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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT04905069
Other study ID # U0702
Secondary ID
Status Recruiting
Phase N/A
First received
Last updated
Start date December 21, 2021
Est. completion date April 2030

Study information

Verified date March 2024
Source Boston Scientific Corporation
Contact Blake Hedstrom
Phone 952-930-6000
Email blake.hedstrom@bsci.com
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


Recruitment information / eligibility

Status Recruiting
Enrollment 500
Est. completion date April 2030
Est. primary completion date April 2027
Accepts healthy volunteers No
Gender Male
Age group 18 Years and older
Eligibility 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 >38° 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 Design


Related Conditions & MeSH terms


Intervention

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.

Locations

Country Name City State
Australia Sir Charles Gairdner Hospital Nedlands Western Australia
Australia Calvary Mater Newcastle Waratah New South Wales
Australia Princess Alexandra Hospital - ROPAIR Woolloongabba Queensland
France Institut Gustave Roussy Villejuif Cedex
Germany MEDICLIN Robert Janker Klinik Bonn
Germany Klinikum Nurnberg Nord Nürnberg
Ireland Bon Secours Radiotherapy Cork Cork
Italy Azienda Ospedaliero Universitaria di Parma Parma
Italy IRCCS Ospedale Sacro Cuore Don Calabria Verona
Spain Hospital Universitario Cruces Barakaldo
Spain GenesisCare, Hospital San Francisco de Asis Madrid
Spain Hospital Universitario Ramón y Cajal Madrid
Switzerland University Hospital Basel Basel
Switzerland Inselspital - University Hospital Bern Bern
United Kingdom Belfast City Hospital Belfast
United Kingdom Bristol Haematology and Oncology Centre Bristol
United Kingdom Velindre Cancer Centre Cardiff Wales
United Kingdom Royal Surrey County Hospital NHS Foundation Trust Guildford Surrey
United Kingdom Royal Marsden Hospital London
United Kingdom Norfolk and Norwich University Hospital NHS Trust Norwich
United Kingdom Derriford General Hospital Plymouth
United States New Jersey Urology, a Summit Health Company Bloomfield New Jersey
United States GenesisCare USA Fort Myers Florida
United States Kansas University Medical Center Kansas City Kansas
United States GenesisCare USA Lakewood Ranch Florida
United States University of Pittsburgh Medical Center Pittsburgh Pennsylvania
United States Florida Urology Partners, LLC Tampa Florida
United States GenesisCare USA Troy Michigan

Sponsors (1)

Lead Sponsor Collaborator
Boston Scientific Corporation

Countries where clinical trial is conducted

United States,  Australia,  France,  Germany,  Ireland,  Italy,  Spain,  Switzerland,  United Kingdom, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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 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
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