Trial Review

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Trial registered on ANZCTR


Registration number
Help: Registration number
ACTRN12626001207303p
Ethics application status
Help: Ethics application status
Submitted, not yet approved
Date submitted
Help: Date submitted
7/09/2026
Date registered
Help: Date registered
30/09/2026
Date last updated
Help: Date last updated
30/09/2026
Date data sharing statement initially provided
Help: Data sharing statement date
30/09/2026
Type of registration
Help: Type of registration
Prospectively registered

Titles & IDs
Public title
Diet-PRO: A neoadjuvant randomised window-of-opportunity trial evaluating the feasibility of a precision nutrition intervention prior to surgery in localised prostate cancer
Scientific title
Diet-PRO: A neoadjuvant randomised window-of-opportunity trial evaluating the feasibility of a precision nutrition intervention prior to surgery in localised prostate cancer
Additional trial identifiers [1] 318372 0
ANZUP 2505
Universal Trial Number (UTN)
Trial acronym
Related trial records

Health condition
Health condition(s) studied:
prostate cancer 343510 0
Condition category
Condition code
Cancer 339613 339613 0 0
Prostate

Intervention/exposure
Study type
Interventional
Description of the intervention or exposure
40 participants with intermediate/high-risk prostate cancer planned for prostatectomy will undergo baseline dietary assessment (by dietitian, and automated self-administered 24-hour dietary assessment (ASA24)).

Participants with high saturated-fat intake (>10% total kCal from saturated-fat, 30 participants) will be randomised 2:1 to receive dietary intervention to lower saturated-fat intake to <10% kCal from fat, while keeping calorie intake consistent for 3 weeks prior to prostatectomy (20 participants) or to continue their usual diet (control; 10 participants). Participants with low saturated fat intake (<10% total kCal from saturated fat, 10 participants) will continue their usual diet.

Participants record their diet using the ASA24 automated self-administered 24-hour dietary assessment. All participants are then assessed by a dietitian who evaluates their baseline saturated fat intake. This occurs within 7 days prior to intervention start.

Participants in the intervention arm are then reviewed an additional time for education around the dietary intervention (also within the 7 days prior to intervention start). The dietary intervention will be personalised by the dietitian to customise the patient's own diet to reduce the saturated fat intake (e.g. swap out butter for alternate spreads). All participants then meet with dietitian at Day 15. All reviews with the dietitian are individual. Participants will complete the ASA24 foot diary weekly during the intervention period prior to their radical prostatectomy.
Intervention code [1] 335259 0
Treatment: Other
Intervention code [2] 335260 0
Lifestyle
Description of the comparator or control
Participants in the low saturated-fat at baseline group will have standard treatment (i.e. continue their usual diet with no change to their dietary intake).

Participants in the high saturated-fat at baseline group who are randomised to the standard treatment arm will continue their usual diet (i.e, no change to their dietary intake).
Control group
Active

Outcomes
Primary outcome [1] 346787 0
Feasibility (adherence to the intervention, target 80%)
Timepoint [1] 346787 0
baseline and weekly prior to surgery for 3-4 weeks post baseline
Primary outcome [2] 346903 0
18 month recruitment rate
Timepoint [2] 346903 0
18 months post-study opening
Secondary outcome [1] 467521 0
Changes in the saturated-fat intake dependent MYC transcriptional signature
Timepoint [1] 467521 0
baseline (pre-intervention biopsy) and prostatectomy
Secondary outcome [2] 468096 0
Changes in plasma lipidomics,
Timepoint [2] 468096 0
Weekly evaluation for a maximum of 4 weeks, evaluating changes over time
Secondary outcome [3] 468097 0
changes in spatial lipidomics of intracellular tumoural lipids
Timepoint [3] 468097 0
at time of radical prostatectomy
Secondary outcome [4] 468098 0
Changes in peripheral blood immune cells
Timepoint [4] 468098 0
Weekly for blood samples up to a maximum of 4 weeks post-baseline.
Secondary outcome [5] 468450 0
Changes in tissue immune cells
Timepoint [5] 468450 0
At baseline and radical prostatectomy for tissue evaluation.

Eligibility
Key inclusion criteria
1. People with localised prostate cancer with either intermediate- or high-risk disease, defined as cT2b – cT4 disease and/or Grade Group 2-5 disease and/or PSA >10.
2. Age >= 18 yrs.
3. ECOG performance status 0-1.
4. Histological confirmation of PCa via a pre-treatment diagnostic biopsy.
5. Study treatment both planned and able to start within 7 days of enrolment.
6. Willing and able to comply with all study requirements, including treatment and biospecimen collection.
7. Signed, written informed consent.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Healthy volunteers
No
Key exclusion criteria
1. Major surgery 20mg of prednisone or equivalent per day).
4. Any concurrent disease or comorbidity that would interfere with the participant’s ability to take part in the study.

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Central randomisation using REDCap
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Redcap: computer-generated random sequence
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Statistical methods / analysis
As this is a feasibility study, a sample size of 30 – 40 participants is estimated and deemed adequate for the trial. This pilot feasibility study will generate initial data needed for a larger scale interventional trial, in order to perform sample size calculations. This will include the proportion of screened patients that have baseline high or low saturated fat intake, and the proportion of patients who have reversal of the saturated-fat intake dependent MYC transcriptional signature.

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
1/12/2026
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
40
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW
Recruitment hospital [1] 30150 0
The Chris O’Brien Lifehouse - Camperdown
Recruitment postcode(s) [1] 46546 0
2050 - Camperdown
Recruitment outside Australia
Country [1] 28501 0
Switzerland
State/province [1] 28501 0

Funding & Sponsors
Funding source category [1] 322935 0
Charities/Societies/Foundations
Name [1] 322935 0
Prostate Cancer Foundation
Country [1] 322935 0
United States of America
Primary sponsor type
Hospital
Name
Chris O"Brien Lifehouse
Address
Country
Australia
Secondary sponsor category [1] 325870 0
None
Name [1] 325870 0
Address [1] 325870 0
Country [1] 325870 0

Ethics approval
Ethics application status
Submitted, not yet approved
Ethics committee name [1] 321360 0
Sydney Local Health District Ethics Review Committee (RPAH Zone)
Ethics committee address [1] 321360 0
Ethics committee country [1] 321360 0
Australia
Date submitted for ethics approval [1] 321360 0
04/09/2026
Approval date [1] 321360 0
Ethics approval number [1] 321360 0

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

Contacts
Principal investigator
Name 153482 0
Dr Tahlia Scheinberg
Address 153482 0
Chris O'Brien Lifehouse, 119 - 143 Missenden Rd, Camperdown NSW 2050
Country 153482 0
Australia
Phone 153482 0
+61 2 8514 0149
Fax 153482 0
Email 153482 0
[email protected]
Contact person for public queries
Name 153483 0
Tahlia Scheinberg
Address 153483 0
Chris O'Brien Lifehouse, 119 - 143 Missenden Rd, Camperdown NSW 2050
Country 153483 0
Australia
Phone 153483 0
+61 2 8514 0149
Fax 153483 0
Email 153483 0
[email protected]
Contact person for scientific queries
Name 153484 0
Tahlia Scheinberg
Address 153484 0
Chris O'Brien Lifehouse, 119 - 143 Missenden Rd, Camperdown NSW 2050
Country 153484 0
Australia
Phone 153484 0
+61 2 8514 0149
Fax 153484 0
Email 153484 0
[email protected]

Data sharing statement
Will the study consider sharing individual participant data?
No


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.