SpaceOAR System Pivotal Study
This study is ongoing, but not recruiting participants.
Sponsor:
Augmenix, Inc.
Information provided by (Responsible Party):
Augmenix, Inc.
ClinicalTrials.gov Identifier:
NCT01538628
First received: February 21, 2012
Last updated: April 22, 2013
Last verified: April 2013
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Purpose
The purpose of this study is to evaluate the safety of the SpaceOAR System when the hydrogel is injected between the rectum and prostate in men undergoing radiation therapy (IG-IMRT) and to evaluate whether use of the SpaceOAR hydrogel results in a reduction of radiation exposure to the anterior rectum.
| Condition | Intervention | Phase |
|---|---|---|
|
Prostate Cancer |
Device: SpaceOAR System |
Phase 3 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Single Blind (Subject) Primary Purpose: Treatment |
| Official Title: | Evaluation of SpaceOAR™ System When Used to Create Space Between the Rectum and Prostate in Men Undergoing IG-IMRT for Localized Stage T1-T2 Prostate Cancer: A Randomized, Multicenter, Parallel Arm Controlled Clinical Study |
Resource links provided by NLM:
Further study details as provided by Augmenix, Inc.:
Primary Outcome Measures:
- Proportion of subjects achieving a reduction of 25% or greater in percent volume of the rectum receiving at least 70 Gy measured from CT scans acquired pre and post SpaceOAR hydrogel injection [ Time Frame: 3 months post index procedure ] [ Designated as safety issue: No ]
- Proportion of subjects experiencing a Grade 1 or greater rectal adverse event or procedure adverse event in the 6 months following treatment [ Time Frame: 6 months following the Index Procedure ] [ Designated as safety issue: Yes ]
Secondary Outcome Measures:
- • Proportion of subjects experiencing a Grade 2 or greater rectal adverse event or procedure adverse event in the 6 months following treatment [ Time Frame: 6 months following Index procedure ] [ Designated as safety issue: Yes ]
| Estimated Enrollment: | 222 |
| Study Start Date: | January 2012 |
| Estimated Study Completion Date: | May 2014 |
| Estimated Primary Completion Date: | March 2014 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: 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
|
Device: 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.
|
|
No Intervention: 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.
|
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Male |
| Accepts Healthy Volunteers: | No |
Criteria
Inclusion Criteria:
- Subjects greater than 18 years old
- 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:
- Prostate greater than 80cc documented within 3 months preceding the Screening/Baseline visit
- 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.
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01538628
Locations
| United States, Arizona | |
| Foundation for Cancer Research and Education | |
| Phoenix, Arizona, United States, 85013 | |
| United States, California | |
| Urological Surgeons of Northern California | |
| Campbell, California, United States, 95008 | |
| Radiological Associates of Sacramento | |
| Sacramento, California, United States, 95815 | |
| United States, Colorado | |
| The Urology Center of Colorado | |
| Denver, Colorado, United States, 80211 | |
| United States, Florida | |
| Lakewood Ranch Oncology Center/21st Century Oncology | |
| Bradenton, Florida, United States, 34202 | |
| 21st Century Oncology | |
| Fort Meyers, Florida, United States, 33907 | |
| United States, Georgia | |
| Emory University | |
| Atlanta, Georgia, United States, 30322 | |
| United States, Maryland | |
| Johns Hopkins University Department of Radiation Oncology and Molecular Radiation Sciences | |
| Baltimore, Maryland, United States, 21231 | |
| Chesapeake Urology Associates, Chesapeake Urology Research Associates (The Prostate Center) | |
| Owings Mills, Maryland, United States, 21117 | |
| United States, Nevada | |
| Northern Nevada Radiation Oncology | |
| Reno, Nevada, United States, 89521 | |
| United States, New Jersey | |
| CentraState Medical Center | |
| Freehold, New Jersey, United States, 07728 | |
| United States, New York | |
| Western New York Urology Associates, LLC and D/B/A Cancer Care of WNY | |
| Erie, Niagara, and Chautauqua County, New York, United States, 14267 | |
| Advanced Radiation Centers of New York | |
| Lake Success, New York, United States, 11042 | |
| University of Rochester | |
| Rochester, New York, United States, 14642 | |
| Upstate Medical University | |
| Syracuse, New York, United States, 13210 | |
| Associated Medical Professionals of NY | |
| Syracuse, New York, United States, 13210 | |
| United States, Ohio | |
| University Hospitals Case Medical Center | |
| Cleveland, Ohio, United States, 44106 | |
| United States, Oregon | |
| Oregon Urology Institute | |
| Springfield, Oregon, United States, 97477 | |
| United States, South Carolina | |
| 21st Century Oncology | |
| Myrtle Beach, South Carolina, United States, 29577 | |
| United States, Washington | |
| Peninsula Cancer Center | |
| Poulsbo, Washington, United States, 98370 | |
Sponsors and Collaborators
Augmenix, Inc.
More Information
No publications provided
| Responsible Party: | Augmenix, Inc. |
| ClinicalTrials.gov Identifier: | NCT01538628 History of Changes |
| Other Study ID Numbers: | AGX-11-001-US |
| Study First Received: | February 21, 2012 |
| Last Updated: | April 22, 2013 |
| Health Authority: | United States: Food and Drug Administration |
Keywords provided by Augmenix, Inc.:
|
Prostate cancer Spacer |
Additional relevant MeSH terms:
|
Prostatic Neoplasms Genital Neoplasms, Male Urogenital Neoplasms Neoplasms by Site |
Neoplasms Genital Diseases, Male Prostatic Diseases |
ClinicalTrials.gov processed this record on May 16, 2013