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| ID | Type | Description | Link |
|---|---|---|---|
| 2012-1107 | Other Identifier | Institutional Review Board | |
| NCI-2013-01081 | Registry Identifier | NCI Trial ID | |
| A534260 | Other Identifier | UW Madison | |
| SMPH\MEDICINE\HEM-ONC | Other Identifier | UW Madison |
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Study supporter (Takeda) ended study drug for prostate cancer; enrollment ended prematurely.
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| Name | Class |
|---|---|
| Millennium Pharmaceuticals, Inc. | INDUSTRY |
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The purpose of this study is to assess whether NaF PET/CT scans can be used to evaluate treatment response in bone metastases in subjects with prostate cancer treated with the investigational drug, TAK-700.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| TAK-700 | Experimental | TAK-700 will be administered at 300 mg orally (PO)twice daily (BID) continuously on 28-day treatment cycles. The most common way of assessing bone metastasis is planar bone scintigraphy or single photon emission computed tomography (SPECT), though both lack high spatial resolution and thus make small metastases detection inaccurate. Positron emission tomography (PET) is a successful imaging modality with a higher resolution than SPECT, but has not been widely adopted in bone imaging. One of the most promising PET imaging agents for detection of bone metastasis is 18F-Sodium Fluoride (Fluorine F 18 Sodium Fluoride, or NaF). NaF uptake is characterized by high and rapid bone uptake accompanied by very rapid blood clearance, which results in a high bone-to-background ration in a short time. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| TAK-700 | Drug | TAK-700 will be administered at 300mg twice per day on 28-day continuous cycles |
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| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants With a Change in Maximum NaF PET/CT Standardized Uptake Values | To measure changes in NaF PET/CT standardized uptake values (SUVmax) from prior to dosing with Tak-700 to12 weeks after starting treatment with TAK-700. Value at three months minus value at baseline. | Baseline and 3 months |
| Number of Participants With Change in Prostate Specific Antigen (PSA) Response Rate | Measure prostate specific antigen (PSA) response rate in patients treated with TAK700, as measured by a decline in the PSA level from baseline to the month 3 assessment according to the Prostate Cancer Clinical Trials Working Group (PCWG2), at least a 50% decrease from baseline. Percent increase or decrease from month three compared to baseline. | Baseline and 3 months |
| Number of Participants With a Change in Total NaF PET/CT Standardized Uptake Values | To measure changes in NaF PET/CT standardized uptake values (SUV total) from prior to dosing with Tak-700 to12 weeks after starting treatment with TAK-700. Percent change from three months to baseline; value at three months minus value at baseline. | Baseline and 3 months |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Subjects Who Experience Adverse Events While on Treatment With TAK 700 | The number of subjects experiencing adverse events per CTCAE 4.0 while on treatment. | Up to 12 months |
| Number of Patients With a Measurable Change in PSA Kinetics With TAK700 From Baseline to Off Treatment |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Justine Y Bruce, MD | University of Wisconsin, Madison | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Wisconsin Carbone Cancer Center | Madison | Wisconsin | 53792 | United States |
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| Label | URL |
|---|---|
| University of Wisconsin Carbone Cancer Center | View source |
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| ID | Title | Description |
|---|---|---|
| FG000 | TAK-700 | TAK-700 was administered at 300 mg orally (PO)twice daily (BID) continuously on 28-day treatment cycles. TAK-700: TAK-700 will be administered at 300mg twice per day on 28-day continuous cycles Fluorine F 18 Sodium Fluoride: Undergo NaF F18 PET/CT scan Positron Emission Tomography: Undergo 18F NaF PET/CT scan Computed Tomography: Undergo 18F NaF PET/CT scan |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
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| Fluorine F 18 Sodium Fluoride | Radiation | Undergo NaF F18 PET/CT scan |
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| Positron Emission Tomography | Procedure | Undergo 18F NaF PET/CT scan |
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| Computed Tomography | Procedure | Undergo 18F NaF PET/CT scan |
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Stable: no change in PSA kinetics Decrease: less than baseline Increase: greater than baseline PSA data was gathered at baseline and off treatment. |
| Up to 14 months |
| Number of Participants With Changes in NaF PET/CT Results in Response to TAK700 | This is an exploratory endpoint as we are planning to identify other new parameters during the PET/CT scanning that may be more predictive of response (such as SUV volume, or dynamic changes during the scanning period). Changes in results at week 12 compared to baseline. Value at 12 weeks minus value at baseline. | At baseline and 12 weeks |
