Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12616001653459
Ethics application status
Approved
Date submitted
15/11/2016
Date registered
30/11/2016
Date last updated
14/03/2022
Date data sharing statement initially provided
14/03/2022
Date results information initially provided
14/03/2022
Type of registration
Prospectively registered

Titles & IDs
Public title
A study investigating alternative ways to plan radiotherapy treatment using MRI alone for prostate cancer.
Scientific title
HIgh precision Prostate Substitute CT External beam Radiotherapy - HIPSTER
Secondary ID [1] 290490 0
CMNDRO-1601
Universal Trial Number (UTN)
Trial acronym
HIPSTER
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Prostate Cancer 300875 0
Condition category
Condition code
Cancer 300696 300696 0 0
Prostate

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
1) Additional T2 weighted MRI sequence added to patients routine MRI scanning session. This is performed once during radiation treatment planning. It will add approximately 6 minutes to the total scanning time. MRI's will be performed at Calvary Mater Newcastle. 2) Technical modification of radiation treatment planning workflow. This intervention will be provided by Clinicians, Physicists and Radiation Therapists who collaborate to plan radiation treatment for prostate cancer patients. The main differences in workflow will be:
A substitute CT scan will be generated, A substitute CT scan is an artificially created CT scan produced from the MRI scan data.
QA procedures will be used to confirm that the substitute CT scan dose calculation is accurate,
A comparison of the substitute CT scan dose calculation with the conventional CT scan dose calculation,
A comparison of marker locations on substitute CT and conventional CT scans for treatment guidance.
Intervention code [1] 296347 0
Treatment: Devices
Intervention code [2] 296349 0
Treatment: Other
Comparator / control treatment
Only one treatment group and all patients will received the same treatment. There is an inbuilt comparator for this study whereby patients will act as their own control. All patients will have a standard of care treatment plan generated from the conventional CT scan. This plan will be compared to the plan generated from the substitute CT scan. If the substitute CT scan dose calculation and marker locations are not shown to be equivalent to the conventional CT scan from the quantitative comparisons performed then the patient will be treated with the routine treatment planning workflow and the standard of care plan generated from the conventional CT scan.
Control group
Active

Outcomes
Primary outcome [1] 300115 0
The outcomes of this study are technical in nature, they are not clinical patient outcomes.
Primary Outcome: Percentage of study patients that substitute CT calculated plan was used clinically. This will be assessed by review of electronic trial treatment data collected during the treatment planning process.
Timepoint [1] 300115 0
Assessed once all participants have been recruited and had radiation treatment planning completed.
Secondary outcome [1] 329095 0
Comparison of dose calculation on substitute CT scan compared to CT scan. This outcome will be assessed by technical review of electronic data collected during the treatment planning process.
Timepoint [1] 329095 0
Assessed once all participants have been recruited and had radiation treatment planning completed.
Secondary outcome [2] 329096 0
Comparison of gold marker locations from substitute CT scans compared to marker locations from conventional CT scans. This outcome will be assessed by technical review of electronic data collected during the treatment planning process.
Timepoint [2] 329096 0
Assessed once all participants have been recruited and had radiation treatment planning completed.

Eligibility
Key inclusion criteria
Men diagnosed with prostate cancer deemed suitable for radiation treatment
Minimum age
18 Years
Maximum age
No limit
Sex
Males
Can healthy volunteers participate?
No
Key exclusion criteria
Unsuitable for radiotherapy including inability to have MRI scans or gold markers inserted, previous pelvic radiotherapy, 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
Who is / are masked / blinded?



Intervention assignment
Other design features
Phase
Not Applicable
Type of endpoint/s
Statistical methods / analysis
No statistical analysis proposed for this study. Feasibility of implementation of MRI-alone planning will be demonstrated if more than 90% of substitute CT patient plans are accepted for treatment.

