Protection of Rectum From High Radiation Doses Using a Spacer

Sponsor

University of Oulu (Other)

Overall Status

Terminated

CT.gov ID

NCT01918605

Collaborator

Oulu University Hospital (Other)

Enrollment

Location

Arms

Actual Duration (Months)

0.1

Patients Per Site Per Month

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Prostatic Neoplasms Genital Neoplasms, Male Urogenital Neoplasms Neoplasms by Site	Device: Diluted spacer Device: Non-diluted spacer	N/A

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.

Study Design

Study Type:

Interventional

Actual Enrollment :

5 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

None (Open Label)

Primary Purpose:

Supportive Care

Official Title:

Protection of Rectum From High Radiation Doses During Prostate Cancer Low-dose Brachytherapy Using Diluted or Non-diluted DuraSeal as a Spacer

Actual Study Start Date :

Jun 1, 2013

Actual Primary Completion Date :

Oct 1, 2017

Actual Study Completion Date :

Oct 1, 2017

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Diluted spacer Single dose of DuraSeal product with DuraSeal components diluted 1:1 in sterile saline injected between rectum and prostate	Device: Diluted spacer Other Names: DuraSeal
Active Comparator: Non-diluted spacer Single dose of DuraSeal product injected between rectum and prostate	Device: Non-diluted spacer Other Names: DuraSeal

Arm

Intervention/Treatment

Experimental: Diluted spacer

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

Device: Diluted spacer

Other Names:

DuraSeal

Active Comparator: Non-diluted spacer

Single dose of DuraSeal product injected between rectum and prostate

Device: Non-diluted spacer

Other Names:

DuraSeal

Outcome Measures

Primary Outcome Measures

Change in spacer volume [1 day, 4 weeks, 8 weeks, 12 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 12 weeks after the operation in order to confirm the extent of spacer.

Secondary Outcome Measures

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, 12 weeks]
Rectum dose will be calculated based on CT scans after brachytherapy.