effectiveness of the spaceoar vue system in subjects with prostate cancer being treated with stereotactic body radiotherapy

Conditions: Prostate Cancer

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.


Eligibility criteria:
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

Keywords: prostate cancer stereotactic body radiotherapy sbrt spacer spaceoar spaceoar vue hypofractionation