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| Name | Class |
|---|---|
| Genentech, Inc. | INDUSTRY |
| Beth Israel Deaconess Medical Center | OTHER |
| Brigham and Women's Hospital | OTHER |
| Rutgers Cancer Institute of New Jersey |
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The purpose of this research study is to assess the efficacy of antiangiogenic therapy (bevacizumab) and androgen deprivation versus androgen deprivation alone at the time of minimal systemic disease (based on rising PSA without metastases).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Group 1 | Experimental | Androgen Deprivation Therapy Plus Bevacizumab |
|
| Group 2 | Experimental | Androgen Deprivation Therapy Alone |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Androgen Deprivation Therapy | Drug | leuprolide: 22.5mg given IM every 3 months for a total of 6 months or, goserelin acetate: 10.8mg given SC every 3 months for a total of 6 months |
| Measure | Description | Time Frame |
|---|---|---|
| Relapse-free Survival | To identify a difference in relapse-free survival in men treated with short course ADT (6 months) versus short course ADT plus bevacizumab. | 2 years |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants With PSA <0.2 ng/ml at Six Months | Number of participants with a PSA <0.2 ng/ml at six months (upon completion of treatment). | Six months (at completion of treatment) |
| Cardiovascular Safety Including Measurement of Blood Pressure During Treatment Period (6 Months). |
Not provided
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Mary-Ellen Taplin, MD | Dana-Farber Cancer Institute | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Johns Hopkins University | Baltimore | Maryland | 21205 | United States | ||
| Beth-Israel Deaconess Medical Center |
Not provided
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| ID | Title | Description |
|---|---|---|
| FG000 | Androgen Deprivation Therapy Plus Bevacizumab | Androgen Deprivation Therapy Plus Bevacizumab Androgen Deprivation Therapy: leuprolide: 22.5mg given IM every 3 months for a total of 6 months or, goserelin acetate: 10.8mg given SC every 3 months for a total of 6 months bicalutamide: 50mg orally daily for 6 months bevacizumab: 15mg/ks given IV every three weeks for a total of 8 infusions over 6 months |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
Not provided
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Not provided
| OTHER |
Not provided
Not provided
Not provided
Not provided
Not provided
|
| bicalutamide | Drug | 50mg orally daily for 6 months |
|
| bevacizumab | Drug | 15mg/ks given IV every three weeks for a total of 8 infusions over 6 months |
|
The number of patients who developed hypertension (greater that 150 systolic or greater than 90 diastolic) during treatment period. |
| 6 months |
| Analysis of Cytokines and Angiogenic Factors in Plasma/Serum | Analysis of cytokines and angiogenic factors in plasma/serum at baseline and at 6 months (end of treatment). | 6 months |
| Boston |
| Massachusetts |
| 02115 |
| United States |
| Dana-Farber Cancer Institute | Boston | Massachusetts | 02115 | United States |
| Karmanos Cancer Institute | Detroit | Michigan | 48201 | United States |
| Cancer Institute of New Jersey | New Brunswick | New Jersey | 08901 | United States |
| Memorial Sloan-Kettering Cancer Center | New York | New York | 10065 | United States |
| The University of Texas M D Anderson Cancer Center | Houston | Texas | 77030 | United States |
| University of Wisconsin Carbone Cancer Center | Madison | Wisconsin | 53792-5669 | United States |
| FG001 | Androgen Deprivation Therapy Alone | Androgen Deprivation Therapy Alone Androgen Deprivation Therapy: leuprolide: 22.5mg given IM every 3 months for a total of 6 months or, goserelin acetate: 10.8mg given SC every 3 months for a total of 6 months bicalutamide: 50mg orally daily for 6 months |
| COMPLETED |
|
| NOT COMPLETED |
|
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | Androgen Deprivation Therapy Plus Bevacizumab | Androgen Deprivation Therapy Plus Bevacizumab Androgen Deprivation Therapy: leuprolide: 22.5mg given IM every 3 months for a total of 6 months or, goserelin acetate: 10.8mg given SC every 3 months for a total of 6 months bicalutamide: 50mg orally daily for 6 months bevacizumab: 15mg/ks given IV every three weeks for a total of 8 infusions over 6 months |
| BG001 | Androgen Deprivation Therapy Alone | Androgen Deprivation Therapy Alone Androgen Deprivation Therapy: leuprolide: 22.5mg given IM every 3 months for a total of 6 months or, goserelin acetate: 10.8mg given SC every 3 months for a total of 6 months bicalutamide: 50mg orally daily for 6 months |
| BG002 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Median | Inter-Quartile Range | years |
| |||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
|
| 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 | Relapse-free Survival | To identify a difference in relapse-free survival in men treated with short course ADT (6 months) versus short course ADT plus bevacizumab. | Posted | Median | 95% Confidence Interval | months | 2 years |
|
|
| |||||||||||||||||||||||||||||
| Secondary | Number of Participants With PSA <0.2 ng/ml at Six Months | Number of participants with a PSA <0.2 ng/ml at six months (upon completion of treatment). | Posted | Number | Number of participants | Six months (at completion of treatment) |
|
| |||||||||||||||||||||||||||||||
