Ignite Creation Date:
2025-12-26 @ 11:13 AM
Ignite Modification Date:
2026-03-09 @ 11:34 PM
Study NCT ID:
NCT01538628
Status:
COMPLETED
Last Update Posted:
2021-03-19
First Post:
2012-02-21
Is Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
SpaceOAR System Pivotal Study
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D011471', 'term': 'Prostatic Neoplasms'}], 'ancestors': [{'id': 'D005834', 'term': 'Genital Neoplasms, Male'}, {'id': 'D014565', 'term': 'Urogenital Neoplasms'}, {'id': 'D009371', 'term': 'Neoplasms by Site'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D005832', 'term': 'Genital Diseases, Male'}, {'id': 'D000091662', 'term': 'Genital Diseases'}, {'id': 'D000091642', 'term': 'Urogenital Diseases'}, {'id': 'D011469', 'term': 'Prostatic Diseases'}, {'id': 'D052801', 'term': 'Male Urogenital Diseases'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'teresa.takle-flach@bsci.com', 'phone': '952-930-6000', 'title': 'Director, Clinical Operations', 'organization': 'Boston Scientific Corporation'}, 'certainAgreement': {'piSponsorEmployee': False, 'restrictiveAgreement': False}}, 'adverseEventsModule': {'eventGroups': [{'id': 'EG000', 'title': 'SpaceOAR', 'description': 'Subjects randomized to receive SpaceOAR hydrogel.', 'otherNumAtRisk': 149, 'deathsNumAtRisk': 149, 'otherNumAffected': 17, 'seriousNumAtRisk': 149, 'deathsNumAffected': 0, 'seriousNumAffected': 21}, {'id': 'EG001', 'title': 'Control', 'description': 'Subjects randomized to not receive SpaceOAR hydrogel.', 'otherNumAtRisk': 73, 'deathsNumAtRisk': 73, 'otherNumAffected': 2, 'seriousNumAtRisk': 73, 'deathsNumAffected': 0, 'seriousNumAffected': 10}], 'otherEvents': [{'term': 'Haematospermia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 149, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 73, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Reproductive system and breast disorders'}, {'term': 'Anorectal pressure', 'stats': [{'groupId': 'EG000', 'numAtRisk': 149, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 73, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders'}, {'term': 'Hematuria', 'stats': [{'groupId': 'EG000', 'numAtRisk': 149, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 73, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Renal and urinary disorders'}, {'term': 'Thigh pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 149, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 73, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Musculoskeletal and connective tissue disorders'}, {'term': 'Discomfort while sitting', 'stats': [{'groupId': 'EG000', 'numAtRisk': 149, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 73, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Musculoskeletal and connective tissue disorders'}, {'term': 'Perineal pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 149, 'numEvents': 4, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 73, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Reproductive system and breast disorders'}, {'term': 'Rectal pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 149, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 73, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders'}, {'term': 'Rectal bleeding', 'stats': [{'groupId': 'EG000', 'numAtRisk': 149, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 73, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders'}, {'term': 'Rectal penetration', 'stats': [{'groupId': 'EG000', 'numAtRisk': 149, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 73, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders'}, {'term': 'Constipation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 149, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 73, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders'}, {'term': 'Flatulence', 'stats': [{'groupId': 'EG000', 'numAtRisk': 149, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 73, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders'}, {'term': 'Lower urinary tract symptoms', 'stats': [{'groupId': 'EG000', 'numAtRisk': 149, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 73, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Renal and urinary disorders'}, {'term': 'Hypotension', 'stats': [{'groupId': 'EG000', 'numAtRisk': 149, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 73, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Vascular disorders'}, {'term': 'Vasovagal presyncope', 'stats': [{'groupId': 'EG000', 'numAtRisk': 149, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 73, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Vascular disorders'}], 'seriousEvents': [{'term': 'Acute coronary syndrome', 'stats': [{'groupId': 'EG000', 'numAtRisk': 149, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 73, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Cardiac