Neoplasms

Urinary Tract, Sexual Organs, and Pregnancy Conditions

All Conditions

Prostatic Neoplasms

Genital Neoplasms, Male

Urogenital Neoplasms

Genital Diseases

Genital Diseases, Male

Urogenital Diseases

Prostatic Diseases

Male Urogenital Diseases

Subjects will receive radiotherapy without the use of the SpaceOAR Vue.

Subjects will receive radiotherapy following injection of the SpaceOAR Vue hydrogel.

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.

SpaceOAR Vue System

Blake Hedstrom

Gwen LeTourneau

John Sylvester, MD

Alexander Engelman, MD

Glen Gejerman, MD

Adam Olson, MD

Jarad Martin, MBChB, PhD

Tanya Holt, MBBS FRANZCR

Jeremy Croker, MD

Pierre Blanchard, MD, PhD

Michael Pinkawa, Dr. Med.

Clemens Albrecht, Dr. med.

Paul Kelly, MB BCh BAO

Nicola Simoni, MD

Filippo Alongi, MD

Alfonso Gomez Iturriaga, MD, PhD

Felipe Couñago, MD, PhD

Asunción Hervás Morón, MBChB, PhD

Jens Lustenberger, MD

Mohamed Shelan, MD

Christos Mikropoulos, MD MSc MRCP

Nachi Palaniappan, MD

Suneil Jain, MB, BCh, PhD

Amit Bahl, MBBS, MD

Vincent Khoo, MD

Jenny Nobes, MBBS, FRCR

Peter Sankey, MB, MRCP

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.

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

Proportion of subjects experiencing late GI toxicity after SBRT treatment with or without placement of the SpaceOAR Vue System hydrogel. Late GI toxicity is defined as the occurrence of a Grade 2 or greater GI adverse event (NCI CTCAE v4) between 3- and 24-months post-SBRT initiation

Proportion of subjects experiencing a decrease in EPIC-26 bowel score greater than or equal to the minimal important difference (MID) in EPIC-26 bowel score from baseline to 24 months post-SBRT initiation.

Boston Scientific Corporation

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