Single Fractions SBRT for Prostate Cancer

Prostate Cancer Clinical Trial

Official title: Single Fractions SBRT in the Treatment of Prostate Cancer: A Phase I Study

Status Recruiting

Clinical Trial 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

Clinical Trial Description

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. ;

Related Conditions & MeSH terms

• Prostate Cancer
• Prostatic Neoplasms

• NCT number: NCT04004312
• Study type: Interventional
• Source: McGill University Health Centre/Research Institute of the McGill University Health Centre
• Contact: Marianna Perna
• Phone: 514-934-1934
• Email: marianna.perna@muhc.mcgill.ca
• Status: Recruiting
• Phase: N/A
• Start date: November 7, 2018
• Completion date: December 20, 2026