disorders'}, {'term': 'Angina unstable', 'stats': [{'groupId': 'EG000', 'numAtRisk': 149, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 73, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Cardiac disorders'}, {'term': 'Arteriosclerosis coronary artery', 'stats': [{'groupId': 'EG000', 'numAtRisk': 149, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 73, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Cardiac disorders'}, {'term': 'Atrial fibrillation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 149, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 73, 'numEvents': 2, 'numAffected': 1}], 'organSystem': 'Cardiac disorders'}, {'term': 'Atrial flutter', 'stats': [{'groupId': 'EG000', 'numAtRisk': 149, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 73, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Cardiac disorders'}, {'term': 'Atrioventricular block complete', 'stats': [{'groupId': 'EG000', 'numAtRisk': 149, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 73, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Cardiac disorders'}, {'term': 'Myocardial infarction', 'stats': [{'groupId': 'EG000', 'numAtRisk': 149, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 73, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Cardiac disorders'}, {'term': 'Tachycardia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 149, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 73, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Cardiac disorders'}, {'term': 'Corneal dystrophy', 'stats': [{'groupId': 'EG000', 'numAtRisk': 149, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 73, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Eye disorders'}, {'term': 'Inguinal hernia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 149, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 73, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders'}, {'term': 'Large intestinal haemorrhage', 'stats': [{'groupId': 'EG000', 'numAtRisk': 149, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 73, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders'}, {'term': 'Oesophagitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 149, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 73, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders'}, {'term': 'Pancreatic carcinoma', 'stats': [{'groupId': 'EG000', 'numAtRisk': 149, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 73, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders'}, {'term': 'Cholelithiasis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 149, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 73, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Hepatobiliary disorders'}, {'term': 'Hepatic cirrhosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 149, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 73, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Hepatobiliary disorders'}, {'term': 'Appendicitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 149, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 73, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Infections and infestations'}, {'term': 'Hip fracture', 'stats': [{'groupId': 'EG000', 'numAtRisk': 149, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 73, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Musculoskeletal and connective tissue disorders'}, {'term': 'Humerus fracture', 'stats': [{'groupId': 'EG000', 'numAtRisk': 149, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 73, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Musculoskeletal and connective tissue disorders'}, {'term': 'Pain in extremity', 'stats': [{'groupId': 'EG000', 'numAtRisk': 149, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 73, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Musculoskeletal and connective tissue disorders'}, {'term': 'Convulsion', 'stats': [{'groupId': 'EG000', 'numAtRisk': 149, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 73, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Nervous system disorders'}, {'term': 'Cognitive disorder', 'stats': [{'groupId': 'EG000', 'numAtRisk': 149, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 73, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Psychiatric disorders'}, {'term': 'Renal cell carcinoma', 'stats': [{'groupId': 'EG000', 'numAtRisk': 149, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 73, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Renal and urinary disorders'}, {'term': 'Urinary retention', 'stats': [{'groupId': 'EG000', 'numAtRisk': 149, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 73, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Renal and urinary disorders'}, {'term': 'Lung infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 149, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 73, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders'}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': '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', 'denoms': [{'units': 'Participants', 'counts': [{'value': '147', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'SpaceOAR', 'description': 'Subjects randomized to receive SpaceOAR hydrogel.'