Ignite Creation Date:
2025-12-24 @ 11:14 PM
Ignite Modification Date:
2025-12-25 @ 8:49 PM
Study NCT ID:
NCT00028769
Status:
COMPLETED
Last Update Posted:
2013-07-16
First Post:
2002-01-04
Is NOT Gene Therapy:
False
Has Adverse Events:
True
Brief Title:
S0032, Combination Chemotherapy Plus Hormone Therapy in Treating Patients With Metastatic 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': 'C053541', 'term': 'bicalutamide'}, {'id': 'D004961', 'term': 'Estramustine'}, {'id': 'D005047', 'term': 'Etoposide'}, {'id': 'D005485', 'term': 'Flutamide'}, {'id': 'D017273', 'term': 'Goserelin'}, {'id': 'D016729', 'term': 'Leuprolide'}, {'id': 'C021277', 'term': 'nilutamide'}, {'id': 'D017239', 'term': 'Paclitaxel'}], 'ancestors': [{'id': 'D009588', 'term': 'Nitrogen Mustard Compounds'}, {'id': 'D009150', 'term': 'Mustard Compounds'}, {'id': 'D006846', 'term': 'Hydrocarbons, Halogenated'}, {'id': 'D006838', 'term': 'Hydrocarbons'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D004958', 'term': 'Estradiol'}, {'id': 'D004963', 'term': 'Estrenes'}, {'id': 'D004962', 'term': 'Estranes'}, {'id': 'D013256', 'term': 'Steroids'}, {'id': 'D000072473', 'term': 'Fused-Ring Compounds'}, {'id': 'D011083', 'term': 'Polycyclic Compounds'}, {'id': 'D011034', 'term': 'Podophyllotoxin'}, {'id': 'D013764', 'term': 'Tetrahydronaphthalenes'}, {'id': 'D009281', 'term': 'Naphthalenes'}, {'id': 'D011084', 'term': 'Polycyclic Aromatic Hydrocarbons'}, {'id': 'D006841', 'term': 'Hydrocarbons, Aromatic'}, {'id': 'D006844', 'term': 'Hydrocarbons, Cyclic'}, {'id': 'D005960', 'term': 'Glucosides'}, {'id': 'D006027', 'term': 'Glycosides'}, {'id': 'D002241', 'term': 'Carbohydrates'}, {'id': 'D000813', 'term': 'Anilides'}, {'id': 'D000577', 'term': 'Amides'}, {'id': 'D000814', 'term': 'Aniline Compounds'}, {'id': 'D000588', 'term': 'Amines'}, {'id': 'D007987', 'term': 'Gonadotropin-Releasing Hormone'}, {'id': 'D010906', 'term': 'Pituitary Hormone-Releasing Hormones'}, {'id': 'D007028', 'term': 'Hypothalamic Hormones'}, {'id': 'D036361', 'term': 'Peptide Hormones'}, {'id': 'D006728', 'term': 'Hormones'}, {'id': 'D006730', 'term': 'Hormones, Hormone Substitutes, and Hormone Antagonists'}, {'id': 'D009479', 'term': 'Neuropeptides'}, {'id': 'D010455', 'term': 'Peptides'}, {'id': 'D000602', 'term': 'Amino Acids, Peptides, and Proteins'}, {'id': 'D009842', 'term': 'Oligopeptides'}, {'id': 'D009419', 'term': 'Nerve Tissue Proteins'}, {'id': 'D011506', 'term': 'Proteins'}, {'id': 'D043823', 'term': 'Taxoids'}, {'id': 'D043822', 'term': 'Cyclodecanes'}, {'id': 'D003516', 'term': 'Cycloparaffins'}, {'id': 'D006840', 'term': 'Hydrocarbons, Alicyclic'}, {'id': 'D004224', 'term': 'Diterpenes'}, {'id': 'D013729', 'term': 'Terpenes'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'phone': '206-667-4623', 'title': 'Study Statistician', 'organization': 'SWOG Statistical Center'}, 'certainAgreement': {'piSponsorEmployee': False, 'restrictiveAgreement': False}}, 'adverseEventsModule': {'timeFrame': 'Patients were assessed for adverse events after every cycle (1 cycle = 21 days) of protocol treatment', 'eventGroups': [{'id': 'EG000', 'title': 'CAD + Chemo', 'description': 'Patients receive Combined androgen deprivation (CAD) therapy with LHRH agonist (goserelin acetate or leuprolide acetate) sq/IM q 1-4 months depending on dose chosen by the treating physician and oral antiandrogen (250 mg/tid of flutamide, 50 mg/d of bicalutamide or 300 mg/d for 30 days then 150 mg/d of nilutamide) given continuously until disease progression and Chemotherapy (4 cycles of estramustine 280 mg orally 3 times daily and etoposide 50 mg/m\\^2 daily for 14 days of each 21-day cycle, with paclitaxel 135 mg/m\\^2 given intravenously within 1 hour on day 2 of each cycle)', 'otherNumAtRisk': 35, 'otherNumAffected': 35, 'seriousNumAtRisk': 35, 'seriousNumAffected': 6}], 'otherEvents': [{'term': 'Anemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 35, 'numAffected': 18}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (2.0)'}, {'term': 'PRBC transfusion', 'stats': [{'groupId': 'EG000', 'numAtRisk': 35, 'numAffected': 2}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (2.0)'}, {'term': 'Abdominal pain/cramping', 'stats': [{'groupId': 'EG000', 'numAtRisk': 35, 'numAffected': 2}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (2.0)'}, {'term': 'Constipation/bowel obstruction', 'stats': [{'groupId': 'EG000', 'numAtRisk': 35, 'numAffected': 6}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (2.0)'}, {'term': 'Diarrhea without colostomy', 'stats': [{'groupId': 'EG000', 'numAtRisk': 35, 'numAffected': 8}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (2.0)'}, {'term': 'Dyspepsia/heartburn', 'stats': [{'groupId': 'EG000', 'numAtRisk': 35, 'numAffected': 3}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (2.0)'}, {'term': 'Esophagitis/dysphagia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 