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
1/12/2016
Actual
20/04/2017
Date of last participant enrolment
Anticipated
1/12/2018
Actual
27/03/2019
Date of last data collection
Anticipated
30/06/2019
Actual
27/03/2019
Sample size
Target
25
Accrual to date
Final
30
Recruitment in Australia
Recruitment state(s)
NSW
Recruitment hospital [1] 6904 0
Calvary Mater Newcastle - Waratah
Recruitment hospital [2] 6905 0
Liverpool Hospital - Liverpool
Recruitment postcode(s) [1] 14573 0
2170 - Liverpool
Recruitment postcode(s) [2] 14572 0
2298 - Waratah

Funding & Sponsors
Funding source category [1] 294916 0
Hospital
Name [1] 294916 0
Calvary Mater Newcastle - Research Grant
Country [1] 294916 0
Australia
Primary sponsor type
Hospital
Name
Calvary Mater Newcastle
Address
Edith St Waratah, NSW, 2298
Country
Australia
Secondary sponsor category [1] 293749 0
None
Name [1] 293749 0
Address [1] 293749 0
Country [1] 293749 0
Other collaborator category [1] 279299 0
Government body
Name [1] 279299 0
CSIRO
Address [1] 279299 0
LVL 5 UQ HEALTH SCIENCES BUILDING 901/16
Royal Brisbane And Women's Hospital
Butterfield St
Herston, QLD, 4029
Country [1] 279299 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 296293 0
Hunter New England Human Research Ethics Committee
Ethics committee address [1] 296293 0
Research Ethics and Governance Office
District Headquarters, Administration Building
Lookout Road,
New Lambton NSW 2305
Ethics committee country [1] 296293 0
Australia
Date submitted for ethics approval [1] 296293 0
29/06/2016
Approval date [1] 296293 0
25/10/2016
Ethics approval number [1] 296293 0
HREC/16/HNE/298

Summary
Brief summary
The primary purpose of this trial is to evaluate whether treatment planning for prostate cancer radiotherapy can be completed using only MRI scans, in place of the standard care which involves both MRI and CT scans.

Who is it for?
You may be eligible to participate in this study if you are aged over 18 years and have been diagnosed with prostate cancer for which you are scheduled to undergo radiotherapy treatment.

Study details
All participants enrolled in this trial will have the standard care CT scan and MRI scan performed as part of their radiotherapy treatment planning, with an extra type of MRI scan added on to the existing MRI. This will add approximately six minutes to the duration of the MRI scan. A team of doctors, physicists and radiation therapists will work together to generate two treatment plans (CT plan and MRI plan). If the treatment plans are similar then the new MRI only treatment plan will be used for treatment. If the two treatment plans differ then the standard care CT and MRI plan will be used for treatment.

Researchers will keep track of the number of times that the new MRI only treatment plan is used, the doses calculated and the locations of any gold markers used.

It is hoped that the findings of this trial will provide information on whether radiotherapy treatment planning for prostate cancer can be completed using only MRI scans, without the need for CT scans. This would reduce the time and cost required for radiotherapy treatment planning in these patients.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 70278 0
Prof Peter Greer
Address 70278 0
Radiation Oncology
Calvary Mater Newcastle
Edith St, Waratah, NSW, 2298
Country 70278 0
Australia
Phone 70278 0
+61 2 4014 3689
Fax 70278 0
Email 70278 0
peter.greer@calvarymater.org.au
Contact person for public queries
Name 70279 0
Ms Sarah Gallagher
Address 70279 0
Radiation Oncology
Calvary Mater Newcastle
Edith St, Waratah, NSW, 2298
Country 70279 0
Australia
Phone 70279 0
+61 2 4014 3949
Fax 70279 0
Email 70279 0
sarah.gallagher@calvarymater.org.au
Contact person for scientific queries
Name 70280 0
Prof Peter Greer
Address 70280 0
Radiation Oncology
Calvary Mater Newcastle
Edith St, Waratah, NSW, 2298
Country 70280 0
Australia
Phone 70280 0
+61 2 4014 3689
Fax 70280 0
Email 70280 0
peter.greer@calvarymater.org.au

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually

Documents added automatically
SourceTitleYear of PublicationDOI
EmbaseA multi-center prospective study for implementation of an MRI-only prostate treatment planning workflow.2019https://dx.doi.org/10.3389/fonc.2019.00826
N.B. These documents automatically identified may not have been verified by the study sponsor.