SpaceOAR System Pivotal Study

Phase 3

Completed

Conditions: Prostate Cancer

Interventions: Device: SpaceOAR System

Registration Number: NCT01538628

Lead Sponsor: Boston Scientific Corporation

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

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.

Recruitment & Eligibility

Status: COMPLETED

Sex: Male

Target Recruitment: 222

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 & Design

Study Type: INTERVENTIONAL

Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
SpaceOAR	SpaceOAR System	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

Primary Outcome Measures

Name	Time	Method
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	3 months post index procedure	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.
Percentage of Subjects Experiencing Grade 1 or Greater Rectal or Procedure Adverse Events Post Index Procedure	6 months 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.

Secondary Outcome Measures

Name	Time	Method
Percentage of Subjects Experiencing Grade 2 or Greater Rectal or Procedure Adverse Events in the 6 Months Following the Index Procedure	6 months post 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.
Change From Baseline in Expanded Prostate Cancer Index Composite (EPIC) Score Following Index Procedure	3 months, 6 months, 12 months, 15 months	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.
Number of SpaceOAR Subjects Experiencing a Procedure-Related Adverse Event (AE) Prior to Initiation of Radiation Therapy	21 days post index procedure, 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.
Number of Subjects Experiencing a Delay in Radiation Therapy Associated With a Procedure or Device-Related Adverse Event	21 days post index procedure	All subjects begin Intensity Modulated Radiation Therapy (IMRT) within 21 days following index procedure (Fiducial Marker Placement with or without SpaceOAR Hydrogel Injection).
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	6 months post 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.

Trial Locations

Locations (19): Urological Surgeons of Northern California
🇺🇸
Campbell, California, United States
21st Century Oncology
🇺🇸
Myrtle Beach, South Carolina, United States
Chesapeake Urology Associates, Chesapeake Urology Research Associates (The Prostate Center)
🇺🇸
Owings Mills, Maryland, 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
Oregon Urology Institute
🇺🇸
Springfield, Oregon, United States
Peninsula Cancer Center
🇺🇸
Poulsbo, Washington, United States
University of Rochester
🇺🇸
Rochester, New York, United States
Foundation for Cancer Research and Education
🇺🇸
Phoenix, Arizona, 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
Emory University
🇺🇸
Atlanta, Georgia, United States
Johns Hopkins University Department of Radiation Oncology and Molecular Radiation Sciences
🇺🇸
Baltimore, Maryland, United States
University Hospitals Case Medical Center
🇺🇸
Cleveland, Ohio, United States
Northern Nevada Radiation Oncology
🇺🇸
Reno, Nevada, United States
Associated Medical Professionals of NY
🇺🇸
Syracuse, New York, United States
Upstate Medical University
🇺🇸
Syracuse, New York, United States