Protection of Rectum From High Radiation Doses

Not Applicable

Completed

• Conditions: Prostate Cancer
• Interventions: Device: DuraSeal

• Registration Number: NCT01601691
• Lead Sponsor: University of Oulu

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.

Study Timeline

• Study Start: 2012-04
• Study First Submitted: 2012-05-14
• Study First Submitted QC: 2012-05-16
• Study First Posted: 2012-05-18
• Primary Completion: 2013-01
• Study Completion: 2013-03
• Status Verified: 2014-11
• Results First Submitted: 2014-11-04
• Results First Submitted QC: 2014-11-13
• Last Update Submitted: 2014-11-13
• Results First Posted: 2014-11-14
• Last Update Posted: 2014-11-14

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Male
• Target Recruitment: 10

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Spacer	DuraSeal	Subjects with spacer injection

Primary Outcome Measures

Name	Time	Method
Spacer Volume Half Life	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.

Secondary Outcome Measures

Name	Time	Method
Side Effects	1 day, 4 weeks, 8 weeks, 12 weeks	Possible side effects will be collected by subject interview and physical examination on specified time frame.
Rectum Radiation Dose	1 day, 4 weeks, 8 weeks	Rectum dose will be calculated based on CT scans after brachytherapy.

Trial Locations

Locations (1)

Oulu University Hospital; 🇫🇮 Oulu, Finland