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Trial registered on ANZCTR


Registration number
ACTRN12618001810202
Ethics application status
Approved
Date submitted
14/10/2018
Date registered
6/11/2018
Date last updated
1/08/2019
Date data sharing statement initially provided
6/11/2018
Type of registration
Prospectively registered

Titles & IDs
Public title
A non-randomised study investigating the use and timing of multiparametric magnetic resonance imaging (mpMRI) and positron emission tomography (PET) to develop imaging biomarkers that will be used to predict treatment response following radiotherapy for prostate cancer treatment.
Scientific title
Development of imaging biomarkers for accurate and informative assessment of treatment outcome following prostate radiotherapy. The BiRT “Sequential Imaging” project (SI-BiRT).
Secondary ID [1] 296304 0
None
Universal Trial Number (UTN)
U1111-1221-9589
Trial acronym
SI-BiRT
Linked study record
N/A

Health condition
Health condition(s) or problem(s) studied:
Prostate Cancer 310006 0
Condition category
Condition code
Cancer 308762 308762 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 therapy(s) and at three time points post radiotherapy, as well as Prostate Specific Membrane Antigen (PSMA) Positron Emission Tomography (PET) prior to the initiation of radiotherapy and at 18-months post radiotherapy. Prostate specific antigen (PSA) blood tests represent the standard measure of treatment response and will be collected at time points 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;
PSMA PET at baseline (may be standard at the site) and again at 18 months post radiotherapy treatment (not standard). The PSMA PET scan involves the use of an intravenously administered radioactive drug (tracer) followed by the scan. The PSMA PET scan will be performed by a suitably qualified allied health professional.
mpMRI - three additional MRI scans with contrast above what is normal standard of care. The MRI scans will involve the use of a contrast agent administered intravenously by the treating doctor. The standard of care MRI used for radiotherapy planning will utilise contrast which may not be standard of care in some centres. The MRI scan will be performed by a suitably qualified allied health professional. mpMRI scans will be performed at time of radiotherapy planning, and then 6, 12 and 18 months post radiotherapy treatment.
Full Blood Count (FBC) and Electrolytes, Urea and Creatinine (EUC) at four timepoints (prior to radiotherapy planning, and then 6, 12 and 18 months post radiotherapy treatment) which are not standard blood tests for this group of patients. Measurement of Testosterone is also not standard in patents not on androgen deprivation therapy (ADT).

Patients who are being treated using ADT as part of their standard treatment for their prostate cancer compared to those that who are not being treated using ADT will complete one additional mpMRI and one additional blood test prior to the commencement of ADT in addition to the interventions outlined above.
Intervention code [1] 312634 0
Diagnosis / Prognosis
Comparator / control treatment
No control group - all patients will receive the same investigations.
Control group
Uncontrolled

Outcomes
Primary outcome [1] 307745 0
The earliest time period following radiotherapy where response to treatment can be assessed by mpMRI'
Timepoint [1] 307745 0
Prior to commencement of ADT (if relevant), at time of radiotherapy planning, 6, 12 and 18 months post radiotherapy treatment.
Primary outcome [2] 307746 0
Response to radiotherapy as assessed by mpMRI
Timepoint [2] 307746 0
Prior to commencement of ADT (if relevant), at time of radiotherapy planning, 6, 12 and 18 months post radiotherapy treatment.
Secondary outcome [1] 352764 0
Full Blood Count blood test results, relative to baseline, following radiotherapy
Timepoint [1] 352764 0
6, 12 and 18 months post radiotherapy treatment.
Secondary outcome [2] 352765 0
Response to radiotherapy as assessed by mpMRI compared with response to radiotherapy as assessed by blood test results - composite outcome
Timepoint [2] 352765 0
Prior to commencement of ADT (if relevant), at time of radiotherapy planning, 6, 12 and 18 months post radiotherapy treatment.
Secondary outcome [3] 352767 0
Features in mpMRI signals that indicate response to radiotherapy
Timepoint [3] 352767 0
6, 12 and 18 months post radiotherapy treatment.
Secondary outcome [4] 353396 0
mpMRI signals relative to baseline, following radiotherapy
Timepoint [4] 353396 0
6, 12 and 18 months post radiotherapy treatment.
Secondary outcome [5] 353397 0
PSA blood test results, relative to baseline, following radiotherapy
Timepoint [5] 353397 0
6, 12 and 18 months post radiotherapy treatment.
Secondary outcome [6] 353575 0
Testosterone concentration blood test results, relative to baseline, following radiotherapy
Timepoint [6] 353575 0
6, 12 and 18 months post radiotherapy treatment.

