N/A
Completed N=15
SpaceOAR System RWS in China
Localized T1-T2 Prostate Cancer
Source: ClinicalTrials.gov NCT05407714 ↗
Enrolled (actual)
15
Serious AEs
0.0%
Results posted
Feb 2024
Primary outcomePrimary: Primary Effectiveness Endpoint — 15.1 mm
Summary
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Primary Effectiveness Endpoint |
15.1 | — |
| PRIMARY Primary Safety Endpoint |
2 | — |
| SECONDARY Functional Success |
14 | — |
Eligibility Criteria
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.
Data sourced from ClinicalTrials.gov (NCT05407714). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.