RecruitingPhase 2Phase 3NCT04654338

2 Ablative RadioTherapy Treatments for Prostate Cancer

Electively Combining Two Ablative RadioTherapy Treatments for Favorable Risk Prostate Cancer Patients (EARTH)

Sponsor

Sunnybrook Health Sciences Centre

Enrollment

30 participants

Start Date

Jul 29, 2020

Study Type

INTERVENTIONAL

Conditions

Prostate Cancer

Summary

Favorable-risk prostate cancer represent a large proportion of patients diagnosed with prostate cancer and image guided radiation therapy (IGRT) is commonly used to treat these patients using protracted courses of up to 39 treatments over 8 weeks. Stereotactic ablative body radiotherapy (SABR) protocols hold the promise of more convenience, less side effects, less cost and improved system capacity without sacrificing excellent cancer control rates. By the same token, prostate high-dose rate (HDR) brachytherapy boost has been shown to be superior to standard external beam radiation. While two HDR fractions appear to optimize patient convenience and outcomes while minimizing costs, we wanted to determine the tolerability of combining one MR-guided HDR treatment with one SABR treatment to further reduce HDR resource use while maintaining favourable treatment outcomes.

Eligibility

Sex: MALE

Plain Language Summary

Simplified for easier understanding

This trial tests whether delivering the full radiation dose for prostate cancer in just 2 large treatments (a technique called ultra-hypofractionated or ablative radiotherapy) is an effective way to treat localized prostate cancer, compared to the usual schedule of many smaller doses. **You may be eligible if...** - You have been diagnosed with low-risk or favorable intermediate-risk prostate cancer (confirmed by biopsy) - Your PSA level is below 20 ng/mL - Your prostate gland is not too large (under 60 cc) - You are able to have an MRI scan **You may NOT be eligible if...** - Your cancer has spread to lymph nodes or other organs - You have had previous radiation to the pelvis - You have previously had prostate surgery (TURP, prostatectomy) or HIFU - You are on hormone therapy (androgen deprivation) - You have significant urinary symptoms (IPSS score above 15) - You have inflammatory bowel disease or connective tissue disease 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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