35, 'numAffected': 3}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (2.0)'}, {'term': 'GI-other', 'stats': [{'groupId': 'EG000', 'numAtRisk': 35, 'numAffected': 3}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (2.0)'}, {'term': 'Nausea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 35, 'numAffected': 20}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (2.0)'}, {'term': 'Proctitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 35, 'numAffected': 4}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (2.0)'}, {'term': 'Stomatitis/pharyngitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 35, 'numAffected': 5}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (2.0)'}, {'term': 'Vomiting', 'stats': [{'groupId': 'EG000', 'numAtRisk': 35, 'numAffected': 9}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (2.0)'}, {'term': 'Edema', 'stats': [{'groupId': 'EG000', 'numAtRisk': 35, 'numAffected': 12}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (2.0)'}, {'term': 'Fatigue/malaise/lethargy', 'stats': [{'groupId': 'EG000', 'numAtRisk': 35, 'numAffected': 30}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (2.0)'}, {'term': 'Fever without neutropenia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 35, 'numAffected': 3}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (2.0)'}, {'term': 'Pain-other', 'stats': [{'groupId': 'EG000', 'numAtRisk': 35, 'numAffected': 15}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (2.0)'}, {'term': 'Infection w/o 3-4 neutropenia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 35, 'numAffected': 3}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (2.0)'}, {'term': 'Respiratory infect w/o neutrop', 'stats': [{'groupId': 'EG000', 'numAtRisk': 35, 'numAffected': 3}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (2.0)'}, {'term': 'Alkaline phosphatase increase', 'stats': [{'groupId': 'EG000', 'numAtRisk': 35, 'numAffected': 5}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (2.0)'}, {'term': 'Bilirubin increase', 'stats': [{'groupId': 'EG000', 'numAtRisk': 35, 'numAffected': 4}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (2.0)'}, {'term': 'Creatinine increase', 'stats': [{'groupId': 'EG000', 'numAtRisk': 35, 'numAffected': 2}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (2.0)'}, {'term': 'Leukopenia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 35, 'numAffected': 21}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (2.0)'}, {'term': 'Lymphopenia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 35, 'numAffected': 4}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (2.0)'}, {'term': 'Neutropenia/granulocytopenia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 35, 'numAffected': 13}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (2.0)'}, {'term': 'SGOT (AST) increase', 'stats': [{'groupId': 'EG000', 'numAtRisk': 35, 'numAffected': 11}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (2.0)'}, {'term': 'SGPT (ALT) increase', 'stats': [{'groupId': 'EG000', 'numAtRisk': 35, 'numAffected': 3}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (2.0)'}, {'term': 'Thrombocytopenia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 35, 'numAffected': 3}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (2.0)'}, {'term': 'Weight gain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 35, 'numAffected': 4}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (2.0)'}, {'term': 'Weight loss', 'stats': [{'groupId': 'EG000', 'numAtRisk': 35, 'numAffected': 3}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (2.0)'}, {'term': 'Anorexia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 35, 'numAffected': 6}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (2.0)'}, {'term': 'Hyperglycemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 35, 'numAffected': 10}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (2.0)'}, {'term': 'Hyperkalemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 35, 'numAffected': 3}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (2.0)'}, {'term': 'Hypoalbuminemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 35, 'numAffected': 6}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (2.0)'}, {'term': 'Hypocalcemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 35, 'numAffected': 2}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (2.0)'}, {'term': 'Hypokalemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 35, 'numAffected': 4}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (2.0)'}, {'term': 'Hyponatremia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 35, 'numAffected': 2}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (2.0)'}, {'term': 'Arthralgia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 35, 'numAffected': 2}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (2.0)'}, {'term': 