Prostate Cancer Clinical Trial

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

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.

View Eligibility Criteria

Eligibility Criteria

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 is for people with:

Prostate Cancer

Estimated Enrollment:

500

Study ID:

NCT04905069

Recruitment Status:

Recruiting

Sponsor:

Boston Scientific Corporation

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There are 27 Locations for this study

See Locations Near You

GenesisCare USA
Fort Myers Florida, 33908, United States
GenesisCare USA
Lakewood Ranch Florida, 34202, United States More Info
John Sylvester, MD
Principal Investigator
Florida Urology Partners, LLC
Tampa Florida, 33609, United States More Info
Alexander Engelman, MD
Principal Investigator
Kansas University Medical Center
Kansas City Kansas, 66160, United States
GenesisCare USA
Troy Michigan, 48098, United States
New Jersey Urology, a Summit Health Company
Bloomfield New Jersey, 07003, United States More Info
Glen Gejerman, MD
Principal Investigator
University of Pittsburgh Medical Center
Pittsburgh Pennsylvania, 15232, United States More Info
Adam Olson, MD
Principal Investigator
Calvary Mater Newcastle
Waratah New South Wales, 2298, Australia More Info
Jarad Martin, MBChB, PhD
Principal Investigator
Princess Alexandra Hospital - ROPAIR
Woolloongabba Queensland, 4102, Australia More Info
Tanya Holt, MBBS FRANZCR
Principal Investigator
Sir Charles Gairdner Hospital
Nedlands Western Australia, 6009, Australia More Info
Jeremy Croker, MD
Principal Investigator
Institut Gustave Roussy
Villejuif Cedex, 94805, France More Info
Pierre Blanchard, MD, PhD
Principal Investigator
MEDICLIN Robert Janker Klinik
Bonn , D-531, Germany More Info
Michael Pinkawa, Dr. Med.
Principal Investigator
Klinikum Nurnberg Nord
Nürnberg , 90419, Germany More Info
Clemens Albrecht, Dr. med.
Principal Investigator
Bon Secours Radiotherapy Cork
Cork , T12 D, Ireland More Info
Paul Kelly, MB BCh BAO
Principal Investigator
Azienda Ospedaliero Universitaria di Parma
Parma , 43126, Italy More Info
Nicola Simoni, MD
Principal Investigator
IRCCS Ospedale Sacro Cuore Don Calabria
Verona , 37024, Italy More Info
Filippo Alongi, MD
Principal Investigator
Hospital Universitario Cruces
Barakaldo , 48903, Spain More Info
Alfonso Gomez Iturriaga, MD, PhD
Principal Investigator
GenesisCare, Hospital San Francisco de Asis
Madrid , 28002, Spain More Info
Felipe Couñago, MD, PhD
Principal Investigator
Hospital Universitario Ramón y Cajal
Madrid , , Spain More Info
Asunción Hervás Morón, MBChB, PhD
Principal Investigator
University Hospital Basel
Basel , CH-40, Switzerland More Info
Jens Lustenberger, MD
Principal Investigator
Inselspital - University Hospital Bern
Bern , 3010, Switzerland More Info
Mohamed Shelan, MD
Principal Investigator
Royal Surrey County Hospital NHS Foundation Trust
Guildford Surrey, GU27X, United Kingdom More Info
Christos Mikropoulos, MD MSc MRCP
Principal Investigator
Velindre Cancer Centre
Cardiff Wales, CF14 , United Kingdom More Info
Nachi Palaniappan, MD
Principal Investigator
Belfast City Hospital
Belfast , BT9 7, United Kingdom More Info
Suneil Jain, MB, BCh, PhD
Principal Investigator
Bristol Haematology and Oncology Centre
Bristol , BS2 8, United Kingdom More Info
Amit Bahl, MBBS, MD
Principal Investigator
Royal Marsden Hospital
London , SW3 6, United Kingdom More Info
Vincent Khoo, MD
Principal Investigator
Norfolk and Norwich University Hospital NHS Trust
Norwich , NR4 7, United Kingdom More Info
Jenny Nobes, MBBS, FRCR
Principal Investigator
Derriford General Hospital
Plymouth , PL6 8, United Kingdom More Info
Peter Sankey, MB, MRCP
Principal Investigator

How clear is this clinincal trial information?

Study is for people with:

Prostate Cancer

Estimated Enrollment:

500

Study ID:

NCT04905069

Recruitment Status:

Recruiting

Sponsor:


Boston Scientific Corporation

How clear is this clinincal trial information?

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