Ignite Creation Date:
2025-12-25 @ 2:04 AM
Ignite Modification Date:
2026-01-28 @ 7:37 PM
Study NCT ID:
NCT00977860
Status:
COMPLETED
Last Update Posted:
2024-05-02
First Post:
2009-09-15
Is Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Hypofractionated SBRT For Prostate Cancer
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': 'stadtermanbm@upmc.edu', 'phone': '412-647-5554', 'title': 'Barbara M Stadterman, MPH, MCCR', 'organization': 'UPMC Hillman Cancer Center'}, 'certainAgreement': {'piSponsorEmployee': True}}, 'adverseEventsModule': {'timeFrame': 'Adverse event data were collected for a period of up to 5 years.', 'eventGroups': [{'id': 'EG000', 'title': 'SBRT', 'description': 'Stereotactic Body Radiation Therapy: 36.25 Gy in 5 fractions (7.25 Gy/fx) delivered over a 2-week period', 'otherNumAtRisk': 163, 'deathsNumAtRisk': 163, 'otherNumAffected': 9, 'seriousNumAtRisk': 163, 'deathsNumAffected': 15, 'seriousNumAffected': 2}], 'otherEvents': [{'term': 'Diarrhea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 163, 'numAffected': 5}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'NCI CTCAE v3.0'}, {'term': 'Urinary frequency/urgency', 'stats': [{'groupId': 'EG000', 'numAtRisk': 163, 'numAffected': 8}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'NCI CTCAE v3.0'}, {'term': 'Fatigue (asthenia, lethargy, malaise)', 'stats': [{'groupId': 'EG000', 'numAtRisk': 163, 'numAffected': 2}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'NCI CTCAE v3.0'}, {'term': 'Other', 'stats': [{'groupId': 'EG000', 'numAtRisk': 163, 'numAffected': 3}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'NCI CTCAE v3.0'}, {'term': 'nocturia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 163, 'numAffected': 1}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'NCI CTCAE v3.0'}, {'term': 'weak stream', 'stats': [{'groupId': 'EG000', 'numAtRisk': 163, 'numAffected': 1}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'NCI CTCAE v3.0'}, {'term': 'hypercholesteremia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 163, 'numAffected': 1}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'NCI CTCAE v3.0'}, {'term': 'Burning - tip of penis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 163, 'numAffected': 1}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'NCI CTCAE v3.0'}, {'term': 'anxiety', 'stats': [{'groupId': 'EG000', 'numAtRisk': 163, 'numAffected': 1}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'NCI CTCAE v3.0'}], 'seriousEvents': [{'term': 'Incontinence', 'stats': [{'groupId': 'EG000', 'numAtRisk': 163, 'numAffected': 1}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'NCI CTCAE v3.0'}, {'term': 'Nocturia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 163, 'numAffected': 1}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'NCI CTCAE v3.0'}, {'term': 'Hematuria', 'stats': [{'groupId': 'EG000', 'numAtRisk': 163, 'numAffected': 1}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'NCI CTCAE v3.0'}, {'term': 'Urinary frequncy', 'stats': [{'groupId': 'EG000', 'numAtRisk': 163, 'numAffected': 1}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'NCI CTCAE v3.0'}, {'term': 'Dysuria', 'stats': [{'groupId': 'EG000', 'numAtRisk': 163, 'numAffected': 1}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'NCI CTCAE v3.0'}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Rate of Acute Grade 3 or Higher GI and GU Toxicities', 'denoms': [{'units': 'Participants', 'counts': [{'value': '2', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'SBRT', 'description': 'Stereotactic Body Radiation Therapy: 36.25 Gy in 5 fractions (7.25 Gy/fx) delivered over a 2-week period'}], 'classes': [{'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Up to 90 days', 'description': 'Number of patients experiencing acute grade 3 or higher GI and GU toxicities. Acute toxicities are those occurring within 90 days of start of treatment, assessed using the NCI Common Toxicity Criteria (CTCAE) version 3.0.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Patients that received SBRT therapy.'}, {'type': 'PRIMARY', 'title': 'Rate of Late Grade 3 or Higher GI and GU Toxicities', 'denoms': [{'units': 'Participants', 'counts': [{'value': '163', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'SBRT', 'description': 'Stereotactic Body Radiation Therapy: 36.25 Gy in 5 fractions (7.25 Gy/fx) delivered over a 2-week period'}], 'classes': [{'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'After 90 days post-treatment, up to 5 years per patient', 'description': 'Number of patients experiencing late grade 3 or higher GI and GU toxicities. Late toxicities are those occurring after 90 days post start of treatment, assessed using the NCI Common Toxicity Criteria (CTCAE) version 3.0.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'All enrolled patients that received SBRT therapy.'}, {'type': 'PRIMARY', 'title': 'Biochemical Disease-Free Survival Rate (bDFS)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '163', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'SBRT', 'description': 'Stereotactic Body Radiation Therapy: 36.25 Gy in 5 fractions (7.25 Gy/fx) delivered over a 2-week period'}], 'classes': [{'categories': [{'measurements': [{'value': '7', 'groupId': 'OG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Up to 5 years', 'description': 'Biochemical Disease-Free Survival (bDFS) as defined by Phoenix and ASTRO. Biochemical progression-free survival events were defined as PSA of ≥ 0.4 ng/mL following postoperative radiotherapy, PSA \\> 2.0 ng/mL at any time, clinical progression, initiation of non-protocol hormone therapy, and death from any cause.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'All enrolled patients that received SBRT therapy with PSA assessment.'}, {'type': 'SECONDARY', 'title': 'Rate of Local Failure', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'SBRT', 'description': 'Stereotactic Body Radiation Therapy: 36.25 Gy in 5 fractions (7.25 Gy/fx) delivered over a 2-week period'}], 'timeFrame': 'Up to 5 years', 'description': "Proportion of patients with 'local failure', which is defined as clinical evidence local recurrence. Clinical failure includes a palpable abnormality that has increased in size, failure of regression of a palpable abnormality, or redevelopment of a prostate abnormality after complete response, further confirmed by prostate biopsy.", 'reportingStatus': 'POSTED', 'populationDescription': 'Data were not collected.'}, {'type': 'SECONDARY', 'title': 'Rate of Distant Failure', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'SBRT', 'description': 'Stereotactic Body Radiation Therapy: 36.25 Gy in 5 fractions (7.25 Gy/fx) delivered over a 2-week period'}], 'timeFrame': 'Up to 5 years', 'description': "Proportion of patients with 'distant failure' (includes regional failure) which is defined as documented clinically via bone scan, CT or other imaging study that shows metastatic disease (disease located distant from the prostate area).", 'reportingStatus': 'POSTED', 'populationDescription': 'Data were not collected.'}, {'type': 'SECONDARY', 'title': '5-year Overall Survival (OS)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '163', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'SBRT', 'description': 'Stereotactic Body Radiation Therapy: 36.25 Gy in 5 fractions (7.25 Gy/fx) delivered over a 2-week period'}], 'classes': [{'categories': [{'measurements': [{'value': '93.87', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'At 5 years', 'description': 'Percentage of patients that remained alive 5 years after start of study treatment. Deaths were from any cause.', 'unitOfMeasure': 'percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'All patients that received SBRT therapy.'}, {'type': 'SECONDARY', 'title': 'Quality of Life (QoL) - FACT-G - Prior to Therapy', 'denoms': [{'units': 'Participants', 'counts': [{'value': '36', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'SBRT', 'description': 'Stereotactic Body Radiation Therapy: 36.25 Gy in 5 fractions (7.25 Gy/fx) delivered over a 2-week period'}], 'classes': [{'title': 'PWB', 'categories': [{'measurements': [{'value': '26.06019', 'spread': '2.716213', 'groupId': 'OG000'}]}]}, {'title': 'SWB', 'categories': [{'measurements': [{'value': '23.70186', 'spread': '3.641432', 'groupId': 'OG000'}]}]}, {'title': 'EWB', 'categories': [{'measurements': [{'value': '19.58', 'spread': '4.449', 'groupId': 'OG000'}]}]}, {'title': 'FWB', 'categories': [{'measurements': [{'value': '23.44', 'spread': '5.417', 'groupId': 'OG000'}]}]}, {'title': 'FACTG', 'categories': [{'measurements': [{'value': '92.78983', 'spread': '12.323307', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Prior