'Bone pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 35, 'numAffected': 4}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (2.0)'}, {'term': 'Joint,muscle,bone-other', 'stats': [{'groupId': 'EG000', 'numAtRisk': 35, 'numAffected': 3}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (2.0)'}, {'term': 'Myalgia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 35, 'numAffected': 6}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (2.0)'}, {'term': 'Myalgia/arthralgia, NOS', 'stats': [{'groupId': 'EG000', 'numAtRisk': 35, 'numAffected': 2}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (2.0)'}, {'term': 'Dizziness/light headedness', 'stats': [{'groupId': 'EG000', 'numAtRisk': 35, 'numAffected': 3}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (2.0)'}, {'term': 'Headache', 'stats': [{'groupId': 'EG000', 'numAtRisk': 35, 'numAffected': 5}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (2.0)'}, {'term': 'Sensory neuropathy', 'stats': [{'groupId': 'EG000', 'numAtRisk': 35, 'numAffected': 8}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (2.0)'}, {'term': 'Weakness (motor neuropathy)', 'stats': [{'groupId': 'EG000', 'numAtRisk': 35, 'numAffected': 4}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (2.0)'}, {'term': 'Confusion', 'stats': [{'groupId': 'EG000', 'numAtRisk': 35, 'numAffected': 2}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (2.0)'}, {'term': 'Depression', 'stats': [{'groupId': 'EG000', 'numAtRisk': 35, 'numAffected': 3}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (2.0)'}, {'term': 'Insomnia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 35, 'numAffected': 8}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (2.0)'}, {'term': 'Dysuria', 'stats': [{'groupId': 'EG000', 'numAtRisk': 35, 'numAffected': 3}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (2.0)'}, {'term': 'Hematuria', 'stats': [{'groupId': 'EG000', 'numAtRisk': 35, 'numAffected': 5}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (2.0)'}, {'term': 'Incontinence', 'stats': [{'groupId': 'EG000', 'numAtRisk': 35, 'numAffected': 3}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (2.0)'}, {'term': 'Urinary frequency/urgency', 'stats': [{'groupId': 'EG000', 'numAtRisk': 35, 'numAffected': 5}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (2.0)'}, {'term': 'Urinary retention', 'stats': [{'groupId': 'EG000', 'numAtRisk': 35, 'numAffected': 3}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (2.0)'}, {'term': 'Erectile impotence', 'stats': [{'groupId': 'EG000', 'numAtRisk': 35, 'numAffected': 8}], 'organSystem': 'Reproductive system and breast disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (2.0)'}, {'term': 'Gynecomastia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 35, 'numAffected': 6}], 'organSystem': 'Reproductive system and breast disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (2.0)'}, {'term': 'Libido loss', 'stats': [{'groupId': 'EG000', 'numAtRisk': 35, 'numAffected': 2}], 'organSystem': 'Reproductive system and breast disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (2.0)'}, {'term': 'Cough', 'stats': [{'groupId': 'EG000', 'numAtRisk': 35, 'numAffected': 7}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (2.0)'}, {'term': 'Dyspnea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 35, 'numAffected': 6}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (2.0)'}, {'term': 'Hiccoughs', 'stats': [{'groupId': 'EG000', 'numAtRisk': 35, 'numAffected': 2}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (2.0)'}, {'term': 'Alopecia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 35, 'numAffected': 18}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (2.0)'}, {'term': 'Nail changes', 'stats': [{'groupId': 'EG000', 'numAtRisk': 35, 'numAffected': 2}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (2.0)'}, {'term': 'Pruritus', 'stats': [{'groupId': 'EG000', 'numAtRisk': 35, 'numAffected': 3}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (2.0)'}, {'term': 'Rash/desquamation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 35, 'numAffected': 5}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (2.0)'}, {'term': 'Skin-other', 'stats': [{'groupId': 'EG000', 'numAtRisk': 35, 'numAffected': 3}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (2.0)'}, {'term': 'Hot flashes', 'stats': [{'groupId': 'EG000', 'numAtRisk': 35, 'numAffected': 9}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (2.0)'}, {'term': 'Hypertension', 'stats': [{'groupId': 'EG000', 'numAtRisk': 35, 'numAffected': 2}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (2.0)'}, {'term': 'Thrombosis/embolism', 'stats': [{'groupId': 'EG000', 'numAtRisk': 35, 'numAffected': 3}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (2.0)'}], 'seriousEvents': [{'term': 'Cardiac ischemia/infarction', 'stats': [{'groupId': 'EG000', 