Pelvis Or Involved Node Treatment: Eradicating Recurrence in Prostate Cancer (POINTER-PC) – study protocol paper for a phase III multicentre, open-label randomised controlled trial
Introduction Prostate cancer (PCa) is the most common cancer in men. Recurrence may occur in up to half of patients initially treated with curative intent for high-risk localised/locally advanced PCa. Pelvic nodal recurrence is common in this setting, but no clear standard of care exists for these p...
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BMJ Publishing Group
2024-12-01
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| Online Access: | https://bmjopen.bmj.com/content/14/12/e095560.full |
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| author | Pedro Oliveira Alexandra Smith Suneil Jain Ananya Choudhury Omar Din Vincent Khoo Sophie Alexander Alexandra Gilbert Matthew Carter Samantha Noutch Caroline Dive Joanne Webster Sarah R Brown John Lilley Finbar Slevin Alexandra Clipson Sean Girvan Mohan Hingorani Louise J Murray Olivia Naismith Christopher J H Pagett James Talbot Ann M Henry |
| author_facet | Pedro Oliveira Alexandra Smith Suneil Jain Ananya Choudhury Omar Din Vincent Khoo Sophie Alexander Alexandra Gilbert Matthew Carter Samantha Noutch Caroline Dive Joanne Webster Sarah R Brown John Lilley Finbar Slevin Alexandra Clipson Sean Girvan Mohan Hingorani Louise J Murray Olivia Naismith Christopher J H Pagett James Talbot Ann M Henry |
| author_sort | Pedro Oliveira |
| collection | DOAJ |
| description | Introduction Prostate cancer (PCa) is the most common cancer in men. Recurrence may occur in up to half of patients initially treated with curative intent for high-risk localised/locally advanced PCa. Pelvic nodal recurrence is common in this setting, but no clear standard of care exists for these patients, with potential therapeutic approaches including stereotactic body radiotherapy (SBRT) to the involved node(s) alone, extended nodal irradiation (ENI) to treat sites of potential micrometastatic spread in addition to involved node(s) and androgen deprivation therapy with or without additional systemic anticancer therapies. Based on observational studies, ENI is associated with promising metastasis-free survival (MFS) compared with SBRT and appears to result in low rates of severe late toxicity.Methods and analysis Pelvis Or Involved Node Treatment: Eradicating Recurrence in Prostate Cancer is a UK multicentre, open-label, phase III randomised controlled trial, which will deliver much needed, high-quality evidence of the impact on metastatic progression from ENI compared with SBRT in patients with PCa pelvic nodal recurrence. The trial will also evaluate the long-term toxicity of 5-fraction ENI compared with a standard 20-fraction schedule. The trail will randomise 480 participants in a ratio of 2:1:1 to SBRT, 5-fraction ENI or 20-fraction ENI from 35 to 40 UK radiotherapy sites over 4 years. Coprimary endpoints are MFS at 3 years and participant-reported late bowel toxicity at 3 years. Secondary endpoints include overall survival, biochemical progression-free survival, failure-free survival, patterns of failure, participant-reported/clinician-reported toxicity and health-related quality of life. Collection of blood and tissue samples will enable future evaluation of biomarkers of disease and toxicity and support stratification of salvage therapeutic approaches.Ethics and dissemination Ethical approval was obtained from NHS Health Research Authority, East of England – Cambridgeshire and Hertfordshire Research Ethics Committee (24/EE/0099). Trial results will be published in peer-reviewed journals and adhere to International Committee of Medical Journal Editors guidelines.Trial registration number ISRCTN11089334, registered on 23 September 2024. |
| format | Article |
| id | doaj-art-a687f51e78c74e5b8a3f5e8a702d1251 |
| institution | Kabale University |
| issn | 2044-6055 |
| language | English |
| publishDate | 2024-12-01 |
| publisher | BMJ Publishing Group |
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| spelling | doaj-art-a687f51e78c74e5b8a3f5e8a702d12512024-12-27T04:05:09ZengBMJ Publishing GroupBMJ Open2044-60552024-12-01141210.1136/bmjopen-2024-095560Pelvis Or Involved Node Treatment: Eradicating Recurrence in Prostate Cancer (POINTER-PC) – study protocol paper for a phase III multicentre, open-label randomised controlled trialPedro Oliveira0Alexandra Smith1Suneil Jain2Ananya Choudhury3Omar Din4Vincent Khoo5Sophie Alexander6Alexandra Gilbert7Matthew Carter8Samantha Noutch9Caroline Dive10Joanne Webster11Sarah R Brown12John Lilley13Finbar Slevin14Alexandra Clipson15Sean Girvan16Mohan Hingorani17Louise J Murray18Olivia Naismith19Christopher J H Pagett20James Talbot21Ann M Henry22The Christie NHS Foundation Trust, Manchester, UKLeeds Cancer Research UK Clinical Trials Unit, University of Leeds, Leeds, UKQueen’s University Belfast, Belfast, UKDivision of Cancer Sciences, University of Manchester, Manchester, UKSheffield Teaching Hospitals NHS Foundation Trust, Sheffield, UKThe Royal Marsden NHS Foundation Trust, London, UKThe Institute of Cancer Research, London, UKLeeds Institute of Medical Research, University