| Compare Changes on NaF PET/CT After Treatment With TAK700 With Standard Clinical Outcomes Including PSA Doubling Time, Response Evaluation Criteria in Solid Tumors (RECIST), and Radiographic Progression Free Survival. | Approximately 24 months |
| Number of Participants With a Change in the Number of Circulating Tumor Cells Using One or More Methods (Epispot) | Baseline compared to 12 weeks. Value at three months minus value at baseline. | At baseline and 12 weeks |
| Number of Participants With Change in the Number of Circulating Tumor Cells Using the Cell Search System (Veridex, LLC) Obtained Prior to Beginning Treatment With TAK 700, After Completing One Cycle and After Completing 3 Cycles | Change from baseline to one month and three month. | At baseline, one month, three months |
| PSA Response Rate and Circulating Tumor Cell Counts of Subjects Receiving TAK700 to NaF PET/CT Imaging Results | Baseline, one month, 2 months, 3 months |
| COMPLETED |
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| NOT COMPLETED |
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| ID | Title | Description |
|---|---|---|
| BG000 | TAK-700 | TAK-700 was administered at 300 mg orally (PO)twice daily (BID) continuously on 28-day treatment cycles. TAK-700: TAK-700 will be administered at 300mg twice per day on 28-day continuous cycles Fluorine F 18 Sodium Fluoride: Undergo NaF F18 PET/CT scan Positron Emission Tomography: Undergo 18F NaF PET/CT scan Computed Tomography: Undergo 18F NaF PET/CT scan |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants | Participants |
| ||||||||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
| ||||||||||||||||||||
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
| ||||||||||||||||||||
| Race (NIH/OMB) | Count of Participants | Participants |
| ||||||||||||||||||||
| Region of Enrollment | Number | participants |
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| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Number of Participants With a Change in Maximum NaF PET/CT Standardized Uptake Values | To measure changes in NaF PET/CT standardized uptake values (SUVmax) from prior to dosing with Tak-700 to12 weeks after starting treatment with TAK-700. Value at three months minus value at baseline. | The study closed early so only 8 of 20 planned were enrolled and of the 8, only 4 completed the week 12 scan. | Posted | Count of Participants | Participants | Baseline and 3 months |
|
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| ||||||||||||||||||||||||||||
| Primary | Number of Participants With Change in Prostate Specific Antigen (PSA) Response Rate | Measure prostate specific antigen (PSA) response rate in patients treated with TAK700, as measured by a decline in the PSA level from baseline to the month 3 assessment according to the Prostate Cancer Clinical Trials Working Group (PCWG2), at least a 50% decrease from baseline. Percent increase or decrease from month three compared to baseline. | Study closed early and only 8 of planned 20 enrolled. Four subjects came off study prior to the three month time point. | Posted | Count of Participants | Participants | Baseline and 3 months |
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| |||||||||||||||||||||||||||||
| Secondary | Number of Subjects Who Experience Adverse Events While on Treatment With TAK 700 | The number of subjects experiencing adverse events per CTCAE 4.0 while on treatment. | Posted | Number | participants | Up to 12 months |
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| ||||||||||||||||||||||||||||||
| Secondary | Number of Patients With a Measurable Change in PSA Kinetics With TAK700 From Baseline to Off Treatment | Stable: no change in PSA kinetics Decrease: less than baseline Increase: greater than baseline PSA data was gathered at baseline and off treatment. | Due to study closing early only 8 of planned 20 patients enrolled. | Posted | Count of Participants | Participants | Up to 14 months |
|
| |||||||||||||||||||||||||||||
| Secondary | Number of Participants With Changes in NaF PET/CT Results in Response to TAK700 | This is an exploratory endpoint as we are planning to identify other new parameters during the PET/CT scanning that may be more predictive of response (such as SUV volume, or dynamic changes during the scanning period). Changes in results at week 12 compared to baseline. Value at 12 weeks minus value at baseline. | Due to study closing early only 8 of planned 20 patients enrolled and only 4 of the 8 subjects enrolled completed the week 12 scan. | Posted | Count of Participants | Participants | At baseline and 12 weeks |
|
| |||||||||||||||||||||||||||||
| Secondary | Compare Changes on NaF PET/CT After Treatment With TAK700 With Standard Clinical Outcomes Including PSA Doubling Time, Response Evaluation Criteria in Solid Tumors (RECIST), and Radiographic Progression Free Survival. | Due to study closing early, only 8 of planned 20 patients enrolled. Data for this endpoint was not obtained. | Posted | Approximately 24 months |
|
| ||||||||||||||||||||||||||||||||
| Secondary | Number of Participants With a Change in the Number of Circulating Tumor Cells Using One or More Methods (Epispot) | Baseline compared to 12 weeks. Value at three months minus value at baseline. | Due to study closing early only 8 of 12 patients enrolled, and only 5 subjects obtained a week 12 CTC test. | Posted | Count of Participants | Participants | At baseline and 12 weeks |