'numAtRisk': 35, 'numAffected': 2}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (2.0)'}, {'term': 'Flu-like symptoms-other', 'stats': [{'groupId': 'EG000', 'numAtRisk': 35, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (2.0)'}, {'term': 'Infection with 3-4 neutropenia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 35, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (2.0)'}, {'term': 'Abnormal troponin I (cTnI)', 'stats': [{'groupId': 'EG000', 'numAtRisk': 35, 'numAffected': 1}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (2.0)'}, {'term': 'Leukopenia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 35, 'numAffected': 1}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (2.0)'}, {'term': 'Second primary', 'stats': [{'groupId': 'EG000', 'numAtRisk': 35, 'numAffected': 1}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (2.0)'}, {'term': 'Thrombosis/embolism', 'stats': [{'groupId': 'EG000', 'numAtRisk': 35, 'numAffected': 2}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (2.0)'}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Progression-free Survival', 'denoms': [{'units': 'Participants', 'counts': [{'value': '35', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'CAD + Chemo', 'description': 'Patients receive Combined androgen deprivation (CAD) therapy with LHRH agonist (goserelin acetate or leuprolide acetate) sq/IM q 1-4 months depending on dose chosen by the treating physician and oral antiandrogen (250 mg/tid of flutamide, 50 mg/d of bicalutamide or 300 mg/d for 30 days then 150 mg/d of nilutamide) given continuously until disease progression and Chemotherapy (4 cycles of estramustine 280 mg orally 3 times daily and etoposide 50 mg/m\\^2 daily for 14 days of each 21-day cycle, with paclitaxel 135 mg/m\\^2 given intravenously within 1 hour on day 2 of each cycle)'}], 'classes': [{'categories': [{'measurements': [{'value': '13', 'groupId': 'OG000', 'lowerLimit': '10', 'upperLimit': '16'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': '0-5 years (assessed every 3 months if no progression when the chemotherapy had been finished. Once off chemotherapy, assessed every 3 months until progression)', 'description': "Measured from time of registration to time of first documentation of progression determined from the prostate-specific antigen (PSA) level, clinical criteria, or symptomatic deterioration. PSA progression is defined as a 25% increase greater than baseline. If the patient's PSA level had decrease during the study, a 25% increase from the nadir PSA level, with absolute value of \\>=5 ng/mL is considered progression. CLinical progress is defined as the appearance of any new lesion at any site or death without documented progression. Symptomatic deterioration is defined as a global deterioration of the health status requiring discontinuation of treatment without objective evidence of progression.", 'unitOfMeasure': 'months', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'All eligible patients who started treatment were included in the analysis'}, {'type': 'SECONDARY', 'title': 'Number of Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to Study Drug', 'denoms': [{'units': 'Participants', 'counts': [{'value': '35', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'CAD + Chemo', 'description': 'Patients receive Combined androgen deprivation (CAD) therapy with LHRH agonist (goserelin acetate or leuprolide acetate) sq/IM q 1-4 months depending on dose chosen by the treating physician and oral antiandrogen (250 mg/tid of flutamide, 50 mg/d of bicalutamide or 300 mg/d for 30 days then 150 mg/d of nilutamide) given continuously until disease progression and Chemotherapy (4 cycles of estramustine 280 mg orally 3 times daily and etoposide 50 mg/m\\^2 daily for 14 days of each 21-day cycle, with paclitaxel 135 mg/m\\^2 given intravenously within 1 hour on day 2 of each cycle)'}], 'classes': [{'title': 'Alkaline phosphatase increase', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}]}]}, {'title': 'Anemia', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}]}]}, {'title': 'Bilirubin increase', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}]}]}, {'title': 'Cardiac ischemia/infarction', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}]}]}, {'title': 'Confusion', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}]}]}, {'title': 'Constipation/bowel obstruction', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}]}]}, {'title': 'Edema', 'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}]}]}, {'title': 'Erectile impotence', 'categories': [{'measurements': [{'value': '3', 'groupId': 'OG000'}]}]}, {'title': 'Fatigue/malaise/lethargy', 'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}]}]}, {'title': 'GI-other', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}]}]}, {'title': 