Trial Outcomes & Findings for BioProtect Balloon Implant™ Balloon System Pivotal Study BP-007 (NCT NCT03400150)
NCT ID: NCT03400150
Last Updated: 2025-02-18
Results Overview
Non-inferiority in occurrence of rectal, device or procedure-related Grade \> 1 AEs within 6 months of implantation for balloon as compared to control group
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
222 participants
Primary outcome timeframe
Within 6 months from balloon implantation
Results posted on
2025-02-18
Participant Flow
Participant milestones
| Measure |
ProSpace Group
Marking + ProSpace implantation + IMRT
ProSpace: ProSpace balloon implantation
|
Control Group
Marking + IMRT
Control: Control - Marking \& IMRT are standard of care for prostate cancer - there is no study-specific intervention
|
|---|---|---|
|
Overall Study
STARTED
|
143
|
79
|
|
Overall Study
COMPLETED
|
139
|
78
|
|
Overall Study
NOT COMPLETED
|
4
|
1
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
BioProtect Balloon Implant™ Balloon System Pivotal Study BP-007
Baseline characteristics by cohort
| Measure |
Balloon Group
n=143 Participants
Marking + Balloon implantation + IMRT
Balloon implantation
|
Control Group
n=79 Participants
Marking + IMRT
Control: Control - Marking \& IMRT are standard of care for prostate cancer - there is no study-specific intervention
|
Total
n=222 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
70.2 years
STANDARD_DEVIATION 6.29 • n=5 Participants
|
71.1 years
STANDARD_DEVIATION 7.16 • n=7 Participants
|
70.5 years
STANDARD_DEVIATION 6.61 • n=5 Participants
|
|
Sex: Female, Male
Female
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
143 Participants
n=5 Participants
|
79 Participants
n=7 Participants
|
222 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
2 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
2 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
13 Participants
n=5 Participants
|
6 Participants
n=7 Participants
|
19 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
120 Participants
n=5 Participants
|
65 Participants
n=7 Participants
|
185 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
6 Participants
n=5 Participants
|
6 Participants
n=7 Participants
|
12 Participants
n=5 Participants
|
|
Region of Enrollment
Netherlands
|
13 participants
n=5 Participants
|
7 participants
n=7 Participants
|
20 participants
n=5 Participants
|
|
Region of Enrollment
United States
|
55 participants
n=5 Participants
|
32 participants
n=7 Participants
|
87 participants
n=5 Participants
|
|
Region of Enrollment
Poland
|
26 participants
n=5 Participants
|
13 participants
n=7 Participants
|
39 participants
n=5 Participants
|
|
Region of Enrollment
Ireland
|
5 participants
n=5 Participants
|
2 participants
n=7 Participants
|
7 participants
n=5 Participants
|
|
Region of Enrollment
Israel
|
23 participants
n=5 Participants
|
15 participants
n=7 Participants
|
38 participants
n=5 Participants
|
|
Region of Enrollment
Portugal
|
18 participants
n=5 Participants
|
9 participants
n=7 Participants
|
27 participants
n=5 Participants
|
|
Region of Enrollment
United Kingdom
|
3 participants
n=5 Participants
|
1 participants
n=7 Participants
|
4 participants
n=5 Participants
|
|
Localized prostate cancer
|
143 Participants
n=5 Participants
|
79 Participants
n=7 Participants
|
222 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Within 6 months from balloon implantationNon-inferiority in occurrence of rectal, device or procedure-related Grade \> 1 AEs within 6 months of implantation for balloon as compared to control group
Outcome measures
| Measure |
Balloon Group
n=139 Participants
Marking + balloon implantation + IMRT
|
Control Group
n=78 Participants
Marking + IMRT
Control: Control - Marking \& IMRT are standard of care for prostate cancer - there is no study-specific intervention
|
|---|---|---|
|
Safety Endpoint: Number of Subjects in the Balloon and Control Groups With Rectal, Device or Procedure-related Grade > 1 AEs Within 6 Months of Procedure
|
25 Participants
|
18 Participants
|
PRIMARY outcome
Timeframe: 3 monthsPopulation: The balloon spacer implantation was attempted in 143 subjects. The procedure could not be completed for one subject, resulting in an efficacy endpoint population of 142 balloon subjects.
Observed reduction of at least \>25% in rectal volume receiving 70 Gy (rV70) in patients after spacer implantation, with efficacy of the study confirmed if \>75% of balloon recipients achieved this degree of dose reduction.
