NCT05735652

An Observational Study of Radiotherapy After Injection of SpaceOAR Hydrogel

An Observational Study to Evaluate the Safety and Effectiveness of Radiotherapy for Localized T1-T2 Prostate Cancer in China After Injection of SpaceOAR Hydrogel

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 14 (actual)
• Sponsor: Boston Scientific Corporation · Industry
• Sex: Male
• Age: —
• Healthy volunteers: Not accepted

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.

Detailed description

This study protocol is for the second part of SpaceOAR real world study in which long term follow-up visits will be performed (up to 1 year) outside Boao Medical Tourism Pilot Zone. The SpaceOAR real world study is a retrospective and prospective, single arm, observational study (Ptotocol of SpaceOAR RWS Windchill#: 92743236). Subjects with localized T1-T2 prostate cancer who have already been injected with the SpaceOAR and have received radiotherapy or will receive radiotherapy will be enrolled, and clinical data related to radiotherapy will be collected. For subjects who have already completed radiotherapy before study kick-off, clinical data will be collected retrospectively, such as data related to radiotherapy, AE (if any) and MRI (if any). Follow up vist will be completed if applicable. For subjects who receive therapy after study kick-off, follow up visits at 2 weeks, 6weeks, 3 months and 10 months after radiotherapy will be scheduled to assess bowel, urinary and sexual function and quality of life.

Conditions

• Prostate Cancer

Interventions

Type	Name	Description
DEVICE	SpaceOAR Hydrogel	The SpaceOAR System is an in-situ formed absorbable hydrogel that is administered transperineally (with transrectal ultrasound guidance) between the prostate and rectum

Timeline

• Start date: 2022-11-03
• Primary completion: 2024-04-30
• Completion: 2024-08-21
• First posted: 2023-02-21
• Last updated: 2025-05-30
• Results posted: 2025-03-26

Locations

1 site across 1 country: China