to start of therapy', 'description': 'The Functional Assessment of Cancer Therapy- General (FACT-G) is a self-administered 27-item questionnaire designed to measure four domains of HRQOL in cancer patients. It is comprised of physical (PWB), social (SWB), emotional (EWB), and functional (FWB) well-being subscales: (PWB; 7-items, score range 0-28), (SWB; 7-items, score range 0-28), (EWB; 6-items, score range 0-24), (FWB; 7-items, score range 0-28). The FACT-G generates an overall score of 0-108). All questions in the FACT-G use a 5-point rating scale (0 = Not at all; 1 = A little bit; 2 = Somewhat; 3 = Quite a bit; and 4 = Very much) and asks information regarding the patients last 7 days.', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Patients that received SBRT therapy, that completed quality of life assessments Prior to therapy.'}, {'type': 'SECONDARY', 'title': 'Quality of Life (QoL) - FACT-G - At 24 Months', 'denoms': [{'units': 'Participants', 'counts': [{'value': '21', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'SBRT', 'description': 'Stereotactic Body Radiation Therapy: 36.25 Gy in 5 fractions (7.25 Gy/fx) delivered over a 2-week period'}], 'classes': [{'title': 'PWB', 'categories': [{'measurements': [{'value': '26.10', 'spread': '2.791', 'groupId': 'OG000'}]}]}, {'title': 'SWB', 'categories': [{'measurements': [{'value': '21.95238', 'spread': '6.645819', 'groupId': 'OG000'}]}]}, {'title': 'EWB', 'categories': [{'measurements': [{'value': '21.25', 'spread': '3.370', 'groupId': 'OG000'}]}]}, {'title': 'FWB', 'categories': [{'measurements': [{'value': '22.85', 'spread': '5.824', 'groupId': 'OG000'}]}]}, {'title': 'FACTG', 'categories': [{'measurements': [{'value': '93.15000', 'spread': '14.605211', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'At 24 months (post-start of therapy)', 'description': 'The Functional Assessment of Cancer Therapy- General (FACT-G) is a self-administered 27-item questionnaire designed to measure four domains of HRQOL in cancer patients. It is comprised of physical (PWB), social (SWB), emotional (EWB), and functional (FWB) well-being subscales: (PWB; 7-items, score range 0-28), (SWB; 7-items, score range 0-28), (EWB; 6-items, score range 0-24), (FWB; 7-items, score range 0-28). The FACT-G generates an overall score of 0-108). All questions in the FACT-G use a 5-point rating scale (0 = Not at all; 1 = A little bit; 2 = Somewhat; 3 = Quite a bit; and 4 = Very much) and asks information regarding the patients last 7 days.', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Patients that received SBRT therapy, that completed quality of life assessments Prior to therapy.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'SBRT', 'description': 'Stereotactic Body Radiation Therapy: 36.25 Gy in 5 fractions (7.25 Gy/fx) delivered over a 2-week period'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '163'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '163'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '163', 'groupId': 'BG000'}]}], 'groups': [{'id': 'BG000', 'title': 'SBRT', 'description': 'Stereotactic Body Radiation Therapy: 36.25 Gy in 5 fractions (7.25 Gy/fx) delivered over a 2-week period'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '67.80', 'spread': '6.929', 'groupId': 'BG000'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'Male', 'measurements': [{'value': '163', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Ethnicity (NIH/OMB)', 'classes': [{'categories': [{'title': 'Hispanic or Latino', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'Not Hispanic or Latino', 'measurements': [{'value': '162', 'groupId': 'BG000'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '1', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race (NIH/OMB)', 'classes': [{'categories': [{'title': 'American Indian or Alaska Native', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'Asian', 'measurements': [{'value': '2', 'groupId': 'BG000'}]}, {'title': 'Native Hawaiian or Other Pacific Islander', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'Black or African American', 'measurements': [{'value': '12', 'groupId': 'BG000'}]}, {'title': 'White', 'measurements': [{'value': '148', 'groupId': 'BG000'}]}, {'title': 'More than one race', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '1', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}]}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2023-03-09', 'size': 12876987, 'label': 'Study Protocol and Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'Prot_SAP_000.pdf', 'typeAbbrev': 'Prot_SAP', 'uploadDate': '2023-08-11T07:47', 'hasProtocol': True}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 163}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2010-10-07', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-04', 'dispFirstSubmitDate': '2023-07-03', 'completionDateStruct': {'date': '2022-07-08', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2024-04-04', 'studyFirstSubmitDate': '2009-09-15', 'resultsFirstSubmitDate': '2023-08-12', 'studyFirstSubmitQcDate': '2009-09-15', 'dispFirstPostDateStruct': {'date': '2023-07-28', 'type': 'ACTUAL'}, 'lastUpdatePostDateStruct': {'date': '2024-05-02', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2024-04-04', 'studyFirstPostDateStruct': {'date': '2009-09-16', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2024-05-02', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2022-07-08', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Rate of Acute Grade 3 or Higher GI and GU Toxicities', 'timeFrame': 'Up to 90 days', 'description': 'Number of patients experiencing acute grade 3 or higher GI and GU toxicities. Acute toxicities are those occurring within 90 days of start of treatment, assessed using the NCI Common Toxicity Criteria (CTCAE) version 3.0.'}, {'measure': 'Rate of Late Grade 3 or Higher GI and GU Toxicities', 'timeFrame': 'After 90 days post-treatment, up to 5 years per patient', 'description': 'Number of patients experiencing late grade 3 or higher GI and GU toxicities. Late toxicities are those occurring after 90 days post start of treatment, assessed using the NCI Common Toxicity Criteria (CTCAE) version 3.0.'}, {'measure': 'Biochemical Disease-Free Survival Rate (bDFS)', 'timeFrame': 'Up to 5 years', 'description': 'Biochemical Disease-Free Survival (bDFS) as defined by Phoenix and ASTRO. Biochemical progression-free survival events were defined as PSA of ≥ 0.4 ng/mL following postoperative radiotherapy, PSA \\> 2.0 ng/mL at any time, clinical progression, initiation of non-protocol hormone therapy, and death from any cause.'}], 'secondaryOutcomes': [{'measure': 'Rate of Local Failure', 'timeFrame': 'Up to 5 years', 'description': "Proportion of patients with 'local failure', which is defined as clinical evidence local recurrence. Clinical failure includes a palpable abnormality that has increased in size, failure of regression of a palpable abnormality, or redevelopment of a prostate abnormality after complete response, further confirmed by prostate biopsy."}, {'measure': 'Rate of Distant Failure', 'timeFrame': 'Up to 5 years', 'description': "Proportion of patients with 'distant failure' (includes regional failure) which is defined as documented clinically via bone scan, CT or other imaging study that shows metastatic disease (disease located distant from the prostate area)."}, {'measure': '5-year Overall Survival (OS)', 'timeFrame': 'At 5 years', 'description': 'Percentage of patients that remained alive 5 years after start of study treatment. Deaths were from any cause.'}, {'measure': 'Quality of Life (QoL) - FACT-G - Prior to Therapy', 'timeFrame': 'Prior to start of therapy', 'description': 'The Functional Assessment of Cancer Therapy- General (FACT-G) is a self-administered 27-item questionnaire designed to measure four domains of HRQOL in cancer patients. It is comprised of physical (PWB), social (SWB), emotional (EWB), and functional (FWB) well-being subscales: (PWB; 7-items, score range 0-28), (SWB; 7-items, score range 0-28), (EWB; 6-items, score range 0-24), (FWB; 7-items, score range 0-28). The FACT-G generates an overall score of 0-108). All questions in the FACT-G use a 5-point rating scale (0 = Not at all; 1 = A little bit; 2 = Somewhat; 3 = Quite a bit; and 4 = Very much) and asks information regarding the patients last 7 days.'