Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12607000335493
Ethics application status
Approved
Date submitted
7/06/2007
Date registered
22/06/2007
Date last updated
8/09/2016
Type of registration
Retrospectively registered

Titles & IDs
Public title
Implantation of marker seeds into the prostate; to improve quality of radiotherapy delivery and to allow dose escalation for men with localised prostate cancer
Scientific title
Implantation of marker seeds into the prostate; to improve quality of radiotherapy delivery and to allow dose escalation for men with localised prostate cancer
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Localised prostate cancer in men.
Inter-fraction prostate motion and motion of prostate relative to its position at simulation are potential sources of systematic treatment error. 1886 0
Condition category
Condition code
Cancer 1981 1981 0 0
Prostate

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Nonrandomised study. Three marker seeds will be inserted into the prostate before radiation planning. Using sequential portal films, the seeds can be visualised and measurements will be performed to assess set-up errors over the course of radiation therapy.
The marker seeds will stay in the prostate permanently. The course of radiation therapy will be 7 weeks.
Intervention code [1] 1810 0
Treatment: Devices
Comparator / control treatment
no control group
Control group
Uncontrolled

Outcomes
Primary outcome [1] 2802 0
To assess the feasibility and potential implications for using fiducial markers rather than bony landmarks for realigning patients during treatment.
Every patient will have 7 weeks of radiation therapy treatment. During treatment, they will have daily portal films for the first 2 weeks and then twice per week for the remaining weeks. Measurements of the seeds position will be performed by a medical physicist.
Timepoint [1] 2802 0
The feasibility outcome will be analysed after 20 patients' fiducial markers measurements have been collected.
Secondary outcome [1] 4724 0
To measure organ motion and set-up errors over the course of radiation therapy from sequential portal films with fiducial seed markers implanted in the prostate.
Timepoint [1] 4724 0
During the 7 weeks of radiotherapy, each patient will have daily sequential portal films for the first 2 weeks and then twice per week for the remaining weeks of treatment (i.e. 5 weeks). The portal films will be matched with the planning films to assess organ motion and set-up error.
Outcome will be analysed after 20 patients' fiducial markers measurements have been collected.
Secondary outcome [2] 4725 0
To use the data collected to calculate the appropriate conformal margins for the treatment of localised prosate cancer and then allow for safe dose escalation
Timepoint [2] 4725 0
After 20 patients' fiducial markers measurements have been collected
Secondary outcome [3] 4726 0
During the 7 weeks of radiotherapy treatment, each patient will have daily sequential portal films for the first 2 weeks and then twice per week for the remaining weeks (i.e. 5 weeks). Measurements will be performed by a medical physicist.
Data will be used to calculate the appropriate conformal margins after 20 patients' fiducial markers measurements have been collected.
Timepoint [3] 4726 0
After 20 patients' fiducial markers measurements have been collected

Eligibility
Key inclusion criteria
all men with clinically localised prostate cancer consented for radiotherapy
Minimum age
50 Years
Maximum age
80 Years
Sex
Males
Can healthy volunteers participate?
No
Key exclusion criteria
on anti-coagulants where ceasing the medications are a cardiovascular risk

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
Type of endpoint/s
Efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
1/04/2007
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
20
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)

Funding & Sponsors
Funding source category [1] 2121 0
Hospital
Name [1] 2121 0
Department of Radiation Oncology, Royal Prince Alfred Hospital
Country [1] 2121 0
Australia
Primary sponsor type
Individual
Name
Dr George Hruby
Address
Department of Radiation Oncology
Royal Prince Alfred Hospital Camperdown 2050
Country
Australia
Secondary sponsor category [1] 1927 0
Individual
Name [1] 1927 0
Dr Michael Jackson
Address [1] 1927 0
Department of Radiation Oncology
Royal Prince Alfred Hospital Camperdown 2050
Country [1] 1927 0
Australia
Secondary sponsor category [2] 1928 0
Individual
Name [2] 1928 0
A/Prof Chris Milross
Address [2] 1928 0
Department of Radiation Oncology
Royal Prince Alfred Hospital Camperdown 2050
Country [2] 1928 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 3914 0
Royal Prince Alfred Hospital, Department of Radiation Oncology
Ethics committee address [1] 3914 0
Ethics committee country [1] 3914 0
Australia
Date submitted for ethics approval [1] 3914 0
Approval date [1] 3914 0
19/03/2007
Ethics approval number [1] 3914 0
X07-0007

Summary
Brief summary
This is a study of implantation of marker seeds into the prostate to assess the feasibility of using marker seeds to locate the prostate before daily radiotherapy treatment for men with localised prostate cancer.

Who is it for?

You can join this study if you are a man aged 50–80 years with localised prostate cancer and you are going to have radiation therapy.

Trial details

Participants will have three marker seeds inserted under local anaesthetic into the prostate before radiotherapy. The seeds are like small rods inserted into the prostate gland and act as ‘landmarks’ so radiotherapy can be given as accurately as possible.

All participants will have radiotherapy for 7 weeks. During the 7 weeks of therapy, X-rays will be taken daily for the first 2 weeks to measure the position of the seeds. After that, X-rays will be taken twice a week for 5 weeks to continue to measure the position of the marker seeds. These seeds will stay in your prostate permanently.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 27913 0
Address 27913 0
Country 27913 0
Phone 27913 0
Fax 27913 0
Email 27913 0
Contact person for public queries
Name 10999 0
Dr George Hruby
Address 10999 0
Department of Radiation Oncology
Royal Prince Alfred Hospital
Camperdown NSW 2050
Country 10999 0
Australia
Phone 10999 0
+61 2 95158057
Fax 10999 0
+61 2 95158070
Email 10999 0
[email protected]
Contact person for scientific queries
Name 1927 0
Dr George Hruby
Address 1927 0
Department of Radiation Oncology
Royal Prince Alfred Hospital
Camperdown NSW 2050
Country 1927 0
Australia
Phone 1927 0
+61 2 95158057
Fax 1927 0
+61 2 95158070
Email 1927 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.