TROG 18.01 phase III randomised clinical trial of the Novel Integration of New prostate radiation schedules with adJuvant Androgen deprivation: NINJA study protocol
Introduction Stereotactic body radiotherapy (SBRT) is a non-invasive alternative to surgery for the treatment of non-metastatic prostate cancer (PC). The objectives of the Novel Integration of New prostate radiation schedules with adJuvant Androgen deprivation (NINJA) clinical trial are to compare t...
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BMJ Publishing Group
2019-08-01
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| Series: | BMJ Open |
| Online Access: | https://bmjopen.bmj.com/content/9/8/e030731.full |
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| author | Colin I Tang Christopher Oldmeadow Jeremy Millar Jarad Martin Paul Keall Shankar Siva Peter Greer David Christie Kevin Moore Jason Dowling David Pryor Peter Chong Nicholas McLeod Avi Raman James Lynam Joanne Smart Declan G Murphy Keen Hun Tai Lois Holloway Penny Reeves Amy Hayden Tee Lim Tanya Holt Mark Sidhom |
| author_facet | Colin I Tang Christopher Oldmeadow Jeremy Millar Jarad Martin Paul Keall Shankar Siva Peter Greer David Christie Kevin Moore Jason Dowling David Pryor Peter Chong Nicholas McLeod Avi Raman James Lynam Joanne Smart Declan G Murphy Keen Hun Tai Lois Holloway Penny Reeves Amy Hayden Tee Lim Tanya Holt Mark Sidhom |
| author_sort | Colin I Tang |
| collection | DOAJ |
| description | Introduction Stereotactic body radiotherapy (SBRT) is a non-invasive alternative to surgery for the treatment of non-metastatic prostate cancer (PC). The objectives of the Novel Integration of New prostate radiation schedules with adJuvant Androgen deprivation (NINJA) clinical trial are to compare two emerging SBRT regimens for efficacy with technical substudies focussing on MRI only planning and the use of knowledge-based planning (KBP) to assess radiotherapy plan quality.Methods and analysis Eligible patients must have biopsy-proven unfavourable intermediate or favourable high-risk PC, have an Eastern Collaborative Oncology Group (ECOG) performance status 0-1 and provide written informed consent. All patients will receive 6 months in total of androgen deprivation therapy. Patients will be randomised to one of two SBRT regimens. The first will be 40 Gy in five fractions given on alternating days (SBRT monotherapy). The second will be 20 Gy in two fractions given 1 week apart followed 2 weeks later by 36 Gy in 12 fractions given five times per week (virtual high-dose rate boost (HDRB)). The primary efficacy outcome will be biochemical clinical control at 5 years. Secondary endpoints for the initial portion of NINJA look at the transition of centres towards MRI only planning and the impact of KBP on real-time (RT) plan assessment. The first 150 men will demonstrate accrual feasibility as well as addressing the KBP and MRI planning aims, prior to proceeding with total accrual to 472 patients as a phase III randomised controlled trial.Ethics and dissemination NINJA is a multicentre cooperative clinical trial comparing two SBRT regimens for men with PC. It builds on promising results from several single-armed studies, and explores radiation dose escalation in the Virtual HDRB arm. The initial component includes novel technical elements, and will form an important platform set for a definitive phase III study.Trial registration number ANZCTN 12615000223538. |
| format | Article |
| id | doaj-art-e79f4f8788cf40b08288a3571ae571e3 |
| institution | Kabale University |
| issn | 2044-6055 |
| language | English |
| publishDate | 2019-08-01 |
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| series | BMJ Open |
| spelling | doaj-art-e79f4f8788cf40b08288a3571ae571e32024-11-27T05:15:07ZengBMJ Publishing GroupBMJ Open2044-60552019-08-019810.1136/bmjopen-2019-030731TROG 18.01 phase III randomised clinical trial of the Novel Integration of New prostate radiation schedules with adJuvant Androgen deprivation: NINJA study protocolColin I Tang0Christopher Oldmeadow1Jeremy Millar2Jarad Martin3Paul Keall4Shankar Siva5Peter Greer6David Christie7Kevin Moore8Jason Dowling9David Pryor10Peter Chong11Nicholas McLeod12Avi Raman13James Lynam14Joanne Smart15Declan G Murphy16Keen Hun Tai17Lois Holloway18Penny Reeves19Amy Hayden20Tee Lim21Tanya Holt22Mark Sidhom236 Department of Radiation Oncology, Sir Charles Gairdner Hospital, Perth, Western Australia, AustraliaCREDITSS—Clinical Research Design, Information Technology and Statistical Support Unit, Hunter Medical Research Institute, Newcastle, New South Wales, Australia8 Radiation Oncology, Alfred Health, Melbourne, Victoria, Australia1 Department of Radiation Oncology, Calvary Mater Newcastle, Newcastle, New South Wales, Australia3 Radiation Physics Laboratory, University of Sydney, Sydney, New South Wales, AustraliaDepartment of Radiation Oncology, Peter MacCallum Cancer Centre, Parkville, Victoria, Australia1 Department of Radiation Oncology, Calvary Mater Newcastle, Newcastle, New South Wales, AustraliaGenesiscare, Tugun, Queensland, AustraliaAPC Microbiome Ireland, Patient Collaborator Panel, University College