}], 'classes': [{'categories': [{'measurements': [{'value': '143', 'groupId': 'OG000'}]}]}], 'analyses': [{'pValue': '.0001', 'groupIds': ['OG000'], 'statisticalMethod': 'Exact binomial test', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER_LEGACY', 'statisticalComment': 'testing the null hypothesis that the proportion for SpaceOAR is less than or equal to 0.70.'}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': '3 months post index procedure', 'description': '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.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'SpaceOAR Group Only'}, {'type': 'PRIMARY', 'title': 'Percentage of Subjects Experiencing Grade 1 or Greater Rectal or Procedure Adverse Events Post Index Procedure', 'denoms': [{'units': 'Participants', 'counts': [{'value': '149', 'groupId': 'OG000'}, {'value': '73', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'SpaceOAR', 'description': 'Subjects randomized to receive SpaceOAR hydrogel.'}, {'id': 'OG001', 'title': 'Control', 'description': 'Subjects randomized to not receive SpaceOAR hydrogel.'}], 'classes': [{'categories': [{'measurements': [{'value': '34.2', 'groupId': 'OG000', 'lowerLimit': '26.7', 'upperLimit': '42.4'}, {'value': '31.5', 'groupId': 'OG001', 'lowerLimit': '21.1', 'upperLimit': '43.4'}]}]}], 'paramType': 'NUMBER', 'timeFrame': '6 months post index procedure', 'description': '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.', 'unitOfMeasure': 'percentage of subjects', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Intent-to-Treat (ITT) population was defined to be all randomized subjects (SpaceOAR and Control group).'}, {'type': 'SECONDARY', 'title': 'Percentage of Subjects Experiencing Grade 2 or Greater Rectal or Procedure Adverse Events in the 6 Months Following the Index Procedure', 'denoms': [{'units': 'Participants', 'counts': [{'value': '149', 'groupId': 'OG000'}, {'value': '73', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'SpaceOAR', 'description': 'Subjects randomized to receive SpaceOAR hydrogel.'}, {'id': 'OG001', 'title': 'Control', 'description': 'Subjects randomized to not receive SpaceOAR hydrogel.'}], 'classes': [{'categories': [{'measurements': [{'value': '10', 'groupId': 'OG000', 'lowerLimit': '3.3', 'upperLimit': '12.0'}, {'value': '3', 'groupId': 'OG001', 'lowerLimit': '0.9', 'upperLimit': '11.5'}]}]}], 'paramType': 'NUMBER', 'timeFrame': '6 months post index procedure', 'description': '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.', 'unitOfMeasure': 'percentage of subjects', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Intent-to-Treat (ITT) population was defined to be all randomized subjects (SpaceOAR and Control group).'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in Expanded Prostate Cancer Index Composite (EPIC) Score Following Index Procedure', 'denoms': [{'units': 'Participants', 'counts': [{'value': '149', 'groupId': 'OG000'}, {'value': '73', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'SpaceOAR', 'description': 'Subjects randomized to receive SpaceOAR hydrogel.'}, {'id': 'OG001', 'title': 'Control', 'description': 'Subjects randomized to not receive SpaceOAR hydrogel.'}], 'classes': [{'title': 'Change in Urinary Assessment Composite Score at 3 Months', 'denoms': [{'units': 'Participants', 'counts': [{'value': '146', 'groupId': 'OG000'}, {'value': '65', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-11.69', 'spread': '13.20', 'groupId': 'OG000'}, {'value': '-11.20', 'spread': '16.50', 'groupId': 'OG001'}]}]}, {'title': 'Change in Urinary Assessment Composite Score at 6 Months', 'denoms': [{'units': 'Participants', 'counts': [{'value': '144', 'groupId': 'OG000'}, {'value': '71', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '1.38', 'spread': '9.82', 'groupId': 'OG000'}, {'value': '-0.83', 'spread': '13.12', 'groupId': 'OG001'}]}]}, {'title': 'Change in Urinary Assessment Composite Score at 12 Months', 'denoms': [{'units': 'Participants', 'counts': [{'value': '142', 'groupId': 'OG000'}, {'value': '70', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0.12', 'spread': '11.74', 'groupId': 'OG000'}, {'value': '0.30', 'spread': '13.51', 'groupId': 'OG001'}]}]}, {'title': 'Change in Urinary Assessment Composite Score at 15 Months', 'denoms': [{'units': 'Participants', 'counts': [{'value': '144', 'groupId': 'OG000'}, {'value': '68', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '1.69', 'spread': '11.74', 'groupId': 