cancers - NCI
After a median follow-up period of just over 6 years, about 95% of men in both treatment groups remained alive without a recurrence of their ...
Stereotactic body radiation therapy with optional focal ...
SBRT represents a valid treatment option for men with low/intermediate risk PCa. · Adding a focal boost to the intraprostatic tumor may improve disease control.
Safety and outcome of stereotactic body radiation therapy ...
Overall survival was 94.09% at 3 years with no deaths attributed to prostate cancer. Conclusions: SBRT treatment of 45Gy/5Fx with hydrogel is ...
Comparison of outcomes and toxicities among radiation ...
SBRT had promising rates of BF, with shorter follow-up (5-year FFBF of >90% for low-risk patients). Similarly, BT (5-year FFBF for low-, intermediate-, and high ...
Unbiased Results
We believe in providing patients with all the options.
Your Data Stays Your Data
We only share your information with the clinical trials you're trying to access.
Verified Trials Only
All of our trials are run by licensed doctors, researchers, and healthcare companies.