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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT04905069




Registration number
NCT04905069
Ethics application status
Date submitted
24/05/2021
Date registered
27/05/2021

Titles & IDs
Public title
Effectiveness of the SpaceOAR Vue System in Subjects With Prostate Cancer Being Treated With Stereotactic Body Radiotherapy
Scientific title
Effectiveness of the SpaceOAR Vue System in Subjects With Prostate Cancer Being Treated With Stereotactic Body Radiotherapy
Secondary ID [1] 0 0
U0702
Universal Trial Number (UTN)
Trial acronym
SABRE
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Prostate Cancer 0 0
Condition category
Condition code
Cancer 0 0 0 0
Prostate

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Devices - SpaceOAR Vue System

No intervention: No-Spacer Control - Subjects will receive radiotherapy without the use of the SpaceOAR Vue.

Experimental: SpaceOAR Vue - Subjects will receive radiotherapy following injection of the SpaceOAR Vue hydrogel.


Treatment: Devices: 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.
Intervention code [1] 0 0
Treatment: Devices
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Late Gastrointestinal (GI) Toxicity
Timepoint [1] 0 0
3 to 24 months post-SBRT initiation
Secondary outcome [1] 0 0
EPIC-26 bowel score
Timepoint [1] 0 0
24 months post-SBRT initiation

Eligibility
Key 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.
Minimum age
18 Years
Maximum age
No limit
Sex
Males
Can healthy volunteers participate?
No
Key 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
Purpose of the study
Prevention
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
NA
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
21/12/2021
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
1/04/2030
Actual
Sample size
Target
500
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW,QLD,WA
Recruitment hospital [1] 0 0
Calvary Mater Newcastle - Waratah
Recruitment hospital [2] 0 0
Princess Alexandra Hospital - ROPAIR - Woolloongabba
Recruitment hospital [3] 0 0
Sir Charles Gairdner Hospital - Nedlands
Recruitment postcode(s) [1] 0 0
2298 - Waratah
Recruitment postcode(s) [2] 0 0
4102 - Woolloongabba
Recruitment postcode(s) [3] 0 0
6009 - Nedlands
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
Florida
Country [2] 0 0
United States of America
State/province [2] 0 0
Kansas
Country [3] 0 0
United States of America
State/province [3] 0 0
Michigan
Country [4] 0 0
United States of America
State/province [4] 0 0
New Jersey
Country [5] 0 0
United States of America
State/province [5] 0 0
Pennsylvania
Country [6] 0 0
France
State/province [6] 0 0
Cedex
Country [7] 0 0
France
State/province [7] 0 0
Levallois-Perret
Country [8] 0 0
Germany
State/province [8] 0 0
Bonn
Country [9] 0 0
Germany
State/province [9] 0 0
Nürnberg
Country [10] 0 0
Ireland
State/province [10] 0 0
Cork
Country [11] 0 0
Italy
State/province [11] 0 0
Parma
Country [12] 0 0
Italy
State/province [12] 0 0
Verona
Country [13] 0 0
Spain
State/province [13] 0 0
Barakaldo
Country [14] 0 0
Spain
State/province [14] 0 0
Madrid
Country [15] 0 0
Switzerland
State/province [15] 0 0
Basel
Country [16] 0 0
Switzerland
State/province [16] 0 0
Bern
Country [17] 0 0
United Kingdom
State/province [17] 0 0
Surrey
Country [18] 0 0
United Kingdom
State/province [18] 0 0
Wales
Country [19] 0 0
United Kingdom
State/province [19] 0 0
Belfast
Country [20] 0 0
United Kingdom
State/province [20] 0 0
Bristol
Country [21] 0 0
United Kingdom
State/province [21] 0 0
London
Country [22] 0 0
United Kingdom
State/province [22] 0 0
Norwich
Country [23] 0 0
United Kingdom
State/province [23] 0 0
Plymouth

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
Boston Scientific Corporation
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Suneil Jain, MB, BCh, PhD
Address 0 0
Queen's University, Belfast
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Blake Hedstrom
Address 0 0
Country 0 0
Phone 0 0
952-930-6000
Fax 0 0
Email 0 0
[email protected]
Contact person for scientific queries

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

No documents have been uploaded by study researchers.


Results not provided in https://clinicaltrials.gov/study/NCT04905069