Trial Review

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Trial registered on ANZCTR


Registration number
Help: Registration number
ACTRN12626001070325
Ethics application status
Help: Ethics application status
Approved
Date submitted
Help: Date submitted
27/07/2026
Date registered
Help: Date registered
31/08/2026
Date last updated
Help: Date last updated
31/08/2026
Date data sharing statement initially provided
Help: Data sharing statement date
31/08/2026
Type of registration
Help: Type of registration
Prospectively registered

Titles & IDs
Public title
A non-randomised study investigating the use of multi-parametric magnetic resonance imaging (mpMRI) to develop imaging biomarkers that will be used to escalate dose to subregions of tumour that are resistant to radiation therapy
Scientific title
The use of multi-parametric magnetic resonance imaging (mpMRI) to develop imaging biomarkers of hypoxia in prostate cancer
Additional trial identifiers [1] 316732 0
None
Universal Trial Number (UTN)
Trial acronym
HYPOXIM
Related trial records

Health condition
Health condition(s) studied:
Prostate cancer 341011 0
Condition category
Condition code
Cancer 337158 337158 0 0
Prostate

Intervention/exposure
Study type
Interventional
Description of the intervention or exposure
All participants will be recruited after diagnosis of localised prostate cancer and before commencing any treatment, including prostatectomy, radiation therapy, or androgen deprivation therapy. Standard clinical management will proceed according to the treating team and will not be influenced by the study results. All participants will undergo research-specific MRI scans in addition to standard of care imaging. All participants will undergo MRI safety screening in accordance with local clinical policy prior to study imaging.

This feasibility study is designed in two stages:
Stage 1 (6 participants): Participants will receive research-specific MRI scans only.
Stage 2 (25 participants): Participants will receive research-specific MRI scans. Their archived diagnostic biopsy tissue samples will be collected and analysed.

Stage 2 will commence immediately after the completion of Stage 1. Participants from Stage 1 are not able to participate in Stage 2.

MRI scans (all participants) – Multi-parametric MRI is the use of several MRI techniques to provide complimentary information about the structure and the biological characteristics of tissue. This study will use multi-parametric techniques, that are not used in standard-of-care MRI, to provide additional information on tissue composition, function, metabolism and oxygenation. As total imaging time is like to be >1 hour, participants will undergo two research-specific MRI scan sessions. The two sessions may be performed on the same day or up to 7 days apart (note this is subject to scanner and participant availability, exact timing cannot be pre-specified) and must be completed after diagnostic biopsy and before any prostate cancer treatment is initiated. MRI scanning will be performed on a 3 Tesla MRI scanner by suitably qualified MRI radiographers according to the study MRI acquisition guidelines. The second MRI session will include administration of the standard clinical dose of the gadolinium-based contrast agent gadobutrol (Gadovist®, Bayer, Germany). An intravenous cannula will be inserted by trained staff and used for contrast administration at a standard clinical dose of 0.1 mL/kg body weight (equivalent to 0.1 mmol/kg). Injection will be performed by a power injector to obtain a constant injection rate and will be timed by the radiographer to occur just after the DCE-MRI acquisition is started. The MRI scans will be performed in the supine position, and each session will take up to one hour including setup time. Participants will be asked to remain still throughout the scans.

Diagnostic biopsy tissue collection and analysis (participants recruited to Stage 2 only) – No additional biopsy procedures will be performed. Archived prostate biopsy tissue samples remaining after completion of standard diagnostic assessments will be collected upon recruitment, together with the diagnostic MRI and ultrasound images used during the biopsy procedure. The tissue samples will undergo research-specific molecular analyses for biomarkers of tumour hypoxia. These analyses are not part of standard clinical care and will be used to validate and correlate the MRI findings with tissue-based measures of hypoxia.

Prostate cancer treatment and all clinical management decisions will remain standard of care and will not be affected by the MRI or molecular biomarker results. The imaging and tissue analysis data will be used solely for research purposes to develop and validate MRI methods for identifying hypoxia in prostate cancer.
Intervention code [1] 333428 0
Diagnosis / Prognosis
Description of the comparator or control
No control group - all patients will receive the same investigations.

