Protection of Rectum From High Radiation Doses
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.
Interventional
Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Supportive Care
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 8 to 16 weeks after the operation in order to confirm the extent of spacer.
1 day, 4 weeks, 8 weeks
No
Markku Vaarala, MD, PhD
Principal Investigator
Oulu Univeristy Hospital
Finland: National Supervisory Authority for Welfare and Health
241/2011
NCT01601691
April 2012
March 2013
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