'OG000'}, {'value': '2.2', 'spread': '11.66', 'groupId': 'OG001'}]}]}, {'title': 'Change in Sexual Assessment Composite Score at 3 Months', 'denoms': [{'units': 'Participants', 'counts': [{'value': '140', 'groupId': 'OG000'}, {'value': '64', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-7.60', 'spread': '17.36', 'groupId': 'OG000'}, {'value': '-4.86', 'spread': '19.83', 'groupId': 'OG001'}]}]}, {'title': 'Change in Sexual Assessment Composite Score at 6 Months', 'denoms': [{'units': 'Participants', 'counts': [{'value': '137', 'groupId': 'OG000'}, {'value': '69', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-3.44', 'spread': '16.74', 'groupId': 'OG000'}, {'value': '-2.35', 'spread': '18.68', 'groupId': 'OG001'}]}]}, {'title': 'Change in Sexual Assessment Composite Score at 12 Months', 'denoms': [{'units': 'Participants', 'counts': [{'value': '138', 'groupId': 'OG000'}, {'value': '68', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-7.21', 'spread': '19.32', 'groupId': 'OG000'}, {'value': '-8.29', 'spread': '20.51', 'groupId': 'OG001'}]}]}, {'title': 'Change in Sexual Assessment Composite Score at 15 Months', 'denoms': [{'units': 'Participants', 'counts': [{'value': '137', 'groupId': 'OG000'}, {'value': '66', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-6.55', 'spread': '19.71', 'groupId': 'OG000'}, {'value': '-5.33', 'spread': '21.52', 'groupId': 'OG001'}]}]}, {'title': 'Change in Bowel Habits Assessment Composite Score at 3 Months', 'denoms': [{'units': 'Participants', 'counts': [{'value': '145', 'groupId': 'OG000'}, {'value': '65', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-7.47', 'spread': '12.69', 'groupId': 'OG000'}, {'value': '-6.24', 'spread': '12.05', 'groupId': 'OG001'}]}]}, {'title': 'Change in Bowel Habits Assessment Composite Score at 6 Months', 'denoms': [{'units': 'Participants', 'counts': [{'value': '143', 'groupId': 'OG000'}, {'value': '68', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-0.78', 'spread': '8.52', 'groupId': 'OG000'}, {'value': '-2.44', 'spread': '9.54', 'groupId': 'OG001'}]}]}, {'title': 'Change in Bowel Habits Assessment Composite Score at 12 Months', 'denoms': [{'units': 'Participants', 'counts': [{'value': '142', 'groupId': 'OG000'}, {'value': '69', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-0.95', 'spread': '9.69', 'groupId': 'OG000'}, {'value': '-3.08', 'spread': '8.61', 'groupId': 'OG001'}]}]}, {'title': 'Change in Bowel Habits Assessment Composite Score at 15 Months', 'denoms': [{'units': 'Participants', 'counts': [{'value': '143', 'groupId': 'OG000'}, {'value': '66', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-0.02', 'spread': '9.41', 'groupId': 'OG000'}, {'value': '-2.14', 'spread': '9.29', 'groupId': 'OG001'}]}]}, {'title': 'Change in Hormonal Assessment Composite Score at 3 Months', 'denoms': [{'units': 'Participants', 'counts': [{'value': '141', 'groupId': 'OG000'}, {'value': '61', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-2.69', 'spread': '9.96', 'groupId': 'OG000'}, {'value': '-3.87', 'spread': '8.99', 'groupId': 'OG001'}]}]}, {'title': 'Change in Hormonal Assessment Composite Score at 6 Months', 'denoms': [{'units': 'Participants', 'counts': [{'value': '139', 'groupId': 'OG000'}, {'value': '67', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-0.71', 'spread': '9.05', 'groupId': 'OG000'}, {'value': '-2.35', 'spread': '11.33', 'groupId': 'OG001'}]}]}, {'title': 'Change in Hormonal Assessment Composite Score at 12 Months', 'denoms': [{'units': 'Participants', 'counts': [{'value': '135', 'groupId': 'OG000'}, {'value': '65', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-0.71', 'spread': '9.45', 'groupId': 'OG000'}, {'value': '-0.81', 'spread': '8.88', 'groupId': 'OG001'}]}]}, {'title': 'Change in Hormonal Assessment Composite Score at 15 Months', 'denoms': [{'units': 'Participants', 'counts': [{'value': '137', 'groupId': 'OG000'}, {'value': '65', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0.03', 'spread': '9.58', 'groupId': 'OG000'}, {'value': '0.70', 'spread': '8.92', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': '3 months, 6 months, 12 months, 15 months', 'description': '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.', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': '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.'}, {'type': 'SECONDARY', 'title': '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', 'denoms': [{'units': 'Participants', 'counts': [{'value': '149', 'groupId': 'OG000'}, {'value': '72', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'SpaceOAR', 'description': 'Subjects randomized to receive SpaceOAR hydrogel.'}, {'id': 'OG001', 'title': 'Control', 'description': 'Subjects randomized to not receive SpaceOAR hydrogel.'