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166 Radiation Therapy and IRreversible Electroporation (RTIRE) for Intermediate Risk Prostate Cancer
Published online by Cambridge University Press: 03 April 2024
Abstract
OBJECTIVES/GOALS: Prostate cancer treatment is associated with significant genitourinary side effects. There is a critical need for treatment with decreased morbidity. We report the development of a novel treatment paradigm combining irreversible electroporation and lower dose radiation to provide prostate cancer patients with a less morbid treatment. METHODS/STUDY POPULATION: Intermediate risk prostate cancer patients will undergo focal irreversible electroporation followed by low dose, whole gland radiation therapy. The primary endpoint is freedom from clinically significant cancer on biopsy at 12-month follow up. Secondary endpoints include safety profile, oncologic efficacy, effectiveness of RT and need for secondary treatment. This trial (NCT05345444) and currently actively recruiting patients after initial feasibility trial. Sample size is calculated to detect an increase in the proportion of patients who are cancer free at 1-year, from 0.80 to 0.95. An exact binomial test with a 10% one-sided significance level will have 94.3% power to detect the difference between the null and alternative hypothesis when the sample size is 42. RESULTS/ANTICIPATED RESULTS: This is a clinical trial in progress. DISCUSSION/SIGNIFICANCE: Combined irreversible electroporation (IRE) and a lower dose radiotherapy (RTIRE) may provide prostate cancer patients a treatment with minimal side effects.
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- This is an Open Access article, distributed under the terms of the Creative Commons Attribution-NonCommercial-NoDerivatives licence (https://creativecommons.org/licenses/by-nc-nd/4.0/), which permits non-commercial re-use, distribution, and reproduction in any medium, provided the original work is unaltered and is properly cited. The written permission of Cambridge University Press must be obtained for commercial re-use or in order to create a derivative work.
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- © The Author(s), 2024. The Association for Clinical and Translational Science