Ignite Creation Date:
2025-12-24 @ 6:58 PM
Ignite Modification Date:
2026-02-23 @ 8:07 PM
Study NCT ID:
NCT00349557
Status:
COMPLETED
Last Update Posted:
2014-07-16
First Post:
2006-07-05
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Bevacizumab With Hormonal and Radiotherapy for High-Risk Prostate Cancer
Sponsor:
Organization:
Raw JSON
{'hasResults': False, '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': 'D000068258', 'term': 'Bevacizumab'}, {'id': 'C053541', 'term': 'bicalutamide'}, {'id': 'D017273', 'term': 'Goserelin'}, {'id': 'D050397', 'term': 'Radiotherapy, Intensity-Modulated'}], 'ancestors': [{'id': 'D061067', 'term': 'Antibodies, Monoclonal, Humanized'}, {'id': 'D000911', 'term': 'Antibodies, Monoclonal'}, {'id': 'D000906', 'term': 'Antibodies'}, {'id': 'D007136', 'term': 'Immunoglobulins'}, {'id': 'D007162', 'term': 'Immunoproteins'}, {'id': 'D001798', 'term': 'Blood Proteins'}, {'id': 'D011506', 'term': 'Proteins'}, {'id': 'D000602', 'term': 'Amino Acids, Peptides, and Proteins'}, {'id': 'D012712', 'term': 'Serum Globulins'}, {'id': 'D005916', 'term': 'Globulins'}, {'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': 'D009842', 'term': 'Oligopeptides'}, {'id': 'D009419', 'term': 'Nerve Tissue Proteins'}, {'id': 'D020266', 'term': 'Radiotherapy, Conformal'}, {'id': 'D011881', 'term': 'Radiotherapy, Computer-Assisted'}, {'id': 'D011878', 'term': 'Radiotherapy'}, {'id': 'D013812', 'term': 'Therapeutics'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 18}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2006-04'}, 'statusVerifiedDate': '2014-07', 'lastUpdateSubmitDate': '2014-07-15', 'studyFirstSubmitDate': '2006-07-05', 'studyFirstSubmitQcDate': '2006-07-06', 'lastUpdatePostDateStruct': {'date': '2014-07-16', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2006-07-07', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'To determine the acute (within 90 days from 1st day of radiation therapy) toxicities from intensity modulated radiation therapy (IMRT) in conjunction with bevacizumab, bicalutamide, and goserelin.'}], 'secondaryOutcomes': [{'measure': 'To evaluate the late toxicities (>90 days from 1st day of radiation therapy) of IMRT, bevacizumab, bicalutamide, and goserelin. Patients will be followed on study for toxicity evaluation for at least one year from day 1 if radiation therapy.'}, {'measure': 'To determine the tolerability of the combination of bevacizumab and hormonal therapy.'}]}, 'conditionsModule': {'keywords': ['Prostate Cancer', 'High-Risk Prostate Cancer', '1st line therapy'], 'conditions': ['Prostate Cancer']}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to determine the acute and late toxicities from radiation therapy in combination with bevacizumab (given every 2 weeks for 16 weeks then every 3 weeks for 12 weeks), bicalutamide (every day for 16 weeks) and goserelin (every 3 months for 2 years).', 'detailedDescription': 'Although there is no data on the toxicity with concurrent bevacizumab and hormonal therapy, the combination is not expected to increase toxicity seen when given as a single agent. Abnormal tumor microenvironments, tumor progression, and metastatic spread are major factors contributing to treatment failures in radiotherapy. Anti-VEGF agents (e.g. bevacizumab) can help overcome these factors through several different mechanisims.\n\nStudies also demonstrate prolonged use of anti-VEGF agents with radiation therapy was more effective at preventing metastases from irradiated tumors compared to a short course. Patients generally start hormonal therapy and daily radiotherapy at the same time. This study will delay the start of radiotherapy until 8 weeks after the start of hormonal therapy and bevacizumab.'}, 'eligibilityModule': {'sex': 'MALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* High Risk Prostate Cancer as defined as ONE of the following:\n\n 1. Clinical T2b-T4\n 2. Gleason sum score 8-10\n 3. PSA more than 20 and Gleason sum score 7\n 4. In addition, clinical T2a patients are eligible if 5 or more biopsies contain Gleason 4+3 cancer (minimum of 10 biopsies total required)\n* No evidence of metastatic disease within 60 days of enrollment, confirmed by physical examination, chest x-ray, bone scan, and computed tomography of the abdomen and pelvis\n* ECOG performance status of 0, 1 or 2\n\nExclusion Criteria:\n\n* Concurrent or prior treatment with radiation, cytotoxic, biologic therapy for prostate cancer; any major surgery within four weeks, prior hormonal therapy (except finasteride for obstructive voiding symptoms)\n* Major surgical procedure, open biopsy, or significant traumatic injury within 28 days prior to Day 0, anticipation of need for major surgical procedure during the course of the study; Minor surgical procedures such as fine needle aspirations or core biopsies within 7 days prior to Day 0\n* Presence of central nervous system or brain metastases\n* Blood pressure of \\>150/100 mmHg\n* History of myocardial infarction within 6 months\n* History of stroke within 6 months\n* Current, recent (within 4 weeks of the first infusion of this study), or planned participation in an experimental drug study other than a Genentech-sponsored bevacizumab cancer study'}, 'identificationModule': {'nctId': 'NCT00349557', 'briefTitle': 'Bevacizumab With Hormonal and Radiotherapy for High-Risk Prostate Cancer', 'organization': {'class': 'OTHER', 'fullName': 'Benaroya Research Institute'}, 'officialTitle': 'Pilot Phase II Trial of Bevacizumab in Combination With Hormonal and Radiotherapy in Patients With High-Risk Prostate Cancer', 'orgStudyIdInfo': {'id': 'BRI 3031500'}}, 'armsInterventionsModule': {'interventions': [{'name': 'bevacizumab, bicalutamide and goserelin', 'type': 'DRUG'}, {'name': 'intensity modulated radiation therapy (IMRT)', 'type': 'PROCEDURE'}]}, 'contactsLocationsModule': {'locations': [{'zip': '98101', 'city': 'Seattle', 'state': 'Washington', 'country': 'United States', 'facility': 'Virginia Mason Medical Center', 'geoPoint': {'lat': 47.60621, 'lon': -122.33207}}], 'overallOfficials': [{'name': 'Jacqueline Vuky, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Virginia Mason Medical Center'}, {'name': 'Huong Pham, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Virginia Mason Medical Center'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Benaroya Research Institute', 'class': 'OTHER'}, 'collaborators': [{'name': 'Genentech, Inc.', 'class': 'INDUSTRY'}]}}}