Effectiveness of the SpaceOAR Vue System in Subjects With Prostate Cancer

Running, not enrolling · Not applicable

Conditions studied: Prostate Cancer

In brief

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.

Key facts

Study ID: NCT04905069
Run by: Boston Scientific Corporation
People needed: 500
Starts: 2021-12-21
Expected to finish: 2030-12-01
Last updated by the study team: 2026-07-13

Who can join

Age: 18 and older. Sex: male. Healthy volunteers: not accepted.

You may qualify if…

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.

You may not qualify if…

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

Where it is running

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

Full record on ClinicalTrials.gov

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