Study Stopped
Insufficient enrollment.
Protection of Rectum From High Radiation Doses Using a Spacer
1 other identifier
interventional
5
1 country
1
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable
Started Jun 2013
Longer than P75 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
June 1, 2013
CompletedFirst Submitted
Initial submission to the registry
August 5, 2013
CompletedFirst Posted
Study publicly available on registry
August 8, 2013
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 1, 2017
CompletedStudy Completion
Last participant's last visit for all outcomes
October 1, 2017
CompletedOctober 27, 2017
October 1, 2017
4.3 years
August 5, 2013
October 25, 2017
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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 Outcomes (2)
Side effects
1 day, 4 weeks, 8 weeks, 12 weeks
Rectum radiation dose
1 day, 4 weeks, 8 weeks, 12 weeks
Study Arms (2)
Diluted spacer
EXPERIMENTALSingle dose of DuraSeal product with DuraSeal components diluted 1:1 in sterile saline injected between rectum and prostate
Non-diluted spacer
ACTIVE COMPARATORSingle dose of DuraSeal product injected between rectum and prostate
Interventions
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, 90029, Finland
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Markku Vaarala, MD,PhD
Oulu University Hospital
- STUDY CHAIR
Merja Korpela, MD
Oulu University Hospital
- STUDY CHAIR
Vesa-Pekka Heikkilä, PhL
Oulu University Hospital
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- SUPPORTIVE CARE
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Associate Chief Urologist
Study Record Dates
First Submitted
August 5, 2013
First Posted
August 8, 2013
Study Start
June 1, 2013
Primary Completion
October 1, 2017
Study Completion
October 1, 2017
Last Updated
October 27, 2017
Record last verified: 2017-10