of Leeds, Leeds, UKLeeds Cancer Research UK Clinical Trials Unit, University of Leeds, Leeds, UKLeeds Cancer Research UK Clinical Trials Unit, University of Leeds, Leeds, UKCancer Research UK National Biomarker Centre, University of Manchester, Manchester, UKLeeds Cancer Research UK Clinical Trials Unit, University of Leeds, Leeds, UKLeeds Cancer Research UK Clinical Trials Unit, University of Leeds, Leeds, UKLeeds Teaching Hospitals NHS Trust, Leeds, UKLeeds Institute of Medical Research, University of Leeds, Leeds, UKCancer Research UK National Biomarker Centre, University of Manchester, Manchester, UKLeeds Cancer Research UK Clinical Trials Unit, University of Leeds, Leeds, UKHull University Teaching Hospitals NHS Trust, Hull, UKLeeds Institute of Medical Research, University of Leeds, Leeds, UKThe Royal Marsden NHS Foundation Trust, London, UKLeeds Teaching Hospitals NHS Trust, Leeds, UKThe Royal Marsden NHS Foundation Trust, Sutton, UKLeeds Institute of Medical Research, University of Leeds, Leeds, UKIntroduction Prostate cancer (PCa) is the most common cancer in men. Recurrence may occur in up to half of patients initially treated with curative intent for high-risk localised/locally advanced PCa. Pelvic nodal recurrence is common in this setting, but no clear standard of care exists for these patients, with potential therapeutic approaches including stereotactic body radiotherapy (SBRT) to the involved node(s) alone, extended nodal irradiation (ENI) to treat sites of potential micrometastatic spread in addition to involved node(s) and androgen deprivation therapy with or without additional systemic anticancer therapies. Based on observational studies, ENI is associated with promising metastasis-free survival (MFS) compared with SBRT and appears to result in low rates of severe late toxicity.Methods and analysis Pelvis Or Involved Node Treatment: Eradicating Recurrence in Prostate Cancer is a UK multicentre, open-label, phase III randomised controlled trial, which will deliver much needed, high-quality evidence of the impact on metastatic progression from ENI compared with SBRT in patients with PCa pelvic nodal recurrence. The trial will also evaluate the long-term toxicity of 5-fraction ENI compared with a standard 20-fraction schedule. The trail will randomise 480 participants in a ratio of 2:1:1 to SBRT, 5-fraction ENI or 20-fraction ENI from 35 to 40 UK radiotherapy sites over 4 years. Coprimary endpoints are MFS at 3 years and participant-reported late bowel toxicity at 3 years. Secondary endpoints include overall survival, biochemical progression-free survival, failure-free survival, patterns of failure, participant-reported/clinician-reported toxicity and health-related quality of life. Collection of blood and tissue samples will enable future evaluation of biomarkers of disease and toxicity and support stratification of salvage therapeutic approaches.Ethics and dissemination Ethical approval was obtained from NHS Health Research Authority, East of England – Cambridgeshire and Hertfordshire Research Ethics Committee (24/EE/0099). Trial results will be published in peer-reviewed journals and adhere to International Committee of Medical Journal Editors guidelines.Trial registration number ISRCTN11089334, registered on 23 September 2024.https://bmjopen.bmj.com/content/14/12/e095560.full |
| spellingShingle | Pedro Oliveira Alexandra Smith Suneil Jain Ananya Choudhury Omar Din Vincent Khoo Sophie Alexander Alexandra Gilbert Matthew Carter Samantha Noutch Caroline Dive Joanne Webster Sarah R Brown John Lilley Finbar Slevin Alexandra Clipson Sean Girvan Mohan Hingorani Louise J Murray Olivia Naismith Christopher J H Pagett James Talbot Ann M Henry Pelvis Or Involved Node Treatment: Eradicating Recurrence in Prostate Cancer (POINTER-PC) – study protocol paper for a phase III multicentre, open-label randomised controlled trial BMJ Open |
| title | Pelvis Or Involved Node Treatment: Eradicating Recurrence in Prostate Cancer (POINTER-PC) – study protocol paper for a phase III multicentre, open-label randomised controlled trial |
| title_full | Pelvis Or Involved Node Treatment: Eradicating Recurrence in Prostate Cancer (POINTER-PC) – study protocol paper for a phase III multicentre, open-label randomised controlled trial |
| title_fullStr | Pelvis Or Involved Node Treatment: Eradicating Recurrence in Prostate Cancer (POINTER-PC) – study protocol paper for a phase III multicentre, open-label randomised controlled trial |
| title_full_unstemmed | Pelvis Or Involved Node Treatment: Eradicating Recurrence in Prostate Cancer (POINTER-PC) – study protocol paper for a phase III multicentre, open-label randomised controlled trial |
| title_short | Pelvis Or Involved Node Treatment: Eradicating Recurrence in Prostate Cancer (POINTER-PC) – study protocol paper for a phase III multicentre, open-label randomised controlled trial |
| title_sort | pelvis or involved node treatment eradicating recurrence in prostate cancer pointer pc study protocol paper for a phase iii multicentre open label randomised controlled trial |
| url | https://bmjopen.bmj.com/content/14/12/e095560.full |
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