Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12625000784415
Ethics application status
Approved
Date submitted
22/04/2025
Date registered
24/07/2025
Date last updated
24/07/2025
Date data sharing statement initially provided
24/07/2025
Type of registration
Prospectively registered

Titles & IDs
Public title
A study exploring the feasibility of conducting lifestyle changes in patients with advanced prostate cancer
Scientific title
A pilot study to investigate the effects of lifestyle intervention on physical activity and diet in patients with metastatic prostate cancer receiving novel hormonal agents: the ACTIDIET-PRO study
Secondary ID [1] 314151 0
Nil known
Universal Trial Number (UTN)
U1111-1321-2966
Trial acronym
ACTIDIET-PRO
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Metastatic castration-resistant prostate cancer 336982 0
Condition category
Condition code
Cancer 333445 333445 0 0
Prostate

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Enrolled participants will undertake a 12-week lifestyle intervention of intensified physical activity and a controlled dietary regimen.

Exercise prescription is supervised by an exercise physiologist, and will be tailored to each participant’s fitness and comorbidities. The exercise intervention consist of two face to face small group (up to 6 participants) or individual supervised sessions per week lasting up to one hour, and one pre-instructed home-session (duration personalised, usually 30-60 minutes) including cardio and resistance training. The level of intensity is assessed via Borg RPE (target 13-15). Examples of assessments performed during the intervention may include a 6-minute walk test and stair climbing test. Examples of training prescribed during the intervention include: aerobic exercise such as step count prescription and cycling, and resistance training exercises such as dumbbell press, theraband row, and squats. The specific prescription will vary from participant to participant, according to the expertise of the treating exercise physiologist.

The dietary regimen will consist of a balanced diet consisting of low total fat, low saturated fat, high omega-3 fatty acids, optimised protein content and low simple carbohydrates. Participants are encouraged to aim to adhere to the diet for as many meals as possible during the 12 week intervention, and will be provided access to over 70 pages of handouts and recipes enabling them to prepare their own meals and identify healthy meals on a menu. They will also have 2 follow up diet consultations throughout the intervention to address any concerns and queries.

Adherence is assessed via determining the fraction of scheduled physical activity appointments and self-trainings attended and carried out by patients, the fraction of exercises completed during face-to-face training sessions and the fraction of days of adherence to the prescribed dietary regimen according to structured 24 hour dietary recall.
Intervention code [1] 330740 0
Lifestyle
Intervention code [2] 331093 0
Treatment: Other
Comparator / control treatment
ACTIDIET-PRO is a monocentric, open label, prospective, interventional, one-arm study with no control group.
Control group
Uncontrolled

Outcomes
Primary outcome [1] 341017 0
Study initiation rate
Timepoint [1] 341017 0
End of Study
Primary outcome [2] 341499 0
Retention rate
Timepoint [2] 341499 0
End of study
Primary outcome [3] 341500 0
Exercise Adherence rate
Timepoint [3] 341500 0
End of study
Secondary outcome [1] 445801 0
Percentage of Prostate Specific Antigen (PSA) non-progressors
Timepoint [1] 445801 0
Baseline, weeks 8, 12 and 24 post-intervention commencement.
Secondary outcome [2] 445802 0
Percentage of participants free of radiographic progression
Timepoint [2] 445802 0
Baseline, weeks 12 and 24 post-intervention commencement
Secondary outcome [3] 445803 0
Changes in PSA doubling time
Timepoint [3] 445803 0
Baseline, weeks 8, 12 and 24 post-intervention commencement
Secondary outcome [4] 445804 0
Changes in participant-reported Fatigue
Timepoint [4] 445804 0
Baseline, weeks 8, 12 and 24 post intervention-commencement
Secondary outcome [5] 445805 0
Time to subsequent treatment
Timepoint [5] 445805 0
Cumulative data will be assessed at the conclusion of the study.
Secondary outcome [6] 445806 0
Observational data regarding dietary intake
Timepoint [6] 445806 0
Baseline, weeks 8, 12, and 24 post intervention-commencement
Secondary outcome [7] 445808 0
Changes in lipid signature from baseline
Timepoint [7] 445808 0
Baseline, week 8 post intervention-commencement
Secondary outcome [8] 445809 0
Changes in immune signature from baseline
Timepoint [8] 445809 0
Baseline, week 8 post intervention-commencement
Secondary outcome [9] 445810 0
Aerobic exercise relative dose intensity (AExRDI)
Timepoint [9] 445810 0
Weeks 4, 8, 12 post intervention-commencement
Secondary outcome [10] 445811 0
Resistance training exercise relative dose intensity (RTxRDI)
Timepoint [10] 445811 0
Weeks 4, 8, 12 post intervention-commencement
Secondary outcome [11] 447844 0
Safety
Timepoint [11] 447844 0
24 weeks post intervention-commencement
Secondary outcome [12] 448923 0
Changes in participant-reported Quality of Life (QOL)
Timepoint [12] 448923 0
Baseline, weeks 8, 12 and 24 post-intervention commencement
Secondary outcome [13] 449511 0
Diet Adherence Rate [Primary Outcome 4].
Timepoint [13] 449511 0
End of Study

