Evidence map›Paper›PMID 31434782›Full record

ArticleBMJ open2019

TROG 18.01 phase III randomised clinical trial of the Novel Integration of New prostate radiation schedules with adJuvant Androgen deprivation: NINJA study protocol.

Jarad Martin, Paul Keall, Shankar Siva, Peter Greer, David Christie, Kevin Moore, Jason Dowling, David Pryor, Peter Chong, Nicholas McLeod and 14 more

Registry-linked trialOpen access · goldAbstract readClinical Trial Protocol
In one paragraph

Article in BMJ open, 2019. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT07426055 (PRO-BOOST-LC), which is not on this map. Cited by 19 papers.

0numbers the graph read from it
0cells of the map it votes in
19citing papers in PubMed
2.4field-weighted citation impact, top 10% of its field
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

NCT07426055 phase2 / phase3recruitingnot on this mapstarted 2026, after this paper: background citation

PRO-BOOST-LC: A Prospective, Multi-arm Phase II/III Clinical Trial Evaluating the Efficacy and Safety of Whole-Gland Boost Using HDR Brachytherapy, LDR Brachytherapy, or Single-Fraction SBRT Following an Ultrahypofractionated EBRT (VMAT) Backbone (5 Gy x 5 Fractions) Compared to Standard SBRT Monotherapy in Patients With Localized and Locally Advanced Prostate Cancer Staged With PSMA PET/CT

TypeinterventionalSponsorAffidea Nu-med Center of Oncological DIagnostics and TherapyRan2026 to 2035Enrolled1,000ConditionsProstate Cancer (Adenocarcinoma), Prostate Brachytherapy, Stereotactic Body Radiation Therapy (SBRT), Dose Escalation: Solid TumorsArmsStereotactic Body Radiotherapy (SBRT) Monotherapy, External Beam Radiotherapy (EBRT) Backbone, High-Dose-Rate Brachytherapy Boost, Low-Dose-Rate Brachytherapy Boost, Stereotactic Body Radiotherapy (SBRT) Boost
3 · Its place in the literature

Who cites it

19 citing papers in PubMed, 30 citations in OpenAlex.

  1. Trial
  2. Article
  3. Article
  4. Article
  5. Article
  6. Interobserver variability in dominant intraprostatic lesion delineation usingReports of practical oncology and radiotherapy : journal of Greatpoland Cancer Center in Poznan and Polish Society of Radiation Oncology · 2026
    Article
  7. Continuing Professional Development - Radiation Therapy.Journal of medical radiation sciences · 2025
    Article
  8. Article
  9. Article
  10. Article
  11. Article
  12. Article
  13. Review
  14. Article
  15. Article
  16. Visualising the urethra for prostate radiotherapy planning.Journal of medical radiation sciences · 2021
    Article
  17. Article
  18. Article
  19. Article
4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

24 authors at 14 institutions in 2 countries.

Jarad MartinDepartment of Radiation Oncology, Calvary Mater Newcastle, Newcastle, New South Wales, Australia jarad.martin@calvarymater.org.au.ORCID 0000-0002-4929-0278
Paul KeallRadiation Physics Laboratory, University of Sydney, Sydney, New South Wales, Australia.
Shankar SivaSir Peter MacCallum Department of Oncology, University of Melbourne, Melbourne, Victoria, Australia.
Peter GreerDepartment of Radiation Oncology, Calvary Mater Newcastle, Newcastle, New South Wales, Australia.
David ChristieGenesis Care, Southport, Queensland, Australia.ORCID 0000-0001-5494-8751
Kevin MooreDepartment of Medical Physics, University of California San Diego, La Jolla, California, USA.
Jason DowlingThe Australian e-Health Research Centre, CSIRO, Canberra, Australian Capital Territory, Australia.
David PryorDepartment of Radiation Oncology, Princess Alexandra Hospital Health Service District, Woolloongabba, Queensland, Australia.
Peter ChongDepartment of Urology, John Hunter Hospital, New Lambton Heights, New South Wales, Australia.ORCID 0000-0002-1586-3330
Nicholas McLeodDepartment of Urology, John Hunter Hospital, New Lambton Heights, New South Wales, Australia.
Avi RamanDepartment of Urology, John Hunter Hospital, New Lambton Heights, New South Wales, Australia.
James LynamSchool of Medicine and Public Health, University of Newcastle, Callaghan, New South Wales, Australia.
Joanne SmartDepartment of Radiation Oncology, Calvary Mater Newcastle, Newcastle, New South Wales, Australia.
Christopher OldmeadowHunter Medical Research Institute, Newcastle, New South Wales, Australia.
Colin I TangDepartment of Radiation Oncology, Sir Charles Gairdner Hospital, Perth, Western Australia, Australia.
Declan G MurphyUrological Service Team, Peter MacCallum Cancer Centre, Melbourne, Victoria, Australia.
Jeremy MillarDepartment of Radiation Oncology, Alfred Health, Melbourne, Victoria, Australia.
Keen Hun TaiSir Peter MacCallum Department of Oncology, University of Melbourne, Melbourne, Victoria, Australia.
Lois HollowayDepartment of Radiation Oncology, Liverpool Hospital, Liverpool, New South Wales, Australia.
Penny ReevesSchool of Medicine and Public Health, University of Newcastle, Callaghan, New South Wales, Australia.
Amy HaydenDepartment of Radiation Oncology, Westmead Hospital, Westmead, New South Wales, Australia.
Tee LimGenesis Care, Perth, Western Australia, Australia.
Tanya HoltRadiation Oncology Princess Alexandra Raymond Terrace, Brisbane, Queensland, Australia.
Mark SidhomDepartment of Radiation Oncology, Liverpool Hospital, Liverpool, New South Wales, Australia.
Calvary Mater Newcastle Hospital · AUJohn Hunter Hospital · AUHunter Medical Research Institute · AULiverpool Hospital · AUPrincess Alexandra Hospital · AUThe University of Melbourne · AUAlfred Health · AUCommonwealth Scientific and Industrial Research Organisation · AUPeter MacCallum Cancer Centre · AUSir Charles Gairdner Hospital · AUThe University of Sydney · AUUniversity of California San Diego Medical Center · USUniversity of Newcastle Australia · AUWestmead Hospital · AU

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

introductionStereotactic 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 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.

Indexed as

Androgen AntagonistsChemotherapy, AdjuvantClinical Trials, Phase III as TopicCombined Modality TherapyHumansMaleNeoplasm StagingProstatic NeoplasmsRadiosurgeryAndrogen Antagonistscomputer-assisted radiotherapy planningimage-guided radiotherapyintensity modulated radiotherapyprostatic neoplasmsradiotherapyradiotherapy dose hypofractionationstereotactic body radiotherapy

Identifiers

PMID31434782
PMCPMC6707760
OpenAlexW2969857583

What OpenQuestion holds

Textmetadata
LicenceCC BY-NC
Read underepoch 390

Registered trials

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.