Trial Outcomes & Findings for SpaceOAR System RWS in China (NCT NCT05407714)
NCT ID: NCT05407714
Last Updated: 2025-10-27
Results Overview
The distance between the posterior prostatic capsule and anterior rectal wall,
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
15 participants
Primary outcome timeframe
Within 10 days post spaceOAR hydrogel administration.
Results posted on
2025-10-27
Participant Flow
Enrolled 15 subjects, and collected 14 cases valid data .
Participant milestones
| Measure |
SpaceOAR Treatment Arm
Single arm, up to 20 subjects with a pathologically confirmed diagnosis of clinical stage T1 or T2 prostate cancer indicated for radiotherapy will be enrolled, for there are chances of missing data in the real world study. A sample of 14 subjects provides at least 90% power for the primary objective.
SpaceOAR Treatment: SpaceOAR System is intended to temporarily position the anterior rectal wall away from the prostate during radiotherapy for prostate cancer and in creating this space it is the intent of SpaceOAR System to reduce the radiation dose delivered to the anterior rectum.
The SpaceOAR System is composed of biodegradable material and maintains space for the entire course of prostate radiotherapy treatment and is completely absorbed by the patient's body over time.
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|---|---|
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Overall Study
STARTED
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15
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Overall Study
Cases of Valid Data
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14
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Overall Study
COMPLETED
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15
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Overall Study
NOT COMPLETED
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0
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Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
SpaceOAR System RWS in China
Baseline characteristics by cohort
| Measure |
SpaceOAR Treatment Arm
n=15 Participants
Single arm, up to 20 subjects with a pathologically confirmed diagnosis of clinical stage T1 or T2 prostate cancer indicated for radiotherapy will be enrolled, for there are chances of missing data in the real world study. A sample of 14 subjects provides at least 90% power for the primary objective.
SpaceOAR Treatment: SpaceOAR System is intended to temporarily position the anterior rectal wall away from the prostate during radiotherapy for prostate cancer and in creating this space it is the intent of SpaceOAR System to reduce the radiation dose delivered to the anterior rectum.
The SpaceOAR System is composed of biodegradable material and maintains space for the entire course of prostate radiotherapy treatment and is completely absorbed by the patient's body over time.
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|---|---|
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Age, Continuous
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73.7 years
STANDARD_DEVIATION 7.8 • n=5 Participants
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Sex: Female, Male
Female
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0 Participants
n=5 Participants
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Sex: Female, Male
Male
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15 Participants
n=5 Participants
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Race (NIH/OMB)
American Indian or Alaska Native
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0 Participants
n=5 Participants
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Race (NIH/OMB)
Asian
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15 Participants
n=5 Participants
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Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
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0 Participants
n=5 Participants
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Race (NIH/OMB)
Black or African American
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0 Participants
n=5 Participants
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Race (NIH/OMB)
White
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0 Participants
n=5 Participants
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Race (NIH/OMB)
More than one race
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0 Participants
n=5 Participants
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Race (NIH/OMB)
Unknown or Not Reported
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0 Participants
n=5 Participants
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Region of Enrollment
China
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15 participants
n=5 Participants
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PRIMARY outcome
Timeframe: Within 10 days post spaceOAR hydrogel administration.Population: The distance between the posterior prostatic capsule and anterior rectal wall is measured on the axial image slice closest to halfway between apex and base, from posterior edge of prostate to inner rectal wall via MRI.
The distance between the posterior prostatic capsule and anterior rectal wall,
Outcome measures
| Measure |
SpaceOAR Treatment Arm
n=14 Participants
Single arm, up to 20 subjects with a pathologically confirmed diagnosis of clinical stage T1 or T2 prostate cancer indicated for radiotherapy will be enrolled, for there are chances of missing data in the real world study. A sample of 14 subjects provides at least 90% power for the primary objective.
SpaceOAR Treatment: SpaceOAR System is intended to temporarily position the anterior rectal wall away from the prostate during radiotherapy for prostate cancer and in creating this space it is the intent of SpaceOAR System to reduce the radiation dose delivered to the anterior rectum.
