Trial Outcomes & Findings for SpaceOAR System Pivotal Study (NCT NCT01538628)
NCT ID: NCT01538628
Last Updated: 2021-03-19
Results Overview
Measurements calculated and documented by the Core Lab. Measurements performed with the Core Lab blinded to subject identification. Results based on the Core Lab computation are considered as primary.
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
222 participants
Primary outcome timeframe
3 months post index procedure
Results posted on
2021-03-19
Participant Flow
The first subject was treated on January 27, 2012 and the last subject visit occurred on July 15, 2014.
Randomized study, no wash out or run-in period
Participant milestones
| Measure |
SpaceOAR
Subjects meeting the study eligibility criteria will be scheduled for fiducial marker placement using a transperineal approach with ultrasound guidance. Following successful fiducial marker placement, subjects will be randomized (2:1) to the treatment group or control group. Subjects randomized to the treatment group will undergo placement of 10 mL of SpaceOAR hydrogel
SpaceOAR System: Fiducial marker placement followed by randomization to treatment group, i.e., 10mL SpaceOAR hydrogel injection, or control group, i.e., no injection of SpaceOAR hydrogel.
|
Control
Subjects meeting the study eligibility criteria will be scheduled for fiducial marker placement using a transperineal approach with ultrasound guidance. Following successful fiducial marker placement, subjects will be randomized (2:1) to the treatment group or control group. Subjects randomized to the control group will not receive injection of the SpaceOAR hydrogel.
|
|---|---|---|
|
Overall Study
STARTED
|
149
|
73
|
|
Overall Study
COMPLETED
|
148
|
71
|
|
Overall Study
NOT COMPLETED
|
1
|
2
|
Reasons for withdrawal
| Measure |
SpaceOAR
Subjects meeting the study eligibility criteria will be scheduled for fiducial marker placement using a transperineal approach with ultrasound guidance. Following successful fiducial marker placement, subjects will be randomized (2:1) to the treatment group or control group. Subjects randomized to the treatment group will undergo placement of 10 mL of SpaceOAR hydrogel
SpaceOAR System: Fiducial marker placement followed by randomization to treatment group, i.e., 10mL SpaceOAR hydrogel injection, or control group, i.e., no injection of SpaceOAR hydrogel.
|
Control
Subjects meeting the study eligibility criteria will be scheduled for fiducial marker placement using a transperineal approach with ultrasound guidance. Following successful fiducial marker placement, subjects will be randomized (2:1) to the treatment group or control group. Subjects randomized to the control group will not receive injection of the SpaceOAR hydrogel.
|
|---|---|---|
|
Overall Study
Withdrawal by Subject
|
1
|
1
|
|
Overall Study
Lost to Follow-up
|
0
|
1
|
Baseline Characteristics
SpaceOAR System Pivotal Study
Baseline characteristics by cohort
| Measure |
SpaceOAR
n=149 Participants
Subjects randomized to receive SpaceOAR hydrogel.
|
Control
n=73 Participants
Subjects randomized to not receive SpaceOAR hydrogel.
|
Total
n=222 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
66.36 years
STANDARD_DEVIATION 7.73 • n=93 Participants
|
67.66 years
STANDARD_DEVIATION 6.51 • n=4 Participants
|
66.39 years
STANDARD_DEVIATION 7.39 • n=27 Participants
|
|
Sex: Female, Male
Female
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
|
Sex: Female, Male
Male
|
149 Participants
n=93 Participants
|
73 Participants
n=4 Participants
|
222 Participants
n=27 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
5 Participants
n=93 Participants
|
2 Participants
n=4 Participants
|
7 Participants
n=27 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
144 Participants
n=93 Participants
|
71 Participants
n=4 Participants
|
215 Participants
n=27 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=93 Participants
|
2 Participants
n=4 Participants
|
2 Participants
n=27 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
|
Race (NIH/OMB)
Black or African American
|
16 Participants
n=93 Participants
|
8 Participants
n=4 Participants
|
24 Participants
n=27 Participants
|
|
Race (NIH/OMB)
White
|
127 Participants
n=93 Participants
|
61 Participants
n=4 Participants
|
188 Participants
n=27 Participants
|
|
Race (NIH/OMB)
More than one race
|
2 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
2 Participants
n=27 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
4 Participants
n=93 Participants
|
2 Participants
n=4 Participants
|
6 Participants
n=27 Participants
|
|
Region of Enrollment
United States
|
149 participants
n=93 Participants
|
73 participants
n=4 Participants
|
222 participants
n=27 Participants
|
PRIMARY outcome
Timeframe: 3 months post index procedurePopulation: SpaceOAR Group Only
Measurements calculated and documented by the Core Lab. Measurements performed with the Core Lab blinded to subject identification. Results based on the Core Lab computation are considered as primary.
