Ignite Creation Date:
2025-12-25 @ 1:38 AM
Ignite Modification Date:
2026-03-08 @ 12:33 AM
Study NCT ID:
NCT00643994
Status:
COMPLETED
Last Update Posted:
2023-05-09
First Post:
2008-03-20
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
CyberKnife Radiosurgery for Organ-Confined Prostate Cancer: Homogenous Dose Distribution
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'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D016634', 'term': 'Radiosurgery'}], 'ancestors': [{'id': 'D011878', 'term': 'Radiotherapy'}, {'id': 'D013812', 'term': 'Therapeutics'}, {'id': 'D013238', 'term': 'Stereotaxic Techniques'}, {'id': 'D019635', 'term': 'Neurosurgical Procedures'}, {'id': 'D013514', 'term': 'Surgical Procedures, Operative'}, {'id': 'D008919', 'term': 'Investigative Techniques'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'sgodbold@accuray.com', 'phone': '608-824-3421', 'title': 'Director of Clinical Affairs', 'organization': 'Accuray, Inc.'}, 'certainAgreement': {'piSponsorEmployee': False, 'restrictiveAgreement': False}, 'limitationsAndCaveats': {'description': 'A limitation of this study is that of the 21 sites originally enrolling eligible patients, only 14 opted to continue beyond year 5. While 189 patients were followed through year 5, only 135 of these consented to continued follow-up. We also note that several patients were due for their 10-year follow-up during Coronavirus Disease (COVID) lockdowns, hampering study activities such as monitoring visits as well as patient compliance with protocol-required visit windows.'}}, 'adverseEventsModule': {'timeFrame': 'Adverse event data collected from study enrollment through end of protocol follow-up, including fiducial placement, CyberKnife radiosurgery treatment, and scheduled follow-up visits up to 10 years post-CyberKnife treatment.', 'description': 'All adverse events were collected. Serious Adverse Events reported in clinicaltrials.gov are all events meeting serious criteria regardless of causality.', 'eventGroups': [{'id': 'EG000', 'title': 'CyberKnife Stereotactic Radiosurgery', 'description': 'Low and intermediate risk patients received 36.25 Gy delivered in 5 fractions of 7.25 Gy per fraction', 'otherNumAtRisk': 310, 'deathsNumAtRisk': 310, 'otherNumAffected': 302, 'seriousNumAtRisk': 310, 'deathsNumAffected': 21, 'seriousNumAffected': 34}], 'otherEvents': [{'term': 'Fatigue', 'stats': [{'groupId': 'EG000', 'numAtRisk': 310, 'numEvents': 120, 'numAffected': 113}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (3.0)'}, {'term': 'Constipation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 310, 'numEvents': 46, 'numAffected': 43}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (3.0)'}, {'term': 'Diarrhea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 310, 'numEvents': 135, 'numAffected': 120}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (3.0)'}, {'term': 'Flatulence', 'stats': [{'groupId': 'EG000', 'numAtRisk': 310, 'numEvents': 31, 'numAffected': 30}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (3.0)'}, {'term': 'Hemorrhoids', 'stats': [{'groupId': 'EG000', 'numAtRisk': 310, 'numEvents': 17, 'numAffected': 16}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (3.0)'}, {'term': 'Proctitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 310, 'numEvents': 51, 'numAffected': 44}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (3.0)'}, {'term': 'GI Hemorrhage/Bleeding', 'notes': 'rectal bleeding, blood in stool', 'stats': [{'groupId': 'EG000', 'numAtRisk': 310, 'numEvents': 55, 'numAffected': 52}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (3.0)'}, {'term': 'GI Pain', 'notes': 'Abdominal pain, stomach pain, rectal pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 310, 'numEvents': 25, 'numAffected': 25}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (3.0)'}, {'term': 'GU Pain', 'notes': 'Pain with urination (dysuria)', 'stats': [{'groupId': 'EG000', 'numAtRisk': 310, 'numEvents': 231, 'numAffected': 184}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (3.0)'}, {'term': 'Urinary Incontinence', 'stats': [{'groupId': 'EG000', 'numAtRisk': 310, 'numEvents': 38, 'numAffected': 28}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (3.0)'}, {'term': 'Urinary Frequency/Urgency', 'stats': [{'groupId': 'EG000', 'numAtRisk': 310, 'numEvents': 332, 'numAffected': 232}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (3.0)'}, {'term': 'Urinary Retention', 'stats': [{'groupId': 'EG000', 'numAtRisk': 310, 'numEvents': 190, 'numAffected': 157}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (3.0)'}, {'term': 'Urinary Tract Infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 310, 'numEvents': 15, 'numAffected': 14}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (3.0)'}, {'term': 'GU Hemorrhage/Bleeding', 'notes': 'Blood in urine (hematuria), GU hemorrhage', 'stats': [{'groupId': 'EG000', 'numAtRisk': 310, 'numEvents': 63, 'numAffected': 49}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (3.0)'}, {'term': 'Back Pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 310, 'numEvents': 19, 'numAffected': 17}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (3.0)'}, {'term': 'Ejaculatory Dysfunction', 'stats': [{'groupId': 'EG000', 'numAtRisk': 310, 'numEvents': 17, 'numAffected': 16}], 'organSystem': 'Reproductive system and breast disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (3.0)'}, {'term': 'Erectile Dysfunction', 'stats': [{'groupId': 'EG000', 'numAtRisk': 310, 'numEvents': 66, 'numAffected': 66}], 'organSystem': 'Reproductive system and breast disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (3.0)'}, {'term': 'Sexual/Reproductive Pain', 'notes': 'Groin/pelvic pain, pain with ejaculation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 310, 'numEvents': 25, 'numAffected': 23}], 'organSystem': 'Reproductive system and breast disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (3.0)'}], 'seriousEvents': [{'term': 'car accident', 'stats': [{'groupId': 'EG000', 'numAtRisk': 310, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (3.0)'}, {'term': 'Conduction abnormality/ atrioventricular heart block', 'stats': [{'groupId': 'EG000', 'numAtRisk': 310, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (3.0)'}, {'term': 'Cardiopulmonary arrest', 'stats': [{'groupId': 'EG000', 'numAtRisk': 310, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (3.0)'}, {'term': 'Hypertension', 'stats': [{'groupId': 'EG000', 'numAtRisk': 310, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (3.0)'}, {'term': 'left ventricular diastolic dysfunction', 'stats': [{'groupId': 'EG000', 'numAtRisk': 310, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (3.0)'}, {'term': 'Valvular heart disease', 'stats': [{'groupId': 'EG000', 'numAtRisk': 310, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (3.0)'}, {'term': 'Disease progression NOS', 'stats': [{'groupId': 'EG000', 'numAtRisk': 310, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (3.0)'}, {'term': 'Death NOS', 'stats': [{'groupId': 'EG000', 'numAtRisk': 310, 'numEvents': 9, 'numAffected': 9}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (3.0)'}, {'term': 'Dermatology/skin other - cancer', 'stats': [{'groupId': 'EG000', 'numAtRisk': 310, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (3.0)'}, {'term': 'GI - other - cancer', 'stats': [{'groupId': 'EG000', 'numAtRisk': 310, 'numEvents': 3, 'numAffected': 3}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (3.0)'}, {'term': 'Liver dysfunction/failure', 'stats': [{'groupId': 'EG000', 'numAtRisk': 310, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Hepatobiliary disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (3.0)'}, {'term': 'Hepatobiliary/pancreas - other - cancer', 'stats': [{'groupId': 'EG000', 'numAtRisk': 310, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Hepatobiliary disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (3.0)'}, {'term': 'Hepatobiliary/pancreas - other cirrhosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 310, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Hepatobiliary disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (3.0)'}, {'term': 'Infection - heart endocarditis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 310, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (3.0)'}, {'term': 'infection with unknown ANC', 'stats': [{'groupId': 'EG000', 'numAtRisk': 310, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (3.0)'}, {'term': 'Potassium serum -low', 'stats': [{'groupId': 'EG000', 'numAtRisk': 310, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (3.0)'}, {'term': 'Musculoskeletal/soft tissue - fracture', 'stats': [{'groupId': 'EG000', 'numAtRisk': 310, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (3.0)'}, {'term': 'CNS cerebrovascular ischemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 310, 'numEvents': 3, 'numAffected': 3}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (3.0)'}, {'term': 'Neurology - other', 'stats': [{'groupId': 'EG000', 'numAtRisk': 310, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (3.0)'}, {'term': 'Seizure', 'stats': [{'groupId': 'EG000', 'numAtRisk': 310, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (3.0)'}, {'term': 'Syncope (fainting)', 'stats': [{'groupId': 'EG000', 'numAtRisk': 310, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (3.0)'}, {'term': 'Dyspnea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 310, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (3.0)'}, {'term': 'Bronchospasm', 'stats': [{'groupId': 'EG000', 'numAtRisk': 310, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (3.0)'}, {'term': 'Pulmonary/upper respiratory - cancer', 'stats': [{'groupId': 'EG000', 'numAtRisk': 310, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (3.0)'}, {'term': 'Pleural effusion (non-malignant)', 'stats': [{'groupId': 'EG000', 'numAtRisk': 310, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (3.0)'}, {'term': 'Urinary obstruction', 'stats': [{'groupId': 'EG000', 'numAtRisk': 310, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (3.0)'}, {'term': 'Renal/GU - other - cancer', 'stats': [{'groupId': 'EG000', 'numAtRisk': 310, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (3.0)'}, {'term': 'Renal Failure', 'stats': [{'groupId': 'EG000', 'numAtRisk': 310, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (3.0)'}, {'term': 'Other malignancy', 'stats': [{'groupId': 'EG000', 'numAtRisk': 310, 'numEvents': 4, 'numAffected': 2}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (3.0)'}, {'term': 'Thrombosis/thrombus/embolism', 'stats': [{'groupId': 'EG000', 'numAtRisk': 310, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Vascular disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (3.0)'}, {'term': 'vessel-injury artery - aorta', 'stats': [{'groupId': 'EG000', 'numAtRisk': 310, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Vascular disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (3.0)'}, {'term': 'GI - other, diverticulosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 310, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (3.0)'}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Risk for Gastrointestinal (GI) and Genitourinary (GU) Toxicity', 'denoms': [{'units': 'Participants', 'counts': [{'value': '310', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'CyberKnife Stereotactic Radiosurgery', 'description': 'Low and intermediate risk patients received 36.25 Gy delivered in 5 fractions of 7.25 Gy per fraction'}], 'classes': [{'title': 'Probability of experiencing Acute GI Grade 3+ event(s)', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}]}]}, {'title': 'Probability of experiencing Acute GU Grade 3+ event(s)', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}]}]}, {'title': 'Probability of experiencing Late GI Grade 3+ events 5 years post treatment', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}]}]}, {'title': 'Probability of experiencing Late GU Grade 3+ events 5 years post treatment', 'categories': [{'measurements': [{'value': '1.5', 'groupId': 'OG000'}]}]}, {'title': 'Probability of experiencing Late GI Grade 3+ event(s) at 10 years post CK treatment', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}]}]}, {'title': 'Probability of experiencing Late GU Grade 3+ event(s) at 10 years post CK treatment', 'categories': [{'measurements': [{'value': '1.5', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Primary Safety Endpoint was measured at 5 years. Sites and patients had the option of continuing follow-up through 10 years.', 'description': 'To estimate the rates of acute and late Grade 3-5 gastrointestinal and genitourinary toxicities (adverse events \\[AE\\]) observed during the 5 years following CyberKnife (CK) treatment for prostate cancer. Kaplan Meier estimates for 5-yr and 10-yr are reported.\n\nAdverse events occurring within 3 months of treatment were categorized as acute toxicities, and those developing after 3 months were considered late toxicities.\n\nThe rates were determined using the first Grade 3 or higher adverse event per patient, reported as possibly, probably, or definitely related to CK treatment.\n\nThe Common Toxicity Criteria for Adverse Events (CTCAE) Version 3.0 was used to determine the Grade or severity of adverse events in this study, with Grade 3 being severe or medically significant but not immediately life-threatening, Grade 4 being life-threatening and Grade 5 being death related to the adverse event.', 'unitOfMeasure': 'percentage of participants', 'reportingStatus': 'POSTED'}, {'type': 'PRIMARY', 'title': 'Biochemical Disease-Free Survival (bDFS)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '310', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'CyberKnife Stereotactic Radiosurgery', 'description': 'Low and intermediate risk patients received 36.25 Gy delivered in 5 fractions of 7.25 Gy per fraction'}], 'classes': [{'title': 'Probability of remaining disease-free at 5 years post-CyberKnife treatment', 'categories': [{'measurements': [{'value': '97.3', 'groupId': 'OG000'}]}]}, {'title': 'Probability of remaining disease-free at 10 years post-CyberKnife treatment', 'categories': [{'measurements': [{'value': '91.7', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Primary Efficacy Endpoint was measured at 5 years. Sites and patients had the option of continuing follow-up through 10 years.', 'description': "To determine the rate of biochemical Disease-Free Survival (bDFS), using the Phoenix definition, following CyberKnife treatment. Kaplan Meier estimates for 5-yr and 10-yr are reported.\n\nThe Phoenix definition uses a Prostate Specific Antigen (PSA) value exceeding the patient's lowest PSA value (nadir) + 2 ng/mL as an indicator of disease recurrence. The percentage of patients who did not have such a PSA rise or receive any interventional therapy to treat prostate cancer are reported below.", 'unitOfMeasure': 'percentage of participants', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Disease Control and Survival Outcomes', 'denoms': [{'units': 'Participants', 'counts': [{'value': '310', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'CyberKnife Stereotactic Radiosurgery', 'description': 'Low and intermediate risk patients received 36.25 Gy delivered in 5 fractions of 7.25 Gy per fraction'}], 'classes': [{'title': 'Probability of remaining free from Local Failure at 5 years post-CyberKnife treatment', 'categories': [{'measurements': [{'value': '99.7', 'groupId': 'OG000'}]}]}, {'title': 'Probability of remaining free from Local Failure at 10 years post-CyberKnife treatment', 'categories': [{'measurements': [{'value': '96.4', 'groupId': 'OG000'}]}]}, {'title': 'Probability of remaining free from Distant Failure at 5 years post-CyberKnife treatment', 'categories': [{'measurements': [{'value': '99.3', 'groupId': 'OG000'}]}]}, {'title': 'Probability of remaining free from Distant Failure at 10 years post-CyberKnife treatment', 'categories': [{'measurements': [{'value': '98.6', 'groupId': 'OG000'}]}]}, {'title': 'Probability of remaining free from disease at 5 years post-CyberKnife treatment', 'categories': [{'measurements': [{'value': '97.3', 'groupId': 'OG000'}]}]}, {'title': 'Probability of remaining free from disease at 10 years post-CyberKnife treatment', 'categories': [{'measurements': [{'value': '90.1', 'groupId': 'OG000'}]}]}, {'title': 'Probability of remaining free from prostate cancer at 5 years post-CyberKnife treatment', 'categories': [{'measurements': [{'value': '100', 'groupId': 'OG000'}]}]}, {'title': 'Probability of remaining free from prostate cancer at 10 years post-CyberKnife treatment', 'categories': [{'measurements': [{'value': '100', 'groupId': 'OG000'}]}]}, {'title': 'Probability of Overall survival at 5 years post-CyberKnife treatment', 'categories': [{'measurements': [{'value': '95.7', 'groupId': 'OG000'}]}]}, {'title': 'Probability of Overall survival at 10 years post-CyberKnife treatment', 'categories': [{'measurements': [{'value': '83.8', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Secondary outcomes were measured at 5 years. Sites and patients had the option of continuing follow-up through 10 years.', 'description': 'To determine the rates of local failure, distant failure, disease-free survival, disease-specific survival, and overall survival following CyberKnife treatment in prostate cancer patients. Kaplan Meier estimates for 5-yr and 10-yr are reported.', 'unitOfMeasure': 'percentage of participants', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Quality of Life Assessments: American Urological Association (AUA) Symptom Index (SI)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '306', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'CyberKnife Stereotactic Radiosurgery', 'description': 'Low and intermediate risk patients received 36.25 Gy delivered in 5 fractions of 7.25 Gy per fraction'}], 'classes': [{'title': 'Baseline', 'denoms': [{'units': 'Participants', 'counts': [{'value': '306', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '7.58', 'spread': '5.97', 'groupId': 'OG000'}]}]}, {'title': 'Last Day of Treatment', 'denoms': [{'units': 'Participants', 'counts': [{'value': '297', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '12.53', 'spread': '8.11', 'groupId': 'OG000'}]}]}, {'title': '1 Week Post Treatment', 'denoms': [{'units': 'Participants', 'counts': [{'value': '300', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '14.13', 'spread': '8.29', 'groupId': 'OG000'}]}]}, {'title': '1 Month Post Treatment', 'denoms': [{'units': 'Participants', 'counts': [{'value': '299', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '11.64', 'spread': '7.30', 'groupId': 'OG000'}]}]}, {'title': '3 Months Post Treatment', 'denoms': [{'units': 'Participants', 'counts': [{'value': '296', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '7.53', 'spread': '5.54', 'groupId': 'OG000'}]}]}, {'title': '6 Months Post Treatment', 'denoms': [{'units': 'Participants', 'counts': [{'value': '292', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '7.20', 'spread': '5.71', 'groupId': 'OG000'}]}]}, {'title': '12 Months Post Treatment', 'denoms': [{'units': 'Participants', 'counts': [{'value': '283', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '8.49', 'spread': '6.48', 'groupId': 'OG000'}]}]}, {'title': '18 Months Post Treatment', 'denoms': [{'units': 'Participants', 'counts': [{'value': '275', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '7.84', 'spread': '6.27', 'groupId': 'OG000'}]}]}, {'title': '24 Months Post Treatment', 'denoms': [{'units': 'Participants', 'counts': [{'value': '271', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '7.32', 'spread': '5.69', 'groupId': 'OG000'}]}]}, {'title': '36 Months Post Treatment', 'denoms': [{'units': 'Participants', 'counts': [{'value': '239', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '6.59', 'spread': '5.73', 'groupId': 'OG000'}]}]}, {'title': '48 Months Post Treatment', 'denoms': [{'units': 'Participants', 'counts': [{'value': '215', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '6.41', 'spread': '5.90', 'groupId': 'OG000'}]}]}, {'title': '60 Months Post Treatment', 'denoms': [{'units': 'Participants', 'counts': [{'value': '200', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '6.13', 'spread': '6.17', 'groupId': 'OG000'}]}]}, {'title': '72 Months Post Treatment', 'denoms': [{'units': 'Participants', 'counts': [{'value': '117', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '5.62', 'spread': '5.93', 'groupId': 'OG000'}]}]}, {'title': '84 Months Post Treatment', 'denoms': [{'units': 'Participants', 'counts': [{'value': '107', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '5.77', 'spread': '5.85', 'groupId': 'OG000'}]}]}, {'title': '96 Months Post Treatment', 'denoms': [{'units': 'Participants', 'counts': [{'value': '94', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '4.97', 'spread': '6.25', 'groupId': 'OG000'}]}]}, {'title': '108 Months Post Treatment', 'denoms': [{'units': 'Participants', 'counts': [{'value': '81', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '4.60', 'spread': '5.35', 'groupId': 'OG000'}]}]}, {'title': '120 Months Post Treatment', 'denoms': [{'units': 'Participants', 'counts': [{'value': '62', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '4.79', 'spread': '5.33', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Secondary outcomes were measured at 5 years. Sites and patients had the option of continuing follow-up through 10 years.', 'description': 'AUA-SI is a 7-item self-report measure used to assess urinary urgency, frequency, and voiding symptoms with scores ranging from 0 (no symptom) to 5 (symptom occurs almost always).\n\nTotal score: 0-7 mild symptoms; 8-19 moderate symptoms; 20-35 severe symptoms', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'AUA questionnaires were completed by patients for milestone follow-up visits, with 306/310 patients completing a baseline questionnaire. All questions needed to be completed in order to calculate the score. Scores obtained per instructions (if possible) and analyzed even if questionnaires were received/dated outside protocol specified visit window.'