Full Title
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)Purpose
Men who receive external beam radiation therapy (EBRT) for prostate cancer often have a temporary spacer placed between the prostate and the rectum before radiation therapy starts. By creating more room, the spacer may reduce radiation exposure to the rectum and other organs.
In this study, researchers are assessing a new spacer called the SpaceIT hydrogel. The men in this study have low- to intermediate-risk prostate cancer and are planning to have EBRT for their prostate cancer.
The SpaceIT spacer stays in place for about 3 months. After 3 months, the spacer starts to dissolve and is naturally absorbed by the body. It is then excreted through your urine.
If you take part in this study, you will be randomly assigned to get either SpaceIT or a standard spacer.
Who Can Join
To join this study, there are a few conditions. You must:
- Have low- to intermediate-risk prostate cancer, Gleason score 7 or lower, and be planning to get EBRT.
- Be age 18 or older.
Contact
For more information or to see if you can join this study, please call Dr. Thomas Kole’s office at 848-225-6437.
Protocol
25-151
Disease Status
Newly Diagnosed & Relapsed/Refractory