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Trial Outcomes & Findings for Protection of Rectum From High Radiation Doses (NCT NCT01601691)

NCT ID: NCT01601691

Last Updated: 2014-11-14

Results Overview

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.

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

10 participants

Primary outcome timeframe

1 day, 4 weeks, 8 weeks, up-to 16 weeks

Results posted on

2014-11-14

Participant Flow

Participant milestones

Participant milestones
Measure
Spacer
Subjects with spacer injection DuraSeal: Single dose of DuraSeal product with DuraSeal components diluted 1:1 in sterile saline injected between rectum and prostate
Overall Study
STARTED
10
Overall Study
COMPLETED
10
Overall Study
NOT COMPLETED
0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Protection of Rectum From High Radiation Doses

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure
Spacer
n=10 Participants
Subjects with spacer injection DuraSeal: Single dose of DuraSeal product with DuraSeal components diluted 1:1 in sterile saline injected between rectum and prostate
Age, Continuous
66 year
n=5 Participants
Sex: Female, Male
Female
0 Participants
n=5 Participants
Sex: Female, Male
Male
10 Participants
n=5 Participants
Race (NIH/OMB)
American Indian or Alaska Native
0 Participants
n=5 Participants
Race (NIH/OMB)
Asian
0 Participants
n=5 Participants
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
0 Participants
n=5 Participants
Race (NIH/OMB)
Black or African American
0 Participants
n=5 Participants
Race (NIH/OMB)
White
10 Participants
n=5 Participants
Race (NIH/OMB)
More than one race
0 Participants
n=5 Participants
Race (NIH/OMB)
Unknown or Not Reported
0 Participants
n=5 Participants
Region of Enrollment
Finland
10 participants
n=5 Participants

PRIMARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure
Spacer
n=10 Participants
Subjects with spacer injection DuraSeal: Single dose of DuraSeal product with DuraSeal components diluted 1:1 in sterile saline injected between rectum and prostate
Spacer Volume Half Life
47 days
Standard Deviation 12

SECONDARY outcome

Timeframe: 1 day, 4 weeks, 8 weeks, 12 weeks

Possible side effects will be collected by subject interview and physical examination on specified time frame.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 1 day, 4 weeks, 8 weeks

Rectum dose will be calculated based on CT scans after brachytherapy.

Outcome measures

Outcome data not reported

Adverse Events

Spacer

Serious events: 0 serious events
Other events: 2 other events
Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Other adverse events
Measure
Spacer
n=10 participants at risk
Subjects with spacer injection DuraSeal: Single dose of DuraSeal product with DuraSeal components diluted 1:1 in sterile saline injected between rectum and prostate
Gastrointestinal disorders
sensation of pressure in rectum
10.0%
1/10 • Number of events 1
Gastrointestinal disorders
sudden need for defecation
10.0%
1/10 • Number of events 1

Additional Information

Dr. Markku Vaarala

Oulu University Hospital

Phone: +3588315

Results disclosure agreements

  • Principal investigator is a sponsor employee
  • Publication restrictions are in place