}, {'type': 'SECONDARY', 'title': 'Quality of Life Assessments: Expanded Prostate Cancer Index Composite (EPIC) -26 Urinary Incontinence', 'denoms': [{'units': 'Participants', 'counts': [{'value': '300', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'CyberKnife Stereotactic Radiosurgery', 'description': 'Low and intermediate risk patients received 36.25 Gy delivered in 5 fractions of 7.25 Gy per fraction'}], 'classes': [{'title': 'Baseline', 'denoms': [{'units': 'Participants', 'counts': [{'value': '300', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '94.03', 'spread': '11.69', 'groupId': 'OG000'}]}]}, {'title': '1 Month Post Treatment', 'denoms': [{'units': 'Participants', 'counts': [{'value': '296', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '89.30', 'spread': '16.13', 'groupId': 'OG000'}]}]}, {'title': '6 Months Post Treatment', 'denoms': [{'units': 'Participants', 'counts': [{'value': '284', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '92.08', 'spread': '14.70', 'groupId': 'OG000'}]}]}, {'title': '12 Months Post Treatment', 'denoms': [{'units': 'Participants', 'counts': [{'value': '280', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '88.49', 'spread': '17.16', 'groupId': 'OG000'}]}]}, {'title': '24 Months Post Treatment', 'denoms': [{'units': 'Participants', 'counts': [{'value': '267', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '89.03', 'spread': '18.30', 'groupId': 'OG000'}]}]}, {'title': '36 Months Post Treatment', 'denoms': [{'units': 'Participants', 'counts': [{'value': '225', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '89.23', 'spread': '18.33', 'groupId': 'OG000'}]}]}, {'title': '48 Months Post Treatment', 'denoms': [{'units': 'Participants', 'counts': [{'value': '194', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '88.39', 'spread': '17.85', 'groupId': 'OG000'}]}]}, {'title': '60 Months Post Treatment', 'denoms': [{'units': 'Participants', 'counts': [{'value': '173', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '89.04', 'spread': '17.36', 'groupId': 'OG000'}]}]}, {'title': '72 Months Post Treatment', 'denoms': [{'units': 'Participants', 'counts': [{'value': '100', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '89.84', 'spread': '19.18', 'groupId': 'OG000'}]}]}, {'title': '84 Months Post Treatment', 'denoms': [{'units': 'Participants', 'counts': [{'value': '86', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '89.46', 'spread': '17.42', 'groupId': 'OG000'}]}]}, {'title': '96 Months Post Treatment', 'denoms': [{'units': 'Participants', 'counts': [{'value': '71', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '90.79', 'spread': '15.96', 'groupId': 'OG000'}]}]}, {'title': '108 Months Post Treatment', 'denoms': [{'units': 'Participants', 'counts': [{'value': '62', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '90.28', 'spread': '17.13', 'groupId': 'OG000'}]}]}, {'title': '120 Months Post Treatment', 'denoms': [{'units': 'Participants', 'counts': [{'value': '54', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '89.42', 'spread': '17.15', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Secondary outcomes were measured at 5 years. Sites and patients had the option of continuing follow-up through 10 years.', 'description': "EPIC-26 is a short form version of the Expanded Prostate Cancer Index Composite, and is a validated comprehensive instrument developed to measure the health-related quality of life among men with prostate cancer. EPIC-26 consists of 26 items under 5 domains of urinary incontinence, urinary irritative/obstructive, bowel, sexual, and hormonal.\n\nAnswers qualitatively measure patient's bother for each symptom and are then normalized on a scale of 0 (worst) to 100 (best) to calculate domain scores if sufficient input is provided.", 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'EPIC questionnaires were completed by patients at follow-up visits, with 300/310 patients completing a baseline questionnaire. A minimum number of questions needed to be completed within each domain in order to calculate a domain score. Domain scores obtained per instructions (if possible) and analyzed even if questionnaires were received/dated outside protocol specified visit window.'}, {'type': 'SECONDARY', 'title': 'Quality of Life Assessments: EPIC-26 Urinary Irritative Obstructive', 'denoms': [{'units': 'Participants', 'counts': [{'value': '300', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'CyberKnife Stereotactic Radiosurgery', 'description': 'Low and intermediate risk patients received 36.25 Gy delivered in 5 fractions of 7.25 Gy per fraction'}], 'classes': [{'title': 'Baseline', 'denoms': [{'units': 'Participants', 'counts': [{'value': '300', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '87.85', 'spread': '12.56', 'groupId': 'OG000'}]}]}, {'title': '1 Month Post Treatment', 'denoms': [{'units': 'Participants', 'counts': [{'value': '296', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '75.20', 'spread': '18.37', 'groupId': 'OG000'}]}]}, {'title': '6 Months Post Treatment', 'denoms': [{'units': 'Participants', 'counts': [{'value': '284', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '87.82', 'spread': '13.76', 'groupId': 'OG000'}]}]}, {'title': '12 Months Post Treatment', 'denoms': [{'units': 'Participants', 'counts': [{'value': '280', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '84.29', 'spread': '16.57', 'groupId': 'OG000'}]}]}, {'title': '24 Months Post Treatment', 'denoms': [{'units': 'Participants', 'counts': [{'value': '267', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '87.43', 'spread': '13.63', 'groupId': 'OG000'}]}]}, {'title': '36 Months Post Treatment', 'denoms': [{'units': 'Participants', 'counts': [{'value': '225', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '89.64', 'spread': '11.85', 'groupId': 'OG000'}]}]}, {'title': '48 Months Post Treatment', 'denoms': [{'units': 'Participants', 'counts': [{'value': '194', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '88.76', 'spread': '13.45', 'groupId': 'OG000'}]}]}, {'title': '60 Months Post Treatment', 'denoms': [{'units': 'Participants', 'counts': [{'value': '173', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '90.36', 'spread': '12.66', 'groupId': 'OG000'}]}]}, {'title': '72 Months Post Treatment', 'denoms': [{'units': 'Participants', 'counts': [{'value': '100', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '92.57', 'spread': '10.41', 'groupId': 'OG000'}]}]}, {'title': '84 Months Post Treatment', 'denoms': [{'units': 'Participants', 'counts': [{'value': '86', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '92.11', 'spread': '10.65', 'groupId': 'OG000'}]}]}, {'title': '96 Months Post Treatment', 'denoms': [{'units': 'Participants', 'counts': [{'value': '71', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '90.77', 'spread': '12.29', 'groupId': 'OG000'}]}]}, {'title': '108 Months Post Treatment', 'denoms': [{'units': 'Participants', 'counts': [{'value': '62', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '91.70', 'spread': '9.78', 'groupId': 'OG000'}]}]}, {'title': '120 Months Post Treatment', 'denoms': [{'units': 'Participants', 'counts': [{'value': '54', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '92.28', 'spread': '9.24', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Secondary outcomes were measured at 5 years. Sites and patients had the option of continuing follow-up through 10 years.', 'description': "EPIC-26 is a short form version of the Expanded Prostate Cancer Index Composite, and is a validated comprehensive instrument developed to measure the health-related quality of life among men with prostate cancer. EPIC-26 consists of 26 items under 5 domains of urinary incontinence, urinary irritative/obstructive, bowel, sexual, and hormonal.\n\nAnswers qualitatively measure patient's bother for each symptom and are then normalized on a scale of 0 (worst) to 100 (best) to calculate domain scores if sufficient input is provided.", 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'EPIC questionnaires were completed by patients at follow-up visits, with 300/310 patients completing a baseline questionnaire. A minimum number of questions needed to be completed within each domain in order to calculate a domain score. Domain scores obtained per instructions (if possible) and analyzed even if questionnaires were received/dated outside protocol specified visit window.'