Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12621001118897
Ethics application status
Approved
Date submitted
22/07/2021
Date registered
23/08/2021
Date last updated
26/07/2022
Date data sharing statement initially provided
23/08/2021
Type of registration
Prospectively registered

Titles & IDs
Public title
A non-randomised study investigating the use of multiparametric magnetic resonance imaging (mpMRI) to develop imaging biomarkers that will be used to predict treatment response following radiotherapy for prostate cancer.
Scientific title
Development of multiparametric MRI biomarkers for accurate and informative assessment of treatment outcome following prostate radiotherapy. The Auckland BiRT “Sequential Imaging” project (SI-BiRT).
Secondary ID [1] 304810 0
None
Universal Trial Number (UTN)
U1111-1268-2173
Trial acronym
SI-BiRT
Linked study record
ACTRN12618001810202 is a parent study for this trial.

Health condition
Health condition(s) or problem(s) studied:
Prostate Cancer 322953 0
Condition category
Condition code
Cancer 320526 320526 0 0
Prostate

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
This study collects imaging data in the form of multiparametric magnetic resonance imaging (mpMRI) prior to initiation of radiotherapy and at two time points post radiotherapy. Prostate specific antigen (PSA) blood tests represent the standard measure of treatment response and will be collected at each time point in addition to non-standard blood tests corresponding to collection of imaging data in participants undergoing standard radiotherapy for prostate
cancer treatment.

The interventions involved in this study are as follows;
mpMRI - three additional MRI scans with contrast above what is normal standard of care. The MRI scans will involve the use of the contrast agent Gadovist (dosage given per patient weight will be 0.1 mL/kg, equating to 0.1 mmol/kg) administered intravenously by the treating doctor. The mpMRI scan will be performed by a suitably qualified allied health professional. Scans will be performed at time of radiotherapy planning, and then 6 and 12 months post radiotherapy treatment. Full Blood Count (FBC) and Testosterone will be obtained at three timepoints (prior to radiotherapy planning, and then 6 and 12 months post radiotherapy treatment) which are not standard blood tests for this group of patients. Measurement of Testosterone is also not standard in patents who are not receiving androgen deprivation therapy (ADT). Measures of oxygen level in prostate biopsy tissue collected during standard of care biopsy procedures before treatment will be assessed using immunohistochemistry and will be compared with the mpMRI and blood tests. These immunohistochemistry analyses are not standard of care. Adherence to the study protocol will be recorded in case report forms.
Intervention code [1] 321240 0
Diagnosis / Prognosis
Comparator / control treatment
No control group - all patients will receive the same investigations.
Control group
Uncontrolled

Outcomes
Primary outcome [1] 328352 0
Response to radiotherapy as assessed by mpMRI
Timepoint [1] 328352 0
Prior to radiotherapy treatment, 6 and 12 months post radiotherapy treatment
Secondary outcome [1] 398689 0
PSA blood test results, relative to baseline, following radiotherapy
Timepoint [1] 398689 0
Prior to radiotherapy treatment, 6 and 12 months post radiotherapy treatment
Secondary outcome [2] 398690 0
Full Blood Count blood test results, relative to baseline, following radiotherapy
Timepoint [2] 398690 0
Prior to radiotherapy treatment, 6 and 12 months post radiotherapy treatment
Secondary outcome [3] 398691 0
Testosterone concentration blood test results, relative to baseline, following radiotherapy
Timepoint [3] 398691 0
Prior to radiotherapy treatment, 6 and 12 months post radiotherapy treatment
Secondary outcome [4] 398692 0
Response to radiotherapy as assessed by by blood test results
Timepoint [4] 398692 0
Prior to radiotherapy treatment, 6 and 12 months post radiotherapy treatment
Secondary outcome [5] 398693 0
mpMRI signals relative to baseline, following radiotherapy
Timepoint [5] 398693 0
Prior to radiotherapy treatment, 6 and 12 months post radiotherapy treatment
Secondary outcome [6] 399495 0
Features in mpMRI signals relative to baseline, following radiotherapy
Timepoint [6] 399495 0
Prior to radiotherapy treatment, 6 and 12 months post radiotherapy treatment

Eligibility
Key inclusion criteria
Signed, written and informed consent
Biopsy proven localised prostate cancer
>= 18 years of age
Willing and able to comply with all study requirements
Completed MRI safety screening and contrast agent safety screening
Minimum age
18 Years
Maximum age
No limit
Sex
Males
Can healthy volunteers participate?
No
Key exclusion criteria
Mentally impaired participants or participants for who obtaining informed consent would be difficult
Unable to undergo an MRI examination or has contraindications to MRI
Inadequate renal function for contrast administration (eGFR threshold according to protocol) at baseline imaging
Participants who are unable or unwilling to remain still in MRI for up to 60 minutes
Prior pelvic radiotherapy
Any prosthetic implants such as metallic hip prostheses that may cause artefacts in the imaging studies
Prescribed ADT

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
Efficacy
Statistical methods / analysis
This feasibility study is recruiting 10 participants who will all receive a radical course of radiotherapy as part of their primary treatment. There is no randomisation. No statistical justification of participant numbers has been undertaken.

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
17/08/2022
Actual
Date of last participant enrolment
Anticipated
31/12/2022
Actual
Date of last data collection
Anticipated
31/12/2023
Actual
Sample size
Target
10
Accrual to date
Final
Recruitment outside Australia
Country [1] 24001 0
New Zealand
State/province [1] 24001 0
Auckland

Funding & Sponsors
Funding source category [1] 309179 0
Government body
Name [1] 309179 0
Health Research Council of New Zealand
Country [1] 309179 0
New Zealand
Primary sponsor type
University
Name
The University of Auckland
Address
Auckland 1010
Country
New Zealand
Secondary sponsor category [1] 310193 0
None
Name [1] 310193 0
Address [1] 310193 0
Country [1] 310193 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 309038 0
Northern B Health and Disability Ethics Committee
Ethics committee address [1] 309038 0
Ethics committee country [1] 309038 0
New Zealand
Date submitted for ethics approval [1] 309038 0
16/06/2021
Approval date [1] 309038 0
30/09/2021
Ethics approval number [1] 309038 0
21/NTB/163

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 112742 0
Dr Hayley Reynolds
Address 112742 0
Auckland Bioengineering Institute
Level 7, 70 Symonds Street
Grafton
Auckland 1010
Country 112742 0
New Zealand
Phone 112742 0
+64225161584
Fax 112742 0
Email 112742 0
[email protected]
Contact person for public queries
Name 112743 0
Hayley Reynolds
Address 112743 0
Auckland Bioengineering Institute
Level 7, 70 Symonds Street
Grafton
Auckland 1010
Country 112743 0
New Zealand
Phone 112743 0
+64225161584
Fax 112743 0
Email 112743 0
[email protected]
Contact person for scientific queries
Name 112744 0
Hayley Reynolds
Address 112744 0
Auckland Bioengineering Institute
Level 7, 70 Symonds Street
Grafton
Auckland 1010
Country 112744 0
New Zealand
Phone 112744 0
+64225161584
Fax 112744 0
Email 112744 0
[email protected]

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


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
No additional documents have been identified.