Eligibility
Key inclusion criteria
Biopsy proven localised prostate cancer.
Great than or equal to 18 years of age.
Willing and able to comply with all study requirements.
Signed, written and informed consent.
Completed MRI safety screening as per local policy.
Up to 4 months ADT prior to radiotherapy.
No more than 20 participants who receive ADT.
Minimum age
18 Years
Maximum age
No limit
Gender
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 <60 ml/min) at baseline imaging.
Participants who have been clinically diagnosed with severe claustrophobia.
Prior pelvic radiotherapy.
Any prosthetic implants such as metallic hip prostheses that may cause artefacts in the imaging studies.

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 up to 30 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
Recruiting
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW
Recruitment hospital [1] 12143 0
Liverpool Hospital - Liverpool
Recruitment hospital [2] 12144 0
Campbelltown Hospital - Campbelltown
Recruitment hospital [3] 12145 0
Blacktown Hospital - Blacktown
Recruitment hospital [4] 12146 0
Westmead Hospital - Westmead
Recruitment hospital [5] 12147 0
Calvary Mater Newcastle - Waratah
Recruitment hospital [6] 12148 0
St George Hospital - Kogarah
Recruitment postcode(s) [1] 24315 0
2145 - Westmead
Recruitment postcode(s) [2] 24314 0
2148 - Blacktown
Recruitment postcode(s) [3] 24312 0
2170 - Liverpool
Recruitment postcode(s) [4] 24317 0
2217 - Kogarah
Recruitment postcode(s) [5] 24316 0
2298 - Waratah
Recruitment postcode(s) [6] 24313 0
2560 - Campbelltown

Funding & Sponsors
Funding source category [1] 300901 0
Government body
Name [1] 300901 0
National Health and Medical Research Council (NHMRC)
Address [1] 300901 0
16 Marcus Clarke St
Canberra ACT 2601
Country [1] 300901 0
Australia
Primary sponsor type
University
Name
University of Sydney
Address
City Road,
Camperdown/Darlington
NSW 2006
Country
Australia
Secondary sponsor category [1] 300466 0
None
Name [1] 300466 0
Address [1] 300466 0
Country [1] 300466 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 301671 0
South Western Sydney Local Health District Human Research Ethics Committee [EC00136],
Ethics committee address [1] 301671 0
Corner of Elizabeth and Goulburn Streets
LIVERPOOL NSW 2170
Ethics committee country [1] 301671 0
Australia
Date submitted for ethics approval [1] 301671 0
28/09/2018
Approval date [1] 301671 0
10/05/2019
Ethics approval number [1] 301671 0
HREC/18/LPOOL/419

Summary
Brief summary
This phase 1 study will aim to predict a response to radiotherapy treatment in prostate cancer patients.

Who is it for?
You may be eligible to join this study if you are aged 18 years or above, and have been diagnosed with prostate cancer and have been recommended radiotherapy treatment.

Study details
Participants will undergo normal radiotherapy treatment with the addition of up to 5 MRI scans prior to and following radiotherapy treatment, up to 2 PSMA PET scans prior to and following radiotherapy treatment and up to 5 pathology blood tests prior to and following radiotherapy treatment.
This study will determine the pre-treatment clinical and radiographic predictors of local recurrence in prostate cancer patients treated with radiotherapy.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 87730 0
Prof Annette Haworth
Address 87730 0
Faculty of Science, School of Physics
Rm 502 A28
The University of Sydney
NSW 2006
Country 87730 0
Australia
Phone 87730 0
+61 296275457
Fax 87730 0
Email 87730 0
annette.haworth@sydney.edu.au
Contact person for public queries
Name 87731 0
Prof Annette Haworth
Address 87731 0
Faculty of Science, School of Physics
Rm 502 A28
The University of Sydney
NSW 2006
Country 87731 0
Australia
Phone 87731 0
+61 296275457
Fax 87731 0
Email 87731 0
annette.haworth@sydney.edu.au
Contact person for scientific queries
Name 87732 0
Prof Annette Haworth
Address 87732 0
Faculty of Science, School of Physics
Rm 502 A28
The University of Sydney
NSW 2006
Country 87732 0
Australia
Phone 87732 0
+61 296275457
Fax 87732 0
Email 87732 0
annette.haworth@sydney.edu.au

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment
No HREC approval for this
What supporting documents are/will be available?
No other documents available
Summary results
No Results