}, {'type': 'SECONDARY', 'title': 'Quality of Life Assessments: EPIC-26 Bowel', 'denoms': [{'units': 'Participants', 'counts': [{'value': '300', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'CyberKnife Stereotactic Radiosurgery', 'description': 'Low and intermediate risk patients received 36.25 Gy delivered in 5 fractions of 7.25 Gy per fraction'}], 'classes': [{'title': 'Baseline', 'denoms': [{'units': 'Participants', 'counts': [{'value': '300', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '94.88', 'spread': '9.66', 'groupId': 'OG000'}]}]}, {'title': '1 Month Post Treatment', 'denoms': [{'units': 'Participants', 'counts': [{'value': '296', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '83.47', 'spread': '18.83', 'groupId': 'OG000'}]}]}, {'title': '6 Months Post Treatment', 'denoms': [{'units': 'Participants', 'counts': [{'value': '284', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '91.61', 'spread': '13.42', 'groupId': 'OG000'}]}]}, {'title': '12 Months Post Treatment', 'denoms': [{'units': 'Participants', 'counts': [{'value': '280', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '90.12', 'spread': '14.60', 'groupId': 'OG000'}]}]}, {'title': '24 Months Post Treatment', 'denoms': [{'units': 'Participants', 'counts': [{'value': '267', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '92.18', 'spread': '13.00', 'groupId': 'OG000'}]}]}, {'title': '36 Months Post Treatment', 'denoms': [{'units': 'Participants', 'counts': [{'value': '225', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '92.88', 'spread': '11.67', 'groupId': 'OG000'}]}]}, {'title': '48 Months Post Treatment', 'denoms': [{'units': 'Participants', 'counts': [{'value': '194', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '92.52', 'spread': '12.89', 'groupId': 'OG000'}]}]}, {'title': '60 Months Post Treatment', 'denoms': [{'units': 'Participants', 'counts': [{'value': '173', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '92.42', 'spread': '12.63', 'groupId': 'OG000'}]}]}, {'title': '72 Months Post Treatment', 'denoms': [{'units': 'Participants', 'counts': [{'value': '100', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '94.31', 'spread': '9.79', 'groupId': 'OG000'}]}]}, {'title': '84 Months Post Treatment', 'denoms': [{'units': 'Participants', 'counts': [{'value': '86', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '94.29', 'spread': '10.08', 'groupId': 'OG000'}]}]}, {'title': '96 Months Post Treatment', 'denoms': [{'units': 'Participants', 'counts': [{'value': '71', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '93.44', 'spread': '9.46', 'groupId': 'OG000'}]}]}, {'title': '108 Months Post Treatment', 'denoms': [{'units': 'Participants', 'counts': [{'value': '62', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '92.89', 'spread': '9.73', 'groupId': 'OG000'}]}]}, {'title': '120 Months Post Treatment', 'denoms': [{'units': 'Participants', 'counts': [{'value': '54', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '93.77', 'spread': '8.93', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Secondary outcomes were measured at 5 years. Sites and patients had the option of continuing follow-up through 10 years.', 'description': "EPIC-26 is a short form version of the Expanded Prostate Cancer Index Composite, and is a validated comprehensive instrument developed to measure the health-related quality of life among men with prostate cancer. EPIC-26 consists of 26 items under 5 domains of urinary incontinence, urinary irritative/obstructive, bowel, sexual, and hormonal.\n\nAnswers qualitatively measure patient's bother for each symptom and are then normalized on a scale of 0 (worst) to 100 (best) to calculate domain scores if sufficient input is provided.", 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'EPIC questionnaires were completed by patients at follow-up visits, with 300/310 patients completing a baseline questionnaire. A minimum number of questions needed to be completed within each domain in order to calculate a domain score. Domain scores obtained per instructions (if possible) and analyzed even if questionnaires were received/dated outside protocol specified visit window.'}, {'type': 'SECONDARY', 'title': 'Quality of Life Assessments: EPIC-26 Sexual', 'denoms': [{'units': 'Participants', 'counts': [{'value': '300', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'CyberKnife Stereotactic Radiosurgery', 'description': 'Low and intermediate risk patients received 36.25 Gy delivered in 5 fractions of 7.25 Gy per fraction'}], 'classes': [{'title': 'Baseline', 'denoms': [{'units': 'Participants', 'counts': [{'value': '300', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '56.79', 'spread': '31.95', 'groupId': 'OG000'}]}]}, {'title': '1 Month Post Treatment', 'denoms': [{'units': 'Participants', 'counts': [{'value': '296', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '53.74', 'spread': '31.47', 'groupId': 'OG000'}]}]}, {'title': '6 Months Post Treatment', 'denoms': [{'units': 'Participants', 'counts': [{'value': '284', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '53.74', 'spread': '33.49', 'groupId': 'OG000'}]}]}, {'title': '12 Months Post Treatment', 'denoms': [{'units': 'Participants', 'counts': [{'value': '280', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '50.19', 'spread': '32.83', 'groupId': 'OG000'}]}]}, {'title': '24 Months Post Treatment', 'denoms': [{'units': 'Participants', 'counts': [{'value': '267', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '47.71', 'spread': '32.27', 'groupId': 'OG000'}]}]}, {'title': '36 Months Post Treatment', 'denoms': [{'units': 'Participants', 'counts': [{'value': '225', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '47.31', 'spread': '32.36', 'groupId': 'OG000'}]}]}, {'title': '48 Months Post Treatment', 'denoms': [{'units': 'Participants', 'counts': [{'value': '194', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '46.82', 'spread': '31.60', 'groupId': 'OG000'}]}]}, {'title': '60 Months Post Treatment', 'denoms': [{'units': 'Participants', 'counts': [{'value': '173', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '42.88', 'spread': '31.45', 'groupId': 'OG000'}]}]}, {'title': '72 Months Post Treatment', 'denoms': [{'units': 'Participants', 'counts': [{'value': '100', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '47.66', 'spread': '33.93', 'groupId': 'OG000'}]}]}, {'title': '84 Months Post Treatment', 'denoms': [{'units': 'Participants', 'counts': [{'value': '86', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '48.12', 'spread': '34.47', 'groupId': 'OG000'}]}]}, {'title': '96 Months Post Treatment', 'denoms': [{'units': 'Participants', 'counts': [{'value': '71', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '44.16', 'spread': '30.34', 'groupId': 'OG000'}]}]}, {'title': '108 Months Post Treatment', 'denoms': [{'units': 'Participants', 'counts': [{'value': '62', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '43.36', 'spread': '31.36', 'groupId': 'OG000'}]}]}, {'title': '120 Months Post Treatment', 'denoms': [{'units': 'Participants', 'counts': [{'value': '54', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '50.13', 'spread': '31.08', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Secondary outcomes were measured at 5 years. Sites and patients had the option of continuing follow-up through 10 years.', 'description': "EPIC-26 is a short form version of the Expanded Prostate Cancer Index Composite, and is a validated comprehensive instrument developed to measure the health-related quality of life among men with prostate cancer. EPIC-26 consists of 26 items under 5 domains of urinary incontinence, urinary irritative/obstructive, bowel, sexual, and hormonal.