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Trial registered on ANZCTR


Registration number
ACTRN12609000774224
Ethics application status
Approved
Date submitted
6/08/2009
Date registered
7/09/2009
Date last updated
9/07/2012
Type of registration
Prospectively registered

Titles & IDs
Public title
A multi-site study to investigate the optimal bladder filling instructions for prostate cancer patients undergoing radical radiation therapy using Image Guided Radiation Therapy (IGRT) to verify daily bladder volume
Scientific title
A multi-site study to investigate the optimal bladder filling instructions for prostate cancer patients undergoing radical radiation therapy by comparing two different sets of bladder filling instructions (300mL vs. 750mL) and using Image Guided Radiation Therapy (IGRT) to verify daily bladder volume
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Prostate Cancer 243465 0
Condition category
Condition code
Cancer 239767 239767 0 0
Prostate

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
300mL bladder filling instruction.
Patients are instructed to empty their bladder 1 hour prior to every treatment appointment time (including their planning appointment and up to 39 treatment appointments) and then consume 300mL of water (as measured in the water bottle provided) at least 30 minutes prior to every treatment appointment time
Intervention code [1] 237079 0
Treatment: Other
Comparator / control treatment
750mL Standard bladder filling instructions
Patients are instructed to empty their bladder 1 hour prior to every treatment appointment time (including their planning appointment and up to 39 treatment appointments) and then consume 750mL of water (as measured in the water bottle provided) at least 30 minutes prior to every treatment appointment time
Control group
Active

Outcomes
Primary outcome [1] 240531 0
To determine the optimal bladder filling instructions (300ml or 750mL) by determining the magnitude of daily bladder volume variation over a course of treatment using Image Guided Radiation Therapy (IGRT)
Timepoint [1] 240531 0
The bladder volume will be assessed using an IGRT computed tomography (CT) scan daily for the first week of treatment, and then every second day thereafter until the patient's treatment course is completed (between 35 and 39 treatments, delivered 5 times per week over approximately 8 weeks depending on prescribed dose)
Secondary outcome [1] 257084 0
To determine whether there is any difference in the quality of life measures reported by patients randomised to the 2 cohorts using the National Comprehensive Cancer Network (NCCN) distress thermometer and a visual analogue scale.
Timepoint [1] 257084 0
Week 1, 4 and 7 of treatment
Secondary outcome [2] 257085 0
To determine if there is any relationship between patient distress thermometer scores and the average magnitude of bladder volume variation
Timepoint [2] 257085 0
Week 1, 4 and 7 of treatment
Secondary outcome [3] 257086 0
To determine if there is any difference in patient reported toxicity between the 2 cohorts using the NCCI toxicity socring system
Timepoint [3] 257086 0
Weekly during treatment and 4-6 weeks, 6 months and 12 months post-treatment
Secondary outcome [4] 257087 0
To compare between treatment arms the proportion of treatments where small bowel is present in the treatment field as visualised on the verification Computed Tomography (CT) scan.
Timepoint [4] 257087 0
The presence of the small bowel within the treatment field will be assessed using an IGRT CT scan daily for the first week of treatment, and then every second day thereafter until the patient's treatment course is completed (between 35 and 39 treatments, delivered 5 times per week over approximately 8 weeks depending on prescribed dose)
Secondary outcome [5] 257088 0
To determine which set of bladder filling instructions more accurately reproduces the planned bladder dose by calculating the daily bladder dose for each verification CT and comparing it to the planned bladder dose (D100%, D70% and D50%)
Timepoint [5] 257088 0
The planned bladder dose will be calculated using an IGRT CT scan daily for the first week of treatment, and then every second day thereafter until the patient's treatment course is completed (between 35 and 39 treatments, delivered 5 times per week over approximately 8 weeks depending on prescribed dose)
Secondary outcome [6] 257089 0
To investigate any relationship between treatment dose delivered to the bladder (D50%, D70% and D100%) and late bladder toxicity.
Timepoint [6] 257089 0
6 and 12 months post treatment completion
Secondary outcome [7] 257090 0
To determine the proportion of patients in each arm who undergo a repeat planning CT due to initial inadequate bladder filling.
Timepoint [7] 257090 0
Prior to treatment commencement
Secondary outcome [8] 257091 0
To detemine between arms the proportion of patients who require an intervention after each volume review by reviewing the intervention decision making program that uses the IGRT data to calculate if an intervention is required and alerts the treatment staff.
Timepoint [8] 257091 0
The need for an intervention, based on the previous 5 IGRT scans, will be assessed using the intervention decision making program after treatment number 5, 15 and 25 (of 35-39 treatments) of the treatment course.
Secondary outcome [9] 257092 0
To compare between arms the proportion of patients who are taken off the study due to unacceptable planned bladder volume by reviewing the bladder volume recorded on the electronic assessment template completed after the completion of the planning CT.
Timepoint [9] 257092 0
prior to treatment commencement
Secondary outcome [10] 257093 0
To determine if either set of bladder filling instructions demonstrates a decrease in prostate motion relative to bony landmarks for the subset of patients with an intact prostate and fiducial markers implanted by assessing the location of the fiducial markers on each IGRT CT scan
Timepoint [10] 257093 0
The IGRT CT scans will be daily for the first week of treatment, and then every second day thereafter until the patient's treatment course is completed (between 35 and 39 treatments, delivered 5 times per week over approximately 8 weeks depending on prescribed dose)
Secondary outcome [11] 257094 0
To determine the relationship between prostate motion and bladder volume variation
Timepoint [11] 257094 0
The IGRT CT scan will be assessed daily for the first week of treatment, and then every second day thereafter until the patient's treatment course is completed (between 35 and 39 treatments, delivered 5 times per week over approximately 8 weeks depending on prescribed dose)
Secondary outcome [12] 257095 0
To determine if bladder volumes demonstrate any time trends over the course of treatment
Timepoint [12] 257095 0
The bladder volumes will be assessed using an IGRT CT scan daily for the first week of treatment, and then every second day thereafter until the patient's treatment course is completed (between 35 and 39 treatments, delivered 5 times per week over approximately 8 weeks depending on prescribed dose)
Secondary outcome [13] 257096 0
For the subset of patients with an intact prostate, compare between arms the magnitude of daily bladder volume variation over a course of treatment by calculating and comparing the daily bladder volume using the IGRT CT scans
Timepoint [13] 257096 0
The bladder volumes will be assessed using an IGRT CT scan daily for the first week of treatment, and then every second day thereafter until the patient's treatment course is completed (between 35 and 39 treatments, delivered 5 times per week over approximately 8 weeks depending on prescribed dose)

