SpaceOAR System Pivotal Study

Study Overview
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Brief Summary
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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
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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.

Official Title
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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

Conditions
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Prostate Cancer

Intervention / Treatment
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* Device: SpaceOAR System


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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Male

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: SpaceOAR<br>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<br>* 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.<br>|
| No Intervention: Control<br>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. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 
| 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 | 
| 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 | 
| 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 | 
| 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Prostate cancer, Spacer