}, {'measure': 'Quality of Life (QoL) - FACT-G - At 24 Months', 'timeFrame': 'At 24 months (post-start of therapy)', 'description': 'The Functional Assessment of Cancer Therapy- General (FACT-G) is a self-administered 27-item questionnaire designed to measure four domains of HRQOL in cancer patients. It is comprised of physical (PWB), social (SWB), emotional (EWB), and functional (FWB) well-being subscales: (PWB; 7-items, score range 0-28), (SWB; 7-items, score range 0-28), (EWB; 6-items, score range 0-24), (FWB; 7-items, score range 0-28). The FACT-G generates an overall score of 0-108). All questions in the FACT-G use a 5-point rating scale (0 = Not at all; 1 = A little bit; 2 = Somewhat; 3 = Quite a bit; and 4 = Very much) and asks information regarding the patients last 7 days.'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': True}, 'conditionsModule': {'keywords': ['Prostate', 'Stereotactic', 'Radiosurgery'], 'conditions': ['Prostate Cancer']}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to determine, in both low-risk and intermediate-risk cohorts, the rates of acute and late grade 3 or higher gastrointestinal and genitourinary toxicity observed during a 24 month follow up and to estimate the rate of biochemical Disease-Free Survival, Phoenix and American Society for Therapeutic Radiology and Oncology definitions, at 2 years following hypofractionated stereotactic body radiation therapy for low and intermediate risk prostate cancer.', 'detailedDescription': 'Radiosurgery should be ideal for treating prostate cancer because:\n\n* targeting accuracy for static targets is excellent, with an error of about 1mm,\n* it can adjust for intra-fractional organ motion, reducing the volume of the target PTV and therefore the dose to surrounding organs,\n* by using over one-hundred non-conplanar beams, the dose gradient between the prostate and surrounding tissues may be superior to that achieved with conventional linear accelerators,\n* the radiobiology of prostate cancer may favor large dose per fractions.'}, 'eligibilityModule': {'sex': 'MALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Histologically proven prostate adenocarcinoma\n* Gleason score 2-7\n* Biopsy within one year of date of registration\n* Clinical stage T1b-T2b, N0-Nx, M0-Mx (AJCC 6th Edition)\n* T-stage and N-stage determined by physical exam and available imaging studies (ultrasound, CT, and/or MRI)\n* M-stage determined by physical exam, CT or MRI. Bone scan not required unless clinical findings suggest possible osseous metastases.\n* PSA ≤ 20 ng/dL\n* Patients belonging in one of the following risk groups:\n* Low: CS T1b-T2a and Gleason 2-6 and PSA ≤ 10, or\n* Intermediate: CS T2b and Gleason 2-6 and PSA ≤ 10, or CS T1b-T2b, and Gleason 2-6 and PSA ≤ 20 ng/dL, or Gleason 7 and PSA ≤ 10 ng/dL\n* Prostate volume: ≤ 100 cc\n* Determined using: volume = π/6 x length x height x width\n* Measurement from CT or ultrasound ≤90 days prior to registration.\n* ECOG performance status 0-1\n* Completion of patient questionnaires:FACT-G questionnaire, AUA questionnaire, EPIC-26 questionnaire, SHIM questionnaire, Utilization of Sexual Medications/Devices questionnaire\n* Consent signed.\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 treat"}, 'identificationModule': {'nctId': 'NCT00977860', 'briefTitle': 'Hypofractionated SBRT For Prostate Cancer', 'organization': {'class': 'OTHER', 'fullName': 'University of Pittsburgh'}, 'officialTitle': 'Prospective Evaluation Of Hypofractionated Stereotactic Body Radiotherapy For Low And Intermediate Risk Prostate Cancer', 'orgStudyIdInfo': {'id': 'HCC 09-031'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'OTHER', 'label': 'SBRT', 'interventionNames': ['Radiation: Stereotactic Body Radiation Therapy']}], 'interventions': [{'name': 'Stereotactic Body Radiation Therapy', 'type': 'RADIATION', 'otherNames': ['CyberKnife', 'Trilogy', 'True Beam', 'Radiosurgery'], 'description': '36.25 Gy in 5 fractions (7.25 Gy/fx) delivered over a 2-week period', 'armGroupLabels': ['SBRT']}]}, 'contactsLocationsModule': {'locations': [{'zip': '15232', 'city': 'Pittsburgh', 'state': 'Pennsylvania', 'country': 'United States', 'facility': 'UPMC Hillman Cancer Center - Shadyside Radiation Oncology', 'geoPoint': {'lat': 40.44062, 'lon': -79.99589}}], 'overallOfficials': [{'name': 'Adam Olson, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Pittsburgh Medical Center'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Adam Olson', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR_INVESTIGATOR', 'investigatorTitle': 'Clinical Assistant Professor', 'investigatorFullName': 'Adam Olson', 'investigatorAffiliation': 'University of Pittsburgh'}}}}