Ignite Creation Date:
2025-12-25 @ 1:14 AM
Ignite Modification Date:
2025-12-25 @ 11:24 PM
Study NCT ID:
NCT01599793
Status:
COMPLETED
Last Update Posted:
2020-03-26
First Post:
2012-05-14
Is NOT Gene Therapy:
False
Has Adverse Events:
True
Brief Title:
Magnetic Resonance Imaging in Measuring the Effect of Cabozantinib in Patients With Castrate Resistant 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': 'C558660', 'term': 'cabozantinib'}, {'id': 'D009682', 'term': 'Magnetic Resonance Spectroscopy'}], 'ancestors': [{'id': 'D013057', 'term': 'Spectrum Analysis'}, {'id': 'D002623', 'term': 'Chemistry Techniques, Analytical'}, {'id': 'D008919', 'term': 'Investigative Techniques'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'rszmulew@medicine.bsd.uchicago.edu', 'phone': '773-702-7609', 'title': 'Russell Szmulewitz, MD', 'organization': 'University of Chicago'}, 'certainAgreement': {'piSponsorEmployee': True}}, 'adverseEventsModule': {'timeFrame': 'Adverse events were monitored/assessed every two weeks for the first three months and then every 4 weeks thereafter (until one year).', 'description': 'Assessment of toxicities and adverse events were graded according to the Common Toxicity Criteria (CTC), version 4.03.', 'eventGroups': [{'id': 'EG000', 'title': 'Treatment (Enzyme Inhibitor Therapy)', 'description': 'Patients receive cabozantinib PO QD. Treatment continues in the absence of disease progression or unacceptable toxicity.\n\ncabozantinib: Given PO\n\nlaboratory biomarker analysis: Correlative studies\n\nmagnetic resonance imaging: Undergo MRI', 'otherNumAtRisk': 17, 'deathsNumAtRisk': 17, 'otherNumAffected': 15, 'seriousNumAtRisk': 17, 'deathsNumAffected': 1, 'seriousNumAffected': 4}], 'otherEvents': [{'term': 'Fatigue', 'stats': [{'groupId': 'EG000', 'numAtRisk': 17, 'numEvents': 7, 'numAffected': 7}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'V4.03 (CTCAE)'}, {'term': 'mucositis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 17, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'V4.03 (CTCAE)'}, {'term': 'diarrhea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 17, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'V4.03 (CTCAE)'}, {'term': 'plantar erythrodysaesthesia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 17, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'V4.03 (CTCAE)'}, {'term': 'elevated transaminases', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'V4.03 (CTCAE)'}, {'term': 'decreased appetite', 'stats': [{'groupId': 'EG000', 'numAtRisk': 17, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'V4.03 (CTCAE)'}], 'seriousEvents': [{'term': 'Neutrophil count decreased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 17, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'V4.03 (CTCAE)'}, {'term': 'hospitalized with pneumaonia (Aspiration)', 'stats': [{'groupId': 'EG000', 'numAtRisk': 17, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'V4.03 (CTCAE)'}, {'term': 'Dehydration', 'stats': [{'groupId': 'EG000', 'numAtRisk': 17, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'V4.03 (CTCAE)'}, {'term': 'Syncope', 'stats': [{'groupId': 'EG000', 'numAtRisk': 17, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'V4.03 (CTCAE)'}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Change in the Functional MRI Metrics Ktrans Between 2 Weeks and Baseline', 'denoms': [{'units': 'Participants', 'counts': [{'value': '15', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Treatment (Enzyme Inhibitor Therapy)', 'description': 'Patients receive cabozantinib PO QD. Treatment continues in the absence of disease progression or unacceptable toxicity.\n\ncabozantinib: Given PO\n\nlaboratory biomarker analysis: Correlative studies\n\nmagnetic resonance imaging: Undergo MRI'}], 'classes': [{'categories': [{'measurements': [{'value': '0.026', 'spread': '0.005', 'groupId': 'OG000'}]}]}], 'analyses': [{'pValue': '0.0016', 'groupIds': ['OG000'], 'groupDescription': 'The least square means of ktrans at different time points (baseline, 2 weeks, 12 weeks, 24 weeks) are estimated by a linear mixed model. Comparison of means at different time points were performed. The primary result reported below is for the difference of means between 2 weeks and baseline.', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'EQUIVALENCE', 'nonInferiorityComment': 'Testing if the change of ktrans between 2 weeks and baseline = 0 (i.e testing if the difference of means between 2 weeks and baseline =0)'}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'baseline, 2 weeks', 'description': 'Ktrans is a measurement calculating the volume transfer constant of the contrast reagent and essentially is a measurement of vascular perfusion.