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| Secondary | Number of Participants With Change in the Number of Circulating Tumor Cells Using the Cell Search System (Veridex, LLC) Obtained Prior to Beginning Treatment With TAK 700, After Completing One Cycle and After Completing 3 Cycles | Change from baseline to one month and three month. | Due to study closing early only 8 of planned 20 enrolled. All subjects completed one month of treatment; only 4 subjects completed the week 12 scan. | Posted | Count of Participants | Participants | At baseline, one month, three months |
|
| |||||||||||||||||||||||||||||
| Secondary | PSA Response Rate and Circulating Tumor Cell Counts of Subjects Receiving TAK700 to NaF PET/CT Imaging Results | Data was not collected for this outcome measure. | Posted | Baseline, one month, 2 months, 3 months |
|
| ||||||||||||||||||||||||||||||||
| Primary | Number of Participants With a Change in Total NaF PET/CT Standardized Uptake Values | To measure changes in NaF PET/CT standardized uptake values (SUV total) from prior to dosing with Tak-700 to12 weeks after starting treatment with TAK-700. Percent change from three months to baseline; value at three months minus value at baseline. | The study closed early so only 8 of 20 planned were enrolled and of the 8, only 4 completed the week 12 scan. | Posted | Count of Participants | Participants | Baseline and 3 months |
|
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1 year, 11 months
All patients were followed for adverse events for at least 30 days after the last dose of TAK-700, or before the initiation of another systemic antineoplastic therapy, whichever came first. Adverse events were assessed at all study visits and follow ups.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | TAK-700 | TAK-700 was administered at 300 mg orally (PO)twice daily (BID) continuously on 28-day treatment cycles. TAK-700: TAK-700 will be administered at 300mg twice per day on 28-day continuous cycles Fluorine F 18 Sodium Fluoride: Undergo NaF F18 PET/CT scan Positron Emission Tomography: Undergo 18F NaF PET/CT scan Computed Tomography: Undergo 18F NaF PET/CT scan | 1 | 8 | 4 | 8 | 8 | 8 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Dehydration | Gastrointestinal disorders | CTCAE (4.0) | Systematic Assessment |
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| Diarrhea | Gastrointestinal disorders | CTCAE (4.0) | Systematic Assessment |
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| Dyspnea | Respiratory, thoracic and mediastinal disorders | CTCAE (4.0) | Systematic Assessment |
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| Hypokalemia | Metabolism and nutrition disorders | CTCAE (4.0) | Systematic Assessment |
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| Left ventricular systolic dysfunction | Cardiac disorders | CTCAE (4.0) | Systematic Assessment |
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| Nerve impingement | Nervous system disorders | CTCAE (4.0) | Systematic Assessment |
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| Urinary tract infection | Infections and infestations | CTCAE (4.0) | Systematic Assessment |
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| sudden death | General disorders | CTCAE (4.0) | Systematic Assessment | Patient died at home no cause of death determined. |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Abdominal pain | Gastrointestinal disorders | CTCAE (4.0) | Systematic Assessment |
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| Allergic rhinitis | Immune system disorders | CTCAE (4.0) | Systematic Assessment |
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| Anorexia | Gastrointestinal disorders | CTCAE (4.0) | Systematic Assessment |
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| Anxiety | Psychiatric disorders | CTCAE (4.0) | Systematic Assessment |
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| Back pain | Musculoskeletal and connective tissue disorders | CTCAE (4.0) | Systematic Assessment |
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| Bloating | Gastrointestinal disorders | CTCAE (4.0) | Systematic Assessment |
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| Constipation | Gastrointestinal disorders | CTCAE (4.0) | Systematic Assessment |
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| Dehydration | Metabolism and nutrition disorders | CTCAE (4.0) | Systematic Assessment |
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| Depression | Psychiatric disorders | CTCAE (4.0) | Systematic Assessment |
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| Diarrhea | Gastrointestinal disorders | CTCAE (4.0) | Systematic Assessment |
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| Disuria | Renal and urinary disorders | CTCAE (4.0) | Systematic Assessment |
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| Dry mouth | Gastrointestinal disorders | CTCAE (4.0) | Systematic Assessment |
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| Dry skin | Skin and subcutaneous tissue disorders | CTCAE (4.0) | Systematic Assessment |
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| Dyspnea | Respiratory, thoracic and mediastinal disorders | CTCAE (4.0) | Systematic Assessment |
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| Edema limbs | General disorders | CTCAE (4.0) | Systematic Assessment |
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| Ejection fraction decreased | Investigations | CTCAE (4.0) | Systematic Assessment |
