Effectiveness of the SpaceOAR Vue System in Subjects With Prostate Cancer (SABRE)

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

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.

Study Overview

• Status: Active, not recruiting
• Conditions: Prostate Cancer
• Intervention / Treatment: Device: SpaceOAR Vue System

Detailed Description

This study is designed to evaluate the effectiveness of the SpaceOAR Vue System in reducing late gastrointestinal (GI) toxicity in participants undergoing Stereotactic Body Radiotherapy (SBRT) for the treatment of prostate cancer.

• Study Type: Interventional
• Enrollment (Actual): 500
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Australia
  • New South Wales
    • Waratah, New South Wales, Australia, 2298
      • Calvary Mater Newcastle
  • Queensland
    • Woolloongabba, Queensland, Australia, 4102
      • Princess Alexandra Hospital - ROPAIR
  • Western Australia
    • Nedlands, Western Australia, Australia, 6009
      • Sir Charles Gairdner Hospital
• France
  • Levallois-Perret, France, 92300
    • Institut de Radiothérapie & Radiochirurgie HARTMANN
  • Cedex
    • Villejuif, Cedex, France, 94805
      • Institut Gustave Roussy
• Germany
  • Bonn, Germany, D-53129
    • MEDICLIN Robert Janker Klinik
  • Nuremberg, Germany, 90419
    • Klinikum Nürnberg Nord
• Ireland
  • Cork, Ireland, T12 DV56
    • Bon Secours Radiotherapy Cork
• Italy
  • Parma, Italy, 43126
    • Azienda Ospedaliero Universitaria di Parma
  • Rome, Italy
    • Policlinico Universitario Agostino Gemelli
  • Verona, Italy, 37024
    • IRCCS Ospedale Sacro Cuore Don Calabria
• Spain
  • Barakaldo, Spain, 48903
    • Hospital Universitario Cruces
  • Madrid, Spain
    • Hospital Universitario Ramon y Cajal
  • Madrid, Spain, 28002
    • GenesisCare, Hospital San Francisco de Asis
• Switzerland
  • Basel, Switzerland, CH-4031
    • University Hospital Basel
  • Bern, Switzerland, 3010
    • Inselspital - University Hospital Bern
• United Kingdom
  • Belfast, United Kingdom, BT9 7AB
    • Belfast City Hospital
  • Bristol, United Kingdom, BS2 8ED
    • Bristol Haematology and Oncology Centre
  • London, United Kingdom, SW3 6JJ
    • Royal Marsden Hospital
  • Norwich, United Kingdom, NR4 7UY
    • Norfolk and Norwich University Hospital NHS Trust
  • Plymouth, United Kingdom, PL6 8DH
    • Derriford General Hospital
  • Surrey
    • Guildford, Surrey, United Kingdom, GU27XX
      • Royal Surrey County Hospital NHS Foundation Trust
  • Wales
    • Cardiff, Wales, United Kingdom, CF14 2TL
      • Velindre Cancer Centre
• United States
  • Florida
    • Fort Myers, Florida, United States, 33908
      • GenesisCare USA
    • Tampa, Florida, United States, 33609
      • Florida Urology Partners, LLC
  • Kansas
    • Kansas City, Kansas, United States, 66160
      • Kansas University Medical Center
  • Michigan
    • Troy, Michigan, United States, 48098
      • GenesisCare USA
  • New Jersey
    • Bloomfield, New Jersey, United States, 07003
      • New Jersey Urology, a Summit Health Company
  • Pennsylvania
    • Pittsburgh, Pennsylvania, United States, 15232
      • University of Pittsburgh Medical Center
  • South Carolina
    • Myrtle Beach, South Carolina, United States, 29572
      • Dr. John Sylvester

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• Age ≥ 18 years old.
• Subjects must have pathologically confirmed (by routine hematoxylin and eosin (H&E) staining) invasive adenocarcinoma of the prostate and been planning to undergo SBRT.
• Subjects must have intermediate risk prostate cancer as defined by the presence of one or more of the following:
• Clinical Stage T2b - T2c (AJCC 6th edition) tumor
• Gleason Score 7 as determined from a biopsy taken within 9 months preceding Enrollment (randomization)
• Demonstrated blood PSA levels 10-20 ng/ml as measured within 6 months preceding Enrollment (randomization) and prior to commencing androgen deprivation therapy (ADT)
• Subject or authorized representative was informed of the nature of the study and provided written informed consent, approved by the appropriate Institutional Review Board (IRB)/Ethics Committee (EC) of the respective clinical site.