Outcome measures
| Measure |
SpaceOAR
n=147 Participants
Subjects randomized to receive SpaceOAR hydrogel.
|
Control
Subjects randomized to not receive SpaceOAR hydrogel.
|
|---|---|---|
|
Number of Subjects Achieving a Reduction of 25% or Greater in Percent Volume of the Rectum Receiving at Least 70 Gy Measured From CT Scans Acquired Pre and Post SpaceOAR Hydrogel Injection
|
143 Participants
|
—
|
PRIMARY outcome
Timeframe: 6 months post index procedurePopulation: Intent-to-Treat (ITT) population was defined to be all randomized subjects (SpaceOAR and Control group).
The primary safety endpoint was the occurrence of Grade 1 or greater rectal adverse events or procedure adverse events in the 6 months following the Index Procedure. The numbers reflect the percent of subjects in each arm/group that experienced grade 1 or greater rectal or procedure adverse events post index procedure.
Outcome measures
| Measure |
SpaceOAR
n=149 Participants
Subjects randomized to receive SpaceOAR hydrogel.
|
Control
n=73 Participants
Subjects randomized to not receive SpaceOAR hydrogel.
|
|---|---|---|
|
Percentage of Subjects Experiencing Grade 1 or Greater Rectal or Procedure Adverse Events Post Index Procedure
|
34.2 percentage of subjects
Interval 26.7 to 42.4
|
31.5 percentage of subjects
Interval 21.1 to 43.4
|
SECONDARY outcome
Timeframe: 6 months post index procedurePopulation: Intent-to-Treat (ITT) population was defined to be all randomized subjects (SpaceOAR and Control group).
The numbers reflect the percent of subjects in each arm/group that experienced grade 2 or greater rectal or procedure adverse events post index procedure.
Outcome measures
| Measure |
SpaceOAR
n=149 Participants
Subjects randomized to receive SpaceOAR hydrogel.
|
Control
n=73 Participants
Subjects randomized to not receive SpaceOAR hydrogel.
|
|---|---|---|
|
Percentage of Subjects Experiencing Grade 2 or Greater Rectal or Procedure Adverse Events in the 6 Months Following the Index Procedure
|
10 percentage of subjects
Interval 3.3 to 12.0
|
3 percentage of subjects
Interval 0.9 to 11.5
|
SECONDARY outcome
Timeframe: 3 months, 6 months, 12 months, 15 monthsPopulation: Intent-to-Treat (ITT) population was defined to be all randomized subjects (SpaceOAR and Control group). Mean change in score was calculated for the number of subjects providing data at each follow-up visit.
Expanded Prostate Cancer Index Composite (EPIC) is a comprehensive survey instrument designed to assesses the disease-specific aspects of prostate cancer and its therapies and comprises four domains. Scores for each domain (urinary, sexual, bowel, hormonal) range from 0-100, with higher scores indicating improved quality of life. Scores are reported as mean change from baseline at each time point.
Outcome measures
| Measure |
SpaceOAR
n=149 Participants
Subjects randomized to receive SpaceOAR hydrogel.
|
Control
n=73 Participants
Subjects randomized to not receive SpaceOAR hydrogel.
