Study Results
Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.
View full resultsBasic Information
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COMPLETED
PHASE3
222 participants
INTERVENTIONAL
2012-01-31
2014-07-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
SINGLE
Study Groups
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SpaceOAR
Men meeting the study eligibility criteria will be scheduled for fiducial marker placement using a transperineal approach with ultrasound guidance. Following successful fiducial marker placement, subjects will be randomized (2:1) to the treatment group or control group. Subjects randomized to the treatment group will undergo placement of 10 mL of SpaceOAR hydrogel
SpaceOAR System
Fiducial marker placement followed by randomization to treatment group, i.e., 10mL SpaceOAR hydrogel injection, or control group, i.e., no injection of SpaceOAR hydrogel.
Control
Men meeting the study eligibility criteria will be scheduled for fiducial marker placement using a transperineal approach with ultrasound guidance. Following successful fiducial marker placement, subjects will be randomized (2:1) to the treatment group or control group. Subjects randomized to the control group will not receive injection of the SpaceOAR hydrogel.
No interventions assigned to this group
Interventions
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SpaceOAR System
Fiducial marker placement followed by randomization to treatment group, i.e., 10mL SpaceOAR hydrogel injection, or control group, i.e., no injection of SpaceOAR hydrogel.
Eligibility Criteria
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Inclusion Criteria
* Subjects must have pathologically confirmed invasive adenocarcinoma of the prostate and must be planning to undergo IMRT
* Subjects must have clinical stage T1 or T2 as determined from a biopsy taken within 6 months of the baseline/screening visit with Gleason Score less than or equal to 7
* Subjects Screening/Baseline laboratory testing must meet the following laboratory value criteria: PSA less than or equal to 20 ng/mL,hematocrit greater than 30%,serum creatinine less than 2.0 mg/dl, serum AST and ALT less than 2.5 times upper limit of institution normal, and serum bilirubin less than 2.0 mg/dl
* Subject or authorized representative, has been informed of the nature of the study and has provided written informed consent, approved by the appropriate Institutional Review Board (IRB) of the respective clinical site
Exclusion Criteria
* Subjects with extracapsular extension of the prostate cancer, with greater than 50% of the number of biopsy cores positive for cancer, metastatic disease, other ongoing cancers which will be treated during the study, or subjects for whom pelvic lymph node radiotherapy is planned
* Subjects with any prior invasive malignancy (except non-melanomatous skin cancer) unless the subject has been disease free for a minimum of 5 years.
* Subjects who are indicated for androgen deprivation therapy or who have been treated with androgen therapy within the prior 3 months.
18 Years
MALE
No
Sponsors
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Augmenix, Inc.
INDUSTRY
Boston Scientific Corporation
INDUSTRY
Responsible Party
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Locations
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Foundation for Cancer Research and Education
Phoenix, Arizona, United States
Urological Surgeons of Northern California
Campbell, California, United States
Radiological Associates of Sacramento
Sacramento, California, United States
The Urology Center of Colorado
Denver, Colorado, United States
Lakewood Ranch Oncology Center/21st Century Oncology
Bradenton, Florida, United States
21st Century Oncology
Fort Myers, Florida, United States
Emory University
Atlanta, Georgia, United States
Johns Hopkins University Department of Radiation Oncology and Molecular Radiation Sciences
Baltimore, Maryland, United States
Chesapeake Urology Associates, Chesapeake Urology Research Associates (The Prostate Center)
Owings Mills, Maryland, United States
Northern Nevada Radiation Oncology
Reno, Nevada, United States
CentraState Medical Center
Freehold, New Jersey, United States
Western New York Urology Associates, LLC and D/B/A Cancer Care of WNY
Erie, Niagara, and Chautauqua County, New York, United States
Advanced Radiation Centers of New York
Lake Success, New York, United States
University of Rochester
Rochester, New York, United States
Associated Medical Professionals of NY
Syracuse, New York, United States
Upstate Medical University
Syracuse, New York, United States
University Hospitals Case Medical Center
Cleveland, Ohio, United States
Oregon Urology Institute
Springfield, Oregon, United States
21st Century Oncology
Myrtle Beach, South Carolina, United States
Peninsula Cancer Center
Poulsbo, Washington, United States
Countries
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Other Identifiers
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AGX-11-001-US
Identifier Type: -
Identifier Source: org_study_id
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