NCT06451614

SpaceIT Hydrogel System for Perirectal Spacing

SpaceIT Hydrogel System for Perirectal Spacing in Subjects With Low to Intermediate Risk Prostate Cancer Undergoing External Beam Radiotherapy (EBRT)

• Status: Active Not Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 230 (estimated)
• Sponsor: Boston Scientific Corporation · Industry
• Sex: Male
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

To evaluate the safety and effectiveness of the SpaceIT™ Hydrogel System in patients undergoing External Beam Radiotherapy (EBRT) for the treatment of prostate cancer.

Detailed description

HYDROSPACE study is a prospective, randomized, multicenter study to evaluate the safety and effectiveness of SpaceIT in patients undergoing External Beam Radiotherapy (EBRT) for the treatment of prostate cancer. Subjects randomized to the investigational arm will receive SpaceIT Hydrogel System Subjects randomized to the control arm will receive a commercially marketed Boston Scientific perirectal hydrogel spacer, SpaceOAR System or SpaceOAR Vue Hydrogel

Conditions

• Prostate Cancer

Interventions

Type	Name	Description
DEVICE	SpaceIT Hydrogel System	SpaceIT Hydrogel 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 SpaceIT Hydrogel System to reduce the radiation dose delivered to the anterior rectum. The SpaceIT Hydrogel System is composed of a radiopaque, biodegradable material designed to maintain space for approximately 12 weeks and be absorbed in about 6 months, sufficient time to support the intended use. SpaceIT has an iodinated PEG powder making it radiopaque.
DEVICE	Commercially available Boston Scientific Spacer	Boston Scientific's commercially available SpaceOAR Hydrogel System or SpaceOAR Vue Hydrogel 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 Hydrogel System or SpaceOAR Vue Hydrogel System to reduce the radiation dose delivered to the anterior rectum. SpaceOAR and SpaceOAR Vue are both perirectal spacers. SpaceOAR Vue specifically has an iodinated PEG powder making it radiopaque. SpaceOAR does not contain iodinated PEG powder and is not radiopaque. The SpaceOAR Hydrogel System or SpaceOAR Vue Hydrogel System maintains space during prostate radiotherapy treatment and is completely absorbed by the patient's body over time.

Timeline

• Start date: 2024-10-30
• Primary completion: 2026-06-30
• Completion: 2028-03-31
• First posted: 2024-06-11
• Last updated: 2026-04-16

Locations

29 sites across 2 countries: United States, Canada

Regulatory

• FDA-regulated device study