'Hyperglycemia', 'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}]}]}, {'title': 'Infection w/o 3-4 neutropenia', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}]}]}, {'title': 'Infection with 3-4 neutropenia', 'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}]}]}, {'title': 'Leukopenia', 'categories': [{'measurements': [{'value': '9', 'groupId': 'OG000'}]}]}, {'title': 'Lymphopenia', 'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}]}]}, {'title': 'Neutropenia/granulocytopenia', 'categories': [{'measurements': [{'value': '9', 'groupId': 'OG000'}]}]}, {'title': 'PRBC transfusion', 'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}]}]}, {'title': 'Pain-other', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}]}]}, {'title': 'Prothrombin time increase', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}]}]}, {'title': 'Renal failure', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}]}]}, {'title': 'Second primary', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}]}]}, {'title': 'Thrombocytopenia', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}]}]}, {'title': 'Thrombosis/embolism', 'categories': [{'measurements': [{'value': '4', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'up to 5 years after registration', 'description': 'Adverse Events (AEs) are reported by the NCI Common Terminology Criteria for Adverse Events (CTCAE) version 2.0. For each patient, worst grade of each event type is reported. Grade 3 = Severe, Grade 4 = Life-threatening, Grade 5 = Fatal.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Eligible patients who had received any treatment were included in the adverse event summaries. Any CTCAE 2.0 event of Grade 3 (severe), Grade 4 (life threatening), or Grade 5 (fatal) which deemed to be related to protocol treatment are included.'}, {'type': 'PRIMARY', 'title': 'Overall Survival (OS)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '35', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'CAD + Chemo', 'description': 'Patients receive Combined androgen deprivation (CAD) therapy with LHRH agonist (goserelin acetate or leuprolide acetate) sq/IM q 1-4 months depending on dose chosen by the treating physician and oral antiandrogen (250 mg/tid of flutamide, 50 mg/d of bicalutamide or 300 mg/d for 30 days then 150 mg/d of nilutamide) given continuously until disease progression and Chemotherapy (4 cycles of estramustine 280 mg orally 3 times daily and etoposide 50 mg/m\\^2 daily for 14 days of each 21-day cycle, with paclitaxel 135 mg/m\\^2 given intravenously within 1 hour on day 2 of each cycle)'}], 'classes': [{'categories': [{'measurements': [{'value': '38', 'groupId': 'OG000', 'lowerLimit': '28', 'upperLimit': '49'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': '0-5 years', 'description': 'Overall survival is defined from the date of registration to date of death from any cause', 'unitOfMeasure': 'months', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'All eligible patients who started treatment were included in the analysis'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'CAD + Chemo', 'description': 'Patients receive Combined androgen deprivation (CAD) therapy with LHRH agonist (goserelin acetate or leuprolide acetate) sq/IM q 1-4 months depending on dose chosen by the treating physician and oral antiandrogen (250 mg/tid of flutamide, 50 mg/d of bicalutamide or 300 mg/d for 30 days then 150 mg/d of nilutamide) given continuously until disease progression and Chemotherapy (4 cycles of estramustine 280 mg orally 3 times daily and etoposide 50 mg/m\\^2 daily for 14 days of each 21-day cycle, with paclitaxel 135 mg/m\\^2 given intravenously within 1 hour on day 2 of each cycle)'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '41'}]}, {'type': 'Eligible', 'achievements': [{'groupId': 'FG000', 'numSubjects': '36'}]}, {'type': 'Eligible and Began Protocol Therapy', 'achievements': [{'comment': 'One patient refused all protocol treatment and was not evaluable for the present analysis', 'groupId': 'FG000', 'numSubjects': '35'}]}, {'type': 'COMPLETED', 'achievements': [{'comment': 'Patients receive protocol treatments until evidence of disease progression', 'groupId': 'FG000', 'numSubjects': '0'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '41'}]}], 'dropWithdraws': [{'type': 'Adverse Event', 'reasons': [{'groupId': 'FG000', 'numSubjects': '2'}]}, {'type': 'Refusal Unrelated to Adverse Events', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}]}, {'type': 'Progression or Death', 'reasons': [{'groupId': 'FG000', 'numSubjects': '31'}]}, {'type': 'Other - Not Protocol Specified', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}]}, {'type': 'Ineligible', 'reasons': [{'groupId': 'FG000', 'numSubjects': '5'}]}, {'type': 'Not Analyzable', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '35', 'groupId': 'BG000'}]}], 'groups': [{'id': 