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Protection of Rectum From High Radiation Doses Using a Spacer

Primary Purpose

Prostatic Neoplasms, Genital Neoplasms, Male, Urogenital Neoplasms

Status
Terminated
Phase
Not Applicable
Locations
Finland
Study Type
Interventional
Intervention
Diluted spacer
Non-diluted spacer
Sponsored by
University of Oulu
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Prostatic Neoplasms focused on measuring prostate cancer, brachytherapy, spacer, side effect

Eligibility Criteria

50 Years - 78 Years (Adult, Older Adult)MaleDoes not accept healthy volunteers

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 2

Arm Type

Experimental

Active Comparator

Arm Label

Diluted spacer

Non-diluted spacer

Arm Description

Single dose of DuraSeal product with DuraSeal components diluted 1:1 in sterile saline injected between rectum and prostate

Single dose of DuraSeal product injected between rectum and prostate

Outcomes

Primary Outcome Measures

Change in spacer volume
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 12 weeks after the operation in order to confirm the extent of spacer.

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

First Posted
August 5, 2013
Last Updated
October 25, 2017
Sponsor
University of Oulu
Collaborators
Oulu University Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT01918605
Brief Title
Protection of Rectum From High Radiation Doses Using a Spacer
Official Title
Protection of Rectum From High Radiation Doses During Prostate Cancer Low-dose Brachytherapy Using Diluted or Non-diluted DuraSeal as a Spacer
Study Type
Interventional

2. Study Status

Record Verification Date
October 2017
Overall Recruitment Status
Terminated
Why Stopped
Insufficient enrollment.
Study Start Date
June 2013 (Actual)
Primary Completion Date
October 2017 (Actual)
Study Completion Date
October 2017 (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 and non-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. The subjects will be randomized to receive either diluted or non-diluted DuraSeal product as a spacer between prostate and rectum. Diluted or non-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. If the subject is randomized to receive non-diluted DuraSeal, the procedure will be identical with the exception the DuraSeal components will not be diluted. 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, and 4, 8 and 12 weeks after the operation. In addition, magnetic resonance imaging of pelvis performed 12 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
Prostatic Neoplasms, Genital Neoplasms, Male, Urogenital Neoplasms, Neoplasms by Site
Keywords
prostate cancer, brachytherapy, spacer, side effect

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
5 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Diluted spacer
Arm Type
Experimental
Arm Description
Single dose of DuraSeal product with DuraSeal components diluted 1:1 in sterile saline injected between rectum and prostate
Arm Title
Non-diluted spacer
Arm Type
Active Comparator
Arm Description
Single dose of DuraSeal product injected between rectum and prostate
Intervention Type
Device
Intervention Name(s)
Diluted spacer
Other Intervention Name(s)
DuraSeal
Intervention Type
Device
Intervention Name(s)
Non-diluted spacer
Other Intervention Name(s)
DuraSeal
Primary Outcome Measure Information:
Title
Change in spacer volume
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 12 weeks after the operation in order to confirm the extent of spacer.
Time Frame
1 day, 4 weeks, 8 weeks, 12 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, 12 weeks

10. Eligibility

Sex
Male
Minimum Age & Unit of Time
50 Years
Maximum Age & Unit of Time
78 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 University 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, PhL
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

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Protection of Rectum From High Radiation Doses Using a Spacer

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