NCT04905069

Effectiveness of the SpaceOAR Vue System in Subjects With Prostate Cancer

Effectiveness of the SpaceOAR Vue System in Subjects With Prostate Cancer Being Treated With Stereotactic Body Radiotherapy

• Status: Active Not Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 500 (actual)
• Sponsor: Boston Scientific Corporation · Industry
• Sex: Male
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

To demonstrate the effectiveness of the SpaceOAR Vue System in reducing late gastrointestinal (GI) toxicity in subjects undergoing Stereotactic Body Radiotherapy (SBRT) to treat prostate cancer.

Detailed description

This study is designed to evaluate the effectiveness of the SpaceOAR Vue System in reducing late gastrointestinal (GI) toxicity in participants undergoing Stereotactic Body Radiotherapy (SBRT) for the treatment of prostate cancer.

Conditions

• Prostate Cancer

Interventions

Type	Name	Description
DEVICE	SpaceOAR Vue System	The SpaceOAR Vue 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 the SpaceOAR Vue System to reduce the radiation dose delivered to the anterior rectum. The SpaceOAR Vue System is composed of biodegradable material, maintains space for the entire course of prostate radiotherapy treatment and is completely absorbed by the patient's body over time.

Timeline

• Start date: 2021-12-21
• Primary completion: 2027-04-01
• Completion: 2030-04-01
• First posted: 2021-05-27
• Last updated: 2026-04-15

Locations

30 sites across 9 countries: United States, Australia, France, Germany, Ireland, Italy, Spain, Switzerland, United Kingdom

Regulatory

• FDA-regulated device study