Protection of Rectum From High Radiation Doses
Primary Purpose
Prostate Cancer
Status
Completed
Phase
Not Applicable
Locations
Finland
Study Type
Interventional
Intervention
DuraSeal
Sponsored by
About this trial
This is an interventional supportive care trial for Prostate Cancer focused on measuring prostate cancer, brachytherapy, spacer, side effect
Eligibility Criteria
Inclusion Criteria:
- prostate cancer patients with planned low dose brachytherapy for the treatment of prostate cancer
Exclusion Criteria:
- not willing to participate this study
Sites / Locations
- Oulu University Hospital
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Spacer
Arm Description
Subjects with spacer injection
Outcomes
Primary Outcome Measures
Spacer Volume Half Life
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.
Secondary Outcome Measures
Side Effects
Possible side effects will be collected by subject interview and physical examination on specified time frame.
Rectum Radiation Dose
Rectum dose will be calculated based on CT scans after brachytherapy.
Full Information
NCT ID
NCT01601691
First Posted
May 14, 2012
Last Updated
November 13, 2014
Sponsor
University of Oulu
Collaborators
Oulu University Hospital
1. Study Identification
Unique Protocol Identification Number
NCT01601691
Brief Title
Protection of Rectum From High Radiation Doses
Official Title
Protection of Rectum From High Radiation Doses
Study Type
Interventional
2. Study Status
Record Verification Date
November 2014
Overall Recruitment Status
Completed
Study Start Date
April 2012 (undefined)
Primary Completion Date
January 2013 (Actual)
Study Completion Date
March 2013 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Oulu
Collaborators
Oulu University Hospital
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Prostate Cancer
Keywords
prostate cancer, brachytherapy, spacer, side effect
7. Study Design
Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
10 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Spacer
Arm Type
Experimental
Arm Description
Subjects with spacer injection
Intervention Type
Device
Intervention Name(s)
DuraSeal
Intervention Description
Single dose of DuraSeal product with DuraSeal components diluted 1:1 in sterile saline injected between rectum and prostate
Primary Outcome Measure Information:
Title
Spacer Volume Half Life
Description
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.
Time Frame
1 day, 4 weeks, 8 weeks, up-to 16 weeks
Secondary Outcome Measure Information:
Title
Side Effects
Description
Possible side effects will be collected by subject interview and physical examination on specified time frame.
Time Frame
1 day, 4 weeks, 8 weeks, 12 weeks
Title
Rectum Radiation Dose
Description
Rectum dose will be calculated based on CT scans after brachytherapy.
Time Frame
1 day, 4 weeks, 8 weeks
10. Eligibility
Sex
Male
Minimum Age & Unit of Time
50 Years
Maximum Age & Unit of Time
76 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
prostate cancer patients with planned low dose brachytherapy for the treatment of prostate cancer
Exclusion Criteria:
not willing to participate this study
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Markku Vaarala, MD, PhD
Organizational Affiliation
Oulu Univeristy Hospital
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Merja Korpela, MD
Organizational Affiliation
Oulu University Hospital
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
Vesa-Pekka Heikkilä, FL
Organizational Affiliation
Oulu University Hospital
Official's Role
Study Chair
Facility Information:
Facility Name
Oulu University Hospital
City
Oulu
ZIP/Postal Code
90029
Country
Finland
12. IPD Sharing Statement
Citations:
PubMed Identifier
25201125
Citation
Heikkila VP, Karna A, Vaarala MH. DuraSeal as a spacer to reduce rectal doses in low-dose rate brachytherapy for prostate cancer. Radiother Oncol. 2014 Aug;112(2):233-6. doi: 10.1016/j.radonc.2014.08.012. Epub 2014 Sep 4.
Results Reference
derived
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Protection of Rectum From High Radiation Doses
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