|
|---|---|---|
|
Change From Baseline in Expanded Prostate Cancer Index Composite (EPIC) Score Following Index Procedure
Change in Urinary Assessment Composite Score at 3 Months
|
-11.69 score on a scale
Standard Deviation 13.20
|
-11.20 score on a scale
Standard Deviation 16.50
|
|
Change From Baseline in Expanded Prostate Cancer Index Composite (EPIC) Score Following Index Procedure
Change in Urinary Assessment Composite Score at 6 Months
|
1.38 score on a scale
Standard Deviation 9.82
|
-0.83 score on a scale
Standard Deviation 13.12
|
|
Change From Baseline in Expanded Prostate Cancer Index Composite (EPIC) Score Following Index Procedure
Change in Urinary Assessment Composite Score at 12 Months
|
0.12 score on a scale
Standard Deviation 11.74
|
0.30 score on a scale
Standard Deviation 13.51
|
|
Change From Baseline in Expanded Prostate Cancer Index Composite (EPIC) Score Following Index Procedure
Change in Urinary Assessment Composite Score at 15 Months
|
1.69 score on a scale
Standard Deviation 11.74
|
2.2 score on a scale
Standard Deviation 11.66
|
|
Change From Baseline in Expanded Prostate Cancer Index Composite (EPIC) Score Following Index Procedure
Change in Sexual Assessment Composite Score at 3 Months
|
-7.60 score on a scale
Standard Deviation 17.36
|
-4.86 score on a scale
Standard Deviation 19.83
|
|
Change From Baseline in Expanded Prostate Cancer Index Composite (EPIC) Score Following Index Procedure
Change in Sexual Assessment Composite Score at 6 Months
|
-3.44 score on a scale
Standard Deviation 16.74
|
-2.35 score on a scale
Standard Deviation 18.68
|
|
Change From Baseline in Expanded Prostate Cancer Index Composite (EPIC) Score Following Index Procedure
Change in Sexual Assessment Composite Score at 12 Months
|
-7.21 score on a scale
Standard Deviation 19.32
|
-8.29 score on a scale
Standard Deviation 20.51
|
|
Change From Baseline in Expanded Prostate Cancer Index Composite (EPIC) Score Following Index Procedure
Change in Sexual Assessment Composite Score at 15 Months
|
-6.55 score on a scale
Standard Deviation 19.71
|
-5.33 score on a scale
Standard Deviation 21.52
|
|
Change From Baseline in Expanded Prostate Cancer Index Composite (EPIC) Score Following Index Procedure
Change in Bowel Habits Assessment Composite Score at 3 Months
|
-7.47 score on a scale
Standard Deviation 12.69
|
-6.24 score on a scale
Standard Deviation 12.05
|
|
Change From Baseline in Expanded Prostate Cancer Index Composite (EPIC) Score Following Index Procedure
Change in Bowel Habits Assessment Composite Score at 6 Months
|
-0.78 score on a scale
Standard Deviation 8.52
|
-2.44 score on a scale
Standard Deviation 9.54
|
|
Change From Baseline in Expanded Prostate Cancer Index Composite (EPIC) Score Following Index Procedure
Change in Bowel Habits Assessment Composite Score at 12 Months
|
-0.95 score on a scale
Standard Deviation 9.69
|
-3.08 score on a scale
Standard Deviation 8.61
|
|
Change From Baseline in Expanded Prostate Cancer Index Composite (EPIC) Score Following Index Procedure
Change in Bowel Habits Assessment Composite Score at 15 Months
|
-0.02 score on a scale
Standard Deviation 9.41
|
-2.14 score on a scale
Standard Deviation 9.29
|
|
Change From Baseline in Expanded Prostate Cancer Index Composite (EPIC) Score Following Index Procedure
Change in Hormonal Assessment Composite Score at 3 Months
|
-2.69 score on a scale
Standard Deviation 9.96
|
-3.87 score on a scale
Standard Deviation 8.99
|
|
Change From Baseline in Expanded Prostate Cancer Index Composite (EPIC) Score Following Index Procedure
Change in Hormonal Assessment Composite Score at 6 Months
|
-0.71 score on a scale
Standard Deviation 9.05
|
-2.35 score on a scale
Standard Deviation 11.33
|
|
Change From Baseline in Expanded Prostate Cancer Index Composite (EPIC) Score Following Index Procedure
Change in Hormonal Assessment Composite Score at 12 Months
|
-0.71 score on a scale
Standard Deviation 9.45
|
-0.81 score on a scale
Standard Deviation 8.88
|
|
Change From Baseline in Expanded Prostate Cancer Index Composite (EPIC) Score Following Index Procedure
Change in Hormonal Assessment Composite Score at 15 Months
|
0.03 score on a scale
Standard Deviation 9.58
|
0.70 score on a scale
Standard Deviation 8.92
|
SECONDARY outcome
Timeframe: 6 months post procedurePopulation: Intent-to-Treat (ITT) population was defined to be all randomized subjects (SpaceOAR and Control group).
