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Protection of Rectum From High Radiation Doses

50 Years
76 Years
Not Enrolling
Prostate Cancer

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Trial Information

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.

Inclusion Criteria:

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

Exclusion Criteria:

- not willing to participate this study

Type of Study:


Study Design:

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Supportive Care

Outcome Measure:

Change in spacer volume

Outcome 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 8 to 16 weeks after the operation in order to confirm the extent of spacer.

Outcome Time Frame:

1 day, 4 weeks, 8 weeks

Safety Issue:


Principal Investigator

Markku Vaarala, MD, PhD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Oulu Univeristy Hospital


Finland: National Supervisory Authority for Welfare and Health

Study ID:




Start Date:

April 2012

Completion Date:

March 2013

Related Keywords:

  • Prostate Cancer
  • prostate cancer
  • brachytherapy
  • spacer
  • side effect
  • Prostatic Neoplasms