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Single Fractions SBRT in the Treatment of Prostate Cancer: A Phase I Study
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
There is a pre-treatment visit to the radiation oncology department. A gel is injected between the prostate and the rectum. This procedure is done with the use of a transrectal ultrasound, similarly to the prostate biopsy the patient had. A local anesthetic will be applied to numb the skin and to the underneath tissue where the injection will be performed. The procedure itself will take approximately 20 minutes and after a short observation time, the patient returns home. The next visit (approximately after 7 days after the insertion of the gel), a CT scan and MRI-scan will be done. Prior to the scans, a urinary catheter will be inserted in the bladder through the penis, and removed once the scans are done. Using these images, the doctor and the team involved will perform an individualized planning study to establish the safest way the radiation will enter your body. When the treatment plan is ready, patient is called to receive the single treatment. A urinary catheter again will be inserted in the bladder and the patient will be directed to the room where your treatment will be delivered. The treatment should last approximately 30 minutes. After the treatment, the urinary catheter will be removed.
Age
18 - No limit years
Sex
MALE
Healthy Volunteers
No
McGill University Health Centre-Cedars Cancer Centre
Montreal, Quebec, Canada
Start Date
November 7, 2018
Primary Completion Date
January 31, 2027
Completion Date
December 20, 2027
Last Updated
June 25, 2025
12
ESTIMATED participants
Stereotactic Body Radiation Therapy (SBRT)
RADIATION
Lead Sponsor
Fabio Cury
Collaborators
NCT05691465
NCT04550494
Data Source & Attribution
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