The numbers reflect the percent of subjects in each arm/group that required at least one medication change to treat rectal or urinary symptoms in the 6 months post index procedure.
Outcome measures
| Measure |
SpaceOAR
n=149 Participants
Subjects randomized to receive SpaceOAR hydrogel.
|
Control
n=72 Participants
Subjects randomized to not receive SpaceOAR hydrogel.
|
|---|---|---|
|
Percentage of Subjects Requiring at Least One Medication Change for Mitigation of Rectal or Urinary Symptoms or for Procedure-related Events in the 6 Months Following the Index Procedure
|
56.4 percentage of subjects
Interval 48.0 to 64.5
|
63.9 percentage of subjects
Interval 51.7 to 74.9
|
SECONDARY outcome
Timeframe: 21 days post index procedure, prior to initiation of radiation therapyPopulation: SpaceOAR treated subjects experiencing a procedure related AE prior to initiation of radiation therapy.
An event was classified as a Procedure AE if it occurred during during and immediately after the Index Procedure or was deemed to be associated with the Index Procedure by the Clinical Events Committee (CEC). Per protocol subjects were to begin intensity modulated radiation therapy within 21 days following fiducial marker and/or SpaceOAR placement.
Outcome measures
| Measure |
SpaceOAR
n=149 Participants
Subjects randomized to receive SpaceOAR hydrogel.
|
Control
Subjects randomized to not receive SpaceOAR hydrogel.
|
|---|---|---|
|
Number of SpaceOAR Subjects Experiencing a Procedure-Related Adverse Event (AE) Prior to Initiation of Radiation Therapy
|
14 Participants
|
—
|
SECONDARY outcome
Timeframe: 21 days post index procedurePopulation: Intent-to-Treat (ITT) population was defined to be all randomized subjects (SpaceOAR and Control group).
All subjects begin Intensity Modulated Radiation Therapy (IMRT) within 21 days following index procedure (Fiducial Marker Placement with or without SpaceOAR Hydrogel Injection).
Outcome measures
| Measure |
SpaceOAR
n=149 Participants
Subjects randomized to receive SpaceOAR hydrogel.
|
Control
n=73 Participants
Subjects randomized to not receive SpaceOAR hydrogel.
|
|---|---|---|
|
Number of Subjects Experiencing a Delay in Radiation Therapy Associated With a Procedure or Device-Related Adverse Event
|
0 participants
Interval 0.0 to 2.4
|
0 participants
Interval 0.0 to 4.9
|
Adverse Events
SpaceOAR
Serious events: 21 serious events
Other events: 17 other events
Deaths: 0 deaths
Control
Serious events: 10 serious events
Other events: 2 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
SpaceOAR
n=149 participants at risk
Subjects randomized to receive SpaceOAR hydrogel.
|
Control
n=73 participants at risk
Subjects randomized to not receive SpaceOAR hydrogel.
|
|---|---|---|
|
Cardiac disorders
Acute coronary syndrome
|
0.67%
1/149 • Number of events 1
|
2.7%
2/73 • Number of events 2
|
|
Cardiac disorders
Angina unstable
|
0.67%
1/149 • Number of events 1
|
1.4%
1/73 • Number of events 1
|
|
Cardiac disorders
Arteriosclerosis coronary artery
|
0.00%
0/149
|
2.7%
2/73 • Number of events 2
|
|
Cardiac disorders
Atrial fibrillation
|
0.00%
0/149
|
1.4%
1/73 • Number of events 2
|
|
Cardiac disorders
Atrial flutter
|
0.67%
1/149 • Number of events 1
|
0.00%
0/73
|
|
Cardiac disorders
Atrioventricular block complete
|
0.67%
1/149 • Number of events 1
|
0.00%
0/73
|
|
Cardiac disorders
Myocardial infarction
|
0.00%
0/149
|
1.4%
1/73 • Number of events 1
|
|
Cardiac disorders
