Clinical trial NCT04905069: Effectiveness of the SpaceOAR Vue System in Subjects With Prostate Cancer Being Treated With Stereotactic Body Radiotherapy
Official title: Effectiveness of the SpaceOAR Vue System in Subjects With Prostate Cancer Being Treated With Stereotactic Body Radiotherapy
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Prostate Cancer
Keywords: Prostate
Cancer
Stereotactic Body Radiotherapy
SBRT
Spacer
SpaceOAR
SpaceOAR Vue
Hypofractionation
Lead sponsor: Boston Scientific Corporation
Sponsor class: INDUSTRY
First posted: 2021-05-27
Enrollment: 500
Sex: MALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief 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.


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

Primary outcomes:
measure: Late Gastrointestinal (GI) Toxicity
timeFrame: 3 to 24 months post-SBRT initiation
Secondary outcomes:
measure: EPIC-26 bowel score
timeFrame: 24 months post-SBRT initiation
Other outcomes:
Locations:
city: Fort Myers
country: United States
facility: GenesisCare USA
state: Florida
city: Lakewood Ranch
country: United States
facility: GenesisCare USA
state: Florida
city: Tampa
country: United States
facility: Florida Urology Partners, LLC
state: Florida
city: Kansas City
country: United States
facility: Kansas University Medical Center
state: Kansas
city: Troy
country: United States
facility: GenesisCare USA
state: Michigan
city: Bloomfield
country: United States
facility: New Jersey Urology, a Summit Health Company
state: New Jersey
city: Pittsburgh
country: United States
facility: University of Pittsburgh Medical Center
state: Pennsylvania
city: Waratah
country: Australia
facility: Calvary Mater Newcastle
state: New South Wales
city: Woolloongabba
country: Australia
facility: Princess Alexandra Hospital - ROPAIR
state: Queensland
city: Nedlands
country: Australia
facility: Sir Charles Gairdner Hospital
state: Western Australia
city: Villejuif
country: France
facility: Institut Gustave Roussy
state: Cedex
city: Levallois-Perret
country: France
facility: Institut de Radiothérapie & Radiochirurgie HARTMANN
city: Bonn
country: Germany
facility: MEDICLIN Robert Janker Klinik
city: Nürnberg
country: Germany
facility: Klinikum Nurnberg Nord
city: Cork
country: Ireland
facility: Bon Secours Radiotherapy Cork
city: Parma
country: Italy
facility: Azienda Ospedaliero Universitaria di Parma
city: Rome
country: Italy
facility: Policlinico Universitario Agostino Gemelli
city: Verona
country: Italy
facility: IRCCS Ospedale Sacro Cuore Don Calabria
city: Barakaldo
country: Spain
facility: Hospital Universitario Cruces
city: Madrid
country: Spain
facility: GenesisCare, Hospital San Francisco de Asis
city: Madrid
country: Spain
facility: Hospital Universitario Ramón y Cajal
city: Basel
country: Switzerland
facility: University Hospital Basel
city: Bern
country: Switzerland
facility: Inselspital - University Hospital Bern
city: Guildford
country: United Kingdom
facility: Royal Surrey County Hospital NHS Foundation Trust
state: Surrey
city: Cardiff
country: United Kingdom
facility: Velindre Cancer Centre
state: Wales
city: Belfast
country: United Kingdom
facility: Belfast City Hospital
city: Bristol
country: United Kingdom
facility: Bristol Haematology and Oncology Centre
city: London
country: United Kingdom
facility: Royal Marsden Hospital
city: Norwich
country: United Kingdom
facility: Norfolk and Norwich University Hospital NHS Trust
city: Plymouth
country: United Kingdom
facility: Derriford General Hospital
Study officials:
affiliation: Queen's University, Belfast
name: Suneil Jain, MB, BCh, PhD
role: PRINCIPAL_INVESTIGATOR
References: