Protection of Rectum From High Radiation Doses Using a Spacer

Prostatic Neoplasms Clinical Trial

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT01918605
• Other study ID #: OY-111
• Status: Terminated
• Phase: N/A
• First received: August 5, 2013
• Last updated: October 25, 2017
• Start date: June 2013
• Est. completion date: October 2017

Study information

• Verified date: October 2017
• Source: University of Oulu
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 5
• Est. completion date: October 2017
• Est. primary completion date: October 2017
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 50 Years to 78 Years

Eligibility

Inclusion Criteria:

• prostate cancer patients with planned low-dose brachytherapy for the treatment of prostate cancer

Exclusion Criteria:

• not willing to participate this study

Related Conditions & MeSH terms

• Genital Neoplasms, Male
• Neoplasms
• Neoplasms by Site
• Prostatic Neoplasms
• Urogenital Neoplasms

Intervention

Device:
• Diluted spacer

• Non-diluted spacer

Locations

Country	Name	City	State
Finland	Oulu University Hospital	Oulu

Sponsors (2)

Lead Sponsor	Collaborator
University of Oulu	Oulu University Hospital

Country where clinical trial is conducted

Finland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	1 day, 4 weeks, 8 weeks, 12 weeks
Secondary	Side effects	Possible side effects will be collected by subject interview and physical examination on specified time frame.	1 day, 4 weeks, 8 weeks, 12 weeks
Secondary	Rectum radiation dose	Rectum dose will be calculated based on CT scans after brachytherapy.	1 day, 4 weeks, 8 weeks, 12 weeks