Tachycardia
|
0.67%
1/149 • Number of events 1
|
0.00%
0/73
|
|
Eye disorders
Corneal dystrophy
|
0.67%
1/149 • Number of events 1
|
0.00%
0/73
|
|
Gastrointestinal disorders
Inguinal hernia
|
0.67%
1/149 • Number of events 1
|
0.00%
0/73
|
|
Gastrointestinal disorders
Large intestinal haemorrhage
|
0.67%
1/149 • Number of events 1
|
0.00%
0/73
|
|
Gastrointestinal disorders
Oesophagitis
|
0.67%
1/149 • Number of events 1
|
0.00%
0/73
|
|
Gastrointestinal disorders
Pancreatic carcinoma
|
1.3%
2/149 • Number of events 2
|
0.00%
0/73
|
|
Hepatobiliary disorders
Cholelithiasis
|
0.67%
1/149 • Number of events 1
|
0.00%
0/73
|
|
Hepatobiliary disorders
Hepatic cirrhosis
|
0.00%
0/149
|
1.4%
1/73 • Number of events 1
|
|
Infections and infestations
Appendicitis
|
0.00%
0/149
|
1.4%
1/73 • Number of events 1
|
|
Musculoskeletal and connective tissue disorders
Hip fracture
|
0.67%
1/149 • Number of events 1
|
0.00%
0/73
|
|
Musculoskeletal and connective tissue disorders
Humerus fracture
|
0.67%
1/149 • Number of events 1
|
0.00%
0/73
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
0.00%
0/149
|
1.4%
1/73 • Number of events 1
|
|
Nervous system disorders
Convulsion
|
0.67%
1/149 • Number of events 1
|
0.00%
0/73
|
|
Psychiatric disorders
Cognitive disorder
|
1.3%
2/149 • Number of events 2
|
0.00%
0/73
|
|
Renal and urinary disorders
Renal cell carcinoma
|
0.67%
1/149 • Number of events 1
|
0.00%
0/73
|
|
Renal and urinary disorders
Urinary retention
|
2.0%
3/149 • Number of events 3
|
1.4%
1/73 • Number of events 1
|
|
Respiratory, thoracic and mediastinal disorders
Lung infection
|
0.00%
0/149
|
1.4%
1/73 • Number of events 1
|
Other adverse events
| Measure |
SpaceOAR
n=149 participants at risk
Subjects randomized to receive SpaceOAR hydrogel.
|
Control
n=73 participants at risk
Subjects randomized to not receive SpaceOAR hydrogel.
|
|---|---|---|
|
Reproductive system and breast disorders
Haematospermia
|
0.67%
1/149 • Number of events 1
|
0.00%
0/73
|
|
Gastrointestinal disorders
Anorectal pressure
|
0.67%
1/149 • Number of events 1
|
0.00%
0/73
|
|
Renal and urinary disorders
Hematuria
|
0.67%
1/149 • Number of events 1
|
0.00%
0/73
|
|
Musculoskeletal and connective tissue disorders
Thigh pain
|
0.67%
1/149 • Number of events 1
|
0.00%
0/73
|
|
Musculoskeletal and connective tissue disorders
Discomfort while sitting
|
0.67%
1/149 • Number of events 1
|
0.00%
0/73
|
|
Reproductive system and breast disorders
Perineal pain
|
2.7%
4/149 • Number of events 4
|
0.00%
0/73
|
|
Gastrointestinal disorders
Rectal pain
|
0.67%
1/149 • Number of events 1
|
0.00%
0/73
|
|
Gastrointestinal disorders
Rectal bleeding
|
0.67%
1/149 • Number of events 1
|
0.00%
0/73
|
|
Gastrointestinal disorders
Rectal penetration
|
1.3%
2/149 • Number of events 2
|
0.00%
0/73
|
|
Gastrointestinal disorders
Constipation
|
0.67%
1/149 • Number of events 1
|
0.00%
0/73
|
|
Gastrointestinal disorders
Flatulence
|
0.67%
1/149 • Number of events 1
|
1.4%
1/73 • Number of events 1
|
|
Renal and urinary disorders
Lower urinary tract symptoms
|
0.67%
1/149 • Number of events 1
|
0.00%
0/73
|
|
Vascular disorders
Hypotension
|
0.67%
1/149 • Number of events 1
|
0.00%
0/73
|
|
Vascular disorders
Vasovagal presyncope
|
0.00%
0/149
|
1.4%
1/73 • Number of events 1
|
Additional Information
Director, Clinical Operations
Boston Scientific Corporation
Phone: 952-930-6000
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place