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Trial registered on ANZCTR
Registration number
ACTRN12618001806257
Ethics application status
Approved
Date submitted
2/11/2018
Date registered
6/11/2018
Date last updated
24/03/2024
Date data sharing statement initially provided
6/11/2018
Type of registration
Prospectively registered
Titles & IDs
Public title
The NINJA Clinical Trial: Novel Integration of New prostate radiation schedules with adJuvant Androgen deprivation for patients with intermediate or low-high risk prostate cancer.
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Scientific title
The NINJA Clinical Trial: Novel Integration of New prostate radiation schedules with adJuvant Androgen deprivation
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Secondary ID [1]
295490
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TROG 18.01
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Universal Trial Number (UTN)
U111-1217-1305
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Trial acronym
NINJA
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Prostate Cancer
308759
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Condition category
Condition code
Cancer
307690
307690
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0
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Prostate
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Intervention/exposure
Study type
Interventional
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Description of intervention(s) / exposure
ARM 1: Stereotactic Body Radiotherapy (SBRT) Monotherapy: 40Gy in 5 fractions delivered 1-3x/week (typically 5 treatments given over 2 weeks)
ARM2: Virtual High Dose Rate Brachytherapy (HDRB) Boost: 20gy in 2 fractions delivered once a week followed by a 2 week break and then 36Gy in 12 fractions delivered 4-5x/week. (2 treatments given 1 week apart, combined with a shorter version of conventional external beam radiotherapy)
All participants irrespective of the radiotherapy treatment arm they are allocated will commence 6 months of androgen deprivation therapy (ADT) prior to receiving radiotherapy (approximately 3 to 4 months prior). ADT is given via injection and is considered part of the standard of care for participants eligible for this study. The dose, frequency and administration is dependent on that prescribed by the clinician.
This study will also look at better ways in which we can plan radiotherapy treatment for men with prostate cancer using Magnetic Resonance Imaging (MRI scans) for radiotherapy planning.
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Intervention code [1]
301811
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Treatment: Other
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Comparator / control treatment
The comparator/control treatment for this study is the SBRT monotherapy (Arm 1). The aim is to demonstrate that virtual HDRB boost is superior to SBRT monotherapy.
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Control group
Active
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Outcomes
Primary outcome [1]
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Rate of Biochemical Clinical Control (BCC). Prostate cancer biochemical control measured by Phoenix definition of nadir + 2ng/mL (blood PSA measurement) and/or detection of metastases (imaging or other) or initiation of salvage intervention (further treatment) by the 5 year time point
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Assessment method [1]
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Timepoint [1]
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Assessed 6 wks post SBRT and then 6 monthly up to 5 years
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Secondary outcome [1]
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Rate of replanning following Knowledge Based Planning (KBP) feedback to trial centres. Rate of replanning prior to radiotherapy treatment performed by trial centres following KBP comparison against initial plan. In KBP, a model is developed using a range of patient anatomies and target volumes. This can then be rapidly applied to a new case to either generate a plan de novo, or compare with a conventional plan.
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Assessment method [1]
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Timepoint [1]
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Within 12 months after first 150 participants accrued.
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Secondary outcome [2]
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Rate of trial centre conversion to prostate Magnetic Resonance Imaging (MRI) only planning. The rate of full conversion to MRI based prostate radiotherapy planning (i.e. CT scan no longer required to complete radiotherapy planning). Modern RT planning uses electron density from a CT dataset to calculate dose. Many centres now acquire both a CT and a MRI.
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Assessment method [2]
353550
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Timepoint [2]
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Within 12 months after first 150 participants accrued
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Eligibility
Key inclusion criteria
Unfavourable intermediate or low-high risk prostate cancer
- ISUP 2 AND EITHER PSA 10-20, OR T2b/c AND greater than or equal to 50% Biopsy Cores Positive
- ISUP 3 AND PSA less than or equal to 20 OR
- ISUP 4-5 (NOT predominant pattern 5 disease) OR T3a AND PSA less than and equal to 20
Staging investigations showing N0M0 disease performed within 60 days prior to commencing ADT or antiandrogen:
- For high risk patients, PSMA PET staging within 60 days prior to study entry showing N0M0 disease.
- For unfavourable intermediate risk patients, either PSMA PET alone OR whole body bone scan AND EITHER CT abdomen/pelvis OR MRI prostate/pelvis.
Histologically confirmed prostate cancer
ECOG performance status of 0-1.
Life expectancy greater than 5 years.
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Minimum age
18
Years
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Maximum age
No limit
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Sex
Males
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Can healthy volunteers participate?
No
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Key exclusion criteria
Higher risk prostate cancer:
- T3b or T4 based on all clinical information available including examination and investigations
- PSA greater than 20
- Dominant pattern 5 histology (ie Gleason score 5+4 or 5+5)
Previous pelvic radiotherapy
Prior diagnosis of cancer that was:
- more than 5 years prior to current diagnosis with subsequent evidence of disease recurrence or clinical expectation of recurrence is greater than 10%
- within 5 years of current diagnosis with the exception of successfully treated basal cell or squamous cell skin carcinoma or carcinoma in situ of the cervix
Patients with clinical evidence of metastatic disease.
