RecruitingPhase 2NCT05851547

Dose Escalation For INtraprostatic LEsions

A Phase II Study of the Use of MRI-defined Focal Boosts With Stereotactic Body Radiotherapy for Localized Prostate Cancer


Sponsor

Ottawa Hospital Research Institute

Enrollment

54 participants

Start Date

Nov 23, 2023

Study Type

INTERVENTIONAL

Conditions

Summary

External beam radiotherapy combined with androgen deprivation therapy is a standard treatment option for localized prostate cancer. The current standard involves delivering radiotherapy uniformly throughout the prostate gland in daily fractions, five days per week, for approximately four weeks. In this study, radiotherapy will be delivered using an ultra-hypofractionated approach in three larger fractions on alternating days over one week Multiparametric magnetic resonance imaging will be used to guide focal dose escalation to parts of the gland harboring tumor, which could potentially reduce the risk of cancer recurrence compared to standard dose of radiotherapy. The aim of this study is to confirm that this approach can be delivered safely, that is, with rates of urinary and bowel side effects at 1 year of follow-up that are not significantly greater than the current standard.


Eligibility

Sex: MALEMin Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study is testing whether a higher, more targeted dose of radiation to specific areas within the prostate — while keeping the overall dose to surrounding tissue the same — can improve cancer control in men with intermediate- or high-risk localized prostate cancer. Advanced imaging and radiation technology makes it possible to precisely boost the dose to the most dangerous spots in the prostate. **You may be eligible if...** - You have a confirmed diagnosis of prostate cancer that has not spread outside the prostate (localized) - Your cancer is classified as unfavorable intermediate-risk or high-risk (based on Gleason score, PSA level, and tumor stage) - You are suitable for radiation therapy **You may NOT be eligible if...** - Your cancer has spread to lymph nodes or other organs - You have previously had radiation therapy to the pelvic area - You have a pacemaker or other implant that could interfere with treatment planning - You have inflammatory bowel disease or other conditions that would make pelvic radiation too risky - You are unable to complete the required follow-up visits Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

RADIATIONProstate SBRT with Focal Boost

Prostate stereotactic body radiotherapy delivered to 27 Gy in 3 fractions on alternating days to uninvolved regions with up to 39 Gy in 3 fractions delivered to mpMRI-defined intraprostatic lesions

DRUGTriptorelin Injection

Six months of androgen deprivation therapy for intermediate-risk localized prostate cancer and 24 months for high-risk localized prostate cancer


Locations(1)

The Ottawa Hospital Cancer Centre

Ottawa, Ontario, Canada

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NCT05851547


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