SpaceIT Hydrogel System for Perirectal Spacing

Active:	Yes
Cancer Type:	Prostate Cancer	NCT ID:	NCT06451614
Trial Phases:		Protocol IDs:	U0755 (primary) NCI-2025-01558
Eligibility:	18 Years and older, Male	Study Type:	Treatment
Study Sponsor:	Boston Scientific Corporation
NCI Full Details:	http://clinicaltrials.gov/show/NCT06451614

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.

Objectives

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

Treatment Sites in Georgia

Winship Cancer Institute of Emory University
1365 Clifton Road NE
Building C
Atlanta, GA 30322
winshipcancer.emory.edu

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