Presence of total hip joint replacement
Clinical Target volume greater than 100cc
Severe obstructive lower urinary tract symptoms (IPSS greater than an equal to 20)
Any contraindications to performance of a planning MRI
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Study design
Purpose of the study
Treatment
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Allocation to intervention
Randomised controlled trial
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Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Central randomisation by computer. The Trial Coordinating Centre is responsible for randomising the participant through the randomisation program, and informing the site of the randomisation number and the treatment allocation for the participant randomised in real time. The Trial Coordinator at the participating centre then gives the information about treatment allocation to the trial participant, and treating clinical team. The assignment schedule is unpredictable and those enrolling and assigning participants will not obtain access to the randomisation method. Once a patient is registered on the trial, registration will not be cancelled. The randomization sequence will be hidden in a password protected manner from the staff involved in the trial enrolment process.
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Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Randomisation will be on a 1:1 ratio between the two arms of SBRT Monotherapy (initially experimental arm one, aiming to transition to the standard arm assuming non-inferiority of this approach demonstrated compared with more conventional regimens in randomized control trials) and ‘Virtual HDR Boost’ radiotherapy (initially experimental arm two, transitioning to the sole experimental arm). This is an unblinded study.
Randomisation is via a computer generated sequence, with stratification by risk category (unfavourable intermediate and high) and centre. A validated randomization method will be used via https://www.sealedenvelope.com/.
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Masking / blinding
Open (masking not used)
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Who is / are masked / blinded?
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Intervention assignment
Parallel
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Other design features
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Phase
Not Applicable
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Type of endpoint/s
Efficacy
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Statistical methods / analysis
The statistical justification required to achieve the primary efficacy endpoint follows. Using a similar endpoint as well as a short course of ADT, the CHHiP study 60 Gy arm had 90.2% and 84.2% BCC for intermediate and high risk patients respectively at the 5 year time point. The ASCENDE-RT study also included intermediate and high risk men, managed with 12 months of ADT, and the experimental arm delivered 46 Gy in 23 fractions of EBRT alongside a Brachytherapy boost, a regimen attempting to be emulated in the current study. At 5 years, the BCC was 89%, although with a higher risk patient mix than we are going to accrue on this protocol. Allowing for differences in inter-trial comparisons, it would appear reasonable to expect BCC 86% in the standard SBRT arm. Similar data has been reported for single arm SBRT monotherapy series. For a superiority RCT design, we will aim for a hazard ratio of 0.5 in 5-yr BCC for the virtual HDR arm ie 93%. An HR of 0.5 is chosen because this translates to an absolute improvement of 7%, and any improvements less than this are unlikely to be clinically significant for this particular surrogate endpoint. With alpha 0.05, power of 80%, and drop out of 2% the required phase 3 sample size is 472 men.
For KBP, we hypothesize that a replanning rate of greater than 15% would be clinically significant. Assuming an error rate of plus or minus 6%, at an alpha of 5% with power of 80%, 136 participants are required. Allow 10% drop-out due to technical issues with a new planning paradigm: total of 150 cases.
For MRI planning, having greater than an equal to 50% of centres involved in this aspect of NINJA completely transition to MRI only planning will be deemed a success.
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Recruitment
Recruitment status
Recruiting
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Date of first participant enrolment
Anticipated
10/12/2018
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Actual
29/03/2019
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Date of last participant enrolment
Anticipated
16/01/2025
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Actual
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Date of last data collection
Anticipated
16/01/2030
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Actual
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Sample size
Target
472
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Accrual to date
298
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Final
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Recruitment in Australia
Recruitment state(s)
NSW,QLD
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Recruitment hospital [1]
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Liverpool Hospital - Liverpool
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Recruitment hospital [2]
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Calvary Mater Newcastle - Waratah
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Recruitment hospital [3]
12350
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Princess Alexandra Hospital - Woolloongabba
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Recruitment hospital [4]
12351
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Blacktown Hospital - Blacktown
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Recruitment hospital [5]
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Westmead Hospital - Westmead
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Recruitment hospital [6]
12353
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Campbelltown Hospital - Campbelltown
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Recruitment hospital [7]
26312
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The Canberra Hospital - Garran
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Recruitment hospital [8]
26313
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Royal Brisbane & Womens Hospital - Herston
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Recruitment hospital [9]
26314
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Austin Health - Austin Hospital - Heidelberg
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Recruitment hospital [10]
26315
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Genesis Cancer Care - Gateshead
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Recruitment hospital [11]
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GenesisCare - Hurstville - Hurstville
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Recruitment hospital [12]
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The Royal Adelaide Hospital - Adelaide
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Recruitment hospital [13]
26318
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Sir Charles Gairdner Hospital - Nedlands
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Recruitment hospital [14]
26319
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Wollongong Hospital - Wollongong
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Recruitment postcode(s) [1]
24593
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2145 - Westmead
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Recruitment postcode(s) [2]
24592
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2148 - Blacktown
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Recruitment postcode(s) [3]
24589
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2170 - Liverpool
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Recruitment postcode(s) [4]
42288
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2220 - Hurstville
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Recruitment postcode(s) [5]
42287
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2290 - Gateshead
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Recruitment postcode(s) [6]
24590
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2298 - Waratah
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Recruitment postcode(s) [7]
42293
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2323 - East Maitland
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Recruitment postcode(s) [8]
42292
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2500 - Wollongong
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Recruitment postcode(s) [9]