\n\nTo determine the effect of XL184 on the functional MRI metrics Ktrans, Ktrans parameters were measured at baseline, two week time-point, 12 weeks, and 24 weeks for disease monitoring. Change between baseline and 2 weeks reported.', 'unitOfMeasure': 'per minute (or min-1)', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': '2 individuals had missing values for Ktrans from baseline to 24 weeks'}, {'type': 'SECONDARY', 'title': 'Association of Progression Free Survival (PFS) With Ktrans and ADC', 'denoms': [{'units': 'Participants', 'counts': [{'value': '17', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Treatment (Enzyme Inhibitor Therapy)', 'description': 'Patients receive cabozantinib PO QD. Treatment continues in the absence of disease progression or unacceptable toxicity.\n\ncabozantinib: Given PO\n\nlaboratory biomarker analysis: Correlative studies\n\nmagnetic resonance imaging: Undergo MRI'}], 'classes': [{'categories': [{'measurements': [{'value': '5.100', 'groupId': 'OG000', 'lowerLimit': '2.900', 'upperLimit': '5.700'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'From start of treatment to time of progression or death, whichever occurs first, assessed up to 1 year', 'description': 'Time to progression or progression-free survival (PFS) is defined as the duration of time from start of treatment to time of progression or death, whichever occurs first.\n\nThe approximate survival after standard therapies in this setting is bleak and in the order of months.\n\nToo few events for a meaningful statistical analysis; no significant results were obtained in Cox regression analyses.\n\nTherefore, we calculated the median PFS time and its 95% confidence interval.', 'unitOfMeasure': 'month', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Changes in Bone Scan Response', 'denoms': [{'units': 'Participants', 'counts': [{'value': '11', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Treatment (Enzyme Inhibitor Therapy)', 'description': 'Patients receive cabozantinib PO QD. Treatment continues in the absence of disease progression or unacceptable toxicity.\n\ncabozantinib: Given PO\n\nlaboratory biomarker analysis: Correlative studies\n\nmagnetic resonance imaging: Undergo MRI'}], 'classes': [{'categories': [{'measurements': [{'value': '-0.43750', 'spread': '0.72744', 'groupId': 'OG000'}]}]}], 'analyses': [{'pValue': '0.3291', 'groupIds': ['OG000'], 'paramType': 'Spearman Correlation Coefficients', 'ciNumSides': 'TWO_SIDED', 'paramValue': '0.36853', 'statisticalMethod': 't-test, 2 sided', 'nonInferiorityType': 'OTHER', 'nonInferiorityComment': 'We calculated Spearman Correlation Coefficient between the percent change in Ktrans (from week 0 to 12) and the bone scan response change. We tested if the coefficient = 0'}], 'paramType': 'MEAN', 'timeFrame': 'baseline, 2 weeks', 'description': 'Bone Scan Response at weeks 2, 12, and 24 were collected. Change between baseline and 2 weeks are reported Bone Scan Response were measured as increase, decrease, or stable of bone lesions and scored as 1, -1, or 0, respectively, where higher values represent a worse outcome.', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': '6 individual have missing bone lesions data.'}, {'type': 'SECONDARY', 'title': 'Correlation of Percent Change in the Functional MRI Metrics to RECIST Tumor Measurements', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Treatment (Enzyme Inhibitor Therapy)', 'description': 'Patients receive cabozantinib PO QD. Treatment continues in the absence of disease progression or unacceptable toxicity.\n\ncabozantinib: Given PO\n\nlaboratory biomarker analysis: Correlative studies\n\nmagnetic resonance imaging: Undergo MRI'}], 'timeFrame': 'baseline, 12 weeks, and 24 weeks', 'description': 'The protocol proposed to collect RECIST tumor measurements at weeks 0, 12, and 24.\n\nHowever, the data were not collected', 'reportingStatus': 'POSTED', 'populationDescription': 'Data on RECIST tumor measurements were not collected'}, {'type': 'SECONDARY', 'title': 'Change of PSA Between 12 Weeks and Baseline', 'denoms': [{'units': 'Participants', 'counts': [{'value': '13', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Treatment (Enzyme Inhibitor Therapy)', 'description': 'Patients receive cabozantinib PO QD. Treatment continues in the absence of disease progression or unacceptable toxicity.