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Protection of Rectum From High Radiation Doses

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01601691
Recruitment Status : Completed
First Posted : May 18, 2012
Results First Posted : November 14, 2014
Last Update Posted : November 14, 2014
Sponsor:
Collaborator:
Oulu University Hospital
Information provided by (Responsible Party):
Markku Vaarala, MD, PhD, University of Oulu

Study Description
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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.

Condition or disease Intervention/treatment Phase
Prostate Cancer Device: DuraSeal Not Applicable

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 Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 10 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Supportive Care
Official Title: Protection of Rectum From High Radiation Doses
Study Start Date : April 2012
Actual Primary Completion Date : January 2013
Actual Study Completion Date : March 2013

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
Experimental: Spacer
Subjects with spacer injection
 Device: DuraSeal
Single dose of DuraSeal product with DuraSeal components diluted 1:1 in sterile saline injected between rectum and prostate


Outcome Measures
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Primary Outcome Measures :
  1. Spacer Volume Half Life [ Time Frame: 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 :
  1. Side Effects [ Time Frame: 1 day, 4 weeks, 8 weeks, 12 weeks ]
    Possible side effects will be collected by subject interview and physical examination on specified time frame.

  2. Rectum Radiation Dose [ Time Frame: 1 day, 4 weeks, 8 weeks ]
    Rectum dose will be calculated based on CT scans after brachytherapy.


Eligibility Criteria
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Ages Eligible for Study:   50 Years to 76 Years   (Adult, Older Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

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

Exclusion Criteria:

  • not willing to participate this study
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01601691


Locations
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Finland
Oulu University Hospital
Oulu, Finland, 90029
Sponsors and Collaborators
University of Oulu
Oulu University Hospital
Investigators
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Principal Investigator: Markku Vaarala, MD, PhD Oulu Univeristy Hospital
Study Chair: Merja Korpela, MD Oulu University Hospital
Study Chair: Vesa-Pekka Heikkilä, FL Oulu University Hospital
More Information
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Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: Markku Vaarala, MD, PhD, MD, PhD, University of Oulu
ClinicalTrials.gov Identifier: NCT01601691    
Other Study ID Numbers: 241/2011
First Posted: May 18, 2012    Key Record Dates
Results First Posted: November 14, 2014
Last Update Posted: November 14, 2014
Last Verified: November 2014
Keywords provided by Markku Vaarala, MD, PhD, University of Oulu:
prostate cancer
brachytherapy
spacer
side effect
Additional relevant MeSH terms:
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Prostatic Neoplasms
Genital Neoplasms, Male
Urogenital Neoplasms
 Neoplasms by Site
Neoplasms
Prostatic Diseases