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| Name | Class |
|---|---|
| Augmenix, Inc. | INDUSTRY |
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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)
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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 |
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| 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. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| 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 |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Foundation for Cancer Research and Education | Phoenix | Arizona | 85013 | United States | ||
| Urological Surgeons of Northern California |
Randomized study, no wash out or run-in period
The first subject was treated on January 27, 2012 and the last subject visit occurred on July 15, 2014.
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| ID | Title | Description |
|---|---|---|
| FG000 | SpaceOAR | 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. |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
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| 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 |
| Campbell |
| California |
| 95008 |
| United States |
| Radiological Associates of Sacramento | Sacramento | California | 95815 | United States |
| The Urology Center of Colorado | Denver | Colorado | 80211 | United States |
| Lakewood Ranch Oncology Center/21st Century Oncology | Bradenton | Florida | 34202 | United States |
| 21st Century Oncology | Fort Myers | Florida | 33907 | United States |
| Emory University | Atlanta | Georgia | 30322 | United States |
| Johns Hopkins University Department of Radiation Oncology and Molecular Radiation Sciences | Baltimore | Maryland | 21231 | United States |
| Chesapeake Urology Associates, Chesapeake Urology Research Associates (The Prostate Center) | Owings Mills | Maryland | 21117 | United States |
| Northern Nevada Radiation Oncology | Reno | Nevada | 89521 | United States |
| CentraState Medical Center | Freehold | New Jersey | 07728 | United States |
| Western New York Urology Associates, LLC and D/B/A Cancer Care of WNY | Erie, Niagara, and Chautauqua County | New York | 14267 | United States |
| Advanced Radiation Centers of New York | Lake Success | New York | 11042 | United States |
| University of Rochester | Rochester | New York | 14642 | United States |
| Associated Medical Professionals of NY | Syracuse | New York | 13210 | United States |
| Upstate Medical University | Syracuse | New York | 13210 | United States |
| University Hospitals Case Medical Center | Cleveland | Ohio | 44106 | United States |
| Oregon Urology Institute | Springfield | Oregon | 97477 | United States |
| 21st Century Oncology | Myrtle Beach | South Carolina | 29577 | United States |
| Peninsula Cancer Center | Poulsbo | Washington | 98370 | United States |
| FG001 | Control | 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. |
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| NOT COMPLETED |
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| ID | Title | Description |
|---|---|---|
| BG000 | SpaceOAR | Subjects randomized to receive SpaceOAR hydrogel. |
| BG001 | Control | Subjects randomized to not receive SpaceOAR hydrogel. |
| BG002 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Standard Deviation | years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Ethnicity (NIH/OMB) | Count of Participants | Participants |
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| Race (NIH/OMB) | Subjects may check more than one category, therefore this is why SpaceOAR subjects = 150/149. | Count of Participants | Participants |
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| Region of Enrollment | Number | participants |
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| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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. | SpaceOAR Group Only | Posted | Count of Participants | Participants | 3 months post index procedure |
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| 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. | Intent-to-Treat (ITT) population was defined to be all randomized subjects (SpaceOAR and Control group). | Posted | Number | 95% Confidence Interval | percentage of subjects | 6 months post index procedure |
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| 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. | Intent-to-Treat (ITT) population was defined to be all randomized subjects (SpaceOAR and Control group). | Posted | Number | 95% Confidence Interval | percentage of subjects | 6 months post index procedure |
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| 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. | 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. | Posted | Mean | Standard Deviation | score on a scale | 3 months, 6 months, 12 months, 15 months |
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| 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. | Intent-to-Treat (ITT) population was defined to be all randomized subjects (SpaceOAR and Control group). | Posted | Number | 95% Confidence Interval | percentage of subjects | 6 months post procedure |
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| 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. | SpaceOAR treated subjects experiencing a procedure related AE prior to initiation of radiation therapy. | Posted | Count of Participants | Participants | 21 days post index procedure, prior to initiation of radiation therapy |
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| 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). | Intent-to-Treat (ITT) population was defined to be all randomized subjects (SpaceOAR and Control group). | Posted | Number | 95% Confidence Interval | participants | 21 days post index procedure |
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | SpaceOAR | Subjects randomized to receive SpaceOAR hydrogel. | 0 | 149 | 21 | 149 | 17 | 149 |
| EG001 | Control | Subjects randomized to not receive SpaceOAR hydrogel. | 0 | 73 | 10 | 73 | 2 | 73 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Acute coronary syndrome | Cardiac disorders |
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| Angina unstable | Cardiac disorders |
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| Arteriosclerosis coronary artery | Cardiac disorders |
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| Atrial fibrillation | Cardiac disorders |
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| Atrial flutter | Cardiac disorders |
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| Atrioventricular block complete | Cardiac disorders |
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| Myocardial infarction | Cardiac disorders |
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| Tachycardia | Cardiac disorders |
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| Corneal dystrophy | Eye disorders |
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| Inguinal hernia | Gastrointestinal disorders |
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| Large intestinal haemorrhage | Gastrointestinal disorders |
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| Oesophagitis | Gastrointestinal disorders |
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| Pancreatic carcinoma | Gastrointestinal disorders |
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| Cholelithiasis | Hepatobiliary disorders |
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| Hepatic cirrhosis | Hepatobiliary disorders |
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| Appendicitis | Infections and infestations |
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| Hip fracture | Musculoskeletal and connective tissue disorders |
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| Humerus fracture | Musculoskeletal and connective tissue disorders |
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| Pain in extremity | Musculoskeletal and connective tissue disorders |
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| Convulsion | Nervous system disorders |
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| Cognitive disorder | Psychiatric disorders |
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| Renal cell carcinoma | Renal and urinary disorders |
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| Urinary retention | Renal and urinary disorders |
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| Lung infection | Respiratory, thoracic and mediastinal disorders |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Haematospermia | Reproductive system and breast disorders |
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| Anorectal pressure | Gastrointestinal disorders |
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| Hematuria | Renal and urinary disorders |
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| Thigh pain | Musculoskeletal and connective tissue disorders |
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| Discomfort while sitting | Musculoskeletal and connective tissue disorders |
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| Perineal pain | Reproductive system and breast disorders |
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| Rectal pain | Gastrointestinal disorders |
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| Rectal bleeding | Gastrointestinal disorders |
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| Rectal penetration | Gastrointestinal disorders |
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| Constipation | Gastrointestinal disorders |
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| Flatulence | Gastrointestinal disorders |
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| Lower urinary tract symptoms | Renal and urinary disorders |
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| Hypotension | Vascular disorders |
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| Vasovagal presyncope | Vascular disorders |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Director, Clinical Operations | Boston Scientific Corporation | 952-930-6000 | teresa.takle-flach@bsci.com |
| ID | Term |
|---|---|
| D011471 | Prostatic Neoplasms |
| ID | Term |
|---|---|
| D005834 | Genital Neoplasms, Male |
| D014565 | Urogenital Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D005832 | Genital Diseases, Male |
| D000091662 | Genital Diseases |
| D000091642 | Urogenital Diseases |
| D011469 | Prostatic Diseases |
| D052801 | Male Urogenital Diseases |
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| Male |
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| Not Hispanic or Latino |
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| Unknown or Not Reported |
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| Asian |
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| Native Hawaiian or Other Pacific Islander |
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| Black or African American |
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| White |
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| More than one race |
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| Unknown or Not Reported |
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