\n\ncabozantinib: Given PO\n\nlaboratory biomarker analysis: Correlative studies\n\nmagnetic resonance imaging: Undergo MRI'}], 'classes': [{'categories': [{'measurements': [{'value': '453.04', 'spread': '998.62', 'groupId': 'OG000'}]}]}], 'analyses': [{'pValue': '0.2006', 'groupIds': ['OG000'], 'paramType': 'Spearman Correlation Coefficients', 'ciNumSides': 'TWO_SIDED', 'paramValue': '-0.41818', 'statisticalMethod': 't-test, 2 sided', 'nonInferiorityType': 'OTHER', 'nonInferiorityComment': 'We calculated Spearman Correlation Coefficient between the percent change in Ktrans (from week 0 to 12) and the PSA change. We tested if the coefficient = 0'}], 'paramType': 'MEAN', 'timeFrame': 'baseline, 12 weeks', 'description': 'PSA at weeks 0, 12, and 24 were collected. Change between baseline and 12 weeks are reported', 'unitOfMeasure': 'ng/mL', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'At 12 weeks, 4 individual have missing PSA data.'}, {'type': 'SECONDARY', 'title': 'Correlation of Percent Change in the Functional MRI Metrics With CTC', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Treatment (Enzyme Inhibitor Therapy)', 'description': 'Patients receive cabozantinib PO QD. Treatment continues in the absence of disease progression or unacceptable toxicity.\n\ncabozantinib: Given PO\n\nlaboratory biomarker analysis: Correlative studies\n\nmagnetic resonance imaging: Undergo MRI'}], 'timeFrame': 'baseline, 12 weeks, and 24 weeks', 'description': 'The protocol proposed to collect CTC measurements at weeks 0, 12, and 24. However, the data were not collected', 'reportingStatus': 'POSTED', 'populationDescription': 'data on CTC were not collected'}, {'type': 'SECONDARY', 'title': 'Change in Pain Scale Between 12 Weeks and Baseline', 'denoms': [{'units': 'Participants', 'counts': [{'value': '14', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Treatment (Enzyme Inhibitor Therapy)', 'description': 'Patients receive cabozantinib PO QD. Treatment continues in the absence of disease progression or unacceptable toxicity.\n\ncabozantinib: Given PO\n\nlaboratory biomarker analysis: Correlative studies\n\nmagnetic resonance imaging: Undergo MRI'}], 'classes': [{'categories': [{'measurements': [{'value': '-1.35714', 'spread': '3.77455', 'groupId': 'OG000'}]}]}], 'analyses': [{'pValue': '0.5828', 'groupIds': ['OG000'], 'paramType': 'Spearman Correlation Coefficients', 'ciNumSides': 'TWO_SIDED', 'paramValue': '0.17669', 'statisticalMethod': 't-test, 2 sided', 'nonInferiorityType': 'OTHER', 'nonInferiorityComment': 'We calculated Spearman Correlation Coefficient between the percent change in Ktrans (from week 0 to 12) and the Change in pain scale. We tested if the coefficient = 0'}], 'paramType': 'MEAN', 'timeFrame': 'baseline,12 weeks', 'description': 'Pain scores are measured at baseline and weeks 12, and 24. Change between baseline and 12 weeks are reported .\n\nIn the pain score ranged from 0 to 10. 10 denotes most pain.', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'At 12 weeks, 3 individual have missing pain score data.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Treatment (Enzyme Inhibitor Therapy)', 'description': 'Patients receive cabozantinib PO QD. Treatment continues in the absence of disease progression or unacceptable toxicity.\n\ncabozantinib: Given PO\n\nlaboratory biomarker analysis: Correlative studies\n\nmagnetic resonance imaging: Undergo MRI'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '19'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '17'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '2'}]}], 'dropWithdraws': [{'type': 'Adverse Event', 'reasons': [{'groupId': 'FG000', 'numSubjects': '2'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '17', 'groupId': 'BG000'}]}], 'groups': [{'id': 'BG000', 'title': 'Treatment (Enzyme Inhibitor Therapy)', 'description': 'Patients receive cabozantinib PO QD. Treatment continues in the absence of disease progression or unacceptable toxicity.\n\ncabozantinib: Given PO\n\nlaboratory biomarker analysis: Correlative studies\n\nmagnetic resonance imaging: Undergo MRI'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '68', 'groupId': 'BG000', 'lowerLimit': '51', 'upperLimit': '83'}]}]}], 'paramType': 'MEDIAN', 'unitOfMeasure': 'years', 'dispersionType': 'FULL_RANGE'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'Male', 'measurements': [{'value': '17', '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': '0', 'groupId': 'BG000'}]}, {'title': 'Native Hawaiian or Other Pacific Islander', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'Black or African American', 'measurements': [{'value': '1', 'groupId': 'BG000'}]}, {'title': 'White', 'measurements': [{'value': '16', 'groupId': 'BG000'}]}, {'title': 'More than one race', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'United States', 'categories': [{'measurements': [{'value': '17', 