SpaceOAR System Pivotal Study

NCT01538628 | Completed Phase 3 Results

• 1 other identifier: AGX-11-001-US
• Study Type: interventional
• Target: 222
• Locations: 1 country
• Sites: 20

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)

Conditions

Prostate Cancer

Keywords

Prostate cancer; Spacer

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (5)

• 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

• Change From Baseline in Expanded Prostate Cancer Index Composite (EPIC) Score Following Index Procedure

  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

  6 months post procedure

• 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

• Number of Subjects Experiencing a Delay in Radiation Therapy Associated With a Procedure or Device-Related Adverse Event

  21 days post index procedure

Study Arms (2)

SpaceOAR

EXPERIMENTAL

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

Control

NO INTERVENTION

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.

Interventions

SpaceOAR System DEVICE

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.

SpaceOAR

Eligibility Criteria

• Age: 18 Years+
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Boston Scientific Corporation: lead
• Augmenix, Inc.: collaborator

Study Sites (20)

Foundation for Cancer Research and Education

Phoenix, Arizona, 85013, United States

Location

Urological Surgeons of Northern California

Campbell, California, 95008, United States

Location

Radiological Associates of Sacramento

Sacramento, California, 95815, United States

Location

The Urology Center of Colorado

Denver, Colorado, 80211, United States

Location

Lakewood Ranch Oncology Center/21st Century Oncology

Bradenton, Florida, 34202, United States

Location

21st Century Oncology

Fort Myers, Florida, 33907, United States

Location

Emory University

Atlanta, Georgia, 30322, United States

Location

Johns Hopkins University Department of Radiation Oncology and Molecular Radiation Sciences

Baltimore, Maryland, 21231, United States

Location

Chesapeake Urology Associates, Chesapeake Urology Research Associates (The Prostate Center)

Owings Mills, Maryland, 21117, United States

Location

Northern Nevada Radiation Oncology

Reno, Nevada, 89521, United States

Location

CentraState Medical Center

Freehold, New Jersey, 07728, United States

Location

Western New York Urology Associates, LLC and D/B/A Cancer Care of WNY

Erie, Niagara, and Chautauqua County, New York, 14267, United States

Location

Advanced Radiation Centers of New York

Lake Success, New York, 11042, United States

Location

University of Rochester

Rochester, New York, 14642, United States

Location

Associated Medical Professionals of NY

Syracuse, New York, 13210, United States

Location

Upstate Medical University

Syracuse, New York, 13210, United States

Location

University Hospitals Case Medical Center

Cleveland, Ohio, 44106, United States

Location

Oregon Urology Institute

Springfield, Oregon, 97477, United States

Location

21st Century Oncology

Myrtle Beach, South Carolina, 29577, United States

Location

Peninsula Cancer Center

Poulsbo, Washington, 98370, United States

Location

MeSH Terms

Conditions

Prostatic Neoplasms

Condition Hierarchy (Ancestors)

Genital Neoplasms, Male; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Prostatic Diseases; Male Urogenital Diseases

Results Point of Contact

• Title: Director, Clinical Operations
• Organization: Boston Scientific Corporation

teresa.takle-flach@bsci.com

952-930-6000

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 21, 2012
• First Posted: February 24, 2012
• Study Start: January 1, 2012
• Primary Completion: July 1, 2014
• Study Completion: July 1, 2014
• Last Updated: March 19, 2021
• Results First Posted: March 19, 2021

Record last verified: 2021-02

Locations

US (20)