Boao First Life Care Center-Hospital
Qionghai, Hainan, 571434, China
Completed
NCT Number: NCT05407714
SpaceOAR System RWS in China
This study aims to evaluate the safety and performance of SpaceOAR System when it is used to create space between the rectum and prostate in men undergoing radiotherapy for localized T1-T2 prostate cancer in China via collecting the real word data of SpaceOAR System used, to generate local clinical evidence on Chinese patients.
Completed
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Notify MeKey information
Conditions
Sex eligibility
All sexes
Study type
Interventional
Phase
Not applicable
Primary location
About this study
This study is a retrospective and prospective, single arm, real world study. For those patients who have already received the SpaceOAR treatment before study kick-off, the data at baseline and the day of procedure will be retrospectively collected. For those patients who will receive SpaceOAR treatment after study kick-off, the clinical data at baseline, the day of procedure and 30 days post procedure will be prospectively collected.
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.
Who can participate
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
- Subjects has provided the written informed consent, willing to participate in clinical data collection and willing to receive visit at 30 days post procedure. (for subjects enrolled prospectively)
- Subjects must have been pathologically confirmed prostate cancer with clinical stage T1-T2, and have been treated or will be treated with Space OAR Hydrogel in hospital in Hainan Boao Lecheng medical pilot zone.
Exclusion criteria
- no specific exclusion criteria unless the patients refuse to sign the informed consent.
Treatment and study plan
SpaceOAR Treatment
DeviceSpaceOAR 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.
Primary outcomes
-
Primary Effectiveness Endpoint
Time frame: Within 10 days post spaceOAR hydrogel administration.
The distance between the posterior prostatic capsule and anterior rectal wall,
-
Primary Safety Endpoint
Time frame: Within 30 days following procedure
Subjects with AEs related to SpaceOAR system and/or procedure within 30 days following procedure will be observed.
Secondary outcomes
-
Functional Success
Time frame: Within 10 days post spaceOAR hydrogel administration.
Distance Posterior Prostatic Capsule and Anterior Rectal Wall
Sponsors and collaborators
Lead sponsor
Boston Scientific Corporation
Industry
Registry information
Official study title
A Real Word Study to Evaluate the Safety and Performance of SpaceOAR System When Used to Create Space Between the Rectum and Prostate in Men Undergoing Radiotherapy for Localized T1-T2 Prostate Cancer in China
Important dates
- Study start
- 2022
- Primary completion
- 2023
- Study completion
- 2023
- First posted
- Jun 7, 2022
- Registry last updated
- Oct 27, 2025
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.