Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12624000106538
Ethics application status
Approved
Date submitted
6/12/2023
Date registered
7/02/2024
Date last updated
13/10/2024
Date data sharing statement initially provided
7/02/2024
Type of registration
Prospectively registered

Titles & IDs
Public title
IMProving the quality of life for rAdiation therapy prostate Cancer patienTs (IMPACT)
Scientific title
Reducing the margin in prostate radiotherapy: Optimising radiotherapy with SeedTracker real-time position monitoring system
Secondary ID [1] 311129 0
None
Universal Trial Number (UTN)
Trial acronym
IMPACT
Linked study record
Follow up study for ACTRN12618001421224.

Health condition
Health condition(s) or problem(s) studied:
Prostate cancer 332290 0
Condition category
Condition code
Cancer 329003 329003 0 0
Prostate

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
SeedTracker is a real-time position monitoring tool, developed in South Western Sydney Area Health Service to enable real-time position monitoring in Elekta linear accelerators. The majority of prostate cancer patients undergoing radiotherapy have the radiopaque markers implanted in the prostate for pre-treatment position verification. The SeedTracker system monitors the prostate position during the treatment delivery in real-time by detecting the position of the radiopaque markers via monoscopic x-ray images acquired during treatment delivery.

Treating Radiation Therapists will use Seedtracker in conjunction with the Linear Accelerators to monitor the patient during radiotherapy treatment delivery. This process will also involve the support of Physicists and Radiation Oncologists. This will be delivered daily throughout the prescribed treatment course (20 or 39 days) at the participating hospitals. The treating Radiation Therapists will use Seedtracker to determine the position of the patient's prostate during radiotherapy treatment. If the prostate movement exceeds the set tolerance of 3mm from the planned position, the treatment will be paused and the patient will be realigned to the planned position and treatment will then continue.

Study participants will be required to complete some questionnaires at various timepoints throughout their radiotherapy treatment and at follow up visits with the Radiation Oncologist. It is estimated that these questionnaires will take about 5 minutes to complete.

This study will analyze the collected data to provide insight into treatment margins, treatment accuracy and doses to nearby critical structures (bladder and rectum). This study will also assess changes in patient's quality of life during and after radiotherapy treatment using Seedtracker.
Intervention code [1] 327574 0
Treatment: Devices
Comparator / control treatment
No control group.
Control group
Uncontrolled

Outcomes
Primary outcome [1] 336795 0
Delivered dose to the prostate CTV and organs at risk will be assessed. This will be assessed as a composite primary outcome.
Timepoint [1] 336795 0
At the end of radiotherapy treatment.
Secondary outcome [1] 429684 0
The patients’ Quality of Life (QoL) during and after prostate RT will be assessed.
Timepoint [1] 429684 0
Assessed at the commencement, middle and end of treatment. Assessed at 3, 6, 12, 24, 36 and 60 months after the completion of treatment.
Secondary outcome [2] 430918 0
The patient's biochemical control will be assessed.
Timepoint [2] 430918 0
36 months and 60 months after treatment.

Eligibility
Key inclusion criteria
1. Prostate cancer patients that receive radiotherapy treatment for prostate with current treatment protocol used within Liverpool and Macarthur cancer therapy centres.
2. Patients implanted with three prostate radio opaque markers
3. Patients receiving definitive radiotherapy to the prostate
Minimum age
18 Years
Maximum age
No limit
Sex
Males
Can healthy volunteers participate?
No
Key exclusion criteria
Patients with hip prosthesis

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
Efficacy
Statistical methods / analysis
A sample of 60 patients is sufficient to estimate whether the delivered CTV dose is within a ±0.3% of the planned CTV dose, assuming 0.51% standard deviation (SD) of percentage differences (based on pilot study), minimum 80% power, and 5% statistical significance. The two one-sided test (TOST) for equivalence will be used to compare the percentage difference between the planned CTV dose and the delivered CTV dose is equivalent to within ±0.3%.

A sample of 60 patients is sufficient to detect an equivalence width of ±3.3 in the Bowel EPIC score and a width of ±5.3 in the Urinary EPIC score from baseline to 12 months, assuming 6.6SD and 10.3 SD, a correlation of 0.25 from baseline to 12 months, 80% power, 5% statistical significance and 10% loss to follow up. A multilevel model will be used to model the EPIC scores (Bowel, Urinary and Sexual domains) over the 6 time points. Level 2 will be specified as the patient, and individual follow up time points nested within each patient will be specified as level 1.

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
1/03/2024
Actual
9/10/2024
Date of last participant enrolment
Anticipated
1/02/2026
Actual
Date of last data collection
Anticipated
1/03/2031
Actual
Sample size
Target
60
Accrual to date
1
Final
Recruitment in Australia
Recruitment state(s)
NSW
Recruitment hospital [1] 25920 0
Liverpool Hospital - Liverpool
Recruitment hospital [2] 25921 0
Campbelltown Hospital - Campbelltown
Recruitment postcode(s) [1] 41755 0
2170 - Liverpool
Recruitment postcode(s) [2] 41756 0
2560 - Campbelltown

Funding & Sponsors
Funding source category [1] 315388 0
Hospital
Name [1] 315388 0
In-kind support by Liverpool Cancer Therapy
Country [1] 315388 0
Australia
Funding source category [2] 315631 0
Hospital
Name [2] 315631 0
In-kind support by Macarthur Cancer Therapy
Country [2] 315631 0
Australia
Primary sponsor type
Government body
Name
South Western Sydney Local Health District
Address
Liverpool Hospital, Elizabeth Drive, Liverpool, NSW 2170
Country
Australia
Secondary sponsor category [1] 317450 0
None
Name [1] 317450 0
Address [1] 317450 0
Country [1] 317450 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 314303 0
South Western Sydney Local Health District Human Research Ethics Comitte
Ethics committee address [1] 314303 0
Ethics committee country [1] 314303 0
Australia
Date submitted for ethics approval [1] 314303 0
29/03/2023
Approval date [1] 314303 0
31/05/2023
Ethics approval number [1] 314303 0

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

Contacts
Principal investigator
Name 131126 0
Dr Mark Sidhom
Address 131126 0
Liverpool Hospital, Elizabeth Drive, Liverpool, NSW, 2170
Country 131126 0
Australia
Phone 131126 0
+61 2 87389805
Fax 131126 0
02 87389819
Email 131126 0
mark.sidhom@health.nsw.gov.su
Contact person for public queries
Name 131127 0
Radiation Oncology Trials Unit
Address 131127 0
Liverpool Hospital, Elizabeth Drive, Liverpool, NSW, 2170
Country 131127 0
Australia
Phone 131127 0
+61 429094402
Fax 131127 0
Email 131127 0
swslhd-radoncclinicaltrials@health.nsw.gov.au
Contact person for scientific queries
Name 131128 0
Radiation Oncology Trials Unit
Address 131128 0
Liverpool Hospital, Elizabeth Drive, Liverpool, NSW, 2170
Country 131128 0
Australia
Phone 131128 0
+61 429094402
Fax 131128 0
Email 131128 0
swslhd-radoncclinicaltrials@health.nsw.gov.au

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment
Data will be analyzed to seek correlations and trends. Results will be presented as a whole.


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.