}], 'classes': [{'categories': [{'measurements': [{'value': '56.4', 'groupId': 'OG000', 'lowerLimit': '48.0', 'upperLimit': '64.5'}, {'value': '63.9', 'groupId': 'OG001', 'lowerLimit': '51.7', 'upperLimit': '74.9'}]}]}], 'paramType': 'NUMBER', 'timeFrame': '6 months post procedure', 'description': '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.', 'unitOfMeasure': 'percentage of subjects', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Intent-to-Treat (ITT) population was defined to be all randomized subjects (SpaceOAR and Control group).'}, {'type': 'SECONDARY', 'title': 'Number of SpaceOAR Subjects Experiencing a Procedure-Related Adverse Event (AE) Prior to Initiation of Radiation Therapy', 'denoms': [{'units': 'Participants', 'counts': [{'value': '149', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'SpaceOAR', 'description': 'Subjects randomized to receive SpaceOAR hydrogel.'}], 'classes': [{'categories': [{'measurements': [{'value': '14', 'groupId': 'OG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': '21 days post index procedure, prior to initiation of radiation therapy', 'description': '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.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'SpaceOAR treated subjects experiencing a procedure related AE prior to initiation of radiation therapy.'}, {'type': 'SECONDARY', 'title': 'Number of Subjects Experiencing a Delay in Radiation Therapy Associated With a Procedure or Device-Related Adverse Event', 'denoms': [{'units': 'Participants', 'counts': [{'value': '149', 'groupId': 'OG000'}, {'value': '73', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'SpaceOAR', 'description': 'Subjects randomized to receive SpaceOAR hydrogel.'}, {'id': 'OG001', 'title': 'Control', 'description': 'Subjects randomized to not receive SpaceOAR hydrogel'}], 'classes': [{'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000', 'lowerLimit': '0.0', 'upperLimit': '2.4'}, {'value': '0', 'groupId': 'OG001', 'lowerLimit': '0.0', 'upperLimit': '4.9'}]}]}], 'paramType': 'NUMBER', 'timeFrame': '21 days post index procedure', 'description': 'All subjects begin Intensity Modulated Radiation Therapy (IMRT) within 21 days following index procedure (Fiducial Marker Placement with or without SpaceOAR Hydrogel Injection).', 'unitOfMeasure': 'participants', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Intent-to-Treat (ITT) population was defined to be all randomized subjects (SpaceOAR and Control group).'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'SpaceOAR', 'description': '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\n\nSpaceOAR 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.'}, {'id': 'FG001', 'title': 'Control', 'description': '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.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '149'}, {'groupId': 'FG001', 'numSubjects': '73'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '148'}, {'groupId': 'FG001', 'numSubjects': '71'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '2'}]}], 'dropWithdraws': [{'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '1'}]}, {'type': 'Lost to Follow-up', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '1'}]}]}], 'recruitmentDetails': 'The first subject was treated on January 27, 2012 and the last subject visit occurred on July 15, 2014.', 'preAssignmentDetails': 'Randomized study, no wash out or run-in period'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '149', 'groupId': 'BG000'}, {'value': '73', 'groupId': 'BG001'}, {'value': '222', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'SpaceOAR', 'description': 'Subjects randomized to receive SpaceOAR hydrogel.'}, {'id': 'BG001', 'title': 'Control', 'description': 'Subjects randomized to not receive SpaceOAR hydrogel.'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '66.36', 'spread': '7.73', 'groupId': 'BG000'}, {'value': '67.66', 'spread': '6.51', 'groupId': 'BG001'}, {'value': '66.39', 'spread': '7.39', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '149', 'groupId': 'BG000'}, {'value': '73', 'groupId': 'BG001'}, {'value': '222', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Ethnicity (NIH/OMB)', 'classes': [{'categories': [{'title': 'Hispanic or Latino', 'measurements': [{'value': '5', 'groupId': 'BG000'}, {'value': '2', 'groupId': 'BG001'}, {'value': '7', 'groupId': 'BG002'}]}, {'title': 'Not Hispanic or Latino', 'measurements': [{'value': '144', 'groupId': 'BG000'}, {'value': '71', 'groupId': 'BG001'}, {'value': '215', 'groupId': 'BG002'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race (NIH/OMB)', 'classes': [{'categories': [{'title': 'American Indian or Alaska Native', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Asian', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '2', 'groupId': 'BG001'}, {'value': '2', 'groupId': 'BG002'}]}, {'title': 'Native Hawaiian or Other Pacific