Rectal Spacers Use in Prostate Cancer Radiation Therapy

NARecruitingINTERVENTIONAL
Enrollment

50

Participants

Timeline

Start Date

September 6, 2024

Primary Completion Date

September 30, 2025

Study Completion Date

December 31, 2025

Conditions
Prostate Cancer
Interventions
DEVICE

SpaceOAR Vue

Peri-rectal hydrogel spacer consists of a layer of polyethylene-glycol gel (SpaceOAR vue) in order to outdistance the prostate from anterior rectal wall

DEVICE

BioProtect Balloon Implant System

The balloon spacer is a biodegradable balloon made of poly (L-Lactide-co-caprolactone) which is a co-polymer of Poly Lactide acid and epsilon Caprolactone (BioProtect Balloon Implant System, BioProtect Ltd) inflated with saline, providing around 18 mm space height , and can be deflated and repositioned if needed, both laterally and along the distal /proximal planes, for optimal uniformity of spacing.

Trial Locations (1)

08873

RECRUITING

Procure Proton Therapy Center, Somerset

All Listed Sponsors
lead

Princeton ProCure management, LLC.

OTHER