'BG000', 'title': 'CAD + Chemo', 'description': 'Patients receive Combined androgen deprivation (CAD) therapy with LHRH agonist (goserelin acetate or leuprolide acetate) sq/IM q 1-4 months depending on dose chosen by the treating physician and oral antiandrogen (250 mg/tid of flutamide, 50 mg/d of bicalutamide or 300 mg/d for 30 days then 150 mg/d of nilutamide) given continuously until disease progression and Chemotherapy (4 cycles of estramustine 280 mg orally 3 times daily and etoposide 50 mg/m\\^2 daily for 14 days of each 21-day cycle, with paclitaxel 135 mg/m\\^2 given intravenously within 1 hour on day 2 of each cycle)'}], 'measures': [{'title': 'Age Continuous', 'classes': [{'categories': [{'measurements': [{'value': '60', 'groupId': 'BG000', 'lowerLimit': '45', 'upperLimit': '79'}]}]}], 'paramType': 'MEDIAN', 'unitOfMeasure': 'years', 'dispersionType': 'FULL_RANGE'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'Male', 'measurements': [{'value': '35', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Ethnicity (NIH/OMB)', 'classes': [{'categories': [{'title': 'Hispanic or Latino', 'measurements': [{'value': '3', 'groupId': 'BG000'}]}, {'title': 'Not Hispanic or Latino', 'measurements': [{'value': '32', 'groupId': 'BG000'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '0', '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': '9', 'groupId': 'BG000'}]}, {'title': 'White', 'measurements': [{'value': '26', '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': 'Southwestern Oncology Group Performance Status', 'classes': [{'title': '0', 'categories': [{'measurements': [{'value': '20', 'groupId': 'BG000'}]}]}, {'title': '1', 'categories': [{'measurements': [{'value': '15', 'groupId': 'BG000'}]}]}], 'paramType': 'NUMBER', 'description': 'Patients will be graded according to the Zubrod performance status scale. 0: Fully active, able to carry all pre-disease performance without restriction. 1: Restricted in physically strenuous activity but ambulatory and able to carry out work of a light or sedentary nature. 2: Ambulatory and capable of self-care but unable to carry out any work activities; up and about more than 50% of waking hours. 3: Capable of limited self-care, confined to bed or chair more than 50% of waking hours. 4: Completely disabled; cannot carry on any self-care; totally confined to bed or chair.', 'unitOfMeasure': 'participants'}, {'title': 'Bone Pain Grade (CTC version 2.0)', 'classes': [{'title': 'Missing', 'categories': [{'measurements': [{'value': '2', 'groupId': 'BG000'}]}]}, {'title': '<2', 'categories': [{'measurements': [{'value': '26', 'groupId': 'BG000'}]}]}, {'title': '>=2', 'categories': [{'measurements': [{'value': '7', 'groupId': 'BG000'}]}]}], 'paramType': 'NUMBER', 'description': '0 - none, 1 - mild pain not interfering with function, 2 - moderate pain: pain or analgesics interfering with function, but not interfering with activities of daily living, 3 - severe pain: pain or analgesics severely interfering with activities of daily living, 4 - disabling', 'unitOfMeasure': 'participants'}, {'title': 'Previous Prostatectomy', 'classes': [{'title': 'Yes', 'categories': [{'measurements': [{'value': '6', 'groupId': 'BG000'}]}]}, {'title': 'No/Unknown', 'categories': [{'measurements': [{'value': '29', 'groupId': 'BG000'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}, {'title': 'Gleason Score', 'classes': [{'title': 'Missing', 'categories': [{'measurements': [{'value': '1', 'groupId': 'BG000'}]}]}, {'title': '6', 'categories': [{'measurements': [{'value': '2', 'groupId': 'BG000'}]}]}, {'title': '7', 'categories': [{'measurements': [{'value': '12', 'groupId': 'BG000'}]}]}, {'title': '8', 'categories': [{'measurements': [{'value': '6', 'groupId': 'BG000'}]}]}, {'title': '9-10', 'categories': [{'measurements': [{'value': '14', 'groupId': 'BG000'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 41}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2001-12'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2013-06', 'completionDateStruct': {'date': '2011-07', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2013-06-12', 'studyFirstSubmitDate': '2002-01-04', 'resultsFirstSubmitDate': '2012-11-15', 'studyFirstSubmitQcDate': '2003-01-26', 'lastUpdatePostDateStruct': {'date': '2013-07-16', 'type': 'ESTIMATED'}, 'resultsFirstSubmitQcDate': '2013-06-12', 'studyFirstPostDateStruct': {'date': '2003-01-27', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2013-07-16', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2010-06', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Progression-free Survival', 'timeFrame': '0-5 years (assessed every 3 months if no progression when the chemotherapy had been finished. Once off chemotherapy, assessed every 3 months until progression)', 'description': "Measured from time of registration to time of first documentation of progression determined from the prostate-specific antigen (PSA) level, clinical criteria, or symptomatic deterioration. PSA progression is defined as a 25% increase greater than baseline. If the patient's PSA level had decrease during the study, a 25% increase from the nadir PSA level, with absolute value of \\>=5 ng/mL is considered progression. CLinical progress is defined as the appearance of any new lesion at any site or death without documented progression. Symptomatic deterioration is defined as a global deterioration of the health status requiring discontinuation of treatment without objective evidence of progression."