| Secondary | Cardiovascular Safety Including Measurement of Blood Pressure During Treatment Period (6 Months). | The number of patients who developed hypertension (greater that 150 systolic or greater than 90 diastolic) during treatment period. | Posted | Number | participants | 6 months |
|
| |||||||||||||||||||||||||||||||
| Secondary | Analysis of Cytokines and Angiogenic Factors in Plasma/Serum | Analysis of cytokines and angiogenic factors in plasma/serum at baseline and at 6 months (end of treatment). | Posted | Median | Inter-Quartile Range | pg/ml | 6 months |
|
|
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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 | Group 2 | Androgen Deprivation Therapy Alone Androgen Deprivation Therapy: leuprolide: 22.5mg given IM every 3 months for a total of 6 months or, goserelin acetate: 10.8mg given SC every 3 months for a total of 6 months bicalutamide: 50mg orally daily for 6 months | 5 | 36 | 32 | 36 | ||
| EG001 | Group 1 | Androgen Deprivation Therapy Plus Bevacizumab Androgen Deprivation Therapy: leuprolide: 22.5mg given IM every 3 months for a total of 6 months or, goserelin acetate: 10.8mg given SC every 3 months for a total of 6 months bicalutamide: 50mg orally daily for 6 months bevacizumab: 15mg/ks given IV every three weeks for a total of 8 infusions over 6 months | 18 | 66 | 63 | 66 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Cardiac-ischemia | Cardiac disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Hypertension | Vascular disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Diarrhea w/o prior colostomy | Gastrointestinal disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Vomiting | Gastrointestinal disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Infection w/ unk ANC peritoneal cavity | Infections and infestations | CTCAE (3.0) | Systematic Assessment |
| |
| Infection w/ unk ANC ungual (nails) | Infections and infestations | CTCAE (3.0) | Systematic Assessment |
| |
| Hyperglycemia | Metabolism and nutrition disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Hyponatremia | Metabolism and nutrition disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Musculoskeletal/soft tissue-other | Musculoskeletal and connective tissue disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Syncope | Nervous system disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Head/headache | Nervous system disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Bronchospasm- wheezing | Respiratory, thoracic and mediastinal disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Dyspnea | Respiratory, thoracic and mediastinal disorders | CTCAE (3.0) | Systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Allergic rhinitis | Respiratory, thoracic and mediastinal disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Allergy-other | Immune system disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Bone marrow cellularity | Blood and lymphatic system disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Hemoglobin | Blood and lymphatic system disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Leukocytes | Investigations | CTCAE (3.0) | Systematic Assessment |
| |
| Lymphopenia | Investigations | CTCAE (3.0) | Systematic Assessment |
| |
| Platelets | Investigations | CTCAE (3.0) | Systematic Assessment |
| |
| Sinus bradycardia | Cardiac disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Arrhythmia-other | Cardiac disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Hypertension | Vascular disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Fatigue | General disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Fever w/o neutropenia | General disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Insomnia | Psychiatric disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Rigors/chills | General disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Sweating | Skin and subcutaneous tissue disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Weight gain | Investigations | CTCAE (3.0) | Systematic Assessment |
| |
| Weight loss | Investigations | CTCAE (3.0) | Systematic Assessment |
| |
| Constitutional- other | General disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Bruising | Injury, poisoning and procedural complications | CTCAE (3.0) | Systematic Assessment |
| |
| Dry skin | Skin and subcutaneous tissue disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Alopecia | Skin and subcutaneous tissue disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Hyperpigmentation | Skin and subcutaneous tissue disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Injection site reaction | General disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Pruritus/itching | Skin and subcutaneous tissue disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Rash/desquamation | Skin and subcutaneous tissue disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Rash: acne/acneiform | Skin and subcutaneous tissue disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Skin-other | Skin and subcutaneous tissue disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Hot flashes | Vascular disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Hyopthyroidism | Endocrine disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Endocrine-other | Endocrine disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Anorexia | Metabolism and nutrition disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Constipation | Gastrointestinal disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Dentures or dental prosthesis | Gastrointestinal disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Diarrhea w/o prior colostomy | Gastrointestinal disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Dry mouth | Gastrointestinal disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Dysphagia | Gastrointestinal disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Esophagitis | Gastrointestinal disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Fistula- Anus | Gastrointestinal disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Flatulence | Gastrointestinal disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Gastritis | Gastrointestinal disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Hemorrhoids | Gastrointestinal disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Incontinence- anal | Gastrointestinal disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Muco/stomatitis by exam- larynx | Respiratory, thoracic and mediastinal disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Muco/stomatitis by exam- oral cavity | Gastrointestinal disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Muco/stomatitis (symptom) oral cavity | Gastrointestinal disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Muco/stomatitis (symptom) stomach | Gastrointestinal disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Nausea | Gastrointestinal disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Salivary | Gastrointestinal disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Taste disturbance | Nervous system disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Ulcer- duodenum | Gastrointestinal disorders | CTCAE (3.0) | Systematic Assessment |
| |
| GI-other | Gastrointestinal disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Lower GI- hemorrhage NOS | Gastrointestinal disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Oral cavity- hemorrhage | Gastrointestinal disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Rectum- hemorrhage | Gastrointestinal disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Bladder- hemorrhage | Renal and urinary disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Urinary hemorrhage NOS | Renal and urinary disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Nose- hemorrhage | Respiratory, thoracic and mediastinal disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Hemorrhage-other | Vascular disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Infection Gr0-2 neut- bronchus | Infections and infestations | CTCAE (3.0) | Systematic Assessment |
| |
| Infection Gr0-2 neut- oral cavity | Infections and infestations | CTCAE (3.0) | Systematic Assessment |
| |
| Infection Gr0-2 neut- sinus | Infections and infestations | CTCAE (3.0) | Systematic Assessment |
| |
| Infection Gr0-2 neut- upper airway | Infections and infestations | CTCAE (3.0) | Systematic Assessment |
| |
| Infection Gr0-2 neut- urinary tract | Infections and infestations | CTCAE (3.0) | Systematic Assessment |
| |
| Infection w/ unk ANC oral cavity/gums | Infections and infestations | CTCAE (3.0) | Systematic Assessment |
| |
| Infection w/ unk ANC sinus | Infections and infestations | CTCAE (3.0) | Systematic Assessment |
| |
| Infection w/ unk ANC urinary tract NOS | Infections and infestations | CTCAE (3.0) | Systematic Assessment |
| |
| Infection-other | Infections and infestations | CTCAE (3.0) | Systematic Assessment |
| |
| Edema head and neck | General disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Edema limb | General disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Lymphatics-other | Blood and lymphatic system disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Hypoalbuminemia | Metabolism and nutrition disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Alkaline phosphatase | Investigations | CTCAE (3.0) | Systematic Assessment |
| |
| ALT- SGPT | Investigations | CTCAE (3.0) | Systematic Assessment |
| |
| AST- SGOT | Investigations | CTCAE (3.0) | Systematic Assessment |
| |
| Bilirubin | Investigations | CTCAE (3.0) | Systematic Assessment |
| |
| Hypercholesterolemia | Investigations | CTCAE (3.0) | Systematic Assessment |
| |
| Creatinine | Investigations | CTCAE (3.0) | Systematic Assessment |
| |
| Hyperglycemia | Metabolism and nutrition disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Hemoglobinuria | Renal and urinary disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Hyperkalemia | Metabolism and nutrition disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Hypokalemia | Metabolism and nutrition disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Proteinuria | Renal and urinary disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Hyponatremia | Metabolism and nutrition disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Hypertriglyceridemia | Metabolism and nutrition disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Arthritis | Musculoskeletal and connective tissue disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Extremity-lower (gait/walking) | General disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Extremity upper (function) | Musculoskeletal and connective tissue disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Joint-function | Musculoskeletal and connective tissue disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Nonneuropathic lower extr muscle weak | Musculoskeletal and connective tissue disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Nonneuropathic upper extr muscle weak | Musculoskeletal and connective tissue disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Nonneuropathic