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Trial Details
indicate updates made to monitored data item(s) since trial registration. These data item(s) are monitored to ensure they comply with the WHO / journal editors standards.
 
Request Number: 082073
ACTR Number: ACTRN12607000335493
Trial Status: Registered
Date Submitted: 7/06/2007
Date Registered: 22/06/2007

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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
ANZCTR registration 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
Secondary ID: 
UTN:
Trial acronym:

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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. 
Condition category: Condition code:
Cancer Prostate 

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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:Treatment devices 
Comparator / control treatment: no control group
Control group: Uncontrolled

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Primary outcome: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:The feasibility outcome will be analysed after 20 patients' fiducial markers measurements have been collected. 
Secondary outcome 1: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: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: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:After 20 patients' fiducial markers measurements have been collected 
Secondary outcome 3: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:After 20 patients' fiducial markers measurements have been collected 

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Key inclusion criteria: all men with clinically localised prostate cancer consented for radiotherapy
Minimum Age: 50 Years
Maximum Age: 80 Years
Gender: Males
Healthy volunteers? No
Key exclusion criteria: on anti-coagulants where ceasing the medications are a cardiovascular risk

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Study type: Interventional
Purpose of the study: Treatment
Allocation to intervention: Nonrandomised trial
Describe the procedure for enrolling a subject and allocating the treatment (allocation concealment procedures):
Describe the methods used to generate the sequence in which subjects will be randomised (sequence generation):
Masking / blinding: Open (masking not used)
Assignment: Single group
Other design features (specify):
Type of endpoint(s): Efficacy

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Phase
Anticipated or actual date of first participant enrolement: 1/04/2007
Target sample size: 20
Recruitment status: Completed

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Funding source:Hospital 
Name:Department of Radiation Oncology, Royal Prince Alfred Hospital 
Address:Department of Radiation Oncology Royal Prince Alfred Hospital Camperdown 2050 
Country:Australia 
Primary sponsor: Individual
Name: Dr George Hruby
Address: Department of Radiation Oncology Royal Prince Alfred Hospital Camperdown 2050
Country: Australia
Secondary sponsor 1:Individual 
Name:Dr Michael Jackson 
Address:Department of Radiation Oncology Royal Prince Alfred Hospital Camperdown 2050 
Country:Australia 
Secondary sponsor 2:Individual 
Name:A/Prof Chris Milross 
Address:Department of Radiation Oncology Royal Prince Alfred Hospital Camperdown 2050 
Country:Australia 
Other collaborator: 

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Has the study received approval from at least one ethics committee? Yes
Ethics Committee name:Royal Prince Alfred Hospital, Department of Radiation Oncology 
Address: 
Country:Australia 
Date of approval:19/03/2007 
HREC Number:X07-0007 
Countries of recruitment:Australia 
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:
Presentations / publication list:

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Contact person for public queries
Name: Dr George Hruby
Address: Department of Radiation Oncology Royal Prince Alfred Hospital Camperdown NSW 2050
Country: Australia
Tel: +61 2 95158057
Fax: +61 2 95158070
Email: ghruby@email.cs.nsw.gov.au

Contact person for scientific queries
Name: Dr George Hruby
Address: Department of Radiation Oncology Royal Prince Alfred Hospital Camperdown NSW 2050
Country: Australia
Tel: +61 2 95158057
Fax: +61 2 95158070
Email: ghruby@email.cs.nsw.gov.au

Contact person responsible for updating information
Name: Carol Kwong
Address: Department of Radiation Oncology
Royal Prince Alfred Hosptial Camperdown 2050
Country: Australia
Tel: 9515 6229
Fax: 9515 8057
Email: carol.kwong@email.cs.nsw.gov.au
   
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