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

February 21, 2012
April 22, 2013
January 2012
March 2014   (final data collection date for primary outcome measure)
  • 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 ]
Not Provided
Complete list of historical versions of study NCT01538628 on ClinicalTrials.gov Archive Site
• 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 ]
Not Provided
Not Provided
Not Provided
 
SpaceOAR System Pivotal Study
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

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.

Not Provided
Interventional
Phase 3
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Subject)
Primary Purpose: Treatment
Prostate Cancer
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.
  • 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
    Intervention: Device: SpaceOAR System
  • 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.
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Active, not recruiting
222
May 2014
March 2014   (final data collection date for primary outcome measure)

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.
Male
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT01538628
AGX-11-001-US
No
Augmenix, Inc.
Augmenix, Inc.
Not Provided
Not Provided
Augmenix, Inc.
April 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP