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Effectiveness of the SpaceOAR Vue System in Subjects With Prostate Cancer Being Treated With Stereotactic Body Radiotherapy (SABRE)

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ClinicalTrials.gov Identifier: NCT04905069
Recruitment Status : Recruiting
First Posted : May 27, 2021
Last Update Posted : April 23, 2024
Sponsor:
Information provided by (Responsible Party):
Boston Scientific Corporation

Tracking Information
First Submitted Date  ICMJE May 24, 2021
First Posted Date  ICMJE May 27, 2021
Last Update Posted Date April 23, 2024
Actual Study Start Date  ICMJE December 21, 2021
Estimated Primary Completion Date April 2027   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: May 24, 2021)		 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
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: May 24, 2021)		 EPIC-26 bowel score [ Time Frame: 24 months post-SBRT initiation ]
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.
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Effectiveness of the SpaceOAR Vue System in Subjects With Prostate Cancer Being Treated With Stereotactic Body Radiotherapy
Official Title  ICMJE Effectiveness of the SpaceOAR Vue System in Subjects With Prostate Cancer Being Treated With Stereotactic Body Radiotherapy
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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Condition  ICMJE Prostate Cancer
Intervention  ICMJE 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.
Study Arms  ICMJE
  • 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.
    Intervention: Device: SpaceOAR Vue System
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: May 24, 2021)		 500
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE April 2030
Estimated Primary Completion Date April 2027   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: Male
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Blake Hedstrom 952-930-6000 blake.hedstrom@bsci.com
Contact: Gwen LeTourneau 952-930-6000 Gwen.LeTourneau@bsci.com
Listed Location Countries  ICMJE Australia,   France,   Germany,   Ireland,   Italy,   Spain,   Switzerland,   United Kingdom,   United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT04905069
Other Study ID Numbers  ICMJE U0702
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Product Manufactured in and Exported from the U.S.: Yes
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Current Responsible Party Boston Scientific Corporation
Original Responsible Party Same as current
Current Study Sponsor  ICMJE Boston Scientific Corporation
Original Study Sponsor  ICMJE Same as current
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Suneil Jain, MB, BCh, PhD Queen's University, Belfast
PRS Account Boston Scientific Corporation
Verification Date April 2024

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP