Trial Outcomes & Findings for CT-validation of Ultrasound Based Planning for High Dose Rate (HDR) Prostate Brachytherapy Using Vitesse (NCT NCT01248741)
NCT ID: NCT01248741
Last Updated: 2020-12-11
Results Overview
Precise location of the tip of each needle in 3-dimensional space relative to the prostate determines the pattern of dose delivery. Inaccuracies in needle tip location may lead to differences detected between UltraSound(US)-based and Computed Tomography (CT)-based plans.The distance of the needle tip (as identified on either CT images or US images) protruding beyond the template was measured in mm. The template acted as a fixed reference point as it was locked into the stabilizer/stepper apparatus. The 2 protrusion readings for each needle tip were compared, the difference recorded in mm, and categorized as \< 1 mm, 1-2 mm, 2-3 mm and \> 3 mm.
COMPLETED
NA
20 participants
Treatment was planned and delivered based on ultrasound identification of needles and needle tips relative to prostate. All measurements and comparisons of measurements pertain to the day of the procedure.
2020-12-11
Participant Flow
20 patients were recruited from the target population of men with localized prostate cancer undergoing radical radiotherapy consisting of a combination of external beam radiation and 2 fractions of 10 Gray each of High Dose Rate brachytherapy
Participant milestones
| Measure |
HDR Prostate Brachytherapy
HDR prostate brachytherapy: HDR prostate brachytherapy to be delivered in 2 fractions of 10 Gray as a "boost" combined with external beam radiotherapy
|
|---|---|
|
Overall Study
STARTED
|
20
|
|
Overall Study
COMPLETED
|
20
|
|
Overall Study
NOT COMPLETED
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
CT-validation of Ultrasound Based Planning for High Dose Rate (HDR) Prostate Brachytherapy Using Vitesse
Baseline characteristics by cohort
| Measure |
Localized Prostate Cancer
n=20 Participants
Patients had either intermediate risk or favorable high risk disease suitable for definitive radiotherapy.
|
|---|---|
|
Age, Continuous
|
65 years
n=5 Participants
|
|
Sex: Female, Male
Female
|
0 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
20 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
|
20 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
Canada
|
20 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Treatment was planned and delivered based on ultrasound identification of needles and needle tips relative to prostate. All measurements and comparisons of measurements pertain to the day of the procedure.Precise location of the tip of each needle in 3-dimensional space relative to the prostate determines the pattern of dose delivery. Inaccuracies in needle tip location may lead to differences detected between UltraSound(US)-based and Computed Tomography (CT)-based plans.The distance of the needle tip (as identified on either CT images or US images) protruding beyond the template was measured in mm. The template acted as a fixed reference point as it was locked into the stabilizer/stepper apparatus. The 2 protrusion readings for each needle tip were compared, the difference recorded in mm, and categorized as \< 1 mm, 1-2 mm, 2-3 mm and \> 3 mm.
Outcome measures
| Measure |
Localized Prostate Cancer
n=20 Participants
Patients had either intermediate risk or favorable high risk disease suitable for definitive radiotherapy.
|
|---|---|
|
Accuracy of Needle Tip Identification on TransRectal UltraSound Compared to Computed Tomography
|
1.1 mm
Standard Deviation 0.1
|
Adverse Events
Localized Prostate Cancer
Serious adverse events
| Measure |
Localized Prostate Cancer
n=20 participants at risk
Patients had either intermediate risk or favorable high risk disease suitable for definitive radiotherapy.
|
|---|---|
|
Gastrointestinal disorders
colostomy
|
5.0%
1/20 • Number of events 1
|
Other adverse events
| Measure |
Localized Prostate Cancer
n=20 participants at risk
Patients had either intermediate risk or favorable high risk disease suitable for definitive radiotherapy.
|
|---|---|
|
Renal and urinary disorders
urethral stricture
|
10.0%
2/20 • Number of events 2
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place