SpaceIT Hydrogel System for Perirectal Spacing in Subjects with Low to Intermediate Risk Prostate Cancer Undergoing External Beam Radiotherapy (EBRT): A Multicenter Randomized Controlled Clinical Study (HYDROSPACE)

Brief description of study

The HYDROSPACE study is a clinical trial that aims to check how effective the SpaceIT Hydrogel System is for patients with prostate cancer who are receiving external beam radiotherapy (EBRT). The entire study is expected to last about 36 months, which includes a 12-month period for enrolling patients. In the study, patients will be randomly assigned to receive either the new SpaceIT Hydrogel or a standard treatment called SpaceOAR/SpaceOAR Vue, which is already available. Follow-up check-ups will happen at 3, 6, 12, and 24 months after the procedure to look at any side effects, how well the device works, and how the patients feel about their quality of life using special questionnaires. This study aims to gather important information about the new hydrogel system compared to the usual treatment, helping to understand how safe and effective it is for patients.


Clinical Study Identifier: s24-00971
ClinicalTrials.gov Identifier: NCT06451614
Principal Investigator: Michael J. Zelefsky.
Other Investigators: James S Wysock, Samir Taneja, Aaron Edward Katz, William C Huang, Peter B. Schiff, David R. Wise.


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