Clinical trial NCT01538628: SpaceOAR System Pivotal Study
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Prostate Cancer
Keywords: Prostate cancer
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Lead sponsor: Boston Scientific Corporation
Sponsor class: INDUSTRY
Collaborators: name: Augmenix, Inc.
First posted: 2012-02-24
Enrollment: 222
Sex: MALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility 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.

Primary outcomes:
measure: 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
timeFrame: 3 months post index procedure
measure: Percentage of Subjects Experiencing Grade 1 or Greater Rectal or Procedure Adverse Events Post Index Procedure
timeFrame: 6 months post index procedure
Secondary outcomes:
measure: Percentage of Subjects Experiencing Grade 2 or Greater Rectal or Procedure Adverse Events in the 6 Months Following the Index Procedure
timeFrame: 6 months post index procedure
measure: Change From Baseline in Expanded Prostate Cancer Index Composite (EPIC) Score Following Index Procedure
timeFrame: 3 months, 6 months, 12 months, 15 months
measure: 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
timeFrame: 6 months post procedure
measure: Number of SpaceOAR Subjects Experiencing a Procedure-Related Adverse Event (AE) Prior to Initiation of Radiation Therapy
timeFrame: 21 days post index procedure, prior to initiation of radiation therapy
measure: Number of Subjects Experiencing a Delay in Radiation Therapy Associated With a Procedure or Device-Related Adverse Event
timeFrame: 21 days post index procedure
Other outcomes:
Locations:
city: Phoenix
country: United States
facility: Foundation for Cancer Research and Education
state: Arizona
city: Campbell
country: United States
facility: Urological Surgeons of Northern California
state: California
city: Sacramento
country: United States
facility: Radiological Associates of Sacramento
state: California
city: Denver
country: United States
facility: The Urology Center of Colorado
state: Colorado
city: Bradenton
country: United States
facility: Lakewood Ranch Oncology Center/21st Century Oncology
state: Florida
city: Fort Myers
country: United States
facility: 21st Century Oncology
state: Florida
city: Atlanta
country: United States
facility: Emory University
state: Georgia
city: Baltimore
country: United States
facility: Johns Hopkins University Department of Radiation Oncology and Molecular Radiation Sciences
state: Maryland
city: Owings Mills
country: United States
facility: Chesapeake Urology Associates, Chesapeake Urology Research Associates (The Prostate Center)
state: Maryland
city: Reno
country: United States
facility: Northern Nevada Radiation Oncology
state: Nevada
city: Freehold
country: United States
facility: CentraState Medical Center
state: New Jersey
city: Erie, Niagara, And Chautauqua County
country: United States
facility: Western New York Urology Associates, LLC and D/B/A Cancer Care of WNY
state: New York
city: Lake Success
country: United States
facility: Advanced Radiation Centers of New York
state: New York
city: Rochester
country: United States
facility: University of Rochester
state: New York
city: Syracuse
country: United States
facility: Associated Medical Professionals of NY
state: New York
city: Syracuse
country: United States
facility: Upstate Medical University
state: New York
city: Cleveland
country: United States
facility: University Hospitals Case Medical Center
state: Ohio
city: Springfield
country: United States
facility: Oregon Urology Institute
state: Oregon
city: Myrtle Beach
country: United States
facility: 21st Century Oncology
state: South Carolina
city: Poulsbo
country: United States
facility: Peninsula Cancer Center
state: Washington
Study officials:
References: