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Trial registered on ANZCTR


Registration number
ACTRN12617001102369
Ethics application status
Approved
Date submitted
24/01/2017
Date registered
28/07/2017
Date last updated
1/12/2020
Date data sharing statement initially provided
9/07/2019
Type of registration
Retrospectively registered

Titles & IDs
Public title
Health Technology Assessment of the Clarity Autoscan system: Motion correction and margin reduction in the radiation therapy treatment of prostate cancer
Scientific title
Health Technology Assessment of the Clarity Autoscan system: Motion correction and margin reduction in the radiation therapy treatment of prostate cancer
Secondary ID [1] 291001 0
None
Universal Trial Number (UTN)
U1111-1191-969
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
prostate cancer 301771 0
Condition category
Condition code
Cancer 301461 301461 0 0
Prostate

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
The Clarity Autoscan ultrasound system allows radiation therapists to track the position of the prostate in real time by the application of an ultrasound probe against the perineum during treatment delivery daily. An alert is generated if the prostate moves beyond a pre-specified parameter, allowing the radiation therapist to suspend treatment and take
corrective action to ensure accuracy is maintained. The Clarity Autoscan system is non-invasive and does not utilise any additional radiation. In this study, all patients (both control and intervention groups) will have fiducial markers inserted as per standard practice, in addition to the Clarity Autoscan monitoring.

In the radiation therapy treatment of the prostate with Clarity Autoscan, the margin around the prostate for treatment delivery will be reduced to 5mm (with 3mm in the posterior). The prostate shall be monitored for any motion using ultrasound by qualified radiation therapists during treatment delivery, and if it moves greater than the defined margin (i.e. 5mm, with 3mm in the posterior), the treatment will be paused and the patient position corrected for. This will occur for all daily treatments (up to 39).
Intervention code [1] 296965 0
Treatment: Other
Intervention code [2] 298727 0
Treatment: Devices
Comparator / control treatment
All patients (control and intervention) will have both fiducial markers inserted and Clarity Autoscan for radiation therapy treatment. The control group will be treated with a margin around the prostate of 10mm (with 7mm in the posterior). The prostate shall be monitored for any motion using ultrasound by qualified radiation therapists during treatment delivery, and if it moves greater than the defined margin (i.e. 10mm, with 7mm in the posterior), the treatment will be paused and the patient position corrected for. This will occur for all daily treatments (up to 39).
Control group
Active

Outcomes
Primary outcome [1] 300858 0
Presence of side effects during radiation therapy treatment and at follow up after radiation therapy treatment completion. This will be assessed using the Common Terminology Criteria for Adverse Events (CTCAE) gradings. Side effects (such as urinary incontinence/retention, nocturia, proctitis, diarrheoa) will be assessed through patient interview, physical examination and medical/pathology tests as required. This will be completed by the radiation oncologist or registrar at weekly treatment review appointments and follow up appointments, and entered into MOSAIQ oncology information system.
Timepoint [1] 300858 0
Baseline; every 2 weeks while on treatment (8-9 weeks total); post radiation therapy treatment follow up at 3-month, 6-month, 12-month, and annually up to 5-years.
Secondary outcome [1] 331057 0
To evaluate the cost effectiveness of reduced margins against standard margins, with comparison to other existing intrafraction technologies. This will be assessed through a Health utilisation questionnaire completed by the patient, and hospital chart records to ascertain costs. This questionnaire has been designed by the investigators specifically for this study.
Timepoint [1] 331057 0
At one year follow up (after completion of radiation therapy treatment).
Secondary outcome [2] 331058 0
To explore the patient acceptance of Clarity (with respect to pain/invasiveness). This will be assessed through a "Procedures Experience" questionnaire, where patients rate various aspects of both procedures (such as pain, discomfort, embarrassment) on a likert scale. Additionally, patients will be invited to participate in a qualitative semi-structured interview. This questionnaire has been designed by the investigators specifically for this study.
Timepoint [2] 331058 0
Within 1 week of treatment commencement
Secondary outcome [3] 337343 0
To explore patient preference for prostate motion monitoring – a once-off surgically
invasive insertion procedure, or a daily non-invasive but potentially personally invasive
procedure for 39 treatments. This will be assessed through responses and themes emerging from the qualitative semi-structured interviews.
Timepoint [3] 337343 0
Within 1 week of treatment commencement.

Eligibility
Key inclusion criteria
1. Histological confirmed malignant neoplasm of the prostate
2. Presenting to Townsville Cancer Centre for radiation therapy treatment from March 2017
3. Suitable for fiducial marker implantation and Clarity tracking capabilities
4. An Eastern Cooperative Oncology Group (ECOG) performance status score of 2 or
less
5. Has provided written Informed Consent for participation in this study
Minimum age
50 Years
Maximum age
No limit
Sex
Males
Can healthy volunteers participate?
No
Key exclusion criteria
1. Evidence of distant metastases
2. Major concurrent physical or psychiatric illness which would prevent completion of treatment or adequate follow-up either through disablement or limitation of life expectancy to less than 1 year.
3. Cognition, language or literacy difficulties which would prevent the completion of QOL and other questionnaires.