Islander', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Black or African American', 'measurements': [{'value': '16', 'groupId': 'BG000'}, {'value': '8', 'groupId': 'BG001'}, {'value': '24', 'groupId': 'BG002'}]}, {'title': 'White', 'measurements': [{'value': '127', 'groupId': 'BG000'}, {'value': '61', 'groupId': 'BG001'}, {'value': '188', 'groupId': 'BG002'}]}, {'title': 'More than one race', 'measurements': [{'value': '2', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '2', 'groupId': 'BG002'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '4', 'groupId': 'BG000'}, {'value': '2', 'groupId': 'BG001'}, {'value': '6', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'description': 'Subjects may check more than one category, therefore this is why SpaceOAR subjects = 150/149.', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'United States', 'categories': [{'measurements': [{'value': '149', 'groupId': 'BG000'}, {'value': '73', 'groupId': 'BG001'}, {'value': '222', 'groupId': 'BG002'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['PARTICIPANT']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 222}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2012-01'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-02', 'completionDateStruct': {'date': '2014-07', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2021-02-25', 'studyFirstSubmitDate': '2012-02-21', 'resultsFirstSubmitDate': '2020-12-23', 'studyFirstSubmitQcDate': '2012-02-23', 'lastUpdatePostDateStruct': {'date': '2021-03-19', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2021-02-25', 'studyFirstPostDateStruct': {'date': '2012-02-24', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2021-03-19', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2014-07', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': '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', 'timeFrame': '3 months post index procedure', 'description': '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.'}, {'measure': 'Percentage of Subjects Experiencing Grade 1 or Greater Rectal or Procedure Adverse Events Post Index Procedure', 'timeFrame': '6 months post index procedure', 'description': '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.'}], 'secondaryOutcomes': [{'measure': 'Percentage of Subjects Experiencing Grade 2 or Greater Rectal or Procedure Adverse Events in the 6 Months Following the Index Procedure', 'timeFrame': '6 months post index procedure', 'description': '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.'}, {'measure': 'Change From Baseline in Expanded Prostate Cancer Index Composite (EPIC) Score Following Index Procedure', 'timeFrame': '3 months, 6 months, 12 months, 15 months', 'description': '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.'}, {'measure': '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', 'timeFrame': '6 months post procedure', 'description': '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.'}, {'measure': 'Number of SpaceOAR Subjects Experiencing a Procedure-Related Adverse Event (AE) Prior to Initiation of Radiation Therapy', 'timeFrame': '21 days post index procedure, prior to initiation of radiation therapy', 'description': '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.'}, {'measure': 'Number of Subjects Experiencing a Delay in Radiation Therapy Associated With a Procedure or Device-Related Adverse Event', 'timeFrame': '21 days post index procedure', 'description': 'All subjects begin Intensity Modulated Radiation Therapy (IMRT) within 21 days following index procedure (Fiducial Marker Placement with or without SpaceOAR Hydrogel Injection).'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Prostate cancer', 'Spacer'], 'conditions': ['Prostate Cancer']}, 'descriptionModule': {'briefSummary': 'Evaluate the safety of the SpaceOAR System when the hydrogel is injected between the rectum and prostate in men undergoing radiation therapy (IG-IMRT)', 'detailedDescription': '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.'}, 'eligibilityModule': {'sex': 'MALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Subjects greater than 18 years old\n* Subjects must have pathologically confirmed invasive adenocarcinoma of the prostate and must be planning to undergo IMRT\n* 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\n* 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\n* 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\n\nExclusion Criteria:\n\n* Prostate greater than 80cc documented within 3 months preceding the Screening/Baseline visit\n* 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\n* Subjects with any prior invasive malignancy (except non-melanomatous skin cancer) unless the subject has been disease free for a minimum of 5 years.\n* Subjects who are indicated for androgen deprivation therapy or who have been treated with androgen therapy within the prior 3 months.'