\n\nAnswers qualitatively measure patient's bother for each symptom and are then normalized on a scale of 0 (worst) to 100 (best) to calculate domain scores if sufficient input is provided.", 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'EPIC questionnaires were completed by patients at follow-up visits, with 300/310 patients completing a baseline questionnaire. A minimum number of questions needed to be completed within each domain in order to calculate a domain score. Domain scores obtained per instructions (if possible) and analyzed even if questionnaires were received/dated outside protocol specified visit window.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'CyberKnife Stereotactic Radiosurgery', 'description': 'Low and intermediate risk patients received 36.25 Gy delivered in 5 fractions of 7.25 Gy per fraction'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'comment': 'Received CyberKnife 36.25 Gy delivered in 5 fractions of 7.25 Gy per fraction', 'achievements': [{'comment': '379 patients signed the informed consent form and were enrolled. Of these 379 patients, 69 did not participate in the study due to not meeting eligibility criteria, insurance did not approve participation in a clinical study, or the patient withdrew from study prior to receiving treatment.', 'groupId': 'FG000', 'numSubjects': '310'}]}, {'type': '10-yr Follow up', 'comment': 'optional extension per protocol amendment', 'achievements': [{'groupId': 'FG000', 'numSubjects': '69'}]}, {'type': 'COMPLETED', 'comment': 'Completed required 5-year follow up', 'achievements': [{'groupId': 'FG000', 'numSubjects': '214'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '96'}]}], 'dropWithdraws': [{'type': 'Death', 'reasons': [{'groupId': 'FG000', 'numSubjects': '24'}]}, {'type': 'Lost to Follow-up', 'reasons': [{'groupId': 'FG000', 'numSubjects': '72'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '310', 'groupId': 'BG000'}]}], 'groups': [{'id': 'BG000', 'title': 'CyberKnife Stereotactic Radiosurgery', 'description': '36.25 Gy delivered in 5 fractions of 7.25 Gy per fraction'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '67.6', 'groupId': 'BG000', 'lowerLimit': '41.1', 'upperLimit': '89.0'}]}]}], 'paramType': 'MEAN', 'description': 'Age at time of CK treatment', 'unitOfMeasure': 'years', 'dispersionType': 'FULL_RANGE'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'Male', 'measurements': [{'value': '310', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race/Ethnicity, Customized', 'classes': [{'title': 'American Indian or Alaska Native', 'categories': [{'measurements': [{'value': '0', 'groupId': 'BG000'}]}]}, {'title': 'Asian', 'categories': [{'measurements': [{'value': '5', 'groupId': 'BG000'}]}]}, {'title': 'Black/African American', 'categories': [{'measurements': [{'value': '18', 'groupId': 'BG000'}]}]}, {'title': 'Hispanic/Latino', 'categories': [{'measurements': [{'value': '5', 'groupId': 'BG000'}]}]}, {'title': 'Native Hawaiian or Other Pacific Islander', 'categories': [{'measurements': [{'value': '1', 'groupId': 'BG000'}]}]}, {'title': 'White', 'categories': [{'measurements': [{'value': '280', 'groupId': 'BG000'}]}]}, {'title': 'Unknown', 'categories': [{'measurements': [{'value': '1', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'United States', 'categories': [{'measurements': [{'value': '310', 'groupId': 'BG000'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}, {'title': 'Clinical Stage (Tumor)', 'classes': [{'title': 'T1b = Tumor incidental histological finding in >5% of tissue resected', 'categories': [{'measurements': [{'value': '3', 'groupId': 'BG000'}]}]}, {'title': 'T1c = Tumor identified by needle biopsy found in one or both sides, but not palpable', 'categories': [{'measurements': [{'value': '244', 'groupId': 'BG000'}]}]}, {'title': 'T2a = Tumor involves ½ of one side or less', 'categories': [{'measurements': [{'value': '54', 'groupId': 'BG000'}]}]}, {'title': 'T2b = Tumor involves >½ of one side but not both sides', 'categories': [{'measurements': [{'value': '9', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'description': 'Clinical T category of prostate cancer, estimated by investigator at the time of patient screening.', 'unitOfMeasure': 'Participants'}, {'title': 'Total Gleason Score', 'classes': [{'title': 'Gleason 2 - 6', 'categories': [{'measurements': [{'value': '181', 'groupId': 'BG000'}]}]}, {'title': 'Gleason 7', 'categories': [{'measurements': [{'value': '129', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'description': 'The Gleason score is calculated by adding together the two grades of cancer cells that make up the largest areas of the biopsied tissue sample. The Gleason score usually ranges from 6 to 10. Cancer cells that look similar to healthy cells receive a low score. Cancer cells that look less like healthy cells or look more aggressive receive a higher score.\n\nPatients with Gleason scores 2-6 are in the Low Risk Group. Patients with Gleason scores of 7 are in the Intermediate Risk Group.', 'unitOfMeasure': 'Participants'}, {'title': 'Prostate Specific Antigen (PSA)', 'classes': [{'categories': [{'measurements': [{'value': '5.53', 'groupId': 'BG000', 'lowerLimit': '0.04', 'upperLimit': '17.90'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'ng/mL', 'dispersionType': 'FULL_RANGE'}, {'title': 'Eastern Cooperative Oncology Group (ECOG) Performance Status', 'classes': [{'title': '0 = Fully active, able to carry on all pre-disease performance without restriction', 'categories': [{'measurements': [{'value': '293', 'groupId': 'BG000'}]}]}, {'title': '1 = Restricted in physically strenuous activity', 'categories': [{'measurements': [{'value': '10', 'groupId': 'BG000'}]}]}, {'title': '2 = Capable of all selfcare but unable to carry out any work activities', 'categories': [{'measurements': [{'value': '0', 'groupId': 'BG000'}]}]}, {'title': '3 = Capable of only limited selfcare', 'categories': [{'measurements': [{'value': '1', 'groupId': 'BG000'}]}]}, {'title': 'Unreported', 'categories': [{'measurements': [{'value': '6', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'description': "The ECOG Performance Status Scale describes a patient's level of functioning in terms of their ability to care for themself, daily activity, and physical ability (walking, working, etc.).