Prostate CancerSABRENCT04905069
Effectiveness of the SpaceOAR Vue System in Subjects With Prostate Cancer
A study testing SpaceOAR Vue System in people with Prostate Cancer, run by Boston Scientific Corporation at 30 sites in 9 countries.
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. Read more about this study
- Who is it for?
- Ages 18 years and older, men only
- Conditions the study is for
- Prostate Cancer
- What is being tested?
- SpaceOAR Vue System
- Type of treatment
- Injection or infusion, Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 500 participants
- Where
- 30 sitesin 9 countries
- Study dates
- 21 Dec 2021to Dec 2030
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Men only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Show all 20Show fewer
- 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
Trial locations and contacts
30 sites in 9 countries.
30 sites in 9 countries
United States7 sites
New Jersey Urology, a Summit Health Company
Bloomfield, New Jersey, 07003
GenesisCare USA
Fort Myers, Florida, 33908
Kansas University Medical Center
Kansas City, Kansas, 66160
Dr. John Sylvester
Myrtle Beach, South Carolina, 29572
University of Pittsburgh Medical Center
Pittsburgh, Pennsylvania, 15232
Florida Urology Partners, LLC
Tampa, Florida, 33609
GenesisCare USA
Troy, Michigan, 48098
United Kingdom7 sites
Belfast City Hospital
Belfast, BT9 7AB
Bristol Haematology and Oncology Centre
Bristol, BS2 8ED
Velindre Cancer Centre
Cardiff, Wales, CF14 2TL
Royal Surrey County Hospital NHS Foundation Trust
Guildford, Surrey, GU27XX
Royal Marsden Hospital
London, SW3 6JJ
Norfolk and Norwich University Hospital NHS Trust
Norwich, NR4 7UY
Derriford General Hospital
Plymouth, PL6 8DH
Australia3 sites
Sir Charles Gairdner Hospital
Nedlands, Western Australia, 6009
Calvary Mater Newcastle
Waratah, New South Wales, 2298
Princess Alexandra Hospital - ROPAIR
Woolloongabba, Queensland, 4102
Italy3 sites
Azienda Ospedaliero Universitaria di Parma
Parma, 43126
Policlinico Universitario Agostino Gemelli
Rome
IRCCS Ospedale Sacro Cuore Don Calabria
Verona, 37024
Spain3 sites
Hospital Universitario Cruces
Barakaldo, 48903
GenesisCare, Hospital San Francisco de Asis
Madrid, 28002
Hospital Universitario Ramón y Cajal
Madrid
France2 sites
Institut de Radiothérapie & Radiochirurgie HARTMANN
Levallois-Perret, 92300
Institut Gustave Roussy
Villejuif, Cedex, 94805
Germany2 sites
MEDICLIN Robert Janker Klinik
Bonn, D-53129
Klinikum Nurnberg Nord
Nuremberg, 90419
Switzerland2 sites
University Hospital Basel
Basel, CH-4031
Inselspital - University Hospital Bern
Bern, 3010
About this study
Official title: Effectiveness of the SpaceOAR Vue System in Subjects With Prostate Cancer Being Treated With Stereotactic Body Radiotherapy
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.
Read the detailed description
This study is designed to evaluate the effectiveness of the SpaceOAR Vue System in reducing late gastrointestinal (GI) toxicity in participants undergoing Stereotactic Body Radiotherapy (SBRT) for the treatment of prostate cancer.
- Conditions
- Prostate Cancer
- Being tested
- SpaceOAR Vue System
- Keywords
- Prostate, Cancer, Stereotactic Body Radiotherapy, SBRT, Spacer, SpaceOAR, SpaceOAR Vue, Hypofractionation
- Medical subject headings
- Prostatic Neoplasms, Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SpaceOAR Vue SystemDevice
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.
| Study group | Role | What they receive |
|---|---|---|
| No-Spacer Control | No intervention | Subjects will receive radiotherapy without the use of the SpaceOAR Vue. |
| SpaceOAR Vue | Experimental | Subjects will receive radiotherapy following injection of the SpaceOAR Vue hydrogel. Receives: Device: SpaceOAR Vue System |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 3 to 24 months post-SBRT initiation
Secondary outcomes (1)
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.
Measured: 24 months post-SBRT initiation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 May 2021
- Study start21 Dec 2021
- Primary completionDec 2027 (estimated)
- Study completionDec 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Prostate CancerStudies of the same condition, open and under way.
- More trials run by Boston Scientific CorporationThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 500 participants (actual)
Sponsor and investigators
- Lead sponsor
- Boston Scientific Corporation
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Suneil Jain, MB, BCh, PhD, Principal investigator, Queen's University, Belfast
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04905069
- Sponsor's protocol ID
- U0702
- Acronym
- SABRE
- Status last verified
- Oct 2026
- First submitted
- 24 May 2021
- Last updated
- 13 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effectiveness of the SpaceOAR Vue System in Subjects With Prostate Cancer Being Treated With Stereotactic Body Radiotherapy
- ClinicalTrials.gov ID
- NCT04905069
- Acronym / sponsor ID
- SABRE / U0702
- Conditions
- Prostate Cancer
- Keywords
- Prostate, Cancer, Stereotactic Body Radiotherapy, SBRT, Spacer, SpaceOAR, SpaceOAR Vue, Hypofractionation
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 500 participants (actual)
- Lead sponsor
- Boston Scientific CorporationIndustry (pharma, biotech, devices)
- Study start
- 21 Dec 2021 (actual)
- Primary completion
- Dec 2027 (estimated)
- Study completion
- Dec 2030 (estimated)
- First posted
- 27 May 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
This study is designed to evaluate the effectiveness of the SpaceOAR Vue System in reducing late gastrointestinal (GI) toxicity in participants undergoing Stereotactic Body Radiotherapy (SBRT) for the treatment of prostate cancer.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| No-Spacer Control | No intervention | –Subjects will receive radiotherapy without the use of the SpaceOAR Vue. |
| SpaceOAR Vue | Experimental | Device: SpaceOAR Vue SystemSubjects will receive radiotherapy following injection of the SpaceOAR Vue hydrogel. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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)
Key exclusion criteria (20 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| SpaceOAR Vue SystemThe 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. | Device | SpaceOAR Vue |
Primary outcome
Late Gastrointestinal (GI) Toxicity
Time frame: 3 to 24 months post-SBRT initiation
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
1 secondary outcome
EPIC-26 bowel score
Time frame: 24 months post-SBRT initiation
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Oct 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Suneil Jain, MB, BCh, PhD principal investigator
Queen's University, Belfast
30 sites in 9 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing SpaceOAR Vue System in people with Prostate Cancer, run by Boston Scientific Corporation at 30 sites in 9 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 20 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 13 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 30 sites in United States, United Kingdom, Australia, Italy, Spain and 4 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Late Gastrointestinal (GI) Toxicity (time frame: 3 to 24 months post-SBRT initiation). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Oct 2026; AzTrials last refreshed its copy on 7 Nov 2026.