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RECRUITING
NCT05597852
NA

Using Rectal Hydrogel Spacer for Salvage SABR in Prostate Cancer

Sponsor: Sunnybrook Health Sciences Centre

View on ClinicalTrials.gov

Summary

There are several single institutional series that have reported their experience with salvage radiotherapy options that include EBRT, LDR and HDR brachytherapy. Gastrointestinal (GI) toxicity with salvage radiotherapy range between14-58%, respectively for patients undergoing re-irradiation. There is a concern for an increased risk of fistula development in these patients who receive second course of radiation. Hypofractionation using SABR has been utilized in the re-irradiation setting for prostate cancer with good tumor control and toxicity outcomes. In order to decrease the rectal toxicity, dose to the rectum should be kept as low as possible. Several techniques can be used to achieve this: tighter dosimetric dose painting, better patient or organ immobilization or use of a biodegradable gel. The Investigators ropose a phase I study to assess placement of a hydrogel spacer between the prostate and rectum, in an effort to decrease toxicity and improve patient's bowel quality of life.

Official title: Feasibility of Integrating Rectal Hydrogel Spacer for Salvage Treatment Using Stereotactic Ablative Body Radiotherapy for Locally Recurrent Prostate Cancer

Key Details

Gender

MALE

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

10

Start Date

2021-11-30

Completion Date

2027-11-30

Last Updated

2022-10-28

Healthy Volunteers

No

Conditions

Interventions

DEVICE

SpaceOAR

SpaceOAR hydrogel spacer between the prostate and rectum, in an effort to decrease toxicity and improve patient's bowel quality of life.

Locations (1)

Sunnybrook Odette Cancer Centre

Toronto, Ontario, Canada