}, {'measure': 'Overall Survival (OS)', 'timeFrame': '0-5 years', 'description': 'Overall survival is defined from the date of registration to date of death from any cause'}], 'secondaryOutcomes': [{'measure': 'Number of Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to Study Drug', 'timeFrame': 'up to 5 years after registration', 'description': 'Adverse Events (AEs) are reported by the NCI Common Terminology Criteria for Adverse Events (CTCAE) version 2.0. For each patient, worst grade of each event type is reported. Grade 3 = Severe, Grade 4 = Life-threatening, Grade 5 = Fatal.'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['adenocarcinoma of the prostate', 'stage IV prostate cancer', 'recurrent prostate cancer'], 'conditions': ['Prostate Cancer']}, 'descriptionModule': {'briefSummary': 'RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Androgens can stimulate the growth of prostate cancer cells. Drugs such as goserelin, leuprolide, flutamide, or bicalutamide may stop the adrenal glands from producing androgens. Combining chemotherapy with hormone therapy may kill more tumor cells.\n\nPURPOSE: Phase II trial to study the effectiveness of combination chemotherapy plus hormone therapy in treating patients who have metastatic prostate cancer.', 'detailedDescription': 'OBJECTIVES:\n\n* Determine the progression-free and overall survival in patients with high-risk metastatic adenocarcinoma of the prostate treated with early estramustine, etoposide, and paclitaxel with combined androgen-blockade therapy.\n* Determine the type, frequency, and severity of toxicity of this regimen in this patient population.\n\nOUTLINE: This is a multicenter study.\n\n* Androgen-blockade therapy: Patients receive a standard regimen of luteinizing hormone-releasing hormone agonist therapy comprising either goserelin subcutaneously once monthly or once every 3 months or leuprolide intramuscularly once monthly, once every 3 months, or once every 4 months. Patients also receive a standard regimen of antiandrogen therapy comprising oral bicalutamide, oral flutamide, or oral nilutamide once daily. Treatment continues in the absence of disease progression or unacceptable toxicity.\n* Chemotherapy: Beginning 14-30 days after initiation of androgen-blockade therapy, patients receive oral estramustine three times daily and oral etoposide once daily on days 1-14 and paclitaxel IV over 1 hour on day 2. Treatment repeats every 21 days for 4 courses in the absence of disease progression or unacceptable toxicity.\n\nPatients are followed every 3 months until disease progression, every 6 months for 2 years, and then annually for 3 years.\n\nPROJECTED ACCRUAL: A total of 80 patients will be accrued for this study within 2 years.'}, 'eligibilityModule': {'sex': 'MALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'DISEASE CHARACTERISTICS:\n\n* Histologically or cytologically confirmed high-risk adenocarcinoma of the prostate\n\n * Clinical stage D2 disease as evidenced by one of the following:\n\n * Visceral disease (liver, lung, or other viscera)\n * Bone metastases to sites in both the axial (spine, pelvis, ribs, or skull) and appendicular (claviculae, humeri, or femora) skeleton\n* No prior or concurrent (treated or untreated) brain metastases\n\n * Patients with clinical evidence of brain metastasis must have a negative brain CT or MRI\n* No evidence of untreated spinal cord compression\n\nPATIENT CHARACTERISTICS:\n\nAge:\n\n* Over 18\n\nPerformance status:\n\n* Zubrod 0-2\n\nLife expectancy:\n\n* Not specified\n\nHematopoietic:\n\n* Absolute granulocyte count at least 1,500/mm\\^3\n* Platelet count at least 100,000/mm\\^3\n* No active hypercoagulability\n\nHepatic:\n\n* Not specified\n\nRenal:\n\n* Not specified\n\nCardiovascular:\n\n* No transient ischemic attacks, stroke, or myocardial infarction within the past 6 months\n* No active coronary artery disease requiring antianginal therapy\n* No active thrombophlebitis\n\nPulmonary:\n\n* No history of pulmonary embolus\n\nOther:\n\n* No other prior malignancy within the past 5 years except adequately treated basal cell or squamous cell skin cancer or adequately treated stage I or II cancer currently in complete remission\n\nPRIOR CONCURRENT