Protection of Rectum From High Radiation Doses
November 13, 2014 updated by: Markku Vaarala, MD, PhD, University of Oulu
The purpose of this study is to evaluate the usefulness of diluted DuraSeal product as a spacer between prostate and rectum in prostate cancer low dose brachytherapy.
Study Overview
Detailed Description
Radiation therapy for prostate cancer leads to inappropriate radiation dose to the rectum wall leading rectum adverse effects in long term for some patients.
A resorbable spaces between prostate and rectum could decrease the incidence of these side effect.
In this trial, men with prostate cancer with intention to curative treatment by low dose brachytherapy will be recruited.
Diluted DuraSeal will be applied between rectum and prostate at the end of the brachytherapy seed implantation procedure.
After the implantation of the brachytherapy seeds, a needle is placed between rectum and prostate through perineal skin under transrectal ultrasound guidance.
The proper position of the needle is confirmed by the injection of 10-15 ml sterile saline solution.
After that, DuraSeal components are diluted in 1:1 with sterile saline and 6-10 ml of this diluted product will be injected using DuraSeal applicator.
The resolution of the spacer will be followed by repeated plain computer tomography (CT) of pelvis performed a day before operation, a day after the operation, 4 weeks after the operation and 8 weeks after the operation.
In addition, magnetic resonance imaging of pelvis performed 8 to 16 weeks after the operation.
The space created between prostate and rectum will be documented by plain CT and magnetic resonance imaging.
Rectum radiation dose will be calculated based on these scans.
Time to DuraSeal resolution will be evaluated from the scans.
Possible side effects will be collected by subject interviews during follow-up visits at 4, 8 and 12 weeks after the operation.
Study Type
Interventional
Enrollment (Actual)
10
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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-
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Oulu, Finland, 90029
- Oulu University Hospital
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
50 years to 76 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
Male
Description
Inclusion Criteria:
- prostate cancer patients with planned low dose brachytherapy for the treatment of prostate cancer
Exclusion Criteria:
- not willing to participate this study
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Supportive Care
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Spacer
Subjects with spacer injection
|
Single dose of DuraSeal product with DuraSeal components diluted 1:1 in sterile saline injected between rectum and prostate
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Spacer Volume Half Life
Time Frame: 1 day, 4 weeks, 8 weeks, up-to 16 weeks
|
Time to spacer resolution will be measured based on the distance between rectum wall and prostate on CT scans before operation and on defined time frame.
In addition, magnetic resonance imaging of pelvis will be performed 8 to 16 weeks after the operation in order to confirm the extent of spacer.
Spacer volume half life is reported.
|
1 day, 4 weeks, 8 weeks, up-to 16 weeks
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Side Effects
Time Frame: 1 day, 4 weeks, 8 weeks, 12 weeks
|
Possible side effects will be collected by subject interview and physical examination on specified time frame.
|
1 day, 4 weeks, 8 weeks, 12 weeks
|
|
Rectum Radiation Dose
Time Frame: 1 day, 4 weeks, 8 weeks
|
Rectum dose will be calculated based on CT scans after brachytherapy.
|
1 day, 4 weeks, 8 weeks
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Collaborators
Investigators
- Principal Investigator: Markku Vaarala, MD, PhD, Oulu Univeristy Hospital
- Study Chair: Merja Korpela, MD, Oulu University Hospital
- Study Chair: Vesa-Pekka Heikkilä, FL, Oulu University Hospital
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
April 1, 2012
Primary Completion (Actual)
January 1, 2013
Study Completion (Actual)
March 1, 2013
Study Registration Dates
First Submitted
May 14, 2012
First Submitted That Met QC Criteria
May 16, 2012
First Posted (Estimate)
May 18, 2012
Study Record Updates
Last Update Posted (Estimate)
November 14, 2014
Last Update Submitted That Met QC Criteria
November 13, 2014
Last Verified
November 1, 2014
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 241/2011
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