Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12624001441505
Ethics application status
Approved
Date submitted
16/10/2024
Date registered
11/12/2024
Date last updated
11/12/2024
Date data sharing statement initially provided
11/12/2024
Type of registration
Prospectively registered

Titles & IDs
Public title
Exercise as a novel therapeutic approach for sensitising prostate cancer to radiotherapy
Scientific title
Exercise as a novel therapeutic approach for sensitising prostate cancer to radiotherapy
Secondary ID [1] 313162 0
Nil known
Universal Trial Number (UTN)
Trial acronym
ERADICATE-REX
Linked study record
This record is a sub-study of ACTRN12624000786594

Health condition
Health condition(s) or problem(s) studied:
Prostate cancer 335439 0
Condition category
Condition code
Cancer 331998 331998 0 0
Prostate
Physical Medicine / Rehabilitation 332143 332143 0 0
Other physical medicine / rehabilitation

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Participants will attend a single session of resistance exercise (also known as resistance training or strength training) before starting their treatment with external beam radiation therapy; specifically, the exercise session will be performed within 7 days prior to radiation therapy commencement. The exercise session/intervention will be individually supervised by an appropriately qualified exercise professional (e.g., an Exercise and Sports Science Australia [ESSA] accredited exercise physiologist) and will be delivered face to face (in person). The exercise session will comprise 20 minutes of resistance training targeting the major upper- and lower-body muscle groups and will be performed at moderate to vigorous intensity. Resistance training will include 4-5 exercises that involve the major upper- and lower-body muscle groups, including squats, calf raises, deadlifts, and step ups (or appropriate alternatives depending on participant constitution and ability). Each resistance exercise will be performed for 2-3 sets at a load of 8-12 repetitions per set (i.e., the maximum load with which 8-12 repetitions can be performed with correct form, approximately 75% 1RM). The exercise intervention will be delivered at a medical research facility in the Perth metropolitan area. Intervention adherence will be assessed by the supervising exercise physiologist by recording the amount of completed exercise (i.e., duration, intensity, and volume).
Intervention code [1] 329729 0
Treatment: Other
Comparator / control treatment
No control group
Control group
Uncontrolled

Outcomes
Primary outcome [1] 339599 0
Change in tumour perfusion
Timepoint [1] 339599 0
Baseline/pre exercise and immediately post exercise (within 7 days prior to radiation therapy commencement)
Primary outcome [2] 339600 0
Change in tumour hypoxia
Timepoint [2] 339600 0
Baseline/pre exercise and immediately post exercise (within 7 days prior to radiation therapy commencement)
Secondary outcome [1] 440548 0
Change in tumour apparent diffusion coefficient (ADC)
Timepoint [1] 440548 0
Baseline/pre exercise and immediately post exercise (within 7 days prior to radiation therapy commencement)
Secondary outcome [2] 440557 0
Exercise adherence/compliance
Timepoint [2] 440557 0
Assessed during the exercise session
Secondary outcome [3] 440558 0
Safety
Timepoint [3] 440558 0
Assessed during the exercise session

Eligibility
Key inclusion criteria
I) Patients diagnosed with localised or locally advanced prostate cancer;
II) Patients scheduled for conventional or hypofractionated external beam radiotherapy; and
III) Approval from treating oncologist to participate in study.
Minimum age
18 Years
Maximum age
No limit
Sex
Males
Can healthy volunteers participate?
No
Key exclusion criteria
I) Previous radical prostatectomy;
II) Patients already engaging in regular exercise (defined as undertaking structured, i.e. planned and individualised, aerobic or resistance exercise on 2 or more days per week within the past 3 months);
III) Acute illness or musculoskeletal/ cardiovascular/ neurological disorder that could put patients at risk during exercise testing or training;
IV) Bone metastases; and
V) Contraindication to magnetic resonance imaging.

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
Blinded (masking used)
Who is / are masked / blinded?



The people analysing the results/data
Intervention assignment
Single group
Other design features
Phase
Not Applicable
Type of endpoint/s
Safety/efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
16/12/2024
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
12
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
WA

Funding & Sponsors
Funding source category [1] 317604 0
Government body
Name [1] 317604 0
Cancer Australia
Country [1] 317604 0
Australia
Primary sponsor type
University
Name
Edith Cowan University
Address
Country
Australia
Secondary sponsor category [1] 319912 0
None
Name [1] 319912 0
Address [1] 319912 0
Country [1] 319912 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 316307 0
Edith Cowan University Human Research Ethics Committee
Ethics committee address [1] 316307 0
Ethics committee country [1] 316307 0
Australia
Date submitted for ethics approval [1] 316307 0
09/10/2024
Approval date [1] 316307 0
07/11/2024
Ethics approval number [1] 316307 0

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

Contacts
Principal investigator
Name 137474 0
Dr Oliver Schumacher
Address 137474 0
Exercise Medicine Research Institute, Edith Cowan University, 270 Joondalup Drive, Joondalup WA 6027
Country 137474 0
Australia
Phone 137474 0
+61 8 6304 3444
Fax 137474 0
Email 137474 0
o.schumacher@ecu.edu.au
Contact person for public queries
Name 137475 0
Mrs Cailyn Walker
Address 137475 0
Exercise Medicine Research Institute, Edith Cowan University, 270 Joondalup Drive, Joondalup WA 6027
Country 137475 0
Australia
Phone 137475 0
+61 8 6304 2307
Fax 137475 0
Email 137475 0
cailyn.walker@ecu.edu.au
Contact person for scientific queries
Name 137476 0
Dr Oliver Schumacher
Address 137476 0
Exercise Medicine Research Institute, Edith Cowan University, 270 Joondalup Drive, Joondalup WA 6027
Country 137476 0
Australia
Phone 137476 0
+61 8 6304 3444
Fax 137476 0
Email 137476 0
o.schumacher@ecu.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


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.