SpaceOAR System Pivotal Study

Prostate Cancer Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01538628
• Other study ID #: AGX-11-001-US
• Status: Completed
• Phase: Phase 3
• Start date: January 2012
• Est. completion date: July 2014

Study information

• Verified date: February 2021
• Source: Boston Scientific Corporation
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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)

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 information / eligibility

• Status: Completed
• Enrollment: 222
• Est. completion date: July 2014
• Est. primary completion date: July 2014
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Prostate Cancer
• Prostatic Neoplasms

Intervention

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.

Locations

Country	Name	City	State
United States	Emory University	Atlanta	Georgia
United States	Johns Hopkins University Department of Radiation Oncology and Molecular Radiation Sciences	Baltimore	Maryland
United States	Lakewood Ranch Oncology Center/21st Century Oncology	Bradenton	Florida
United States	Urological Surgeons of Northern California	Campbell	California
United States	University Hospitals Case Medical Center	Cleveland	Ohio
United States	The Urology Center of Colorado	Denver	Colorado
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	21st Century Oncology	Fort Myers	Florida
United States	CentraState Medical Center	Freehold	New Jersey
United States	Advanced Radiation Centers of New York	Lake Success	New York
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	Foundation for Cancer Research and Education	Phoenix	Arizona
United States	Peninsula Cancer Center	Poulsbo	Washington
United States	Northern Nevada Radiation Oncology	Reno	Nevada
United States	University of Rochester	Rochester	New York
United States	Radiological Associates of Sacramento	Sacramento	California
United States	Oregon Urology Institute	Springfield	Oregon
United States	Associated Medical Professionals of NY	Syracuse	New York
United States	Upstate Medical University	Syracuse	New York

Sponsors (2)

Lead Sponsor	Collaborator
Boston Scientific Corporation	Augmenix, Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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