\n\nIt was developed by the ECOG and published in 1982.", 'unitOfMeasure': 'Participants'}, {'title': 'American Joint Committee on Cancer (AJCC) 6th Edition Risk Group', 'classes': [{'title': 'Low: Clinical Stage (CS) T1b-T2a, Gleason 2-6, Prostate Specific Antigen (PSA) ≤ 10 ng/ml', 'categories': [{'measurements': [{'value': '172', 'groupId': 'BG000'}]}]}, {'title': 'Intermediate: CS T2b, Gleason 2-6, PSA ≤ 10 ng/ml', 'categories': [{'measurements': [{'value': '1', 'groupId': 'BG000'}]}]}, {'title': 'Intermediate: CS T1b-T2b, and Gleason 2-6, PSA ≤ 20 ng/ml', 'categories': [{'measurements': [{'value': '37', 'groupId': 'BG000'}]}]}, {'title': 'Intermediate: CS T1b-T2b and Gleason 7, PSA ≤ 10 ng/ml', 'categories': [{'measurements': [{'value': '100', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}]}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2013-05-13', 'size': 10652737, 'label': 'Study Protocol and Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'Prot_SAP_000.pdf', 'typeAbbrev': 'Prot_SAP', 'uploadDate': '2023-02-03T10:58', 'hasProtocol': True}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 379}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2007-12'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-04', 'completionDateStruct': {'date': '2021-01-27', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2023-04-17', 'studyFirstSubmitDate': '2008-03-20', 'resultsFirstSubmitDate': '2023-02-03', 'studyFirstSubmitQcDate': '2008-03-20', 'lastUpdatePostDateStruct': {'date': '2023-05-09', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2023-04-17', 'studyFirstPostDateStruct': {'date': '2008-03-26', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2023-05-09', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2021-01-27', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Risk for Gastrointestinal (GI) and Genitourinary (GU) Toxicity', 'timeFrame': 'Primary Safety Endpoint was measured at 5 years. Sites and patients had the option of continuing follow-up through 10 years.', 'description': 'To estimate the rates of acute and late Grade 3-5 gastrointestinal and genitourinary toxicities (adverse events \\[AE\\]) observed during the 5 years following CyberKnife (CK) treatment for prostate cancer. Kaplan Meier estimates for 5-yr and 10-yr are reported.\n\nAdverse events occurring within 3 months of treatment were categorized as acute toxicities, and those developing after 3 months were considered late toxicities.\n\nThe rates were determined using the first Grade 3 or higher adverse event per patient, reported as possibly, probably, or definitely related to CK treatment.\n\nThe Common Toxicity Criteria for Adverse Events (CTCAE) Version 3.0 was used to determine the Grade or severity of adverse events in this study, with Grade 3 being severe or medically significant but not immediately life-threatening, Grade 4 being life-threatening and Grade 5 being death related to the adverse event.'}, {'measure': 'Biochemical Disease-Free Survival (bDFS)', 'timeFrame': 'Primary Efficacy Endpoint was measured at 5 years. Sites and patients had the option of continuing follow-up through 10 years.', 'description': "To determine the rate of biochemical Disease-Free Survival (bDFS), using the Phoenix definition, following CyberKnife treatment. Kaplan Meier estimates for 5-yr and 10-yr are reported.\n\nThe Phoenix definition uses a Prostate Specific Antigen (PSA) value exceeding the patient's lowest PSA value (nadir) + 2 ng/mL as an indicator of disease recurrence. The percentage of patients who did not have such a PSA rise or receive any interventional therapy to treat prostate cancer are reported below."}], 'secondaryOutcomes': [{'measure': 'Disease Control and Survival Outcomes', 'timeFrame': 'Secondary outcomes were measured at 5 years. Sites and patients had the option of continuing follow-up through 10 years.', 'description': 'To determine the rates of local failure, distant failure, disease-free survival, disease-specific survival, and overall survival following CyberKnife treatment in prostate cancer patients. Kaplan Meier estimates for 5-yr and 10-yr are reported.'}, {'measure': 'Quality of Life Assessments: American Urological Association (AUA) Symptom Index (SI)', 'timeFrame': 'Secondary outcomes were measured at 5 years. Sites and patients had the option of continuing follow-up through 10 years.', 'description': 'AUA-SI is a 7-item self-report measure used to assess urinary urgency, frequency, and voiding symptoms with scores ranging from 0 (no symptom) to 5 (symptom occurs almost always).\n\nTotal score: 0-7 mild symptoms; 8-19 moderate symptoms; 20-35 severe symptoms'}, {'measure': 'Quality of Life Assessments: Expanded Prostate Cancer Index Composite (EPIC) -26 Urinary Incontinence', 'timeFrame': 'Secondary outcomes were measured at 5 years. Sites and patients had the option of continuing follow-up through 10 years.', 'description': "EPIC-26 is a short form version of the Expanded Prostate Cancer Index Composite, and is a validated comprehensive instrument developed to measure the health-related quality of life among men with prostate cancer. EPIC-26 consists of 26 items under 5 domains of urinary incontinence, urinary irritative/obstructive, bowel, sexual, and hormonal.\n\nAnswers qualitatively measure patient's bother for each symptom and are then normalized on a scale of 0 (worst) to 100 (best) to calculate domain scores if sufficient input is provided."}, {'measure': 'Quality of Life Assessments: EPIC-26 Urinary Irritative Obstructive', 'timeFrame': 'Secondary outcomes were measured at 5 years. Sites and patients had the option of continuing follow-up through 10 years.', 'description': "EPIC-26 is a short form version of the Expanded Prostate Cancer Index Composite, and is a validated comprehensive instrument developed to measure the health-related quality of life among men with prostate cancer. EPIC-26 consists of 26 items under 5 domains of urinary incontinence, urinary irritative/obstructive, bowel, sexual, and hormonal.\n\nAnswers qualitatively measure patient's bother for each symptom and are then normalized on a scale of 0 (worst) to 100 (best) to calculate domain scores if sufficient input is provided."}, {'measure': 'Quality of Life Assessments: EPIC-26 Bowel', 'timeFrame': 'Secondary outcomes were measured at 5 years. Sites and patients had the option of continuing follow-up through 10 years.', 'description': "EPIC-26 is a short form version of the Expanded Prostate Cancer Index Composite, and is a validated comprehensive instrument developed to measure the health-related quality of life among men with prostate cancer. EPIC-26 consists of 26 items under 5 domains of urinary incontinence, urinary irritative/obstructive, bowel, sexual, and hormonal.\n\nAnswers qualitatively measure patient's bother for each symptom and are then normalized on a scale of 0 (worst) to 100 (best) to calculate domain scores if sufficient input is provided."}, {'measure': 'Quality of Life Assessments: EPIC-26 Sexual', 'timeFrame': 'Secondary outcomes were measured at 5 years. Sites and patients had the option of continuing follow-up through 10 years.', 'description': "EPIC-26 is a short form version of the Expanded Prostate Cancer Index Composite, and is a validated comprehensive instrument developed to measure the health-related quality of life among men with prostate cancer. EPIC-26 consists of 26 items under 5 domains of urinary incontinence, urinary irritative/obstructive, bowel, sexual, and hormonal.\n\nAnswers qualitatively measure patient's bother for each symptom and are then normalized on a scale of 0 (worst) to 100 (best) to calculate domain scores if sufficient input is provided."}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['Prostate Cancer', 'CyberKnife', 'Stereotactic Radiosurgery', 'Radiotherapy', 'Radiation', 'Prostate Tumor', 'Prostate Surgery'], 'conditions': ['Prostate Cancer', 'Prostatic Cancer', 'Prostate Neoplasms', 'Prostatic Neoplasms', 'Cancer of the Prostate']}, 'referencesModule': {'references': [{'pmid': '30191864', 'type': 'DERIVED', 'citation': 'Meier RM, Bloch DA, Cotrutz C, Beckman AC, Henning GT, Woodhouse SA, Williamson SK, Mohideen N, Dombrowski JJ, Hong RL, Brachman DG, Linson PW, Kaplan ID. Multicenter Trial of Stereotactic Body Radiation Therapy for Low- and Intermediate-Risk Prostate Cancer: Survival and Toxicity Endpoints. Int J Radiat Oncol Biol Phys. 2018 Oct 1;102(2):296-303. doi: 10.1016/j.ijrobp.2018.05.040. Epub 2018 Jun 1.'