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Reirradiation Options for Previously Irradiated Prostate cancer (RO-PIP): Feasibility study investigating toxicity outcomes following reirradiation with stereotactic body radiotherapy (SBRT) versus high-dose-rate brachytherapy (HDR-BT)

INTRODUCTION: Radiotherapy is the most common curative treatment for non-metastatic prostate cancer; however, up to 13% of patients will develop local recurrence within 10 years. Patients can undergo further and potentially curative treatment including salvage surgery, brachytherapy (BT), external b...

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Autores principales: Zhong, Jim, Brown, Sarah, Serra, Maria, Shuttleworth, Pam, Bownes, Peter, Thompson, Christopher, Reed, Rachel, Reeves, Kimberley, Dubec, Michael, McHugh, Damien, Eccles, Cynthia, Chuter, Robert, Tsang, Yat Man, Taylor, N Jane, West, Catharine, Buckley, David, Scarsbrook, Andrew, Choudhury, Ananya, Hoskin, Peter, Henry, Ann
Formato: Online Artículo Texto
Lenguaje:English
Publicado: BMJ Publishing Group 2022
Materias:
Acceso en línea:https://www.ncbi.nlm.nih.gov/pmc/articles/PMC9644357/
https://www.ncbi.nlm.nih.gov/pubmed/36351720
http://dx.doi.org/10.1136/bmjopen-2022-068580
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author Zhong, Jim
Brown, Sarah
Serra, Maria
Shuttleworth, Pam
Bownes, Peter
Thompson, Christopher
Reed, Rachel
Reeves, Kimberley
Dubec, Michael
McHugh, Damien
Eccles, Cynthia
Chuter, Robert
Tsang, Yat Man
Taylor, N Jane
West, Catharine
Buckley, David
Scarsbrook, Andrew
Choudhury, Ananya
Hoskin, Peter
Henry, Ann
author_facet Zhong, Jim
Brown, Sarah
Serra, Maria
Shuttleworth, Pam
Bownes, Peter
Thompson, Christopher
Reed, Rachel
Reeves, Kimberley
Dubec, Michael
McHugh, Damien
Eccles, Cynthia
Chuter, Robert
Tsang, Yat Man
Taylor, N Jane
West, Catharine
Buckley, David
Scarsbrook, Andrew
Choudhury, Ananya
Hoskin, Peter
Henry, Ann
author_sort Zhong, Jim
collection PubMed
description INTRODUCTION: Radiotherapy is the most common curative treatment for non-metastatic prostate cancer; however, up to 13% of patients will develop local recurrence within 10 years. Patients can undergo further and potentially curative treatment including salvage surgery, brachytherapy (BT), external beam radiotherapy, high-intensity focused ultrasound and cryotherapy. Systematic review shows that high-dose-rate (HDR) BT and stereotactic body radiotherapy (SBRT) have the best outcomes in terms of biochemical control and lowest side effects. The reirradiation options for previously irradiated prostate cancer (RO-PIP) trial aims to determine the feasibility of recruitment to a trial randomising patients to salvage HDR-BT or SBRT and provide prospective data on patient recorded toxicity outcomes that will inform a future phase III trial. METHODS AND ANALYSIS: The primary endpoint of the RO-PIP feasibility study is to evaluate the patient recruitment potential over 2 years to a trial randomising to either SBRT or HDR-BT for patients who develop local recurrence of prostate cancer following previous radiation therapy. The aim is to recruit 60 patients across 3 sites over 2 years and randomise 1:1 to SBRT or HDR-BT. Secondary objectives include recording clinician and patient-reported outcome measures to evaluate treatment-related toxicity. In addition, the study aims to identify potential imaging, genomic and proteomic biomarkers that are predictive of toxicity and outcome based on hypoxia status, a prognostic marker of prostate cancer. ETHICS AND DISSEMINATION: This study has been approved by the Yorkshire and The Humber—Bradford Leeds Research Ethics Committee (Reference: 21/YH/0305, IRAS: 297060, January 2022). The results will be presented in national and international conferences, published in peer-reviewed journals and will be communicated to relevant stakeholders. A plain English report will be shared with the study participants, patients’ organisations and media. TRIAL REGISTRATION NUMBER: ISRCTN 12238218 (Amy Ackroyd NIHR CPMS Team).