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)
Sealed opaque envelopes
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Block randomisation with a ratio of 1:1, generated through a computerised sequence generation.
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s


Intervention assignment
Parallel
Other design features
Phase
Phase 2 / Phase 3
Type of endpoint/s
Safety/efficacy
Statistical methods / analysis
Extrapolation from similar research where interventions have increased accuracy and/or reduced rectal dose indicates that a reduction in toxicity greater than or equal to 2 of 20% in the intervention group relative to the control group is realistic 16–18. With 90%CI and alpha = 0.05, a total of 260 participants will be required to demonstrate this reduction in toxicity of 20% in the intervention group relative to the control group (Altman 1991). The sample size for this study will be calculated again after the completion of the first 20 patients’ treatment because of the lack of prior data on which to calculate size. This will allow for the collation of acute toxicity data, which will more accurately inform the sample size. It will again be revisited at 50 patients to ensure appropriateness, with power calculated based on the 50 patients’ data.

Recruitment
Recruitment status
Active, not recruiting
Date of first participant enrolment
Anticipated
Actual
4/07/2017
Date of last participant enrolment
Anticipated
31/07/2020
Actual
7/01/2020
Date of last data collection
Anticipated
15/04/2021
Actual
Sample size
Target
260
Accrual to date
Final
56
Recruitment in Australia
Recruitment state(s)
QLD
Recruitment hospital [1] 7386 0
The Townsville Hospital - Douglas
Recruitment postcode(s) [1] 15179 0
4814 - Douglas

Funding & Sponsors
Funding source category [1] 295427 0
Hospital
Name [1] 295427 0
Townsville Hospital and Health Service
Country [1] 295427 0
Australia
Primary sponsor type
Hospital
Name
The Townsville Hospital
Address
PO BOX 670
Townsville Qld 4810
Country
Australia
Secondary sponsor category [1] 294247 0
None
Name [1] 294247 0
Address [1] 294247 0
Country [1] 294247 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 296759 0
Townsville Hospital and Health Service HREC
Ethics committee address [1] 296759 0
Ethics committee country [1] 296759 0
Australia
Date submitted for ethics approval [1] 296759 0
20/01/2017
Approval date [1] 296759 0
09/03/2017
Ethics approval number [1] 296759 0
HREC/17/QTHS/9
Ethics committee name [2] 298281 0
James Cook University Human Ethics Research Committee
Ethics committee address [2] 298281 0
James Cook University
Douglas, QLD
4811
Ethics committee country [2] 298281 0
Australia
Date submitted for ethics approval [2] 298281 0
14/04/2017
Approval date [2] 298281 0
08/05/2017
Ethics approval number [2] 298281 0
H6970

Summary
Brief summary
The primary purpose of this trial is to evaluate the safety, clinical outcomes, patient preferences and economic benefits of reduced margins for radiation therapy for prostate cancer, with the use of the Clarity Autoscan ultrasound system.

Who is it for?
You may be eligible to participate in this trial if you are aged 50 or over and have been diagnosed with prostate cancer, for which you are scheduled to commence radiation therapy treatment.

Study details
All participants enrolled in this trial will be randomly allocated (by chance) to receive either a reduced margin around the prostate during radiation therapy of 3-5mm, or to receive the standard margin of 7-10mm. All patients, regardless of allocation will have fiducial markers inserted prior to commencement of treatment, and will have the Clarity Autoscan ultrasound monitoring prostate motion throughout treatment, increasing the accuracy of treatment. The allocated treatment protocol will continue for all radiation therapy treatment sessions (up to 39).

Researchers will ask participants for their preference regarding monitoring during radiotherapy, and the acceptability of the Clarity Autoscan system. Participants will also be followed up for up to five years post treatment to assess side effects and for one year to evaluate the cost-effectiveness of the motion monitoring.

It is hoped that the findings from this trial can be used to inform a health technology assessment reviewing the safety, efficacy and cost-efficacy of reduced margins during radiotherapy for prostate cancer using the Clarity Autoscan system.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 71974 0
Mrs Amy Brown
Address 71974 0
PO Box 670
The Townsville Hospital
Townsville, Qld, 4810
Country 71974 0
Australia
Phone 71974 0
+61 7 4433 1600
Fax 71974 0
Email 71974 0
[email protected]
Contact person for public queries
Name 71975 0
Amy Brown
Address 71975 0
PO Box 670
The Townsville Hospital
Townsville, Qld, 4810
Country 71975 0
Australia
Phone 71975 0
+61 7 4433 1600
Fax 71975 0
Email 71975 0
[email protected]
Contact person for scientific queries
Name 71976 0
Amy Brown
Address 71976 0
PO Box 670
The Townsville Hospital
Townsville, Qld, 4810
Country 71976 0
Australia
Phone 71976 0
+61 7 4433 1600
Fax 71976 0
Email 71976 0
[email protected]

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment
Individual data not available


What supporting documents are/will be available?

Doc. No.TypeCitationLinkEmailOther DetailsAttachment
2803Study protocol  [email protected]
2804Ethical approval  [email protected]



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.