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

Evaluate the safety of the SpaceOAR System when the hydrogel is injected between the rectum and prostate in men undergoing radiation therapy (IG-IMRT)

Study Overview

• Status: Completed
• Conditions: Prostate Cancer
• Intervention / Treatment: Device: SpaceOAR System

Detailed Description

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.

• Study Type: Interventional
• Enrollment (Actual): 222
• Phase: Phase 3

Contacts and Locations

Study Locations

• United States
  • Arizona
    • Phoenix, Arizona, United States, 85013
      • Foundation for Cancer Research and Education
  • California
    • Campbell, California, United States, 95008
      • Urological Surgeons of Northern California
    • Sacramento, California, United States, 95815
      • Radiological Associates of Sacramento
  • Colorado
    • Denver, Colorado, United States, 80211
      • The Urology Center of Colorado
  • Florida
    • Bradenton, Florida, United States, 34202
      • Lakewood Ranch Oncology Center/21st Century Oncology
    • Fort Myers, Florida, United States, 33907
      • 21st Century Oncology
  • Georgia
    • Atlanta, Georgia, United States, 30322
      • Emory University
  • Maryland
    • Baltimore, Maryland, United States, 21231
      • Johns Hopkins University Department of Radiation Oncology and Molecular Radiation Sciences
    • Owings Mills, Maryland, United States, 21117
      • Chesapeake Urology Associates, Chesapeake Urology Research Associates (The Prostate Center)
  • Nevada
    • Reno, Nevada, United States, 89521
      • Northern Nevada Radiation Oncology
  • New Jersey
    • Freehold, New Jersey, United States, 07728
      • CentraState Medical Center
  • New York
    • Erie, Niagara, And Chautauqua County, New York, United States, 14267
      • Western New York Urology Associates, LLC and D/B/A Cancer Care of WNY
    • Lake Success, New York, United States, 11042
      • Advanced Radiation Centers of New York
    • Rochester, New York, United States, 14642
      • University of Rochester
    • Syracuse, New York, United States, 13210
      • Upstate Medical University
    • Syracuse, New York, United States, 13210
      • Associated Medical Professionals of Ny
  • Ohio
    • Cleveland, Ohio, United States, 44106
      • University Hospitals Case Medical Center
  • Oregon
    • Springfield, Oregon, United States, 97477
      • Oregon Urology Institute
  • South Carolina
    • Myrtle Beach, South Carolina, United States, 29577
      • 21st Century Oncology
  • Washington
    • Poulsbo, Washington, United States, 98370
      • Peninsula Cancer Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Male

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number 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	Measurements calculated and documented by the Core Lab. Measurements performed with the Core Lab blinded to subject identification. Results based on the Core Lab computation are considered as primary.	3 months post index procedure
Percentage of Subjects Experiencing Grade 1 or Greater Rectal or Procedure Adverse Events Post Index Procedure	The primary safety endpoint was the occurrence of Grade 1 or greater rectal adverse events or procedure adverse events in the 6 months following the Index Procedure. The numbers reflect the percent of subjects in each arm/group that experienced grade 1 or greater rectal or procedure adverse events post index procedure.	6 months post index procedure

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Percentage of Subjects Experiencing Grade 2 or Greater Rectal or Procedure Adverse Events in the 6 Months Following the Index Procedure	The numbers reflect the percent of subjects in each arm/group that experienced grade 2 or greater rectal or procedure adverse events post index procedure.	6 months post index procedure
Change From Baseline in Expanded Prostate Cancer Index Composite (EPIC) Score Following Index Procedure	Expanded Prostate Cancer Index Composite (EPIC) is a comprehensive survey instrument designed to assesses the disease-specific aspects of prostate cancer and its therapies and comprises four domains. Scores for each domain (urinary, sexual, bowel, hormonal) range from 0-100, with higher scores indicating improved quality of life. Scores are reported as mean change from baseline at each time point.	3 months, 6 months, 12 months, 15 months
Percentage of Subjects Requiring at Least One Medication Change for Mitigation of Rectal or Urinary Symptoms or for Procedure-related Events in the 6 Months Following the Index Procedure	The numbers reflect the percent of subjects in each arm/group that required at least one medication change to treat rectal or urinary symptoms in the 6 months post index procedure.	6 months post procedure
Number of SpaceOAR Subjects Experiencing a Procedure-Related Adverse Event (AE) Prior to Initiation of Radiation Therapy	An event was classified as a Procedure AE if it occurred during during and immediately after the Index Procedure or was deemed to be associated with the Index Procedure by the Clinical Events Committee (CEC). Per protocol subjects were to begin intensity modulated radiation therapy within 21 days following fiducial marker and/or SpaceOAR placement.	21 days post index procedure, prior to initiation of radiation therapy
Number of Subjects Experiencing a Delay in Radiation Therapy Associated With a Procedure or Device-Related Adverse Event	All subjects begin Intensity Modulated Radiation Therapy (IMRT) within 21 days following index procedure (Fiducial Marker Placement with or without SpaceOAR Hydrogel Injection).	21 days post index procedure

Collaborators and Investigators

• Sponsor: Boston Scientific Corporation
• Collaborators: Augmenix, Inc.

Study record dates

Study Major Dates

• Study Start: January 1, 2012
• Primary Completion (Actual): July 1, 2014
• Study Completion (Actual): July 1, 2014

Study Registration Dates

• First Submitted: February 21, 2012
• First Submitted That Met QC Criteria: February 23, 2012
• First Posted (Estimate): February 24, 2012

Study Record Updates

• Last Update Posted (Actual): March 19, 2021
• Last Update Submitted That Met QC Criteria: February 25, 2021
• Last Verified: February 1, 2021

More Information

Terms related to this study

• Keywords: Prostate cancer; Spacer
• Additional Relevant MeSH Terms: Neoplasms; Urogenital Neoplasms; Neoplasms by Site; Genital Neoplasms, Male; Prostatic Diseases; Prostatic Neoplasms
• Other Study ID Numbers: AGX-11-001-US