Outcome measures
| Measure |
Balloon Group
n=142 Participants
Marking + balloon implantation + IMRT
|
Control Group
Marking + IMRT
Control: Control - Marking \& IMRT are standard of care for prostate cancer - there is no study-specific intervention
|
|---|---|---|
|
Efficacy Endpoint: Number of Subjects in the Balloon Group With Reduction of >25% in Rectal Volume Receiving 70 Gy (rV70)
|
139 Participants
|
—
|
Adverse Events
Balloon Group
Serious events: 12 serious events
Other events: 108 other events
Deaths: 1 deaths
Control Group
Serious events: 10 serious events
Other events: 60 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Balloon Group
n=143 participants at risk
Marking + Balloon implantation + IMRT
Balloon implantation
|
Control Group
n=79 participants at risk
Marking + IMRT
Control: Control - Marking \& IMRT are standard of care for prostate cancer - there is no study-specific intervention
|
|---|---|---|
|
Renal and urinary disorders
Acute urinary retention
|
0.00%
0/143 • Events within 6 months from implantation
CTCAE 4.0
|
1.3%
1/79 • Events within 6 months from implantation
CTCAE 4.0
|
|
Vascular disorders
Cerebral vascular retention
|
0.70%
1/143 • Events within 6 months from implantation
CTCAE 4.0
|
1.3%
1/79 • Events within 6 months from implantation
CTCAE 4.0
|
|
Respiratory, thoracic and mediastinal disorders
Pneumonia
|
0.00%
0/143 • Events within 6 months from implantation
CTCAE 4.0
|
2.5%
2/79 • Events within 6 months from implantation
CTCAE 4.0
|
|
Product Issues
Rectal bleeding
|
1.4%
2/143 • Events within 6 months from implantation
CTCAE 4.0
|
0.00%
0/79 • Events within 6 months from implantation
CTCAE 4.0
|
|
Product Issues
Rectal wall puncture
|
0.70%
1/143 • Events within 6 months from implantation
CTCAE 4.0
|
0.00%
0/79 • Events within 6 months from implantation
CTCAE 4.0
|
|
Investigations
Other
|
7.0%
10/143 • Events within 6 months from implantation
CTCAE 4.0
|
8.9%
7/79 • Events within 6 months from implantation
CTCAE 4.0
|
Other adverse events
| Measure |
Balloon Group
n=143 participants at risk
Marking + Balloon implantation + IMRT
Balloon implantation
|
Control Group
n=79 participants at risk
Marking + IMRT
Control: Control - Marking \& IMRT are standard of care for prostate cancer - there is no study-specific intervention
|
|---|---|---|
|
Renal and urinary disorders
Burning with urination
|
9.8%
14/143 • Events within 6 months from implantation
CTCAE 4.0
|
16.5%
13/79 • Events within 6 months from implantation
CTCAE 4.0
|
|
Gastrointestinal disorders
Diarrhea
|
8.4%
12/143 • Events within 6 months from implantation
CTCAE 4.0
|
12.7%
10/79 • Events within 6 months from implantation
CTCAE 4.0
|
|
Renal and urinary disorders
Dysuria
|
23.1%
33/143 • Events within 6 months from implantation
CTCAE 4.0
|
20.3%
16/79 • Events within 6 months from implantation
CTCAE 4.0
|
|
General disorders
Erectile dysfunction
|
6.3%
9/143 • Events within 6 months from implantation
CTCAE 4.0
|
10.1%
8/79 • Events within 6 months from implantation
CTCAE 4.0
|
|
General disorders
Fatigue
|
17.5%
25/143 • Events within 6 months from implantation
CTCAE 4.0
|
10.1%
8/79 • Events within 6 months from implantation
CTCAE 4.0
|
|
Renal and urinary disorders
Hot flashes
|
7.0%
10/143 • Events within 6 months from implantation
CTCAE 4.0
|
10.1%
8/79 • Events within 6 months from implantation
CTCAE 4.0
|
|
Renal and urinary disorders
Nocturia
|
17.5%
25/143 • Events within 6 months from implantation
CTCAE 4.0
|
13.9%
11/79 • Events within 6 months from implantation
CTCAE 4.0
|
|
Renal and urinary disorders
Urgent, frequent urination
|
31.5%
45/143 • Events within 6 months from implantation
CTCAE 4.0
|
35.4%
28/79 • Events within 6 months from implantation
CTCAE 4.0
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: OTHER