Clinical Research Directory
Browse clinical research sites, groups, and studies.
Single Fractions SBRT for Prostate Cancer
Sponsor: Fabio Cury
Summary
It is a phase I study of radical hypofractionation delivering one single fraction of SBRT in patients with low- and favorable intermediate-risk prostate cancer that will undergo placement of the SpaceOAR hydrogel prior to treatment. Our hypothesis is that treatments can be safely delivered in one single fraction using SBRT provided the separation between the prostate and rectum is increased using the hydrogel
Official title: Single Fractions SBRT in the Treatment of Prostate Cancer: A Phase I Study
Key Details
Gender
MALE
Age Range
18 Years - Any
Study Type
INTERVENTIONAL
Enrollment
12
Start Date
2018-11-07
Completion Date
2027-12-20
Last Updated
2025-06-25
Healthy Volunteers
No
Conditions
Interventions
Stereotactic Body Radiation Therapy (SBRT)
Shorter radiation therapy means that a higher dose will be offered. To limit side effects of exposure to a high dose, a medical device protecting the rectum will be used. The medical device to be used is called SpaceOAR hydrogel (device). The SpaceOAR hydrogel creates space between the rectum and the prostate, making it much less likely that the rectum is exposed to radiation. It is injected into place prior to the start of radiation treatment using a needle. Patients may be awake or asleep under local anesthesia for the procedure. SpaceOAR hydrogel is not painful, it remains stable during radiation therapy and then is gradually absorbed by the body over the course of approximately six months, once radiation therapy has been completed.
Locations (1)
McGill University Health Centre-Cedars Cancer Centre
Montreal, Quebec, Canada