Ignite Creation Date:
2025-12-24 @ 6:41 PM
Ignite Modification Date:
2026-01-24 @ 2:23 AM
Study NCT ID:
NCT00653757
Status:
COMPLETED
Last Update Posted:
2012-03-19
First Post:
2008-04-04
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Intensity-Modulated Radiation Therapy in Treating Patients With Stage I, Stage II, Stage III, or Stage IV 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': 'D017273', 'term': 'Goserelin'}, {'id': 'D016729', 'term': 'Leuprolide'}, {'id': 'D061089', 'term': 'Radiotherapy, Image-Guided'}, {'id': 'D050397', 'term': 'Radiotherapy, Intensity-Modulated'}], 'ancestors': [{'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': 'D011878', 'term': 'Radiotherapy'}, {'id': 'D013812', 'term': 'Therapeutics'}, {'id': 'D020266', 'term': 'Radiotherapy, Conformal'}, {'id': 'D011881', 'term': 'Radiotherapy, Computer-Assisted'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1', 'PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 100}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2002-03'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2012-03', 'completionDateStruct': {'date': '2007-12', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2012-03-15', 'studyFirstSubmitDate': '2008-04-04', 'studyFirstSubmitQcDate': '2008-04-04', 'lastUpdatePostDateStruct': {'date': '2012-03-19', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2008-04-07', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2006-12', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Toxicity'}, {'measure': 'Survival rates'}, {'measure': 'Freedom from biochemical relapse rates'}, {'measure': 'Local control rates'}, {'measure': 'Distant failure rates'}, {'measure': 'Biochemical freedom from failure rates'}, {'measure': 'Comparison of outcomes to patients treated with conventional radiotherapy and intensity-modulated radiotherapy without radioimmunoguidance'}], 'secondaryOutcomes': [{'measure': 'Obstructive urinary symptoms'}, {'measure': 'Sexual health as assessed by inventory questionnaire'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['stage I prostate cancer', 'stage II prostate cancer', 'stage III prostate cancer', 'stage IV prostate cancer'], 'conditions': ['Prostate Cancer']}, 'descriptionModule': {'briefSummary': 'RATIONALE: Radiation therapy uses high-energy x-rays to kill tumor cells. Using scintigraphy to plan specialized radiation therapy that delivers a high dose of radiation directly to the tumor may kill more tumor cells and cause less damage to normal tissue.\n\nPURPOSE: This phase I/II trial is studying the side effects and best way to give intensity-modulated radiation therapy and to see how well it works in treating patients with stage I, stage II, stage III, or stage IV prostate cancer.', 'detailedDescription': 'OBJECTIVES:\n\n* To assess the feasibility of radioimmunoguided intensity-modulated radiotherapy (IMRT) for stage I-IV prostate cancer.\n* To determine the toxicity and tolerance of this regimen in these patients.\n* To determine the tumor response based on physical examination and serial measurements of the serum prostate-specific antigen (PSA) levels in these patients.\n* To determine the outcome of patients treated on this study with radioimmunoguided IMRT compared to 2 control groups of patients treated at Mayo Scottsdale Clinic (MSC).\n\nOUTLINE: Patients undergo radioimmunoguided intensity-modulated radiotherapy once daily, 5 days a week for 8½ weeks. Beginning the last week of radiotherapy, some patients receive leuprolide acetate intramuscularly every 3-4 months or goserelin subcutaneously every 3 months for 6 months, 12 months, or until disease progression.\n\nAfter completion of study treatment, patients are followed every 3-4 months for 1 year, every 6 months for 4 years and annually thereafter'}, 'eligibilityModule': {'sex': 'MALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '19 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'DISEASE CHARACTERISTICS:\n\n* Pathologically confirmed prostate cancer\n\n * Stage I-IV disease (T1-4, N0-1, M0)\n* No evidence of distant metastases (M0) on physical examination or bone scan\n\nPATIENT CHARACTERISTICS:\n\n* ECOG performance status 0-2\n* Hemoglobin ≥ 10.0 g/dL\n* WBC ≥ 3,000/mcL\n* Platelet count ≥ 90,000/mm\n* AST \\< 2 times the upper limit of normal\n* No allergy to leuprolide acetate or goserelin\n\nPRIOR CONCURRENT THERAPY:\n\n* Not specified'}, 'identificationModule': {'nctId': 'NCT00653757', 'briefTitle': 'Intensity-Modulated Radiation Therapy in Treating Patients With Stage I, Stage II, Stage III, or Stage IV Prostate Cancer', 'organization': {'class': 'OTHER', 'fullName': 'Mayo Clinic'}, 'officialTitle': 'Phase I/II Study of Radioimmunoguided Intensity Modulated Radiotherapy (IMRT) for Prostate Cancer', 'orgStudyIdInfo': {'id': 'CDR0000588847'}, 'secondaryIdInfos': [{'id': 'P30CA015083', 'link': 'https://reporter.nih.gov/quickSearch/P30CA015083', 'type': 'NIH'}, {'id': '390-02', 'type': 'OTHER', 'domain': 'Mayo Clinic Cancer Center'}, {'id': '390-02', 'type': 'OTHER', 'domain': 'Mayo Clinic IRB'}]}, 'armsInterventionsModule': {'interventions': [{'name': 'goserelin acetate', 'type': 'DRUG'}, {'name': 'leuprolide acetate', 'type': 'DRUG'}, {'name': 'image-guided radiation therapy', 'type': 'RADIATION'}, {'name': 'intensity-modulated radiation therapy', 'type': 'RADIATION'}]}, 'contactsLocationsModule': {'locations': [{'city': 'Scottsdale', 'state': 'Arizona', 'country': 'United States', 'facility': 'Mayo Clinic in Arizona', 'geoPoint': {'lat': 33.50921, 'lon': -111.89903}}], 'overallOfficials': [{'name': 'Steven E. Schild, M.D.', 'role': 'STUDY_CHAIR', 'affiliation': 'Mayo Clinic'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Mayo Clinic', 'class': 'OTHER'}, 'collaborators': [{'name': 'National Cancer Institute (NCI)', 'class': 'NIH'}], 'responsibleParty': {'oldNameTitle': 'Steven E Schild, M.D.', 'oldOrganization': 'Mayo Clinic Cancer Center'}}}}