Exclusion Criteria:

• Prostate >80 cc documented within 9 months preceding Enrollment (randomization)
• Clinical stage T3 or T4 (AJCC 6th edition) tumor
• Blood PSA level >20 ng/ml as measured within 6 months preceding Enrollment (randomization) and prior to commencing androgen deprivation therapy (ADT)
• Gleason Score ≥ 8 as determined from a biopsy taken within 9 months preceding Enrollment (randomization)
• Subjects who had MRI evidence of gross posterior extracapsular extension (ECE) of the prostate cancer. (Note: MRI should be from within 9 months preceding Enrollment (randomization). If MRI is contraindicated, a digital rectal exam may be performed to confirm the absence of gross posterior ECE)
• Subjects who had metastatic disease, other ongoing cancers which were treated during the study or subjects for whom pelvic lymph node radiotherapy was planned.
• Subjects with any prior invasive malignancy (except non-melanomatous skin cancer) unless the subject had been disease free for a minimum of 3 years.
• History of prostatectomy, transurethral prostate surgery (e.g. TUNA, TUMT, TURP) if performed within 1 year prior to screening, other local prostate cancer therapy (e.g., cryotherapy or brachytherapy) or previous pelvic irradiation at any time prior to screening.
• History of prior pelvic surgery requiring low anterior or abdominoperineal resections or rectal surgery.
• History of or active inflammatory bowel disease (IBD) such as Crohn's disease or ulcerative colitis.
• History of or current perirectal disease that may interfere with interpretation of study outcomes including anal or perianal diseases such as fistula.
• Bleeding hemorrhoids requiring medical intervention within the prior three months.
• Diagnosed active bleeding disorder or a clinically significant coagulopathy. Note: Patients on anticoagulants may be included if the anticoagulant medication can be discontinued for index procedure.
• Active inflammatory or infectious process involving the perineum, gastrointestinal (GI) or urinary tract based on positive diagnosis or suspected diagnosis in the presence of fever >38⁰ C, WBC > 12,000/uL.
• Compromised immune system or prior diagnoses for human immunodeficiency virus (HIV) (with a detectable viral load within the last 6 months)/acquired immunodeficiency syndrome (AIDS) or autoimmune disease.
• If a subject was enrolled in another investigational drug or device trial that had not completed the primary endpoint or that clinically interfered with this study.
• Unable to comply with the study requirements or follow-up schedule.
• Any condition the Investigator believed would interfere with the intent of the study or would make participation not in the best interest of the patient.
• Known iodine sensitivity or allergy
• Known polyethylene glycol (PEG) sensitivity or allergy

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
No Intervention: No-Spacer Control; Subjects will receive radiotherapy without the use of the SpaceOAR Vue.
Experimental: SpaceOAR Vue; Subjects will receive radiotherapy following injection of the SpaceOAR Vue hydrogel.	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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Late Gastrointestinal (GI) Toxicity	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	3 to 24 months post-SBRT initiation

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
EPIC-26 bowel score	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.	24 months post-SBRT initiation

Collaborators and Investigators

• Sponsor: Boston Scientific Corporation
• Investigators: Principal Investigator: Suneil Jain, MB, BCh, PhD, Queen's University, Belfast

Study record dates

Study Major Dates

• Study Start (Actual): December 21, 2021
• Primary Completion (Estimated): April 1, 2027
• Study Completion (Estimated): April 1, 2030

Study Registration Dates

• First Submitted: May 24, 2021
• First Submitted That Met QC Criteria: May 24, 2021
• First Posted (Actual): May 27, 2021

Study Record Updates

• Last Update Posted (Actual): May 12, 2026
• Last Update Submitted That Met QC Criteria: May 11, 2026
• Last Verified: May 1, 2026

More Information

Terms related to this study

• Keywords: Cancer; Prostate; SBRT; Spacer; Hypofractionation; Stereotactic Body Radiotherapy; SpaceOAR; SpaceOAR Vue
• Additional Relevant MeSH Terms: Urogenital Diseases; Genital Diseases; Genital Neoplasms, Male; Urogenital Neoplasms; Neoplasms by Site; Genital Diseases, Male; Prostatic Diseases; Male Urogenital Diseases; Neoplasms; Prostatic Neoplasms
• Other Study ID Numbers: U0702

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: Yes