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 : May 22, 2023
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|Condition or disease||Intervention/treatment||Phase|
|Prostate Cancer||Device: SpaceOAR Vue System||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||500 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||Effectiveness of the SpaceOAR Vue System in Subjects With Prostate Cancer Being Treated With Stereotactic Body Radiotherapy|
|Actual Study Start Date :||December 21, 2021|
|Estimated Primary Completion Date :||December 2025|
|Estimated Study Completion Date :||December 2028|
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.
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.
- 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
- 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.
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|Ages Eligible for Study:||18 Years and older (Adult, Older Adult)|
|Sexes Eligible for Study:||Male|
|Accepts Healthy Volunteers:||No|
- Age ≥ 18 years old.
- Subjects must have pathologically confirmed (by routine hematoxylin and eosin (H&E) staining) invasive adenocarcinoma of the prostate and must have been planning to undergo SBRT.
- Subjects must have one or more of the following:
- Clinical Stage T2b - T2c (AJCC 6th edition) tumor
- Gleason Score 7 as determined from a biopsy taken within 6 months of the baseline/screening visit
- Demonstrated blood PSA levels 10-20 ng/ml as measured during the Subject Enrollment/Baseline visit
- 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.
- Prostate >80 cc documented within 3 months preceding the Screening/Baseline visit
- Clinical stage T3 or T4 (AJCC 6th edition) tumor
- Blood PSA level >20 ng/ml as measured during Subject Enrollment/Baseline visit
- Gleason Score ≥ 8
- Subjects who had MRI evidence of posterior extracapsular extension (ECE) of the prostate cancer. 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, ulcerative colitis, or irritable bowel disease.
- 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.
- Active bleeding disorder or a clinically significant coagulopathy defined as a Partial Thromboplastin Time (PTT) >35s or International Normalized Ratio (INR) > 1.4 or platelet count less than 100,000 per mm³. 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: WBC < 4000 /uL or > 12,000/uL 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.
- Contraindication for safe MRI, implants, or other conditions that would interfere with imaging required for the study (e.g., Non-MRI compatible pacemaker or metal that negatively impacts the MRI image at the discretion of the investigator).
- 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
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04905069
|Contact: Blake Hedstromfirstname.lastname@example.org|
|Contact: Gwen LeTourneau||952-930-6000||Gwen.LeTourneau@bsci.com|
|Principal Investigator:||Suneil Jain, MB, BCh, PhD||Queen's University, Belfast|
|Responsible Party:||Boston Scientific Corporation|
|Other Study ID Numbers:||
|First Posted:||May 27, 2021 Key Record Dates|
|Last Update Posted:||May 22, 2023|
|Last Verified:||May 2023|
|Individual Participant Data (IPD) Sharing Statement:|
|Plan to Share IPD:||No|
|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|
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