Ignite Creation Date:
2025-12-24 @ 3:42 PM
Ignite Modification Date:
2025-12-29 @ 7:26 PM
Study NCT ID:
NCT02177292
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2025-07-01
First Post:
2014-06-18
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
High-Dose Lymph Node Intensity Modulated Radiation Therapy and Hypofractionated Prostate (SIB)
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': 'D011878', 'term': 'Radiotherapy'}, {'id': 'D050397', 'term': 'Radiotherapy, Intensity-Modulated'}, {'id': 'D061089', 'term': 'Radiotherapy, Image-Guided'}], 'ancestors': [{'id': 'D013812', 'term': 'Therapeutics'}, {'id': 'D020266', 'term': 'Radiotherapy, Conformal'}, {'id': 'D011881', 'term': 'Radiotherapy, Computer-Assisted'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 80}}, 'statusModule': {'overallStatus': 'ACTIVE_NOT_RECRUITING', 'startDateStruct': {'date': '2010-06-23', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-06', 'completionDateStruct': {'date': '2030-06-21', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-06-26', 'studyFirstSubmitDate': '2014-06-18', 'studyFirstSubmitQcDate': '2014-06-25', 'lastUpdatePostDateStruct': {'date': '2025-07-01', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2014-06-27', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2026-04-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change from baseline PSA level', 'timeFrame': '4 months', 'description': 'PSA level in blood is measured in units of nanograms per milliliter.'}, {'measure': 'Change from baseline PSA level', 'timeFrame': '7 months', 'description': 'PSA level in blood is measured in units of nanograms per milliliter.'}, {'measure': 'Change from baseline PSA level', 'timeFrame': '10 months', 'description': 'PSA level in blood is measured in units of nanograms per milliliter.'}, {'measure': 'Change from baseline PSA level', 'timeFrame': '13 months', 'description': 'PSA level in blood is measured in units of nanograms per milliliter.'}, {'measure': 'Change from baseline PSA level', 'timeFrame': '16 months', 'description': 'PSA level in blood is measured in units of nanograms per milliliter.'}, {'measure': 'Change from baseline PSA level', 'timeFrame': '19 months', 'description': 'PSA level in blood is measured in units of nanograms per milliliter.'}, {'measure': 'Change from baseline PSA level', 'timeFrame': '22 months', 'description': 'PSA level in blood is measured in units of nanograms per milliliter.'}, {'measure': 'Change from baseline PSA level', 'timeFrame': '25 months', 'description': 'PSA level in blood is measured in units of nanograms per milliliter.'}, {'measure': 'Change from baseline PSA level', 'timeFrame': '31 months', 'description': 'PSA level in blood is measured in units of nanograms per milliliter.'}, {'measure': 'Change from baseline PSA level', 'timeFrame': '37 months', 'description': 'PSA level in blood is measured in units of nanograms per milliliter.'}, {'measure': 'Change from baseline PSA level', 'timeFrame': '43 months', 'description': 'PSA level in blood is measured in units of nanograms per milliliter.'}, {'measure': 'Change from baseline PSA level', 'timeFrame': '49 months', 'description': 'PSA level in blood is measured in units of nanograms per milliliter.'}, {'measure': 'Change from baseline PSA level', 'timeFrame': '55 months', 'description': 'PSA level in blood is measured in units of nanograms per milliliter.'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': True}, 'conditionsModule': {'conditions': ['Prostate Cancer']}, 'referencesModule': {'references': [{'pmid': '17544601', 'type': 'BACKGROUND', 'citation': 'Kupelian PA, Willoughby TR, Reddy CA, Klein EA, Mahadevan A. Hypofractionated intensity-modulated radiotherapy (70 Gy at 2.5 Gy per fraction) for localized prostate cancer: Cleveland Clinic experience. Int J Radiat Oncol Biol Phys. 2007 Aug 1;68(5):1424-30. doi: 10.1016/j.ijrobp.2007.01.067. Epub 2007 Jun 4.'