Eligibility
Key inclusion criteria
Eastern Cooperative Oncology Group (ECOG) performance status 0-1
Histological confirmation of adenocarcinoma of the prostate
Prescribed radical radiation therapy with dose between 70-78Gy
Written informed consent
Ability to document information in patient diary in English
Ability to complete Quality of Life (QoL) assessments in English
Minimum age
60 Years
Maximum age
No limit
Sex
Males
Can healthy volunteers participate?
No
Key exclusion criteria
Previous pelvic Radiation Therapy
Hip prothesis
Concurrrent or previous malignancy within 5 years prior to randomisation (except non-melanomatous skin cancer)
Urinary catheter
Urinary incontinence
Urinary outflow obstruction
Already participating in another clinical study
Inflammatory bowel disease
Patients whose planned bladder volume is deemed unacceptable by their treating radiation oncologist

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)
Central randomisation by computer
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Stratified allocation using minimisation procedures.
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
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
7/09/2009
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
210
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
VIC

Funding & Sponsors
Funding source category [1] 237459 0
Government body
Name [1] 237459 0
Victorian Cancer Agency
Country [1] 237459 0
Australia
Primary sponsor type
Individual
Name
Dr Kellie Knight
Address
Peter MacCallum Cancer Centre
C/O Monash medical Centre, Moorabbin campus
865 Centre Rd
East Bentleigh Vic 3165
Country
Australia
Secondary sponsor category [1] 236944 0
Hospital
Name [1] 236944 0
Peter Mac Callum Cancer Centre
Address [1] 236944 0
Locked Bag 1
A'Beckett St
Melbourne VIC 8001
Country [1] 236944 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 239585 0
Peter MacCallum Cancer Centre
Ethics committee address [1] 239585 0
Locked Bag 1
A'Beckett St
Melbourne VIC 8006
Ethics committee country [1] 239585 0
Australia
Date submitted for ethics approval [1] 239585 0
Approval date [1] 239585 0
15/07/2009
Ethics approval number [1] 239585 0
09/24

Summary
Brief summary
This study aims to determine the optimal bladder filling instructions for prostate cancer patients undergoing radical radiation therapy using Image Guided Radiation Therapy (IGRT)

Who is it for?
You can join this study if you are undergoing radical radiation therapy using Image Guided Radiation Therapy (IGRT) as treatment for prostate cancer.

Trial details
Participants will be divided into two groups. One group will be asked to empty their bladder 1 hour prior to their treatment appointment time, and then consume 300mL of water at least 30 minutes prior to their treatment appointment time. The second group will be asked to empty their bladder 1 hour prior to their treatment appointment time, and then consume 750mL of water at least 30 minutes prior to their treatment appointment time. The amount of daily bladder volume variation over the course of treatment will be measured daily in week 1 of treatment, and then every 2nd day until treatment is completed. Participants will also be asked to complete some questions measuring quality of life and distress, in weeks 1, 4 an 7 of treatment. Further monitoring will occur 6months and 12 months after treatment has completed.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 30014 0
Address 30014 0
Country 30014 0
Phone 30014 0
Fax 30014 0
Email 30014 0
Contact person for public queries
Name 13261 0
Dr Kellie Knight
Address 13261 0
Peter MacCallum Cancer Centre
C/O Monash Medical Centre, Moorabbin Campus
865 Centre Rd
East Bentleigh
VIC 3165
Country 13261 0
Australia
Phone 13261 0
+61 3 9928 8994
Fax 13261 0
Email 13261 0
[email protected]
Contact person for scientific queries
Name 4189 0
Dr Kellie Knight
Address 4189 0
Peter MacCallum Cancer Centre
C/O Monash Medical Centre, Moorabbin Campus
865 Centre Rd
East Bentleigh
VIC 3165
Country 4189 0
Australia
Phone 4189 0
+61 3 9928 8994
Fax 4189 0
Email 4189 0
[email protected]

No information has been provided regarding IPD availability


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.