ANZCTR - Registration

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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 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]

CMNDRO-1601

Universal Trial Number (UTN)

Trial acronym

HIPSTER

Linked study record

Health condition

Health condition(s) or problem(s) studied:

Prostate Cancer

Condition category

Condition code

Cancer

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]

Treatment: Devices

Intervention code [2]

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]

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]

Assessed once all participants have been recruited and had radiation treatment planning completed.

Secondary outcome [1]

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]

Assessed once all participants have been recruited and had radiation treatment planning completed.

Secondary outcome [2]

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]

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?

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

Accrual to date

Final

Recruitment in Australia

Recruitment state(s)

NSW

Recruitment hospital [1]

Calvary Mater Newcastle - Waratah

Recruitment hospital [2]

Liverpool Hospital - Liverpool

Recruitment postcode(s) [1]

2298 - Waratah

Recruitment postcode(s) [2]

2170 - Liverpool

Funding & Sponsors

Funding source category [1]

Hospital

Name [1]

Calvary Mater Newcastle - Research Grant

Address [1]

Edith St Waratah, NSW, 2298

Country [1]

Australia

Primary sponsor type

Hospital

Name

Calvary Mater Newcastle

Address

Edith St Waratah, NSW, 2298

Country

Australia

Secondary sponsor category [1]

None

Name [1]

Address [1]

Country [1]

Other collaborator category [1]

Government body

Name [1]

CSIRO

Address [1]

LVL 5 UQ HEALTH SCIENCES BUILDING 901/16
Royal Brisbane And Women's Hospital
Butterfield St
Herston, QLD, 4029

Country [1]

Australia

Ethics approval

Ethics application status

Approved

Ethics committee name [1]

Hunter New England Human Research Ethics Committee

Ethics committee address [1]

Research Ethics and Governance Office
District Headquarters, Administration Building
Lookout Road,
New Lambton NSW 2305

Ethics committee country [1]

Australia

Date submitted for ethics approval [1]

29/06/2016

Approval date [1]

25/10/2016

Ethics approval number [1]

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

Prof Peter Greer

Address

Radiation Oncology
Calvary Mater Newcastle
Edith St, Waratah, NSW, 2298

Country

Australia

Phone

+61 2 4014 3689

Fax

peter.greer@calvarymater.org.au

Contact person for public queries

Name

Sarah Gallagher

Address

Radiation Oncology
Calvary Mater Newcastle
Edith St, Waratah, NSW, 2298

Country

Australia

Phone

+61 2 4014 3949

Fax

sarah.gallagher@calvarymater.org.au

Contact person for scientific queries

Name

Peter Greer

Address

Radiation Oncology
Calvary Mater Newcastle
Edith St, Waratah, NSW, 2298

Country

Australia

Phone

+61 2 4014 3689

Fax

peter.greer@calvarymater.org.au

Data sharing statement

Will individual participant data (IPD) for this trial be available (including data dictionaries)?

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

No documents have been uploaded by study researchers.

Documents added automatically

Source	Title	Year of Publication	DOI
Embase	A multi-center prospective study for implementation of an MRI-only prostate treatment planning workflow.	2019	https://dx.doi.org/10.3389/fonc.2019.00826

N.B. These documents automatically identified may not have been verified by the study sponsor.

Trial Review

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Documents added manually

Documents added automatically