Trial Review

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Trial registered on ANZCTR


Registration number
Help: Registration number
ACTRN12626001164381
Ethics application status
Help: Ethics application status
Approved
Date submitted
Help: Date submitted
19/03/2026
Date registered
Help: Date registered
18/09/2026
Date last updated
Help: Date last updated
18/09/2026
Date data sharing statement initially provided
Help: Data sharing statement date
18/09/2026
Date results provided
Help: Date results provided
18/09/2026
Type of registration
Help: Type of registration
Retrospectively registered

Titles & IDs
Public title
Real-time prostate cancer diagnosis - Surgical guidance in adult patients
Scientific title
Assessing the ability to diagnose prostate cancer during routine biopsy and prostatectomy procedures accurately in adult patients.
Additional trial identifiers [1] 316820 0
Nil known
Universal Trial Number (UTN)
Trial acronym
Related trial records

Health condition
Health condition(s) studied:
Prostate Cancer 341169 0
Condition category
Condition code
Cancer 337261 337261 0 0
Prostate

Intervention/exposure
Study type
Interventional
Description of the intervention or exposure
Condition is prostate cancer. One off biopsy sample.
The principal aim of the study is to demonstrate in vivo (intraoperative) prostate cancer diagnosis and grading. The participants will receive routine standard of care for their procedure. During the procedure, the clinician will perform two or three in vivo measurements using our instrument. The exact number of measurements for each patient is at the clinician's sole discretion. No clinical decision is made using the Raman data. All clinical decisions strictly follow the current standard of care and are independent of the study.
The Raman measurements take 20 seconds. The study will increase the overall clinical procedure time by no more than 1-2 min. The Raman data will be compared to post-procedure histopathology results.
Patients are not contacted after the procedure.
All participants have a suspicion of prostate cancer due to an elevated PSA level or MRI data showing suspicious regions.
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Equipment used:
1. In vivo measurements completed in this study: Raman spectroscopy measurements
2. Instrument will be used to take these measurements: Raman spectrometer (HT-SPEC-785-03]
3. Sterilised custom-designed Raman probes. These probes are 18 gauge in diameter. They have been designed to comply with medical-grade equipment guidelines.
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Measurement protocol:
1- Measurement protocol during routine biopsy screening procedures.
Measurement steps:
i. The patient will be prepared per standard clinical protocols for the biopsy procedure.
ii. The surgeon will proceed with normal biopsy collection procedure.
When at a location of interest for our study
iii. The surgeon will place the optical probe inside the current guiding equipment.
iv. The optical probe will be guided to the location of interest through the guiding sheath.
v. Once in place, the surgeon will trigger the measurement. One measurement takes about 5 to 7 seconds, and we will take up to 3 measurements.
vi. When the measurements are completed, the surgeon will remove the optical probe.
From this point, the clinician will return to the standard clinical care protocols.
vii. The surgeon continues with the standard biopsy collection procedure.
The optical probe will then be cleaned and sterilised.
The optical probes will be decontaminated using Tristel Trio wipes system as recommended by the clinical team. The guiding tools used are all sterile disposable tools. The Tristel Trio Wipes System is a comprehensive solution for the decontamination of semi-critical, non-lumened medical devices. It combines cleaning, high-level disinfection and rinsing with traceability.
The surgeon alone will decide how many locations of interest they will measure with our optical probe to ensure the best clinical outcome for the patient and maintain minimum disruption to the clinical workflow. A standard biopsy collection procedure takes between 45 min and 1h. We will ensure that our study does not extend the duration of the standard procedure by more than 3 to 4 minutes.

2- In vivo measurements during routine prostatectomy procedures using the SORS probe.
Measurement steps:
i. Using standard clinical care protocols, the surgeon will remove part of, or the entire, prostate as predefined and agreed upon with the patient to ensure best clinical outcome. Our study does not influence these decisions.
ii. When appropriate and at his discretion, the surgeon will use our probe to assess specific areas of the surgical margins where they want to take a biopsy sample. One measurement takes about 15 seconds.
From this point, the clinician will return to the standard clinical care protocols.
iii. After measuring the area with our probe, the surgeon will take a biopsy sample
iv. The biopsy samples will follow standard clinical workflow.
The surgeon alone will decide how many locations of interest they will measure with our optical probe to ensure the best clinical outcome for the patient and maintain the clinical workflow. On average, a prostatectomy procedure takes between 1h30min to 2h. We will ensure that measurements with our optical probe do not extend the duration of the standard procedure by more than 8 to 10 minutes.
It is part of a routine operation and the patient is assessed as per standard of care by hospital staff.
Intervention code [1] 333505 0
Diagnosis / Prognosis
Description of the comparator or control
No control group.
Patients are seen by the clinician as part of their care following elevated PSA results or MRI showing suspicious regions. During routine pre-procedure appointments, the nursing staff proposes to patients that they take part in our study. If the patient accepts, they are enrolled in our study. If they are enrolled in the study, we will perform in vivo measurements with our device during their procedure and compare our results with the pathology results.