THERAPY:\n\nBiologic therapy:\n\n* At least 4 weeks since prior biologic therapy and recovered\n* No concurrent biologic therapy\n\nChemotherapy:\n\n* No prior cytotoxic chemotherapy\n* No other concurrent chemotherapy\n\nEndocrine therapy:\n\n* Prior androgen-blockade therapy (e.g., luteinizing hormone-releasing hormone agonist and antiandrogen therapy) allowed if administered for a duration of less than 30 days\n* Prior neoadjuvant hormonal therapy allowed\n\nRadiotherapy:\n\n* At least 4 weeks since prior radiotherapy and recovered\n* No concurrent radiotherapy\n\nSurgery:\n\n* At least 4 weeks since prior surgery and recovered\n\nOther:\n\n* No concurrent bisphosphonates'}, 'identificationModule': {'nctId': 'NCT00028769', 'briefTitle': 'S0032, Combination Chemotherapy Plus Hormone Therapy in Treating Patients With Metastatic Prostate Cancer', 'organization': {'class': 'NETWORK', 'fullName': 'SWOG Cancer Research Network'}, 'officialTitle': 'Phase II Evaluation of Early Oral Estramustine, Oral Etoposide and Intravenous Paclitaxel in Combination With Hormone Therapy in Patients With High-Risk Metastatic Adenocarinoma of the Prostate', 'orgStudyIdInfo': {'id': 'CDR0000069132'}, 'secondaryIdInfos': [{'id': 'S0032', 'type': 'OTHER', 'domain': 'SWOG'}, {'id': 'U10CA032102', 'link': 'https://reporter.nih.gov/quickSearch/U10CA032102', 'type': 'NIH'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Hormone therapy, estramustine, etoposide and paclitaxel', 'description': 'Hormone therapy (leuprolide, bicalutamide, nilutamide, goserelin, flutamide), estramustine, etoposide and paclitaxel', 'interventionNames': ['Drug: bicalutamide', 'Drug: estramustine', 'Drug: etoposide', 'Drug: flutamide', 'Drug: goserelin', 'Drug: leuprolide', 'Drug: nilutamide', 'Drug: paclitaxel']}], 'interventions': [{'name': 'bicalutamide', 'type': 'DRUG', 'armGroupLabels': ['Hormone therapy, estramustine, etoposide and paclitaxel']}, {'name': 'estramustine', 'type': 'DRUG', 'otherNames': ['estramustine phosphate sodium'], 'armGroupLabels': ['Hormone therapy, estramustine, etoposide and paclitaxel']}, {'name': 'etoposide', 'type': 'DRUG', 'armGroupLabels': ['Hormone therapy, estramustine, etoposide and paclitaxel']}, {'name': 'flutamide', 'type': 'DRUG', 'armGroupLabels': ['Hormone therapy, estramustine, etoposide and paclitaxel']}, {'name': 'goserelin', 'type': 'DRUG', 'armGroupLabels': ['Hormone therapy, estramustine, etoposide and paclitaxel']}, {'name': 'leuprolide', 'type': 'DRUG', 'otherNames': ['leuprolide acetate'], 'armGroupLabels': ['Hormone therapy, estramustine, etoposide and paclitaxel']}, {'name': 'nilutamide', 'type': 'DRUG', 'armGroupLabels': ['Hormone therapy, estramustine, etoposide and paclitaxel']}, {'name': 'paclitaxel', 'type': 'DRUG', 'armGroupLabels': ['Hormone therapy, estramustine, etoposide and paclitaxel']}]}, 'contactsLocationsModule': {'locations': [{'zip': '36607', 'city': 'Mobile', 'state': 'Alabama', 'country': 'United States', 'facility': 'MBCCOP - Gulf Coast', 'geoPoint': {'lat': 30.69436, 'lon': -88.04305}}, {'zip': '85006-2726', 'city': 'Phoenix', 'state': 'Arizona', 'country': 'United States', 'facility': 'CCOP - Western Regional, Arizona', 'geoPoint': {'lat': 33.44838, 'lon': -112.07404}}, {'zip': '85012', 'city': 'Phoenix', 'state': 'Arizona', 'country': 'United States', 'facility': 'Veterans Affairs Medical Center - Phoenix (Carl T. Hayden)', 'geoPoint': {'lat': 33.44838, 'lon': -112.07404}}, {'zip': '85723', 'city': 'Tucson', 'state': 'Arizona', 'country': 'United States', 'facility': 'Veterans Affairs Medical Center - Tucson', 'geoPoint': {'lat': 32.22174, 'lon': -110.92648}}, {'zip': '85724', 'city': 'Tucson', 'state': 'Arizona', 'country': 'United States', 'facility': 'Arizona Cancer Center at University of Arizona Health Sciences Center', 'geoPoint': {'lat': 32.22174, 'lon': -110.92648}}, {'zip': '72205', 'city': 'Little Rock', 'state': 'Arkansas', 'country': 'United States', 'facility': 'Arkansas Cancer Research Center at University of Arkansas for Medical Sciences', 'geoPoint': {'lat': 34.74648, 'lon': -92.28959}}, {'zip': '72205', 'city': 'Little Rock', 'state': 'Arkansas', 'country': 'United States', 'facility': 'Veterans Affairs Medical Center - Little Rock', 'geoPoint': {'lat': 34.74648, 'lon': -92.28959}}, {'zip': '91010-3000', 'city': 'Duarte', 'state': 'California', 'country': 'United States', 'facility': 'City of Hope Comprehensive Cancer Center', 'geoPoint': {'lat': 34.13945, 'lon': -117.97729}}, {'zip': '90033', 'city': 'Los Angeles', 'state': 'California', 'country': 'United States', 'facility': 'USC/Norris Comprehensive Cancer Center and Hospital', 'geoPoint': {'lat': 34.05223, 'lon': -118.24368}}, {'zip': '90073', 'city': 'Los Angeles', 'state': 'California', 'country': 'United States', 'facility': 'Veterans Affairs Medical Center - 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