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Trial registered on ANZCTR


Registration number
ACTRN12609000512224
Ethics application status
Approved
Date submitted
22/12/2008
Date registered
29/06/2009
Date last updated
8/01/2020
Date data sharing statement initially provided
8/01/2020
Type of registration
Prospectively registered

Titles & IDs
Public title
Cone Beam Computed Tomography image guided radiation therapy for prostate cancer to improve treatment accuracy and outcomes.
Scientific title
Improved radiation delivery accuracy to the clinical treatment volume and concommitant reduction in incidental dose to organs-at-risk: assessment and optimisation of cone-beam computed tomography as a potential future standard of care for highly conformal radiation mono-therapy for prostate carcinoma
Secondary ID [1] 300204 0
CBCT
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Prostate Cancer 4153 0
Condition category
Condition code
Cancer 4691 4691 0 0
Prostate

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Cone-beam computed tomography (CBCT) with low-energy x-rays is a new image-guidance modality in external beam radiotherapy that permits diagnostic-quality three-dimensional cross-sectional images of a patient to be acquired while lying in the actual treatment position under a medical linear accelerator. Computed Tomography requires multiple projection images of the patient to be acquired over a 180degree or 360 degree rotation of the imaging device. CBCT is hence similar to the more ubiquitous Computed Axial Tomography (CAT) scanners used in diagnostic radiology, except in the mathematical details of filtered back-projection and axial reconstruction from a conical projection of diagnostic x-rays. The high quality of soft-tissue definition in CBCT allows the full spatial extent and orientation of the prostate gland to be imaged routinely with minimal additional radiation exposure, and CBCT does not depend on any invasive implantation of fiducial markers.

CBCT therefore provides the most comprehensive information about the prostate, bladder and rectum status, and can be used immediately prior to radiation to correct for the displacement of the prostate gland with sub-millimeter accuracy. Hence, the highest degree of treatment accuracy is made feasible with CBCT and this technique can itself be used as a diagnostic-quality reference against which the accuracy of conventional portal imaging of bony landmarks and other fiducial-based methods can be benchmarked.

The additional radiation dose (in excess to the prescribed radiation dose) to the patient due to the low-energy x-rays used in CBCT has been measured by an accredited medical physicist according to International Electrotechnical Commission standards, and the additional dose would not exceed a volume weighted integral dose of 3 centigray (cGy) per CBCT scan in the imaging area. For relative comparison, the dose to the clinical target volume for each fraction of treatment is 200 cGy. Hence, even in a worst-case estimate where CBCT were prescribed for each fraction of treatment, the additional imaging dose would amount to no more than 0.15% of the radiation treatment dose. The increased accuracy of radiation delivery to a mobile target, such as a prostate gland, concommitantly with improved sparing of adjacent organs-at-risk leading to reduced risk of radiotherapy-related side effects arising from the additional x-radiation exposure.

The radiation therapy dose prescribed for patients in phase 1 is 7400cGy in 37 fractions at 200cGy per daily fraction, 5 fractions per week, over 7 and a half weeks. The imaging x-ray dose due to weekly CBCT (7 scans) is 21 cGy.

The radiation therapy dose prescribed for patients in phase 2 is 7400cGy in 37 fractions at 200cGy per daily fraction, 5 fractions per week, over 7 and a half weeks. Phase 2 will recruit different patients to those used for Phase 1 of the study. The imaging x-ray dose due to daily CBCT in the first 3 fractions followed by weekly scans (10 in total) is 30 cGy.

Phase 3 is purely digital re-analysis of image data already collected in phase 2, involving clinical assessment of a novel technique of mathematical image reconstruction. Hence no additional patients are to be recruited in Phase 3 (the data used will be from patients who attend phase 2) and no additional scans will be required.
Intervention code [1] 4413 0
Treatment: Other
Comparator / control treatment
Not Applicable as this is a Single Group Study
Control group
Uncontrolled

Outcomes
Primary outcome [1] 5556 0
Comparison of prescribed dose coverage of the TV (p) in CBCT guided set-up with current pattern of care. The prescribed dose coverage will be assessed using a commercial treatment dosimetry system able to fuse multiple image sets and calculate dose-volume histograms.
Timepoint [1] 5556 0
6 months from patient enrolment
Secondary outcome [1] 9360 0
Comparison of image quality and work flow efficiency between Limited Angle Cone-Beam computed tomography (LA-CBCT) and Cone-beam computed tomography(CBCT). Workflow efficiency and image quality will be measured by time and ability to localize the TV (p) accurately.
Timepoint [1] 9360 0
12 months from patient enrolment
Secondary outcome [2] 9361 0
Inter-observer variation in defining the prostate gland location over the course of treatment compared to when using either Cone-beam computed tomography (CBCT) or Limited-angle cone-beam digital tomosynthesis (LA-CBDT).
Timepoint [2] 9361 0
6 months from patient enrolment

Eligibility
Key inclusion criteria
Histologically confirmed prostate adenocarcinoma Localised prostate cancer of any T-stage Gleason score and Prostate Specific Antigen (PSA)
Planned by Computed Tomography (CT) study for radical radiotherapy that is - 7400 centigrays (cGy) in 37 fractions. Informed consents obtained for treatment and for clinical study
Minimum age
18 Years
Maximum age
No limit
Sex
Males
Can healthy volunteers participate?
Yes
Key exclusion criteria
Prior radical prostatectomy.
Prior high dose pelvic radiation therapy

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
Phase 1 / Phase 2
Type of endpoint/s
Safety/efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
1/07/2009
Actual
4/10/2010
Date of last participant enrolment
Anticipated
Actual
29/06/2011
Date of last data collection
Anticipated
Actual
2/09/2013
Sample size
Target
75
Accrual to date
Final
20
Recruitment in Australia
Recruitment state(s)

Funding & Sponsors
Funding source category [1] 4324 0
Self funded/Unfunded
Name [1] 4324 0
Country [1] 4324 0
Australia
Primary sponsor type
Commercial sector/Industry
Name
Perth Radiation Oncology
Address
24 Salvado Road
WEMBLEY WA 6014
Country
Australia
Secondary sponsor category [1] 3896 0
None
Name [1] 3896 0
Address [1] 3896 0
Country [1] 3896 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 6373 0
Bellberry Human Research and Ethics Committee
Ethics committee address [1] 6373 0
Ethics committee country [1] 6373 0
Australia
Date submitted for ethics approval [1] 6373 0
Approval date [1] 6373 0
05/11/2008
Ethics approval number [1] 6373 0
B151/08

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

Contacts
Principal investigator
Name 35058 0
Dr Chris Harper
Address 35058 0
24 Salvado Road Wembley WA 6014
Country 35058 0
Australia
Phone 35058 0
+61, 08, 63182800
Fax 35058 0
Email 35058 0
[email protected]
Contact person for public queries
Name 12405 0
Sema Cakan
Address 12405 0
Perth Radiation Oncology
24 Salvado Road Wembley WA 6014
Country 12405 0
Australia
Phone 12405 0
+61 8 9381 5655
Fax 12405 0
+61 8 9381 4364
Email 12405 0
[email protected]
Contact person for scientific queries
Name 3333 0
Dr Chris Harper / Dr Tee Lim
Address 3333 0
Perth Radiation Oncology
24 Salvado Road Wembley WA 6014
Country 3333 0
Australia
Phone 3333 0
+61 8 9381 5655
Fax 3333 0
+61 9 9381 4364
Email 3333 0
[email protected] or [email protected]

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
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.