Effectiveness of the SpaceOAR Vue System in Subjects With Prostate Cancer

NCT04905069 | Active Not Recruiting FDA Device

• 1 other identifier: U0702
• Study Type: interventional
• Target: 500
• Locations: 9 countries
• Sites: 30

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.

Conditions

Prostate Cancer

Keywords

Prostate; Cancer; Stereotactic Body Radiotherapy; SBRT; Spacer; SpaceOAR; SpaceOAR Vue; Hypofractionation

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• EPIC-26 bowel score

  24 months post-SBRT initiation

Study Arms (2)

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.

Device: SpaceOAR Vue System

Interventions

SpaceOAR Vue System DEVICE

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.

SpaceOAR Vue

Eligibility Criteria

• Age: 18 Years+
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Boston Scientific Corporation: lead

Study Sites (30)

GenesisCare USA

Fort Myers, Florida, 33908, United States

Location

Florida Urology Partners, LLC

Tampa, Florida, 33609, United States

Location

Kansas University Medical Center

Kansas City, Kansas, 66160, United States

Location

GenesisCare USA

Troy, Michigan, 48098, United States

Location

New Jersey Urology, a Summit Health Company

Bloomfield, New Jersey, 07003, United States

Location

University of Pittsburgh Medical Center

Pittsburgh, Pennsylvania, 15232, United States

Location

Dr. John Sylvester

Myrtle Beach, South Carolina, 29572, United States

Location

Calvary Mater Newcastle

Waratah, New South Wales, 2298, Australia

Location

Princess Alexandra Hospital - ROPAIR

Woolloongabba, Queensland, 4102, Australia

Location

Sir Charles Gairdner Hospital

Nedlands, Western Australia, 6009, Australia

Location

Institut Gustave Roussy

Villejuif, Cedex, 94805, France

Location

Institut de Radiothérapie & Radiochirurgie HARTMANN

Levallois-Perret, 92300, France

Location

MEDICLIN Robert Janker Klinik

Bonn, D-53129, Germany

Location

Klinikum Nurnberg Nord

Nuremberg, 90419, Germany

Location

Bon Secours Radiotherapy Cork

Cork, T12 DV56, Ireland

Location

Azienda Ospedaliero Universitaria di Parma

Parma, 43126, Italy

Location

Policlinico Universitario Agostino Gemelli

Rome, Italy

Location

IRCCS Ospedale Sacro Cuore Don Calabria

Verona, 37024, Italy

Location

Hospital Universitario Cruces

Barakaldo, 48903, Spain

Location

GenesisCare, Hospital San Francisco de Asis

Madrid, 28002, Spain

Location

Hospital Universitario Ramón y Cajal

Madrid, Spain

Location

University Hospital Basel

Basel, CH-4031, Switzerland

Location

Inselspital - University Hospital Bern

Bern, 3010, Switzerland

Location

Royal Surrey County Hospital NHS Foundation Trust

Guildford, Surrey, GU27XX, United Kingdom

Location

Velindre Cancer Centre

Cardiff, Wales, CF14 2TL, United Kingdom

Location

Belfast City Hospital

Belfast, BT9 7AB, United Kingdom

Location

Bristol Haematology and Oncology Centre

Bristol, BS2 8ED, United Kingdom

Location

Royal Marsden Hospital

London, SW3 6JJ, United Kingdom

Location

Norfolk and Norwich University Hospital NHS Trust

Norwich, NR4 7UY, United Kingdom

Location

Derriford General Hospital

Plymouth, PL6 8DH, United Kingdom

Location

MeSH Terms

Conditions

Prostatic Neoplasms; Neoplasms

Condition Hierarchy (Ancestors)

Genital Neoplasms, Male; Urogenital Neoplasms; Neoplasms by Site; Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Prostatic Diseases; Male Urogenital Diseases

Study Officials

• Suneil Jain, MB, BCh, PhD

  Queen's University, Belfast

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 24, 2021
• First Posted: May 27, 2021
• Study Start: December 21, 2021
• Primary Completion (Estimated): April 1, 2027
• Study Completion (Estimated): April 1, 2030
• Last Updated: May 12, 2026

Record last verified: 2026-05

Data Sharing

• IPD Sharing: Will not share

Locations

AU (3); DE (2); GB (7); CH (2); US (7); FR (2); IE (1); IT (3); ES (3)