}], 'seeAlsoLinks': [{'url': 'http://www.accuray.com', 'label': 'Accuray Website'}]}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to determine the effects of CyberKnife radiosurgery in patients with early stage organ-confined prostate cancer.', 'detailedDescription': 'The CyberKnife Robotic Radiosurgery System is a unique radiosurgical system capable of treating tumors anywhere in the body noninvasively and with sub-millimeter accuracy. The CyberKnife System delivers radiation using a precise targeting methodology allowing a focal treatment margin around the target, thus limiting the volume of adjacent tissue receiving high doses radiation. This in turn allows the delivery of high doses of radiation to the prostate over a short series of treatments.'}, 'eligibilityModule': {'sex': 'MALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Patient must be at least 18 years of age\n* Histologically proven prostate adenocarcinoma\n* Patients belonging in one of the following risk groups:\n\nLow: Clinical Stage (CS) T1b-T2a and Gleason 2-6 and Prostate Specific Antigen (PSA) ≤ 10, or Intermediate: CS T2b and Gleason 2-6 and PSA ≤ 10 or CS T1b-T2b, and Gleason 2-6 and PSA ≤ 20 ng/ml or Gleason 7 and PSA ≤ 10 ng/ml\n\n* Prostate volume: ≤ 100 cc\n* Eastern Cooperative Oncology Group (ECOG) performance status 0-1\n\nExclusion Criteria:\n\n* Prior prostatectomy or cryotherapy of the prostate\n* Prior radiotherapy to the prostate or lower pelvis\n* Implanted hardware or other material that would prohibit appropriate treatment planning or treatment delivery, in the investigator's opinion\n* Chemotherapy for a malignancy in the last 5 years\n* History of an invasive malignancy (other than this prostate cancer, or basal or squamous skin cancers) in the last 5 years.\n* Hormone ablation for two months prior to enrollment, or during treatment."}, 'identificationModule': {'nctId': 'NCT00643994', 'briefTitle': 'CyberKnife Radiosurgery for Organ-Confined Prostate Cancer: Homogenous Dose Distribution', 'organization': {'class': 'INDUSTRY', 'fullName': 'Accuray Incorporated'}, 'officialTitle': 'Prospective Evaluation of CyberKnife Stereotactic Radiosurgery for Low and Intermediate Risk Prostate Cancer: Homogenous Dose Distribution', 'orgStudyIdInfo': {'id': 'ACCP001.4'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'CyberKnife Stereotactic Radiosurgery', 'description': '36.25 Gy delivered in 5 fractions of 7.25 Gy per fraction in patients with low and intermediate risk prostate cancer.', 'interventionNames': ['Radiation: CyberKnife Stereotactic Radiosurgery']}], 'interventions': [{'name': 'CyberKnife Stereotactic Radiosurgery', 'type': 'RADIATION', 'otherNames': ['CyberKnife'], 'description': '36.25 Gy delivered in 5 fractions of 7.25 Gy per fraction', 'armGroupLabels': ['CyberKnife Stereotactic Radiosurgery']}]}, 'contactsLocationsModule': {'locations': [{'zip': '85013', 'city': 'Phoenix', 'state': 'Arizona', 'country': 'United States', 'facility': "St. Joseph's Hospital and Medical Center", 'geoPoint': {'lat': 33.44838, 'lon': -112.07404}}, {'zip': '92037', 'city': 'La Jolla', 'state': 'California', 'country': 'United States', 'facility': 'Scripps Cancer Center - CyberKnife of Southern California at Vista', 'geoPoint': {'lat': 32.84727, 'lon': -117.2742}}, {'zip': '92660', 'city': 'Newport Beach', 'state': 'California', 'country': 'United States', 'facility': 'The CyberKnife at Newport Diagnostic Center', 'geoPoint': {'lat': 33.61891, 'lon': -117.92895}}, {'zip': '20057', 'city': 'Washington D.C.', 'state': 'District of Columbia', 'country': 'United States', 'facility': 'Georgetown University', 'geoPoint': {'lat': 38.89511, 'lon': -77.03637}}, {'zip': '34982', 'city': 'Ft. Pierce', 'state': 'Florida', 'country': 'United States', 'facility': 'Coastal CyberKnife and Radiation Oncology', 'geoPoint': {'lat': 27.44671, 'lon': -80.32561}}, {'zip': '33458', 'city': 'Jupiter', 'state': 'Florida', 'country': 'United States', 'facility': 'Jupiter Medical Center & CyberKnife Center of Palm Beach', 'geoPoint': {'lat': 26.93422, 'lon': -80.09421}}, {'zip': '60005', 'city': 'Arlington Heights', 'state': 'Illinois', 'country': 'United States', 'facility': 'Northwest Community Hospital', 'geoPoint': {'lat': 42.08836, 'lon': -87.98063}}, {'zip': '61761', 'city': 'Normal', 'state': 'Illinois', 'country': 'United States', 'facility': 'Community Cancer Center', 'geoPoint': {'lat': 40.5142, 'lon': -88.99063}}, {'zip': '40503', 'city': 'Lexington', 'state': 'Kentucky', 'country': 'United States', 'facility': 'Central Baptist Hospital', 'geoPoint': {'lat': 37.98869, 'lon': -84.47772}}, {'zip': '21215', 'city': 'Baltimore', 'state': 'Maryland', 'country': 'United States', 'facility': 'Sinai Hospital of Baltimore', 'geoPoint': {'lat': 39.29038, 'lon': -76.61219}}, {'zip': '21237', 'city': 'Baltimore', 'state': 'Maryland', 'country': 'United States', 'facility': 'Franklin Square Hospital Center', 'geoPoint': {'lat': 39.29038, 'lon': -76.61219}}, {'zip': '02215', 'city': 'Boston', 'state': 'Massachusetts', 'country': 'United States', 'facility': 'Beth Israel Deaconess Medical Center', 'geoPoint': {'lat': 42.35843, 'lon': -71.05977}}, {'zip': '48106', 'city': 'Ann Arbor', 'state': 'Michigan', 'country': 'United States', 'facility': 'St. Joseph Mercy Hospital', 'geoPoint': {'lat': 42.27756, 'lon': -83.74088}}, {'zip': '63367', 'city': 'St Louis', 'state': 'Missouri', 'country': 'United States', 'facility': 'Lake Saint Louis Oncology', 'geoPoint': {'lat': 38.62727, 'lon': -90.19789}}, {'zip': '63367', 'city': 'St Louis', 'state': 'Missouri', 'country': 'United States', 'facility': 'Saint Louis University', 'geoPoint': {'lat': 38.62727, 'lon': -90.19789}}, {'zip': '89503', 'city': 'Reno', 'state': 'Nevada', 'country': 'United States', 'facility': "St. Mary's Regional Medical Center", 'geoPoint': {'lat': 39.52963, 'lon': -119.8138}}, {'zip': '08618', 'city': 'Trenton', 'state': 'New Jersey', 'country': 'United States', 'facility': 'Capital Health', 'geoPoint': {'lat': 40.21705, 'lon': -74.74294}}, {'zip': '15057', 'city': 'Syracuse', 'state': 'New York', 'country': 'United States', 'facility': 'Hematology Oncology Associates of Central New York', 'geoPoint': {'lat': 43.04812, 'lon': -76.14742}}, {'zip': '22205', 'city': 'Arlington', 'state': 'Virginia', 'country': 'United States', 'facility': 'Virginia Hospital Center', 'geoPoint': {'lat': 38.88101, 'lon': -77.10428}}, {'zip': '98122', 'city': 'Seattle', 'state': 'Washington', 'country': 'United States', 'facility': 'Swedish Cancer Center', 'geoPoint': {'lat': 47.60621, 'lon': -122.33207}}, {'zip': '98664', 'city': 'Vancouver', 'state': 'Washington', 'country': 'United States', 'facility': 'Southwest Washington Medical Center', 'geoPoint': {'lat': 45.63873, 'lon': -122.66149}}, {'zip': '98664', 'city': 'Vancouver', 'state': 'Washington', 'country': 'United States', 'facility': 'Southwest Washington Regional Cancer Center', 'geoPoint': {'lat': 45.63873, 'lon': -122.66149}}, {'zip': '54911', 'city': 'Appleton', 'state': 'Wisconsin', 'country': 'United States', 'facility': 'ThedaCare Appleton Medical Center', 'geoPoint': {'lat': 44.26193, 'lon': -88.41538}}], 'overallOfficials': [{'name': 'Robert Meier, MD', 'role': 'STUDY_CHAIR', 'affiliation': 'Swedish Cancer Center'}, {'name': 'Irving Kaplan, MD', 'role': 'STUDY_CHAIR', 'affiliation': 'Beth Israel Deaconess Medical Center'}, {'name': 'Martin Sanda, MD', 'role': 'STUDY_CHAIR', 'affiliation': 'Beth Israel Deaconess Medical Center'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Accuray Incorporated', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}