Cork, Cork, Ireland8 The Australian e-Health Research Centre, CSIRO, Canberra, Australian Capital Territory, Australia9 Department of Radiation Oncology, Princess Alexandra Hospital Health Service District, Woolloongabba, Queensland, Australia10 Department of Urology, John Hunter Hospital, New Lambton Heights, New South Wales, Australia10 Department of Urology, John Hunter Hospital, New Lambton Heights, New South Wales, Australia10 Department of Urology, John Hunter Hospital, New Lambton Heights, New South Wales, Australia2 School of Medicine and Public Health, University of Newcastle, Callaghan, New South Wales, Australia1 Department of Radiation Oncology, Calvary Mater Newcastle, Newcastle, New South Wales, Australia13 Urological Service Team, Peter MacCallum Cancer Centre, Melbourne, Victoria, Australia4 Sir Peter MacCallum Department of Oncology, University of Melbourne, Melbourne, Victoria, Australia15 Department of Radiation Oncology, Liverpool Hospital, Liverpool, New South Wales, AustraliaHealth Research Economics, Hunter Medical Research Institute, New Lambton, New South Wales, Australia17 Department of Radiation Oncology, Westmead Hospital, Westmead, New South Wales, Australia18 Genesis Care, Perth, Western Australia, Australia19 Radiation Oncology Princess Alexandra Raymond Terrace, Brisbane, Queensland, Australia15 Department of Radiation Oncology, Liverpool Hospital, Liverpool, New South Wales, AustraliaIntroduction Stereotactic body radiotherapy (SBRT) is a non-invasive alternative to surgery for the treatment of non-metastatic prostate cancer (PC). The objectives of the Novel Integration of New prostate radiation schedules with adJuvant Androgen deprivation (NINJA) clinical trial are to compare two emerging SBRT regimens for efficacy with technical substudies focussing on MRI only planning and the use of knowledge-based planning (KBP) to assess radiotherapy plan quality.Methods and analysis Eligible patients must have biopsy-proven unfavourable intermediate or favourable high-risk PC, have an Eastern Collaborative Oncology Group (ECOG) performance status 0-1 and provide written informed consent. All patients will receive 6 months in total of androgen deprivation therapy. Patients will be randomised to one of two SBRT regimens. The first will be 40 Gy in five fractions given on alternating days (SBRT monotherapy). The second will be 20 Gy in two fractions given 1 week apart followed 2 weeks later by 36 Gy in 12 fractions given five times per week (virtual high-dose rate boost (HDRB)). The primary efficacy outcome will be biochemical clinical control at 5 years. Secondary endpoints for the initial portion of NINJA look at the transition of centres towards MRI only planning and the impact of KBP on real-time (RT) plan assessment. The first 150 men will demonstrate accrual feasibility as well as addressing the KBP and MRI planning aims, prior to proceeding with total accrual to 472 patients as a phase III randomised controlled trial.Ethics and dissemination NINJA is a multicentre cooperative clinical trial comparing two SBRT regimens for men with PC. It builds on promising results from several single-armed studies, and explores radiation dose escalation in the Virtual HDRB arm. The initial component includes novel technical elements, and will form an important platform set for a definitive phase III study.Trial registration number ANZCTN 12615000223538.https://bmjopen.bmj.com/content/9/8/e030731.full |
| spellingShingle | Colin I Tang Christopher Oldmeadow Jeremy Millar Jarad Martin Paul Keall Shankar Siva Peter Greer David Christie Kevin Moore Jason Dowling David Pryor Peter Chong Nicholas McLeod Avi Raman James Lynam Joanne Smart Declan G Murphy Keen Hun Tai Lois Holloway Penny Reeves Amy Hayden Tee Lim Tanya Holt Mark Sidhom TROG 18.01 phase III randomised clinical trial of the Novel Integration of New prostate radiation schedules with adJuvant Androgen deprivation: NINJA study protocol BMJ Open |
| title | TROG 18.01 phase III randomised clinical trial of the Novel Integration of New prostate radiation schedules with adJuvant Androgen deprivation: NINJA study protocol |
| title_full | TROG 18.01 phase III randomised clinical trial of the Novel Integration of New prostate radiation schedules with adJuvant Androgen deprivation: NINJA study protocol |
| title_fullStr | TROG 18.01 phase III randomised clinical trial of the Novel Integration of New prostate radiation schedules with adJuvant Androgen deprivation: NINJA study protocol |
| title_full_unstemmed | TROG 18.01 phase III randomised clinical trial of the Novel Integration of New prostate radiation schedules with adJuvant Androgen deprivation: NINJA study protocol |
| title_short | TROG 18.01 phase III randomised clinical trial of the Novel Integration of New prostate radiation schedules with adJuvant Androgen deprivation: NINJA study protocol |
| title_sort | trog 18 01 phase iii randomised clinical trial of the novel integration of new prostate radiation schedules with adjuvant androgen deprivation ninja study protocol |
| url | https://bmjopen.bmj.com/content/9/8/e030731.full |
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