generalized weakness | Musculoskeletal and connective tissue disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Musculoskeletal/soft tissue-other | Musculoskeletal and connective tissue disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Ataxia | Nervous system disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Cognitive disturbance | Nervous system disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Confusion | Psychiatric disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Dizziness | Nervous system disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Memory impairment | Nervous system disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Agitation | Psychiatric disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Anxiety | Psychiatric disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Depression | Psychiatric disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Neuropathy CN II vision | Eye disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Neuropathy CN IX pharynx ear tongue | Nervous system disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Neuropathy-sensory | Nervous system disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Neurologic-other | Nervous system disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Glaucoma | Eye disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Vision-blurred | Eye disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Ocular-other | Eye disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Abdomen- pain | Gastrointestinal disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Anus- pain | Gastrointestinal disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Back- pain | Musculoskeletal and connective tissue disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Buttock- pain | Musculoskeletal and connective tissue disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Chest wall- pain | Musculoskeletal and connective tissue disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Chest/thoracic pain NOS | General disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Extremity-limb- pain | Musculoskeletal and connective tissue disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Head/headache | Nervous system disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Joint- pain | Musculoskeletal and connective tissue disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Muscle- pain | Musculoskeletal and connective tissue disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Neck- pain | Musculoskeletal and connective tissue disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Neuropathic- pain | Nervous system disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Oral cavity- pain | Gastrointestinal disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Scalp- pain | Skin and subcutaneous tissue disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Scrotum- pain | Reproductive system and breast disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Throat/pharynx/larynx- pain | Respiratory, thoracic and mediastinal disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Pain-other | General disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Cough | Respiratory, thoracic and mediastinal disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Dyspnea | Respiratory, thoracic and mediastinal disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Nasal cavity/paranasal sinus reaction | Respiratory, thoracic and mediastinal disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Obstruction- airway-bronchus | Respiratory, thoracic and mediastinal disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Voice changes/dysarthria | Respiratory, thoracic and mediastinal disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Pulmonary/Upper Respiratory-other | Respiratory, thoracic and mediastinal disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Incontinence urinary | Renal and urinary disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Urinary frequency/urgency | Renal and urinary disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Urinary retention | Renal and urinary disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Renal/GU-other | Renal and urinary disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Intra-op injury Face NOS | Injury, poisoning and procedural complications | CTCAE (3.0) | Systematic Assessment |
| |
| Erectile impotence | Reproductive system and breast disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Libido | Psychiatric disorders | CTCAE (3.0) | Systematic Assessment |
|
Not provided
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Mary-Ellen Taplin, MD | Dana Farber Cancer Institute | 617-632-6328 | Mary_taplin@dfci.harvard.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 |
Not provided
Not provided
| ID | Term |
|---|---|
| D000726 | Androgen Antagonists |
| C053541 | bicalutamide |
| D000068258 | Bevacizumab |
| ID | Term |
|---|---|
| D006727 | Hormone Antagonists |
| D006730 | Hormones, Hormone Substitutes, and Hormone Antagonists |
| D045505 | Physiological Effects of Drugs |
| D020228 | Pharmacologic Actions |
| D020164 | Chemical Actions and Uses |
| D061067 | Antibodies, Monoclonal, Humanized |
| D000911 | Antibodies, Monoclonal |
| D000906 | Antibodies |
| D007136 | Immunoglobulins |
| D007162 | Immunoproteins |
| D001798 | Blood Proteins |
| D011506 | Proteins |
| D000602 | Amino Acids, Peptides, and Proteins |
| D012712 | Serum Globulins |
| D005916 | Globulins |
Not provided
Not provided
| Male |
|
|
|
|