TROG 18.01 phase III randomised clinical trial of the Novel Integration of New prostate radiation schedules with adJuvant Androgen deprivation: NINJA study protocol
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
Affiliations
Colin I Tang
6 Department of Radiation Oncology, Sir Charles Gairdner Hospital, Perth, Western Australia, Australia
Christopher Oldmeadow
CREDITSS—Clinical Research Design, Information Technology and Statistical Support Unit, Hunter Medical Research Institute, Newcastle, New South Wales, Australia
Jeremy Millar
8 Radiation Oncology, Alfred Health, Melbourne, Victoria, Australia
Jarad Martin
1 Department of Radiation Oncology, Calvary Mater Newcastle, Newcastle, New South Wales, Australia
Paul Keall
3 Radiation Physics Laboratory, University of Sydney, Sydney, New South Wales, Australia
Shankar Siva
Department of Radiation Oncology, Peter MacCallum Cancer Centre, Parkville, Victoria, Australia
Peter Greer
1 Department of Radiation Oncology, Calvary Mater Newcastle, Newcastle, New South Wales, Australia
David Christie
Genesiscare, Tugun, Queensland, Australia
Kevin Moore
APC Microbiome Ireland, Patient Collaborator Panel, University College Cork, Cork, Ireland
Jason Dowling
8 The Australian e-Health Research Centre, CSIRO, Canberra, Australian Capital Territory, Australia
David Pryor
9 Department of Radiation Oncology, Princess Alexandra Hospital Health Service District, Woolloongabba, Queensland, Australia
Peter Chong
10 Department of Urology, John Hunter Hospital, New Lambton Heights, New South Wales, Australia
Nicholas McLeod
10 Department of Urology, John Hunter Hospital, New Lambton Heights, New South Wales, Australia
Avi Raman
10 Department of Urology, John Hunter Hospital, New Lambton Heights, New South Wales, Australia
James Lynam
2 School of Medicine and Public Health, University of Newcastle, Callaghan, New South Wales, Australia
Joanne Smart
1 Department of Radiation Oncology, Calvary Mater Newcastle, Newcastle, New South Wales, Australia
Declan G Murphy
13 Urological Service Team, Peter MacCallum Cancer Centre, Melbourne, Victoria, Australia
Keen Hun Tai
4 Sir Peter MacCallum Department of Oncology, University of Melbourne, Melbourne, Victoria, Australia
Lois Holloway
15 Department of Radiation Oncology, Liverpool Hospital, Liverpool, New South Wales, Australia
Penny Reeves
Health Research Economics, Hunter Medical Research Institute, New Lambton, New South Wales, Australia
Amy Hayden
17 Department of Radiation Oncology, Westmead Hospital, Westmead, New South Wales, Australia
Tee Lim
18 Genesis Care, Perth, Western Australia, Australia
Tanya Holt
19 Radiation Oncology Princess Alexandra Raymond Terrace, Brisbane, Queensland, Australia
Mark Sidhom
15 Department of Radiation Oncology, Liverpool Hospital, Liverpool, New South Wales, Australia
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.