'groupId': 'BG000'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}]}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2013-08-13', 'size': 708102, 'label': 'Study Protocol and Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'Prot_SAP_000.pdf', 'typeAbbrev': 'Prot_SAP', 'uploadDate': '2018-01-31T12:00', 'hasProtocol': True}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'DIAGNOSTIC', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 19}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2012-05'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-03', 'completionDateStruct': {'date': '2018-12', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2020-03-25', 'studyFirstSubmitDate': '2012-05-14', 'resultsFirstSubmitDate': '2019-09-10', 'studyFirstSubmitQcDate': '2012-05-15', 'lastUpdatePostDateStruct': {'date': '2020-03-26', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2020-03-25', 'studyFirstPostDateStruct': {'date': '2012-05-16', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2020-03-26', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2017-12', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change in the Functional MRI Metrics Ktrans Between 2 Weeks and Baseline', 'timeFrame': 'baseline, 2 weeks', 'description': 'Ktrans is a measurement calculating the volume transfer constant of the contrast reagent and essentially is a measurement of vascular perfusion.\n\nTo determine the effect of XL184 on the functional MRI metrics Ktrans, Ktrans parameters were measured at baseline, two week time-point, 12 weeks, and 24 weeks for disease monitoring. Change between baseline and 2 weeks reported.'}], 'secondaryOutcomes': [{'measure': 'Association of Progression Free Survival (PFS) With Ktrans and ADC', 'timeFrame': 'From start of treatment to time of progression or death, whichever occurs first, assessed up to 1 year', 'description': 'Time to progression or progression-free survival (PFS) is defined as the duration of time from start of treatment to time of progression or death, whichever occurs first.\n\nThe approximate survival after standard therapies in this setting is bleak and in the order of months.\n\nToo few events for a meaningful statistical analysis; no significant results were obtained in Cox regression analyses.\n\nTherefore, we calculated the median PFS time and its 95% confidence interval.'}, {'measure': 'Changes in Bone Scan Response', 'timeFrame': 'baseline, 2 weeks', 'description': 'Bone Scan Response at weeks 2, 12, and 24 were collected. Change between baseline and 2 weeks are reported Bone Scan Response were measured as increase, decrease, or stable of bone lesions and scored as 1, -1, or 0, respectively, where higher values represent a worse outcome.'}, {'measure': 'Correlation of Percent Change in the Functional MRI Metrics to RECIST Tumor Measurements', 'timeFrame': 'baseline, 12 weeks, and 24 weeks', 'description': 'The protocol proposed to collect RECIST tumor measurements at weeks 0, 12, and 24.\n\nHowever, the data were not collected'}, {'measure': 'Change of PSA Between 12 Weeks and Baseline', 'timeFrame': 'baseline, 12 weeks', 'description': 'PSA at weeks 0, 12, and 24 were collected. Change between baseline and 12 weeks are reported'}, {'measure': 'Correlation of Percent Change in the Functional MRI Metrics With CTC', 'timeFrame': 'baseline, 12 weeks, and 24 weeks', 'description': 'The protocol proposed to collect CTC measurements at weeks 0, 12, and 24. However, the data were not collected'}, {'measure': 'Change in Pain Scale Between 12 Weeks and Baseline', 'timeFrame': 'baseline,12 weeks', 'description': 'Pain scores are measured at baseline and weeks 12, and 24. Change between baseline and 12 weeks are reported .\n\nIn the pain score ranged from 0 to 10. 10 denotes most pain.'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['castrate resistant prostate cancer', 'CRPC', 'cabozantinib', 'XL184'], 'conditions': ['Bone Metastases', 'Castrate-resistant Prostate Cancer', 'Recurrent Prostate Cancer', 'Stage IV Prostate Cancer']}, 'descriptionModule': {'briefSummary': 'This study is being done to help researchers understand more about prostate cancer that has spread to the bones by using the newest magnetic resonance imaging (MRI) techniques and to better understand the effect of an experimental drug called XL184 (or cabozantinib) on bone disease. The other purposes of the study are to better understand the effect of XL184 on prostate cancer progression, bone pain, and on any cancer cells that patients may have circulating within the blood (called circulating tumor cells)', 'detailedDescription': 'PRIMARY OBJECTIVES:\n\nI. To determine effect of XL184 on the functional MRI metrics Ktrans and apparent diffusion coefficient (ADC) within castrate resistant prostate cancer bone metastases.