}, 'identificationModule': {'nctId': 'NCT01538628', 'briefTitle': 'SpaceOAR System Pivotal Study', 'organization': {'class': 'INDUSTRY', 'fullName': 'Boston Scientific Corporation'}, 'officialTitle': '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', 'orgStudyIdInfo': {'id': 'AGX-11-001-US'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'SpaceOAR', 'description': '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', 'interventionNames': ['Device: SpaceOAR System']}, {'type': 'NO_INTERVENTION', 'label': 'Control', 'description': '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': [{'name': 'SpaceOAR System', 'type': 'DEVICE', 'description': '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.', 'armGroupLabels': ['SpaceOAR']}]}, 'contactsLocationsModule': {'locations': [{'zip': '85013', 'city': 'Phoenix', 'state': 'Arizona', 'country': 'United States', 'facility': 'Foundation for Cancer Research and Education', 'geoPoint': {'lat': 33.44838, 'lon': -112.07404}}, {'zip': '95008', 'city': 'Campbell', 'state': 'California', 'country': 'United States', 'facility': 'Urological Surgeons of Northern California', 'geoPoint': {'lat': 37.28717, 'lon': -121.94996}}, {'zip': '95815', 'city': 'Sacramento', 'state': 'California', 'country': 'United States', 'facility': 'Radiological Associates of Sacramento', 'geoPoint': {'lat': 38.58157, 'lon': -121.4944}}, {'zip': '80211', 'city': 'Denver', 'state': 'Colorado', 'country': 'United States', 'facility': 'The Urology Center of Colorado', 'geoPoint': {'lat': 39.73915, 'lon': -104.9847}}, {'zip': '34202', 'city': 'Bradenton', 'state': 'Florida', 'country': 'United States', 'facility': 'Lakewood Ranch Oncology Center/21st Century Oncology', 'geoPoint': {'lat': 27.49893, 'lon': -82.57482}}, {'zip': '33907', 'city': 'Fort Myers', 'state': 'Florida', 'country': 'United States', 'facility': '21st Century Oncology', 'geoPoint': {'lat': 26.62168, 'lon': -81.84059}}, {'zip': '30322', 'city': 'Atlanta', 'state': 'Georgia', 'country': 'United States', 'facility': 'Emory University', 'geoPoint': {'lat': 33.749, 'lon': -84.38798}}, {'zip': '21231', 'city': 'Baltimore', 'state': 'Maryland', 'country': 'United States', 'facility': 'Johns Hopkins University Department of Radiation Oncology and Molecular Radiation Sciences', 'geoPoint': {'lat': 39.29038, 'lon': -76.61219}}, {'zip': '21117', 'city': 'Owings Mills', 'state': 'Maryland', 'country': 'United States', 'facility': 'Chesapeake Urology Associates, Chesapeake Urology Research Associates (The Prostate Center)', 'geoPoint': {'lat': 39.41955, 'lon': -76.78025}}, {'zip': '89521', 'city': 'Reno', 'state': 'Nevada', 'country': 'United States', 'facility': 'Northern Nevada Radiation Oncology', 'geoPoint': {'lat': 39.52963, 'lon': -119.8138}}, {'zip': '07728', 'city': 'Freehold', 'state': 'New Jersey', 'country': 'United States', 'facility': 'CentraState Medical Center', 'geoPoint': {'lat': 40.26011, 'lon': -74.27376}}, {'zip': '14267', 'city': 'Erie, Niagara, and Chautauqua County', 'state': 'New York', 'country': 'United States', 'facility': 'Western New York Urology Associates, LLC and D/B/A Cancer Care of WNY'}, {'zip': '11042', 'city': 'Lake Success', 'state': 'New York', 'country': 'United States', 'facility': 'Advanced Radiation Centers of New York', 'geoPoint': {'lat': 40.77066, 'lon': -73.71763}}, {'zip': '14642', 'city': 'Rochester', 'state': 'New York', 'country': 'United States', 'facility': 'University of Rochester', 'geoPoint': {'lat': 43.15478, 'lon': -77.61556}}, {'zip': '13210', 'city': 'Syracuse', 'state': 'New York', 'country': 'United States', 'facility': 'Associated Medical Professionals of NY', 'geoPoint': {'lat': 43.04812, 'lon': -76.14742}}, {'zip': '13210', 'city': 'Syracuse', 'state': 'New York', 'country': 'United States', 'facility': 'Upstate Medical University', 'geoPoint': {'lat': 43.04812, 'lon': -76.14742}}, {'zip': '44106', 'city': 'Cleveland', 'state': 'Ohio', 'country': 'United States', 'facility': 'University Hospitals Case Medical Center', 'geoPoint': {'lat': 41.4995, 'lon': -81.69541}}, {'zip': '97477', 'city': 'Springfield', 'state': 'Oregon', 'country': 'United States', 'facility': 'Oregon Urology Institute', 'geoPoint': {'lat': 44.04624, 'lon': -123.02203}}, {'zip': '29577', 'city': 'Myrtle Beach', 'state': 'South Carolina', 'country': 'United States', 'facility': '21st Century Oncology', 'geoPoint': {'lat': 33.68906, 'lon': -78.88669}}, {'zip': '98370', 'city': 'Poulsbo', 'state': 'Washington', 'country': 'United States', 'facility': 'Peninsula Cancer Center', 'geoPoint': {'lat': 47.73593, 'lon': -122.64654}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Boston Scientific Corporation', 'class': 'INDUSTRY'}, 'collaborators': [{'name': 'Augmenix, Inc.', 'class': 'INDUSTRY'}], 'responsibleParty': {'type': 'SPONSOR'}}}}