Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12618001421224
Ethics application status
Approved
Date submitted
17/08/2018
Date registered
24/08/2018
Date last updated
1/06/2022
Date data sharing statement initially provided
11/02/2021
Date results information initially provided
1/06/2022
Type of registration
Prospectively registered

Titles & IDs
Public title
Improving cancer targeting accuracy in prostate radiotherapy with SeedTracker real-time image guidance system- A Phase I study
Scientific title
Improving cancer targeting accuracy in prostate radiotherapy with SeedTracker real-time image guidance system- A Phase I study
Secondary ID [1] 295475 0
Nil Known
Universal Trial Number (UTN)
Trial acronym
SUPER-I
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Prostate Cancer 308738 0
Condition category
Condition code
Cancer 307675 307675 0 0
Prostate

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
SeedTracker is a real-time position monitoring tool, developed in South Western Sydney Local Health District (SWSLHD), which works in conjunction with the software system in Elekta Linear Accelerators. The majority of prostate cancer patients undergoing radiotherapy have the radiopaque markers implanted in the prostate for pre-treatment position verification. The SeedTracker system monitors the prostate position during the treatment delivery in real-time by detecting the position of the radiopaque markers via monoscopic x-ray images acquired during treatment delivery.
Treating Radiation Therapists will use the SeedTracker in conjunction with the Linear accelerators, with Physics support to monitor the patient during their treatment delivery. This will be delivered daily throughout the prescribed treatment course (20 or 39 days) at the participating hospitals.
This study will assess the use of SeedTracker on patients receiving radiotherapy to the prostate in terms of safety and efficacy impacts to the department and patients through use of surveys and collated treatment delivery times. The study will also quantify prostate motion during treatment and corrections required for position deviations by recording daily data.
The study will analyse collected data to provide insight on any additional workload or resources required for the implementation of real-time position monitoring in conventional prostate radiotherapy and improve radiotherapy treatment delivery accuracy.
Intervention code [1] 301792 0
Treatment: Devices
Comparator / control treatment
No Control Group
Control group
Uncontrolled

Outcomes
Primary outcome [1] 306659 0
Intrafraction prostate motion will be assessed using the 'SeedTracker' log.
Timepoint [1] 306659 0
Assessed during radiotherapy proceedure
Primary outcome [2] 307184 0
The number of position deviations that exceeds the set tolerance criteria will be assessed using the 'SeedTracker' log.
Timepoint [2] 307184 0
Assessed during radiotherapy procedure
Secondary outcome [1] 349169 0
Impact and safety of introducing SeedTracker real-time position monitoring for prostate radiotherapy on departmental resources, scheduling and patient treatment time, will be assessed by the 'SeedTracker - User Evaluation Form' completed by treatment staff. This survey was designed specifically for this study. This is a composite outcome.
Timepoint [1] 349169 0
Assessed weekly during radiotherapy procedures for up to 10 weeks per patient

Eligibility
Key inclusion criteria
1. Prostate cancer patients that receive radiotherapy treatment for prostate with current treatment protocol used within Liverpool and Macarthur cancer therapy centres.
2. Patients implanted with three prostate radio opaque markers
3. Patients receiving definitive radiotherapy to the prostate
Minimum age
18 Years
Maximum age
No limit
Sex
Males
Can healthy volunteers participate?
No
Key exclusion criteria
1. Patients with hip prosthesis

Study design
Purpose of the study
Treatment
Allocation to intervention
Non-randomised trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Single group
Other design features
Phase
Not Applicable
Type of endpoint/s
Safety/efficacy
Statistical methods / analysis
Prostate Motion trajectory: The prostate motion trajectory during the treatment delivery of all the treatment fractions of all patients will be collected and recorded in SeedTracker system. The number and types of position deviations observed will be analysed to study the intrafraction motion patterns and frequency of position deviations in the studied cohorts of patients.
Treatment time: The overall treatment time for each treatment session with the SeedTracker real-time monitoring will be measured from the activity monitor in Mosaiq Record and Verify system. This time will be compared with the retrospective prostate cancer patients’ treatment activity time to quantify the impact of utilising the SeedTracker real-time monitoring system in departments’ human and treatment machine time resources.
Data for technical assessment of the SeedTracker system: Feedback and recommendations from the individual members of the multidisciplinary team from the participating centres will be collected on a weekly basis. Information on the technical and workflow aspects of the real-time position monitoring with SeedTracker system will be collected.

