Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12624001297516p
Ethics application status
Submitted, not yet approved
Date submitted
30/09/2024
Date registered
25/10/2024
Date last updated
25/10/2024
Date data sharing statement initially provided
25/10/2024
Type of registration
Prospectively registered

Titles & IDs
Public title
The observation of radiotherapy doses achieved when planning on an empty bladder versus a full Bladder for prostate radiotherapy treatment.
Scientific title
An observational prospective study comparing radiotherapy treatment plans on patients with a full bladder and empty bladder who are diagnosed with Prostate Cancer.
Secondary ID [1] 313073 0
Nil known
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Prostate Cancer 335314 0
Prostate Cancer with Seminal Vesical involvement 335315 0
Condition category
Condition code
Cancer 331891 331891 0 0
Prostate

Intervention/exposure
Study type
Observational
Patient registry
False
Target follow-up duration
Target follow-up type
Description of intervention(s) / exposure
1. Empty bladder V full Bladder for prostate radiotherapy _ GenesisCare National Patient Information and Consent Form (PICF) will be given to the patients. They will have the opportunity to read the information in their own time regarding the procedure, time taken to be apart of the study and also the collection of data and any risks to the patient as part of the study. Once happy the patient can consent to the procedure if they wish to participate.
2. Radiation Oncologists will go thoroughly assess each patient who is intended for the study. They will explain the procedure and other information associated to the study. The Radiation Oncologists have a wealth of experience in this field and have submitted their up-to-date CV's to Human Research Ethics Committee (HREC). Radiation Therapists involved in the study will explain the procedure in detail with regards to the Computed Tomography scans needed. the Radiation Therapists have a wealth of experience in this field and have submitted their up-to-date CV's to HREC.
3. The mode of delivery will be face to face. The radiotherapy planning team will use the empty bladder scan and the full bladder scan to create two prostate radiotherapy plans. In doing so, differences and similarities in doses to the prostate will be observed and recorded. The use of the full bladder plan will be used as the usual standard of car for the patients treatment.
For the preparation of the first CT scan, we will follow our usual full bladder protocol. We will ensure an optimally full bladder, which the patient will have to achieve during each radiotherapy treatment, which is our current standard of care. Following the first CT scan the patient will be asked to immediately empty their bladder. The patient can take as long as they need to fully empty their bladder and after doing so will then have another CT scan whilst their bladder is empty. This scan in not our current standard of care. We will use this scan to help with the planning comparison.
4. The patient will come for one radiotherapy planning scan session as per the current standard of care. The extra Computed Tomography scan will be completed on the same day if the patient agrees to participate in the study. The extra scan will take approximately 20 minutes. This research study involves exposure to a small amount of radiation. As part of everyday living, everyone is exposed to naturally occurring background radiation and receives a dose of about 2 millisieverts (mSv) each year. The effective dose from this study is about 9.5 mSv. The dose from this study is comparable to that received from many diagnostic medical x-ray and nuclear medicine procedures. At this dose level, no harmful effects of radiation have been demonstrated as any effect is too small to measure.
The study team will use the data collected and observe the data over a 12 month period.
5. The study will be performed at GenesisCare Southport and GenesisCare Tugun in QLD.
Intervention code [1] 329634 0
Not applicable
Comparator / control treatment
Comparator- will be comparing an empty bladder radiotherapy plan to a current standard of care full bladder radiotherapy plan for radiotherapy to the prostate.
Control group
Active

Outcomes
Primary outcome [1] 339506 0
Differences in bladder dose in radiotherapy plans.
Timepoint [1] 339506 0
Immediately after the completion of the CT scans, the data will be sent to the radiotherapy planning team, where they will create two seperate plans, one using the full bladder scan and the other using the empty bladder scan. Once all plans for the 20 patients have been finalised, the study team will comparr the data from the radiotherapy plans. This could take approximately 12 months to compare data.
Secondary outcome [1] 440224 0
Nil
Timepoint [1] 440224 0
Nil

Eligibility
Key inclusion criteria
• Prostate only and Prostate with SVs, confirmed by Histopathology
• 18 years +
• Male
• No previous Radiotherapy
• Curative intent
• Signed written and informed consent
• Willingness to comply with study procedure
Minimum age
18 Years
Maximum age
No limit
Sex
Males
Can healthy volunteers participate?
No
Key exclusion criteria
• Patients who cannot empty their bladder sufficiently enough. Or whether they have a sensation of wanting to empty or if they double void on a regular occurrence.
• Previous radiotherapy to the prostate

Study design
Purpose
Duration
Selection
Timing
Statistical methods / analysis

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
2/12/2024
Actual
Date of last participant enrolment
Anticipated
1/01/2026
Actual
Date of last data collection
Anticipated
1/01/2026
Actual
Sample size
Target
20
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
QLD

Funding & Sponsors
Funding source category [1] 317514 0
Commercial sector/Industry
Name [1] 317514 0
GenesisCare
Country [1] 317514 0
Australia
Primary sponsor type
Commercial sector/Industry
Name
GenesisCare
Address
Country
Australia
Secondary sponsor category [1] 319958 0
None
Name [1] 319958 0
Address [1] 319958 0
Country [1] 319958 0

Ethics approval
Ethics application status
Submitted, not yet approved
Ethics committee name [1] 316228 0
St Vincent’s Hospital Human Research Ethics Committee
Ethics committee address [1] 316228 0
Ethics committee country [1] 316228 0
Australia
Date submitted for ethics approval [1] 316228 0
01/10/2024
Approval date [1] 316228 0
Ethics approval number [1] 316228 0

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

Contacts
Principal investigator
Name 137214 0
Mrs Rebecca Nield
Address 137214 0
GenesisCare Southport, White Street, Southport QLD 4215
Country 137214 0
Australia
Phone 137214 0
+61755521400
Fax 137214 0
Email 137214 0
[email protected]
Contact person for public queries
Name 137215 0
Rebecca Nield
Address 137215 0
GenesisCare Southport, White Street, Southport QLD 4215
Country 137215 0
Australia
Phone 137215 0
+61755521400
Fax 137215 0
Email 137215 0
[email protected]
Contact person for scientific queries
Name 137216 0
Rebecca Nield
Address 137216 0
GenesisCare Southport, White Street, Southport QLD 4215
Country 137216 0
Australia
Phone 137216 0
+61755521400
Fax 137216 0
Email 137216 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


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.