SpaceOAR System Pivotal Study

This study is ongoing, but not recruiting participants.
Sponsor:
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
  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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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 September 29, 2014