The pathologist will report on the biopsied tissue in accordance with standard protocols. The reports detail for each biopsied tissue:
- Presence of cancer or not
- Extent of cancerous region compared to the total length of the biopsy
- Local Gleason pattern 3 to 5 if cancerous tissue
- Overall Gleason score of the biopsied tissue"
Control group
Active

Outcomes
Primary outcome [1] 344777 0
Sensitivity and specificity of Raman spectroscopy when compared to standard pathology lab results measured by tissue biopsy. Sensitivity and specificity will be assessed as a composite primary outcome.
Timepoint [1] 344777 0
1 month after all the pathology for all recruited patients is complete.
Secondary outcome [1] 459151 0
Safety of device
Timepoint [1] 459151 0
Safety is assessed during and immediately after the procedure. It is further assessed by reviewing medical records and pathology results. The pathology results are assessed as soon as available. Typically 2 to 3 weeks after the procedure.

Eligibility
Key inclusion criteria
Suspicion of prostate cancer after elevated Prostate Specific Antigen (PSA).
No patient is selected for this study alone.
All participants are patients seen by a clinician as part of their standard of care treatment.
Minimum age
18 Years
Maximum age
No limit
Sex
Males
Healthy volunteers
No
Key exclusion criteria
No medical or age exclusion criteria.
Not included are patients who cannot provide informed consent.

Study design
Purpose of the study
Diagnosis
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
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
Actual
28/01/2026
Date of last participant enrolment
Anticipated
16/12/2026
Actual
Date of last data collection
Anticipated
15/12/2027
Actual
Sample size
Target
200
Accrual to date
3
Final
Recruitment outside Australia
Country [1] 27945 0
New Zealand
State/province [1] 27945 0
Auckland

Funding & Sponsors
Funding source category [1] 321413 0
Government body
Name [1] 321413 0
MBIE
Country [1] 321413 0
New Zealand
Primary sponsor type
University
Name
The Univeristy of Auckland
Address
Country
New Zealand
Secondary sponsor category [1] 324157 0
None
Name [1] 324157 0
Address [1] 324157 0
Country [1] 324157 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 319952 0
Northern B Health and Disability Ethics Committee 
Ethics committee address [1] 319952 0
Ethics committee country [1] 319952 0
New Zealand
Date submitted for ethics approval [1] 319952 0
14/06/2024
Approval date [1] 319952 0
24/06/2024
Ethics approval number [1] 319952 0

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

Contacts
Principal investigator
Name 148938 0
Dr Claude Aguergaray
Address 148938 0
The University of Auckland, 38 Princes Street, Auckland, 1010, NZ
Country 148938 0
New Zealand
Phone 148938 0
+64 99233820
Fax 148938 0
Email 148938 0
[email protected]
Contact person for public queries
Name 148939 0
Claude Aguergaray
Address 148939 0
The University of Auckland, 38 Princes Street, Auckland, 1010, NZ
Country 148939 0
New Zealand
Phone 148939 0
+64 99233820
Fax 148939 0
Email 148939 0
[email protected]
Contact person for scientific queries
Name 148940 0
Claude Aguergaray
Address 148940 0
The University of Auckland, 38 Princes Street, Auckland, 1010, NZ
Country 148940 0
New Zealand
Phone 148940 0
+64 99233820
Fax 148940 0
Email 148940 0
[email protected]

Data sharing statement
Will the study consider sharing individual participant data?
No
No IPD sharing reason/comment: The data is shared with the patient's referring clinician.



What supporting documents are/will be available?

TypeCitationLinkEmailOther DetailsAttachment
Ethical approvalHDEC  


Results publications and other study-related documents

Documents added manually
TypeIs Peer Reviewed?DOICitations or Other DetailsAttachment
Conference abstractYes Journal of Biophotonics - 2023 - Breugel - Raman spectroscopy system for real-time diagnosis of clinically significant.pdf

Documents added automatically
No additional documents have been identified.