Eligibility
Key inclusion criteria
- Written informed consent according to ICH/GCP regulations before registration.
- Age 18 years or older
- Histology of adenocarcinoma of the prostate
- Ongoing treatment with androgen deprivation therapy (ADT) + androgen receptor pathway inhibitor (ARPI) [abiraterone, enzalutamide, apalutamide or darolutamide].
- Rising PSA (two consecutively rising PSA levels greater thab 25% above nadir at least three weeks apart), with no evidence of clinical or radiographic progression on instrumental evaluation
- PSA doubling time greater than 8 weeks
- Continuation of ongoing systemic treatment is deemed feasible by treating physician
Minimum age
18 Years
Maximum age
No limit
Sex
Males
Can healthy volunteers participate?
No
Key exclusion criteria
- Ongoing treatment with docetaxel, cabazitaxel, radionuclides or investigational treatments
- Evidence of clinical progression or progression of disease on imaging
- Bone metastases excluding the safety of physical exercise
- Prior confirmed severe osteoporosis or other diseases affecting the bone with history of fractures
- Clinically significant cardiovascular disease (i.e. myocardial infarction within 6 months before screening; uncontrolled angina within 3 months before screening; congestive heart failure New York Heart Association class 3 or 4; history of clinically significant arrhythmias; uncontrolled hypertension indicated by systolic blood pressure greater than 170 mm Hg or diastolic blood pressure greater than 105 mm Hg at screening)
- Clinically significant chronic obstructive pulmonary disease (COPD)
- Uncontrolled diabetes which, in the opinion of the investigator, interferes with the ability of the participant to complete the study
- Chronic intake of corticosteroids (greater than 20 mg of prednisone per day)
- Significant obesity (body mass index – BMI equal to or greater than 40)
- Any concurrent disease or comorbid condition that interferes with the ability of the participant to complete the study

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
Statistical methods / analysis

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
1/09/2025
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
30
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW
Recruitment hospital [1] 27726 0
Chris O’Brien Lifehouse - Camperdown
Recruitment postcode(s) [1] 43914 0
2050 - Camperdown

Funding & Sponsors
Funding source category [1] 318661 0
Hospital
Name [1] 318661 0
Chris O’Brien Lifehouse
Country [1] 318661 0
Australia
Primary sponsor type
Hospital
Name
Chris O’Brien Lifehouse
Address
Country
Australia
Secondary sponsor category [1] 321082 0
None
Name [1] 321082 0
Address [1] 321082 0
Country [1] 321082 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 317275 0
St Vincent’s Hospital Human Research Ethics Committee
Ethics committee address [1] 317275 0
Ethics committee country [1] 317275 0
Australia
Date submitted for ethics approval [1] 317275 0
24/03/2025
Approval date [1] 317275 0
21/05/2025
Ethics approval number [1] 317275 0

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

Contacts
Principal investigator
Name 140534 0
Prof Lisa Horvath
Address 140534 0
Chris O’Brien Lifehouse, 119-143 Missenden Rd Camperdown NSW 2050
Country 140534 0
Australia
Phone 140534 0
+61 2 8514 0362
Fax 140534 0
Email 140534 0
[email protected]
Contact person for public queries
Name 140535 0
Lisa Horvath
Address 140535 0
Chris O’Brien Lifehouse, 119-143 Missenden Rd Camperdown NSW 2050
Country 140535 0
Australia
Phone 140535 0
+61 2 8514 0362
Fax 140535 0
Email 140535 0
[email protected]
Contact person for scientific queries
Name 140536 0
Lisa Horvath
Address 140536 0
Chris O’Brien Lifehouse, 119-143 Missenden Rd Camperdown NSW 2050
Country 140536 0
Australia
Phone 140536 0
+61 2 8514 0362
Fax 140536 0
Email 140536 0
[email protected]

Data sharing statement
Will the study consider sharing individual participant data?
Yes
Will there be any conditions when requesting access to individual participant data?
Persons/groups eligible to request access:
• Researchers
Conditions for requesting access:
• Yes, conditions apply:
• Requires review on a case-by-case basis by the trial custodian, sponsor or data sharing committee
• Requires a scientifically sound proposal or protocol
• Requires a data sharing agreement between data requester and trial custodian or sponsor
What individual participant data might be shared?
• De-identified individual participant data:
• All outcomes data
What types of analyses could be done with individual participant data?
• Studies testing whether findings can be repeated or confirmed
When can requests for individual participant data be made (start and end dates)?
From:
At the end of the study
To:
Not yet decided
Where can requests to access individual participant data be made, or data be obtained directly?
• Email of trial custodian, sponsor or committee: [email protected]

Are there extra considerations when requesting access to 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.