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
24/09/2019
Actual
24/03/2020
Date of last participant enrolment
Anticipated
29/07/2021
Actual
12/04/2021
Date of last data collection
Anticipated
30/09/2021
Actual
7/06/2021
Sample size
Target
30
Accrual to date
Final
30
Recruitment in Australia
Recruitment state(s)
NSW
Recruitment hospital [1] 11393 0
Liverpool Hospital - Liverpool
Recruitment hospital [2] 11394 0
Campbelltown Hospital - Campbelltown
Recruitment postcode(s) [1] 23292 0
2170 - Liverpool
Recruitment postcode(s) [2] 23293 0
2560 - Campbelltown

Funding & Sponsors
Funding source category [1] 300064 0
Hospital
Name [1] 300064 0
In-kind support by Liverpool Cancer Therapy
Country [1] 300064 0
Australia
Funding source category [2] 300493 0
Hospital
Name [2] 300493 0
In-kind support by Macarthur Cancer Therapy
Country [2] 300493 0
Australia
Primary sponsor type
Hospital
Name
Liverpool Hospital Cancer Therapy
Address
Liverpool Hospital
Corner of Liverpool and Goulburn streets
Liverpool
New South Wales 2170, Australia
Country
Australia
Secondary sponsor category [1] 299460 0
None
Name [1] 299460 0
Address [1] 299460 0
Country [1] 299460 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 300910 0
South Western Sydney Local Health District Human Research Ethics Committee
Ethics committee address [1] 300910 0
Corner of Goulburn and Elizabeth St, Liverpool Hospital, NSW, 2170
Ethics committee country [1] 300910 0
Australia
Date submitted for ethics approval [1] 300910 0
06/08/2018
Approval date [1] 300910 0
19/10/2018
Ethics approval number [1] 300910 0

Summary
Brief summary
Radiotherapy treats cancer using high energy x-rays in order to destroy cancer cells including prostate cancer via a linear accelerator machine. A new technology, known as the SUPER-I is a prospective study that will assess the safety and efficacy of using the ‘SeedTracker’ system in prostate radiotherapy in South Western Sydney Local Health District.

Who is it for?

You may be eligible for this study if you are an adult male receiving radiotherapy treatment for prostate cancer within the Liverpool or Macarthur cancer therapy centres.

Study details

All participants in this study will undergo their usual radiotherapy treatment schedule. As part of this study, during the radiotherapy treatment, participants will have radiotherapy markers implanted in the prostate in order to detect the position of the prostate in real-time. All blood tests will be performed as standard care by your specialist.

It is hoped that this study will improve radiotherapy treatment delivery accuracy for those with prostate cancer.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 85246 0
Dr Mark Sidhom
Address 85246 0
Liverpool and Macarthur Cancer Therapy Centres
Corner of Campbell and Goulburn Streets, Liverpool 2170, NSW
Country 85246 0
Australia
Phone 85246 0
+61 2 87389806
Fax 85246 0
Email 85246 0
mark.sidhom@health.nsw.gov.au
Contact person for public queries
Name 85247 0
Ms Penny Phan
Address 85247 0
Liverpool and Macarthur Cancer Therapy Centres
Corner of Campbell and Goulburn Streets, Liverpool 2170, NSW
Country 85247 0
Australia
Phone 85247 0
+61 2 87389148
Fax 85247 0
Email 85247 0
penny.phan@health.nsw.gov.au
Contact person for scientific queries
Name 85248 0
Dr Sankar Arumugam
Address 85248 0
Liverpool and Macarthur Cancer Therapy Centres
Corner of Campbell and Goulburn Streets, Liverpool 2170, NSW
Country 85248 0
Australia
Phone 85248 0
+61 2 87389805
Fax 85248 0
Email 85248 0
sankar.arumugam@health.nsw.gov.au

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment
Data will be analysed to show trends within the cohort


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
SourceTitleYear of PublicationDOI
EmbaseImplementing online position monitoring for prostate radiotherapy using an in-house position monitoring system: User experience and impact on workforce.2023https://dx.doi.org/10.1111/1754-9485.13499
N.B. These documents automatically identified may not have been verified by the study sponsor.