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| Fatigue | General disorders | CTCAE (4.0) | Systematic Assessment |
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| Fever | General disorders | CTCAE (4.0) | Systematic Assessment |
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| Generalized muscle weakness | Musculoskeletal and connective tissue disorders | CTCAE (4.0) | Systematic Assessment |
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| Headache | Nervous system disorders | CTCAE (4.0) | Systematic Assessment |
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| Hoarseness | Respiratory, thoracic and mediastinal disorders | CTCAE (4.0) | Systematic Assessment |
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| Hot flashes | Vascular disorders | CTCAE (4.0) | Systematic Assessment |
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| Hypertension | Vascular disorders | CTCAE (4.0) | Systematic Assessment |
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| Hypokalemia | Metabolism and nutrition disorders | CTCAE (4.0) | Systematic Assessment |
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| Hypomagnesemia | Metabolism and nutrition disorders | CTCAE (4.0) | Systematic Assessment |
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| Injury, arm | Injury, poisoning and procedural complications | CTCAE (4.0) | Systematic Assessment |
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| Insomnia | Psychiatric disorders | CTCAE (4.0) | Systematic Assessment |
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| Muscle weakness lower limb | Musculoskeletal and connective tissue disorders | CTCAE (4.0) | Systematic Assessment |
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| Nasal congestion | Respiratory, thoracic and mediastinal disorders | CTCAE (4.0) | Systematic Assessment |
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| Nausea | Gastrointestinal disorders | CTCAE (4.0) | Systematic Assessment |
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| Pain | General disorders | CTCAE (4.0) | Systematic Assessment |
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| Pancreatitis | Gastrointestinal disorders | CTCAE (4.0) | Systematic Assessment |
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| Peripheral sensory neuropathy | Nervous system disorders | CTCAE (4.0) | Systematic Assessment |
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| Productive cough | Respiratory, thoracic and mediastinal disorders | CTCAE (4.0) | Systematic Assessment |
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| Renal calculi | Renal and urinary disorders | CTCAE (4.0) | Systematic Assessment |
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| Rhinitis infective | Infections and infestations | CTCAE (4.0) | Systematic Assessment |
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| Sinusitis | Infections and infestations | CTCAE (4.0) | Systematic Assessment |
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| neoplasms benigh, malignant and unspecified | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | CTCAE (4.0) | Systematic Assessment | squamous cell skin right ear |
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| Stomach pain | Gastrointestinal disorders | CTCAE (4.0) | Systematic Assessment |
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| Urinary frequency | Renal and urinary disorders | CTCAE (4.0) | Systematic Assessment |
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| Urinary incontinence | Renal and urinary disorders | CTCAE (4.0) | Systematic Assessment |
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| Urinary tract infection | Renal and urinary disorders | CTCAE (4.0) | Systematic Assessment |
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| Vomiting | Gastrointestinal disorders | CTCAE (4.0) | Systematic Assessment |
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| Weight loss | Investigations | CTCAE (4.0) | Systematic Assessment |
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| nerve impingement | Nervous system disorders | CTCAE (4.0) | Systematic Assessment |
|
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Justine Bruce | University of Wisconsin Carbone Cancer Center | 608-262-4961 | jybruce@medicine.wisc.edu |
| ID | Term |
|---|---|
| D011471 | Prostatic Neoplasms |
| ID | Term |
|---|---|
| D005834 | Genital Neoplasms, Male |
| D014565 | Urogenital Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D005832 | Genital Diseases, Male |
| D000091662 | Genital Diseases |
| D000091642 | Urogenital Diseases |
| D011469 | Prostatic Diseases |
| D052801 | Male Urogenital Diseases |
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| ID | Term |
|---|---|
| C571806 | orteronel |
| D009682 | Magnetic Resonance Spectroscopy |
| ID | Term |
|---|---|
| D013057 | Spectrum Analysis |
| D002623 | Chemistry Techniques, Analytical |
| D008919 | Investigative Techniques |
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| Unknown or Not Reported |
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| Native Hawaiian or Other Pacific Islander |
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| Black or African American |
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| White |
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| More than one race |
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| Unknown or Not Reported |
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