RecruitingNot ApplicableNCT05786742

Ultra Hypofractionnated Radiotherapy With HDR Brachytherapy Boost.

ULTRA-HYPO Fractionated (UHF) Compared to Moderate-HYPO Fractionated (MHF) Prostate IGRT With HDR Brachytherapy BOOST : A Phase 1-2 Study.


Sponsor

CHU de Quebec-Universite Laval

Enrollment

205 participants

Start Date

Apr 1, 2014

Study Type

INTERVENTIONAL

Conditions

Summary

Phase 1-2 study, comparing ultra-hypofractionnated (UH) to a moderately hypofractionnated (MH) radiation therapy, with image guided HDR prostate brachytherapy. Using iso-equivalent doses, a non-inferiority analysis will be done in order to prove UH non-inferior to MH, toxicity wise. Acceptability, tolerability, acute and late toxicity will be reported. MRI visible dominant intra-prostatic lesion will be outlines and variability between radiation oncologists and radiologists will be reported. As secondary objective, biochemical and clinical failure free survival will be reported at 5 \& 10 years.


Eligibility

Sex: MALEMin Age: 18 YearsMax Age: 95 Years

Plain Language Summary

Simplified for easier understanding

This study is evaluating a radiation treatment approach for localized prostate cancer that combines a short course of external beam radiation (ultra-hypofractionation) with a high-dose internal radiation boost (HDR brachytherapy). Researchers want to see if this combination is effective and manageable for patients. **You may be eligible if...** - You are 18 or older with biopsy-confirmed prostate cancer (adenocarcinoma) - Your cancer is stage T1c or T2 (localized, not spread beyond the prostate) - Your PSA level is below 20 ng/mL - Your Gleason score is 6 or 7 (low to intermediate risk) - Your cancer has not spread to lymph nodes or distant organs **You may NOT be eligible if...** - Your cancer is stage T3 or T4 (has spread outside the prostate) - Your PSA is above 20 ng/mL - Your Gleason score is 8 to 10 (high-risk) - You have severe urinary symptoms (IPSS score > 20) - You have had prior pelvic radiation - You have inflammatory bowel disease or certain autoimmune conditions (lupus, scleroderma) - You have bilateral hip implants 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

RADIATIONgrade and compare reported side effects between groups

Compare experimental ultra hypo fractionation (25 Gy in 5 daily fractions administered starting mid week and ending mid following week) to our standard fractionation (either 37,5 Gy given in 15 daily fractions, or 36 Gy in 12 daily fractions). * Toxicity analysis will be quantitatively evaluated using CTCAE (v5) at 1, 2 and 5 years post-therapy, and has needed at FU visits. Kaplan-Meier statistical analysis will be used to report toxicity evolution through time. * median IPSS scores will be reported at 3, 6, 12 months and yearly (1, 2, 3, 4 et 5) post-therapy. IPSS median time to baseline return will be calculated. * IPSS urinary scores, sexual function (SHIM) and GI toxicity (CTCAE-v5) and quality of life questionnaires ( EPIC-26) will be given at 3, 6 months and yearly thereafter (1, 2, 3, 4 et 5) post-treatment.


Locations(1)

CHUdeQuebec

Québec, Canada

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NCT05786742


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