}]}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to find out the effects (good and bad) of using newer technologies that allow very precise delivery of radiation. These newer technologies are Intensity Modulated Radiation Therapy (IMRT) and Image Guided Radiation Therapy (IGRT).', 'detailedDescription': 'In this study the treating physicians will deliver a high dose of radiation to pelvic lymph nodes of 56 Gy (Gy/Gray = measure of amount of radiation) and at the same time give a boost (additional) radiation to the prostate itself (to 70 Gy). The study will evaluate the response of the cancer and side effects of radiation to pelvic lymph nodes and to the prostate.\n\nIt is hoped that these newer technologies will:\n\n1. allow a higher daily dose of radiation to the tumor and pelvic nodes\n2. avoid nearby normal tissue and organs like the rectum and bladder\n3. prevent the cancer from spreading or coming back'}, 'eligibilityModule': {'sex': 'MALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Histologically confirmed, adenocarcinoma of the prostate\n* T1-2N0M0 with risk of pelvic lymph nodes involvement \\>25% by Roach formula \\[(2/3xPSA) + (Gleason Score - 6)x10\\], or any T3-4N0M0\n* Karnofsky Performance Scale \\> 70.\n* Prostate tumor biopsy grading by Gleason score classification is mandatory prior to registration.\n* No prior pelvic or prostate radiation or chemotherapy for any reason; induction hormonal therapy prior to registration is acceptable.\n* Patients must sign a study-specific consent form prior to registration.\n* No evidence of distant metastases (Bone scanning)\n\nExclusion Criteria:\n\n* Clinical or pathological evidence of distant metastases (M1).\n* Radical surgery for carcinoma of the prostate\n* History of prior chemotherapy\n* History of prior pelvic radiation therapy\n* Children (age \\< 18).'}, 'identificationModule': {'nctId': 'NCT02177292', 'acronym': 'SIB', 'briefTitle': 'High-Dose Lymph Node Intensity Modulated Radiation Therapy and Hypofractionated Prostate (SIB)', 'organization': {'class': 'OTHER', 'fullName': 'Medical College of Wisconsin'}, 'officialTitle': 'A Phase II Trial of High-Dose Pelvic Lymph Node IMRT( Intensity Modulated Radiation Therapy) and Hypofractionated Prostate IMRT for High Risk Prostate Cancer Patients', 'orgStudyIdInfo': {'id': 'PRO00013374'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'IMRT & IGRT Radiation Therapy', 'description': 'In this study we will deliver a high dose of radiation to the pelvic lymph nodes of 56 Gy (Gy/Gray = measure of amount of radiation) and at the same time give a boost (additional) radiation to the prostate itself (to 70 Gy).', 'interventionNames': ['Radiation: Radiation Therapy']}], 'interventions': [{'name': 'Radiation Therapy', 'type': 'RADIATION', 'otherNames': ['Intensity Modulated Radiation Therapy (IMRT) and Image Guided Radiation Therapy (IGRT).'], 'description': 'A high dose of radiation to the pelvic lymph nodes of 56 Gy (Gy/Gray = measure of amount of radiation) and at the same time give a boost (additional) radiation to the prostate itself (to 70 Gy).', 'armGroupLabels': ['IMRT & IGRT Radiation Therapy']}]}, 'contactsLocationsModule': {'locations': [{'zip': '53226', 'city': 'Milwaukee', 'state': 'Wisconsin', 'country': 'United States', 'facility': 'Froedtert & the Medical College of Wisconsin', 'geoPoint': {'lat': 43.0389, 'lon': -87.90647}}], 'overallOfficials': [{'name': 'William Hall, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Medical College of Wisconsin'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Medical College of Wisconsin', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Professor', 'investigatorFullName': 'William Hall', 'investigatorAffiliation': 'Medical College of Wisconsin'}}}}