Effectiveness of the SpaceOAR Vue System in Subjects With Prostate Cancer Being Treated With Stereotactic Body Radiotherapy
NCT ID: NCT04905069
Last Updated: 2026-01-14
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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ACTIVE_NOT_RECRUITING
NA
500 participants
INTERVENTIONAL
2021-12-21
2030-04-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
PREVENTION
NONE
Study Groups
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No-Spacer Control
Subjects will receive radiotherapy without the use of the SpaceOAR Vue.
No interventions assigned to this group
SpaceOAR Vue
Subjects will receive radiotherapy following injection of the SpaceOAR Vue hydrogel.
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.
Interventions
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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.
Eligibility Criteria
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Inclusion Criteria
* 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
* 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
18 Years
MALE
No
Sponsors
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Boston Scientific Corporation
INDUSTRY
Responsible Party
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Principal Investigators
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Suneil Jain, MB, BCh, PhD
Role: PRINCIPAL_INVESTIGATOR
Queen's University, Belfast
Locations
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GenesisCare USA
Fort Myers, 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
Dr. John Sylvester
Myrtle Beach, South Carolina, 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
Institut de Radiothérapie & Radiochirurgie HARTMANN
Levallois-Perret, , France
MEDICLIN Robert Janker Klinik
Bonn, , Germany
Klinikum Nurnberg Nord
Nuremberg, , Germany
Bon Secours Radiotherapy Cork
Cork, , Ireland
Azienda Ospedaliero Universitaria di Parma
Parma, , Italy
Policlinico Universitario Agostino Gemelli
Rome, , 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
Countries
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Other Identifiers
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U0702
Identifier Type: -
Identifier Source: org_study_id
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