Protection of Rectum From High Radiation Doses
1 other identifier
interventional
10
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable prostate-cancer
Started Apr 2012
Shorter than P25 for not_applicable prostate-cancer
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
April 1, 2012
CompletedFirst Submitted
Initial submission to the registry
May 14, 2012
CompletedFirst Posted
Study publicly available on registry
May 18, 2012
CompletedPrimary Completion
Last participant's last visit for primary outcome
January 1, 2013
CompletedStudy Completion
Last participant's last visit for all outcomes
March 1, 2013
CompletedResults Posted
Study results publicly available
November 14, 2014
CompletedNovember 14, 2014
November 1, 2014
9 months
May 14, 2012
November 4, 2014
November 13, 2014
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Spacer Volume Half Life
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.
1 day, 4 weeks, 8 weeks, up-to 16 weeks
Secondary Outcomes (2)
Side Effects
1 day, 4 weeks, 8 weeks, 12 weeks
Rectum Radiation Dose
1 day, 4 weeks, 8 weeks
Study Arms (1)
Spacer
EXPERIMENTALSubjects with spacer injection
Interventions
Single dose of DuraSeal product with DuraSeal components diluted 1:1 in sterile saline injected between rectum and prostate
Eligibility Criteria
You may qualify if:
- prostate cancer patients with planned low dose brachytherapy for the treatment of prostate cancer
You may not qualify if:
- not willing to participate this study
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- University of Oululead
- Oulu University Hospitalcollaborator
Study Sites (1)
Oulu University Hospital
Oulu, Oulu, 90029, Finland
Related Publications (1)
Heikkila VP, Karna A, Vaarala MH. DuraSeal as a spacer to reduce rectal doses in low-dose rate brachytherapy for prostate cancer. Radiother Oncol. 2014 Aug;112(2):233-6. doi: 10.1016/j.radonc.2014.08.012. Epub 2014 Sep 4.
PMID: 25201125DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Results Point of Contact
- Title
- Dr. Markku Vaarala
- Organization
- Oulu University Hospital
Study Officials
- 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
Publication Agreements
- PI is Sponsor Employee
- No
- Restrictive Agreement
- No
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NA
- Masking
- NONE
- Purpose
- SUPPORTIVE CARE
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- MD, PhD
Study Record Dates
First Submitted
May 14, 2012
First Posted
May 18, 2012
Study Start
April 1, 2012
Primary Completion
January 1, 2013
Study Completion
March 1, 2013
Last Updated
November 14, 2014
Results First Posted
November 14, 2014
Record last verified: 2014-11