24594
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2560 - Campbelltown
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Recruitment postcode(s) [10]
42284
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2605 - Garran
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Recruitment postcode(s) [11]
42286
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3084 - Heidelberg
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Recruitment postcode(s) [12]
42285
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4029 - Herston
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Recruitment postcode(s) [13]
24591
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4102 - Woolloongabba
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Recruitment postcode(s) [14]
42289
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5000 - Adelaide
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Recruitment postcode(s) [15]
42290
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6009 - Nedlands
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Recruitment postcode(s) [16]
42291
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6010 - Claremont
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Funding & Sponsors
Funding source category [1]
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Commercial sector/Industry
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Name [1]
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Mundipharma Pty Limited
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Address [1]
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Level 24, 88 Phillip Street, Sydney NSW 2000
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Country [1]
300077
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Australia
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Primary sponsor type
Other Collaborative groups
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Name
Trans Tasman Radiation Oncology Group (TROG)
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Address
Edith Street Waratah NSW 2289
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Country
Australia
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Secondary sponsor category [1]
299475
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Other Collaborative groups
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Name [1]
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Australian and New Zealand Urogenital and Prostate cancer trials group (ANZUP)
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Address [1]
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Life House L6 119-143 Missenden Road Camperdown NSW 2050
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Country [1]
299475
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Australia
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Ethics approval
Ethics application status
Approved
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Ethics committee name [1]
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South Western Sydney Local Health District Human Research Ethics Committee
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Ethics committee address [1]
300924
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Locked Bag 7103, Liverpool BC, NSW 1871
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Ethics committee country [1]
300924
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Australia
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Date submitted for ethics approval [1]
300924
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28/09/2018
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Approval date [1]
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15/10/2018
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Ethics approval number [1]
300924
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HREC/18/LPOOL/420
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Summary
Brief summary
The NINJA clinical trial aims to compare two emerging schedules of radiotherapy in the treatment of prostate cancer. Who is it for? You may be eligible for this study if you are an adult male over the age of 18 who has been diagnosed with intermediate or high risk prostate cancer . Study details Participants will be randomly assigned to one of two radiotherapy schedules as part of this study. In schedule 1 (called Sterotactic Body Radiotherapy) participants will receive 5 radiotherapy treatments over 2 weeks and in schedule 2 (called Virtual High Dose Rate Boost) participants will receive Sterotactic Body Radiotherapy delivered in 2 treatments over 1 week followed by 12 treatments of conventional external beam radiotherapy over 2 and a half weeks. A blood test will be collected at the initial assessment, 6 weeks after radiotherapy and 6 monthly for a period of 5 years. Questionnaires will completed at the initial assessment, 6 weeks after radiotherapy and at 2 and 5 years. It is hoped that this research will potentially improve the accuracy and quality of radiotherapy treatment in prostate cancer.
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Trial website
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Trial related presentations / publications
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Public notes
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Contacts
Principal investigator
Name
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A/Prof Jarad Martin
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Address
85298
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Radiation Oncology
Calvary Mater Newcastle
Corner Edith and Platt Streets
Waratah NSW 2298
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Country
85298
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Australia
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Phone
85298
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+61 2 4014 3631
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Fax
85298
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+61 2 4014 3169
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Email
85298
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Jarad.Martin@calvarymater.org.au
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Contact person for public queries
Name
85299
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Sarah Gallagher
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Address
85299
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Radiation Oncology
Calvary Mater Newcastle
Corner Edith and Platt Streets
Waratah NSW 2298
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Country
85299
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Australia
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Phone
85299
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+61 2 4014 3949
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Fax
85299
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+61 2 4014 3945
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Email
85299
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ninjatrial@calvarymater.org.au
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Contact person for scientific queries
Name
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Jarad Martin
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Address
85300
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Radiation Oncology
Calvary Mater Newcastle
Corner Edith and Platt Streets
Waratah NSW 2298
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Country
85300
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Australia
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Phone
85300
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+61 2 4014 3631
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Fax
85300
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+61 2 4014 3169
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Email
85300
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Jarad.Martin@calvarymater.org.au
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Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
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No/undecided IPD sharing reason/comment
Unknown at this stage
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What supporting documents are/will be available?
No Supporting Document Provided
Results publications and other study-related documents
Documents added manually
No documents have been uploaded by study researchers.
Documents added automatically
Source
Title
Year of Publication
DOI
Dimensions AI
Prostate Virtual High-dose-rate Brachytherapy Boost: 5-Year Results from the PROMETHEUS Prospective Multicentre Trial
2024
https://doi.org/10.1016/j.euo.2024.01.008
N.B. These documents automatically identified may not have been verified by the study sponsor.
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