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spelling pubmed-96443572022-11-15 Reirradiation Options for Previously Irradiated Prostate cancer (RO-PIP): Feasibility study investigating toxicity outcomes following reirradiation with stereotactic body radiotherapy (SBRT) versus high-dose-rate brachytherapy (HDR-BT) Zhong, Jim Brown, Sarah Serra, Maria Shuttleworth, Pam Bownes, Peter Thompson, Christopher Reed, Rachel Reeves, Kimberley Dubec, Michael McHugh, Damien Eccles, Cynthia Chuter, Robert Tsang, Yat Man Taylor, N Jane West, Catharine Buckley, David Scarsbrook, Andrew Choudhury, Ananya Hoskin, Peter Henry, Ann BMJ Open Oncology INTRODUCTION: Radiotherapy is the most common curative treatment for non-metastatic prostate cancer; however, up to 13% of patients will develop local recurrence within 10 years. Patients can undergo further and potentially curative treatment including salvage surgery, brachytherapy (BT), external beam radiotherapy, high-intensity focused ultrasound and cryotherapy. Systematic review shows that high-dose-rate (HDR) BT and stereotactic body radiotherapy (SBRT) have the best outcomes in terms of biochemical control and lowest side effects. The reirradiation options for previously irradiated prostate cancer (RO-PIP) trial aims to determine the feasibility of recruitment to a trial randomising patients to salvage HDR-BT or SBRT and provide prospective data on patient recorded toxicity outcomes that will inform a future phase III trial. METHODS AND ANALYSIS: The primary endpoint of the RO-PIP feasibility study is to evaluate the patient recruitment potential over 2 years to a trial randomising to either SBRT or HDR-BT for patients who develop local recurrence of prostate cancer following previous radiation therapy. The aim is to recruit 60 patients across 3 sites over 2 years and randomise 1:1 to SBRT or HDR-BT. Secondary objectives include recording clinician and patient-reported outcome measures to evaluate treatment-related toxicity. In addition, the study aims to identify potential imaging, genomic and proteomic biomarkers that are predictive of toxicity and outcome based on hypoxia status, a prognostic marker of prostate cancer. ETHICS AND DISSEMINATION: This study has been approved by the Yorkshire and The Humber—Bradford Leeds Research Ethics Committee (Reference: 21/YH/0305, IRAS: 297060, January 2022). The results will be presented in national and international conferences, published in peer-reviewed journals and will be communicated to relevant stakeholders. A plain English report will be shared with the study participants, patients’ organisations and media. TRIAL REGISTRATION NUMBER: ISRCTN 12238218 (Amy Ackroyd NIHR CPMS Team). BMJ Publishing Group 2022-11-08 /pmc/articles/PMC9644357/ /pubmed/36351720 http://dx.doi.org/10.1136/bmjopen-2022-068580 Text en © Author(s) (or their employer(s)) 2022. Re-use permitted under CC BY. Published by BMJ. https://creativecommons.org/licenses/by/4.0/This is an open access article distributed in accordance with the Creative Commons Attribution 4.0 Unported (CC BY 4.0) license, which permits others to copy, redistribute, remix, transform and build upon this work for any purpose, provided the original work is properly cited, a link to the licence is given, and indication of whether changes were made. See: https://creativecommons.org/licenses/by/4.0/.
spellingShingle Oncology
Zhong, Jim
Brown, Sarah
Serra, Maria
Shuttleworth, Pam
Bownes, Peter
Thompson, Christopher
Reed, Rachel
Reeves, Kimberley
Dubec, Michael
McHugh, Damien
Eccles, Cynthia
Chuter, Robert
Tsang, Yat Man
Taylor, N Jane
West, Catharine
Buckley, David
Scarsbrook, Andrew
Choudhury, Ananya
Hoskin, Peter
Henry, Ann
Reirradiation Options for Previously Irradiated Prostate cancer (RO-PIP): Feasibility study investigating toxicity outcomes following reirradiation with stereotactic body radiotherapy (SBRT) versus high-dose-rate brachytherapy (HDR-BT)
title Reirradiation Options for Previously Irradiated Prostate cancer (RO-PIP): Feasibility study investigating toxicity outcomes following reirradiation with stereotactic body radiotherapy (SBRT) versus high-dose-rate brachytherapy (HDR-BT)
title_full Reirradiation Options for Previously Irradiated Prostate cancer (RO-PIP): Feasibility study investigating toxicity outcomes following reirradiation with stereotactic body radiotherapy (SBRT) versus high-dose-rate brachytherapy (HDR-BT)
title_fullStr Reirradiation Options for Previously Irradiated Prostate cancer (RO-PIP): Feasibility study investigating toxicity outcomes following reirradiation with stereotactic body radiotherapy (SBRT) versus high-dose-rate brachytherapy (HDR-BT)
title_full_unstemmed Reirradiation Options for Previously Irradiated Prostate cancer (RO-PIP): Feasibility study investigating toxicity outcomes following reirradiation with stereotactic body radiotherapy (SBRT) versus high-dose-rate brachytherapy (HDR-BT)
title_short Reirradiation Options for Previously Irradiated Prostate cancer (RO-PIP): Feasibility study investigating toxicity outcomes following reirradiation with stereotactic body radiotherapy (SBRT) versus high-dose-rate brachytherapy (HDR-BT)
title_sort reirradiation options for previously irradiated prostate cancer (ro-pip): feasibility study investigating toxicity outcomes following reirradiation with stereotactic body radiotherapy (sbrt) versus high-dose-rate brachytherapy (hdr-bt)
topic Oncology
url https://www.ncbi.nlm.nih.gov/pmc/articles/PMC9644357/
https://www.ncbi.nlm.nih.gov/pubmed/36351720
http://dx.doi.org/10.1136/bmjopen-2022-068580
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