\n\nSECONDARY OBJECTIVES:\n\nI. To quantify progression free survival in men with castrate resistant prostate cancer (CRPC) treated with XL184 according to Prostate Cancer Working Group criteria.\n\nII. To correlate and changes in MRI based functional metrics with bone scan, prostate specific antigen (PSA), Response Evaluation Criteria in Solid Tumors (RECIST) response criteria, circulating tumor cells (CTC) number and with changes in pain.\n\nIII. To explore c-MET, phospho-c-MET staining on circulating tumor cells as a predictive biomarker for response and duration of response to XL-184.\n\nOUTLINE:\n\nPatients receive cabozantinib orally (PO) once daily (QD). Treatment continues in the absence of disease progression or unacceptable toxicity.\n\nAfter completion of study treatment, patients are followed up periodically.'}, 'eligibilityModule': {'sex': 'MALE', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Histologically or cytologically confirmed prostate cancer with progressive disease\n* Evidence of castration resistance defined as disease progression despite a testosterone level \\< 50ng/dL (or surgical castration)\n* Evidence of metastatic disease to the bones within the lumbar spine, sacrum, or pelvic bones that is identifiable on screening pelvic MRI\n* If patient has had prior pelvis radiation therapy (RT), then bone metastases must be out of radiated port (e.g. lumbar or sacral spine)\n* Any prior therapy for castrate disease acceptable other than prior XL184 with a minimum washout of 28 days for any other anticancer therapy\n* Patients with castrate resistant disease post antiandrogen therapy/withdrawal must meet at least one of the following criteria:\n\n * Have not received docetaxel chemotherapy\n * Have received docetaxel chemotherapy but received less then 225mg/m2 cumulative dose\n * Have documented liver metastases\n * Have no pain or pain that does not require a long acting (SR) narcotic\n * Have received mitoxantrone chemotherapy in the past for CRPC\n\nExclusion Criteria:\n\n* Patients who have had chemotherapy or radiotherapy within 4 weeks prior to entering the study\n* Patients who are receiving any other investigational agents\n* Prior treatment with other vascular endothelial growth factor (VEGF) or c-MET targeted therapies\n* History of hematemesis or hemoptysis\n* The subject has uncontrolled or significant intercurrent illness\n* The patient requires concomitant treatment, in therapeutic doses, with anticoagulants'}, 'identificationModule': {'nctId': 'NCT01599793', 'briefTitle': 'Magnetic Resonance Imaging in Measuring the Effect of Cabozantinib in Patients With Castrate Resistant Prostate Cancer', 'organization': {'class': 'OTHER', 'fullName': 'University of Chicago'}, 'officialTitle': 'A Phase II Study of MRI Based Functional Imaging for the Evaluation of Bone Metastasis in Men With Castrate Resistant Prostate Cancer Receiving XL184', 'orgStudyIdInfo': {'id': '12-1031'}, 'secondaryIdInfos': [{'id': 'NCI-2012-00677', 'type': 'REGISTRY', 'domain': 'CTRP (Clinical Trial Reporting Program)'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Treatment (enzyme inhibitor therapy)', 'description': 'Patients receive cabozantinib PO QD. Treatment continues in the absence of disease progression or unacceptable toxicity.', 'interventionNames': ['Drug: cabozantinib', 'Other: laboratory biomarker analysis', 'Procedure: magnetic resonance imaging']}], 'interventions': [{'name': 'cabozantinib', 'type': 'DRUG', 'otherNames': ['XL184'], 'description': 'Given PO', 'armGroupLabels': ['Treatment (enzyme inhibitor therapy)']}, {'name': 'laboratory biomarker analysis', 'type': 'OTHER', 'description': 'Correlative studies', 'armGroupLabels': ['Treatment (enzyme inhibitor therapy)']}, {'name': 'magnetic resonance imaging', 'type': 'PROCEDURE', 'otherNames': ['MRI', 'NMR imaging', 'NMRI', 'nuclear magnetic resonance imaging'], 'description': 'Undergo MRI', 'armGroupLabels': ['Treatment (enzyme inhibitor therapy)']}]}, 'contactsLocationsModule': {'locations': [{'zip': '60637-1470', 'city': 'Chicago', 'state': 'Illinois', 'country': 'United States', 'facility': 'University of Chicago', 'geoPoint': {'lat': 41.85003, 'lon': -87.65005}}], 'overallOfficials': [{'name': 'Russell Szmulewitz', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Chicago Comprehensive Cancer Center'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Chicago', 'class': 'OTHER'}, 'collaborators': [{'name': 'Endeavor Health', 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR'}}}}