Comparator for participants recruited to Stage 2 will be the findings from the biopsy tissue analysis.
Control group
Active

Outcomes
Primary outcome [1] 346450 0
Tumour hypoxia assessed by molecular analysis of biopsy tissue
Timepoint [1] 346450 0
After collection of the archived prostate biopsy tissue sample from the last participant enrolled in Stage 2.
Primary outcome [2] 346635 0
Tumour hypoxia assessed by quantitative MRI
Timepoint [2] 346635 0
After collection of the archived prostate biopsy tissue sample from the last participant enrolled in Stage 2.
Secondary outcome [1] 465877 0
None
Timepoint [1] 465877 0
None

Eligibility
Key inclusion criteria
• Patients aged >= 18 years
• Eastern Cooperative Oncology Group Performance Status 0-2
• Biopsy confirmed localised intermediate risk or high-risk prostate cancer
• Biopsy procedure was full template and MRI-guided, with the diagnostic MRI scan obtained within 12 months prior to the biopsy
• Has provided written informed consent for participation in this study
• Willing and able to undergo the MRI study scans
• Eligible for MRI after safety screening as per local policy
Minimum age
18 Years
Maximum age
No limit
Sex
Males
Healthy volunteers
No
Key exclusion criteria
• Prior treatments, including hormonal, surgical and radiation therapy to the pelvis
• Diagnosed by transurethral resection of the prostate
• Known allergies or hypersensitivity to Gadolinium contrast agents
• Inadequate renal function for contrast administration (eGFR =< 30 mL/min)
• Unable to undergo an MRI examination or has contraindications to MRI
• Participants who have been clinically diagnosed with severe claustrophobia
• Any prosthetic implants such as metallic hip prostheses that may cause artefacts in the imaging studies
• Unable to retrieve biopsy tissue samples acquired during standard of care diagnostic procedure

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
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
This is an exploratory pilot study and, as such, formal sample size calculations have not been performed. However, it is anticipated that a sample size of at least 31 participants (based on pragmatic considerations) would provide sufficient numbers to obtain estimates of outcome parameters with reasonable precision. This feasibility study is designed in two stages, recruiting 6 participants in Stage 1 and 25 participants in Stage 2.

Stage 1 analysis - MRI data from the first six participants will be reviewed to optimise the imaging protocol for clinically feasible scan times while maintaining adequate image quality. The optimised protocol will then be used in all subsequent participants.

Stage 2 analysis - Imaging features will be extracted from regions corresponding to biopsy tissue samples and compared with molecular biomarkers derived from archived biopsy tissue. A subset of candidate MRI features that demonstrate strong association with molecular biomarkers of hypoxia will be identified.

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
1/09/2026
Actual
Date of last participant enrolment
Anticipated
31/03/2028
Actual
Date of last data collection
Anticipated
31/03/2028
Actual
Sample size
Target
31
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW
Recruitment hospital [1] 29249 0
Westmead Hospital - Westmead
Recruitment postcode(s) [1] 45559 0
2145 - Westmead

Funding & Sponsors
Funding source category [1] 321335 0
Hospital
Name [1] 321335 0
Westmead Charitable Trust
Country [1] 321335 0
Australia
Funding source category [2] 321336 0
Government body
Name [2] 321336 0
Cancer Institute NSW
Country [2] 321336 0
Australia
Primary sponsor type
University
Name
The University of Sydney
Address
Country
Australia
Secondary sponsor category [1] 324072 0
None
Name [1] 324072 0
Address [1] 324072 0
Country [1] 324072 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 319873 0
Western Sydney Local Health District Human Research Ethics Committee
Ethics committee address [1] 319873 0
Ethics committee country [1] 319873 0
Australia
Date submitted for ethics approval [1] 319873 0
20/11/2025
Approval date [1] 319873 0
09/03/2026
Ethics approval number [1] 319873 0
2025/ETH02677

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

Contacts
Principal investigator
Name 148674 0
Prof Annette Haworth
Address 148674 0
The University of Sydney, Faculty of Science, School of Physics Rm 502 A28, Physics Road, Camperdown NSW 2006
Country 148674 0
Australia
Phone 148674 0
+61 296275457
Fax 148674 0
Email 148674 0
[email protected]
Contact person for public queries
Name 148675 0
Erin Wang
Address 148675 0
The University of Sydney, Faculty of Science, School of Physics Rm 604 A28, Physics Road, Camperdown NSW 2006
Country 148675 0
Australia
Phone 148675 0
+61 21921663
Fax 148675 0
Email 148675 0
[email protected]
Contact person for scientific queries
Name 148676 0
Erin Wang
Address 148676 0
The University of Sydney, Faculty of Science, School of Physics Rm 604 A28, Physics Road, Camperdown NSW 2006
Country 148676 0
Australia
Phone 148676 0
+61 21921663
Fax 148676 0
Email 148676 0
[email protected]

Data sharing statement
Will the study consider sharing individual participant data?
No
No IPD sharing reason/comment: No HREC approval for sharing



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.