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Brief Title: Effectiveness of the SpaceOAR Vue System in Subjects With Prostate Cancer Being Treated With Stereotactic Body Radiotherapy
Official Title: Effectiveness of the SpaceOAR Vue System in Subjects With Prostate Cancer Being Treated With Stereotactic Body Radiotherapy
Study ID: NCT04905069
Brief Summary: To demonstrate the effectiveness of the SpaceOAR Vue System in reducing late gastrointestinal (GI) toxicity in subjects undergoing Stereotactic Body Radiotherapy (SBRT) to treat prostate cancer.
Detailed Description:
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: MALE
Healthy Volunteers: No
GenesisCare USA, Fort Myers, Florida, United States
GenesisCare USA, Lakewood Ranch, Florida, United States
Florida Urology Partners, LLC, Tampa, Florida, United States
Kansas University Medical Center, Kansas City, Kansas, United States
GenesisCare USA, Troy, Michigan, United States
New Jersey Urology, a Summit Health Company, Bloomfield, New Jersey, United States
University of Pittsburgh Medical Center, Pittsburgh, Pennsylvania, United States
Calvary Mater Newcastle, Waratah, New South Wales, Australia
Princess Alexandra Hospital - ROPAIR, Woolloongabba, Queensland, Australia
Sir Charles Gairdner Hospital, Nedlands, Western Australia, Australia
Institut Gustave Roussy, Villejuif, Cedex, France
MEDICLIN Robert Janker Klinik, Bonn, , Germany
Klinikum Nurnberg Nord, Nürnberg, , Germany
Bon Secours Radiotherapy Cork, Cork, , Ireland
Azienda Ospedaliero Universitaria di Parma, Parma, , Italy
IRCCS Ospedale Sacro Cuore Don Calabria, Verona, , Italy
Hospital Universitario Cruces, Barakaldo, , Spain
GenesisCare, Hospital San Francisco de Asis, Madrid, , Spain
Hospital Universitario Ramón y Cajal, Madrid, , Spain
University Hospital Basel, Basel, , Switzerland
Inselspital - University Hospital Bern, Bern, , Switzerland
Royal Surrey County Hospital NHS Foundation Trust, Guildford, Surrey, United Kingdom
Velindre Cancer Centre, Cardiff, Wales, United Kingdom
Belfast City Hospital, Belfast, , United Kingdom
Bristol Haematology and Oncology Centre, Bristol, , United Kingdom
Royal Marsden Hospital, London, , United Kingdom
Norfolk and Norwich University Hospital NHS Trust, Norwich, , United Kingdom
Derriford General Hospital, Plymouth, , United Kingdom
Name: Suneil Jain, MB, BCh, PhD
Affiliation: Queen's University, Belfast
Role: PRINCIPAL_INVESTIGATOR