166 Radiation Therapy and IRreversible Electroporation (RTIRE) for Intermediate Risk Prostate Cancer
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 p...
| Main Authors: | , , , , , , |
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| Format: | Article |
| Language: | English |
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Cambridge University Press
2024-04-01
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| Series: | Journal of Clinical and Translational Science |
| Online Access: | https://www.cambridge.org/core/product/identifier/S2059866124001596/type/journal_article |
| _version_ | 1797226918303498240 |
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| author | Timothy McClure Francesca Khani Brian Robinson Ariel E Marciscano Christopher Barbieri Joseph Osborne Himanshu Nagar |
| author_facet | Timothy McClure Francesca Khani Brian Robinson Ariel E Marciscano Christopher Barbieri Joseph Osborne Himanshu Nagar |
| author_sort | Timothy McClure |
| collection | DOAJ |
| description | 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. |
| first_indexed | 2024-04-24T14:32:32Z |
| format | Article |
| id | doaj.art-e01b66cb89174ffb9c9200bac008acf9 |
| institution | Directory Open Access Journal |
| issn | 2059-8661 |
| language | English |
| last_indexed | 2024-04-24T14:32:32Z |
| publishDate | 2024-04-01 |
| publisher | Cambridge University Press |
| record_format | Article |
| series | Journal of Clinical and Translational Science |
| spelling | doaj.art-e01b66cb89174ffb9c9200bac008acf92024-04-03T02:00:11ZengCambridge University PressJournal of Clinical and Translational Science2059-86612024-04-018505010.1017/cts.2024.159166 Radiation Therapy and IRreversible Electroporation (RTIRE) for Intermediate Risk Prostate CancerTimothy McClure0Francesca Khani1Brian Robinson2Ariel E Marciscano3Christopher Barbieri4Joseph Osborne5Himanshu Nagar6Weill Cornell MedicineDepartment of Pathology, New York Presbyterian/Weill Cornell Medicine, New York, NY, USADepartment of Pathology, New York Presbyterian/Weill Cornell Medicine, New York, NY, USADepartment of Radiation Oncology, New York Presbyterian/Weill Cornell Medicine, New York, NY, USADepartment of Urology, New York Presbyterian/Weill Cornell Medicine, New York, NY, USADepartment of Molecular Imaging and Therapeutics, New York Presbyterian/Weill Cornell Medicine, New York, NY, USADepartment of Radiation Oncology, New York Presbyterian/Weill Cornell Medicine, New York, NY, USAOBJECTIVES/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.https://www.cambridge.org/core/product/identifier/S2059866124001596/type/journal_article |
| spellingShingle | Timothy McClure Francesca Khani Brian Robinson Ariel E Marciscano Christopher Barbieri Joseph Osborne Himanshu Nagar 166 Radiation Therapy and IRreversible Electroporation (RTIRE) for Intermediate Risk Prostate Cancer Journal of Clinical and Translational Science |
| title | 166 Radiation Therapy and IRreversible Electroporation (RTIRE) for Intermediate Risk Prostate Cancer |
| title_full | 166 Radiation Therapy and IRreversible Electroporation (RTIRE) for Intermediate Risk Prostate Cancer |
| title_fullStr | 166 Radiation Therapy and IRreversible Electroporation (RTIRE) for Intermediate Risk Prostate Cancer |
| title_full_unstemmed | 166 Radiation Therapy and IRreversible Electroporation (RTIRE) for Intermediate Risk Prostate Cancer |
| title_short | 166 Radiation Therapy and IRreversible Electroporation (RTIRE) for Intermediate Risk Prostate Cancer |
| title_sort | 166 radiation therapy and irreversible electroporation rtire for intermediate risk prostate cancer |
| url | https://www.cambridge.org/core/product/identifier/S2059866124001596/type/journal_article |
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