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RECRUITING
NCT04004312
NA

Single Fractions SBRT for Prostate Cancer

Sponsor: Fabio Cury

View on ClinicalTrials.gov

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

RADIATION

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