The SpaceOAR System is composed of biodegradable material and maintains space for the entire course of prostate radiotherapy treatment and is completely absorbed by the patient's body over time.
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|---|---|
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Primary Effectiveness Endpoint
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15.1 mm
Standard Deviation 1.8
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PRIMARY outcome
Timeframe: Within 30 days following procedureSubjects with AEs related to SpaceOAR system and/or procedure within 30 days following procedure will be observed.
Outcome measures
| Measure |
SpaceOAR Treatment Arm
n=15 Participants
Single arm, up to 20 subjects with a pathologically confirmed diagnosis of clinical stage T1 or T2 prostate cancer indicated for radiotherapy will be enrolled, for there are chances of missing data in the real world study. A sample of 14 subjects provides at least 90% power for the primary objective.
SpaceOAR Treatment: SpaceOAR System is intended to temporarily position the anterior rectal wall away from the prostate during radiotherapy for prostate cancer and in creating this space it is the intent of SpaceOAR System to reduce the radiation dose delivered to the anterior rectum.
The SpaceOAR System is composed of biodegradable material and maintains space for the entire course of prostate radiotherapy treatment and is completely absorbed by the patient's body over time.
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|---|---|
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Primary Safety Endpoint
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2 Participants
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SECONDARY outcome
Timeframe: Within 10 days post spaceOAR hydrogel administration.Population: Creation of at least 7.5mm space between the posterior prostatic capsule and anterior rectum wall via comparative pre and post SpaceOAR hydrogel injection MRI scans.
Distance Posterior Prostatic Capsule and Anterior Rectal Wall
Outcome measures
| Measure |
SpaceOAR Treatment Arm
n=14 Participants
Single arm, up to 20 subjects with a pathologically confirmed diagnosis of clinical stage T1 or T2 prostate cancer indicated for radiotherapy will be enrolled, for there are chances of missing data in the real world study. A sample of 14 subjects provides at least 90% power for the primary objective.
SpaceOAR Treatment: SpaceOAR System is intended to temporarily position the anterior rectal wall away from the prostate during radiotherapy for prostate cancer and in creating this space it is the intent of SpaceOAR System to reduce the radiation dose delivered to the anterior rectum.
The SpaceOAR System is composed of biodegradable material and maintains space for the entire course of prostate radiotherapy treatment and is completely absorbed by the patient's body over time.
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|---|---|
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Functional Success
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14 Participants
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Adverse Events
SpaceOAR Treatment Arm
Serious events: 0 serious events
Other events: 4 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
SpaceOAR Treatment Arm
n=15 participants at risk
Single arm, up to 20 subjects with a pathologically confirmed diagnosis of clinical stage T1 or T2 prostate cancer indicated for radiotherapy will be enrolled, for there are chances of missing data in the real world study. A sample of 14 subjects provides at least 90% power for the primary objective.
SpaceOAR Treatment: SpaceOAR System is intended to temporarily position the anterior rectal wall away from the prostate during radiotherapy for prostate cancer and in creating this space it is the intent of SpaceOAR System to reduce the radiation dose delivered to the anterior rectum.
The SpaceOAR System is composed of biodegradable material and maintains space for the entire course of prostate radiotherapy treatment and is completely absorbed by the patient's body over time.
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Renal and urinary disorders
Urinary hesitation
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6.7%
1/15 • Number of events 1 • 30 days post procedure.
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Renal and urinary disorders
Urinary retention
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6.7%
1/15 • Number of events 1 • 30 days post procedure.
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Gastrointestinal disorders
Constipation
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6.7%
1/15 • Number of events 1 • 30 days post procedure.
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Respiratory, thoracic and mediastinal disorders
Influenza
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6.7%
1/15 • Number of events 1 • 30 days post procedure.
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Additional Information
Associate Clinical Trial Manager
BSC International Medical Trading (Shanghai) Co., Ltd
Phone: +13671646036
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place