Neoplasms

Urinary Tract, Sexual Organs, and Pregnancy Conditions

All Conditions

Prostatic Neoplasms

Genital Neoplasms, Male

Urogenital Neoplasms

Genital Diseases

Genital Diseases, Male

Urogenital Diseases

Prostatic Diseases

Male Urogenital Diseases

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

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.

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 System

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

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.

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

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.

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.

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.

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.

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.

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.

All subjects begin Intensity Modulated Radiation Therapy (IMRT) within 21 days following index procedure (Fiducial Marker Placement with or without SpaceOAR Hydrogel Injection).

Augmenix, Inc.

Boston Scientific Corporation

Subjects randomized to receive SpaceOAR hydrogel.

SpaceOAR

Subjects randomized to not receive SpaceOAR hydrogel.

Control

Total

Age, Continuous

Sex: Female, Male

Ethnicity (NIH/OMB)

Subjects may check more than one category, therefore this is why SpaceOAR subjects = 150/149.

Race (NIH/OMB)

United States

Region of Enrollment

Director, Clinical Operations

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

Intent-to-Treat (ITT) population was defined to be all randomized subjects (SpaceOAR and Control group).

Percentage of Subjects Experiencing Grade 1 or Greater Rectal or Procedure Adverse Events Post Index Procedure

Percentage of Subjects Experiencing Grade 2 or Greater Rectal or Procedure Adverse Events in the 6 Months Following the Index Procedure

Change in Urinary Assessment Composite Score at 3 Months

Change in Urinary Assessment Composite Score at 6 Months

Change in Urinary Assessment Composite Score at 12 Months

Change in Urinary Assessment Composite Score at 15 Months

Change in Sexual Assessment Composite Score at 3 Months

Change in Sexual Assessment Composite Score at 6 Months

Change in Sexual Assessment Composite Score at 12 Months

Change in Sexual Assessment Composite Score at 15 Months

Change in Bowel Habits Assessment Composite Score at 3 Months

Change in Bowel Habits Assessment Composite Score at 6 Months

Change in Bowel Habits Assessment Composite Score at 12 Months

Change in Bowel Habits Assessment Composite Score at 15 Months

Change in Hormonal Assessment Composite Score at 3 Months

Change in Hormonal Assessment Composite Score at 6 Months

Change in Hormonal Assessment Composite Score at 12 Months

Change in Hormonal Assessment Composite Score at 15 Months

Intent-to-Treat (ITT) population was defined to be all randomized subjects (SpaceOAR and Control group). Mean change in score was calculated for the number of subjects providing data at each follow-up visit.

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

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

SpaceOAR treated subjects experiencing a procedure related AE prior to initiation of radiation therapy.

Number of SpaceOAR Subjects Experiencing a Procedure-Related Adverse Event (AE) Prior to Initiation of Radiation Therapy

Subjects randomized to not receive SpaceOAR hydrogel

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

Subjects 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

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.

Subjects 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.

Spots Global Cancer Trial Database for SpaceOAR System Pivotal Study

Trial Identification

Conditions

Interventions

Study Description

Keywords

Eligibility

Locations

Contact Details

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