Effectiveness of the SpaceOAR Vue System in Subjects With Prostate Cancer Being Treated With Stereotactic Body Radiotherapy

NAActive, not recruitingINTERVENTIONAL
Enrollment

500

Participants

Timeline

Start Date

December 21, 2021

Primary Completion Date

April 30, 2027

Study Completion Date

April 30, 2030

Conditions
Prostate Cancer
Interventions
DEVICE

SpaceOAR Vue System

"The SpaceOAR Vue System is intended to temporarily position the anterior rectal wall away from the prostate during radiotherapy for prostate cancer and in creating this space it is the intent of the SpaceOAR Vue System to reduce the radiation dose delivered to the anterior rectum.~The SpaceOAR Vue System is composed of biodegradable material, maintains space for the entire course of prostate radiotherapy treatment and is completely absorbed by the patient's body over time."

Trial Locations (30)

2298

Calvary Mater Newcastle, Waratah

3010

Inselspital - University Hospital Bern, Bern

4102

Princess Alexandra Hospital - ROPAIR, Woolloongabba

6009

Sir Charles Gairdner Hospital, Nedlands

15232

University of Pittsburgh Medical Center, Pittsburgh

28002

GenesisCare, Hospital San Francisco de Asis, Madrid

33609

Florida Urology Partners, LLC, Tampa

33908

GenesisCare USA, Fort Myers

34202

GenesisCare USA, Lakewood Rch

37024

IRCCS Ospedale Sacro Cuore Don Calabria, Verona

43126

Azienda Ospedaliero Universitaria di Parma, Parma

48098

GenesisCare USA, Troy

48903

Hospital Universitario Cruces, Barakaldo

66160

Kansas University Medical Center, Kansas City

90419

Klinikum Nurnberg Nord, Nuremberg

92300

Institut de Radiothérapie & Radiochirurgie HARTMANN, Levallois-Perret

94805

Institut Gustave Roussy, Villejuif

07003

New Jersey Urology, a Summit Health Company, Bloomfield

D-53129

MEDICLIN Robert Janker Klinik, Bonn

T12 DV56

Bon Secours Radiotherapy Cork, Cork

Unknown

Policlinico Universitario Agostino Gemelli, Rome

Hospital Universitario Ramón y Cajal, Madrid

CH-4031

University Hospital Basel, Basel

GU27XX

Royal Surrey County Hospital NHS Foundation Trust, Guildford

CF14 2TL

Velindre Cancer Centre, Cardiff

BT9 7AB

Belfast City Hospital, Belfast

BS2 8ED

Bristol Haematology and Oncology Centre, Bristol

SW3 6JJ

Royal Marsden Hospital, London

NR4 7UY

Norfolk and Norwich University Hospital NHS Trust, Norwich

PL6 8DH

Derriford General Hospital, Plymouth

Sponsors
All Listed Sponsors
lead

Boston Scientific Corporation

INDUSTRY