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

Study Overview
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Brief Summary
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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.

Official Title
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Effectiveness of the SpaceOAR Vue System in Subjects With Prostate Cancer Being Treated With Stereotactic Body Radiotherapy

Conditions
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Prostate Cancer

Intervention / Treatment
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* Device: SpaceOAR Vue System


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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Male

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| No Intervention: No-Spacer Control<br>Subjects will receive radiotherapy without the use of the SpaceOAR Vue. | |
| Experimental: SpaceOAR Vue<br>Subjects will receive radiotherapy following injection of the SpaceOAR Vue hydrogel. | Device: SpaceOAR Vue System<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | 24 months post-SBRT initiation | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Spacer, SpaceOAR, SpaceOAR Vue, Hypofractionation, Prostate, Cancer, Stereotactic Body Radiotherapy, SBRT