N/A
Completed N=14
An Observational Study of Radiotherapy After Injection of SpaceOAR Hydrogel
Source: ClinicalTrials.gov NCT05735652 ↗Enrolled (actual)
14
Serious AEs
7.1%
Results posted
Mar 2025
Primary outcomePrimary: Change of Dose Rectum Volume Receiving Radiation Between Radiotherapy Plannings Pre and Post SpaceOAR Hydrogel Injection. — 2.4; 2.7 cc
Summary
This observational study aims to evaluate the safety and effectiveness of radiotherapy for subjects with localized T1-T2 prostate cancer in China who were injected with SpaceOAR Hydrogel, via collecting clinical data related to radiotherapy.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change of Dose Rectum Volume Receiving Radiation Between Radiotherapy Plannings Pre and Post SpaceOAR Hydrogel Injection. |
2.4; 2.7 | — |
| SECONDARY Urinary, Bowel and Sexual Function Assessment Score |
99.4; 92.9; 96.0; 31 | — |
| SECONDARY Quality of Life Was Measured by EQ-5D-5L Scale（the Five-level Version of the EuroQol 5-Dimension Scale) |
1.0 | — |
| SECONDARY The Distance Between Prostate and Rectum |
5.4 | — |
| SECONDARY the Distance Between the Prostate and Rectum |
2.0 | — |
| SECONDARY Adverse Event Related to SpaceOAR Hydrogel (Safety) |
— | — |
Eligibility Criteria
Inclusion Criteria
- Subjects have provided the written informed consent, are willing to participate in clinical data collection and willing to comply with study procedure. (for subjects enrolled prospectively)
- Subjects must have been pathologically confirmed prostate cancer with clinical stage T1-T2, and have been treated with Space OAR Hydrogel, and have received or will receive radiotherapy.
Exclusion Criteria
- All subjects have received radiotherapy or will receive radiotherapy, who have injected with SpaceOAR hydrogel in Boao Medical Pilot Zone.
- There is no specific exclusion criteria unless the patients refuse to sign the informed consent.
Data sourced from ClinicalTrials.gov (NCT05735652). 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.