Ignite Creation Date:
2025-12-25 @ 3:23 AM
Ignite Modification Date:
2025-12-26 @ 2:02 AM
Study NCT ID:
NCT00773305
Status:
COMPLETED
Last Update Posted:
2012-12-28
First Post:
2008-10-15
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Efficacy of Prostate Seed Implantation for Local Control of Early Stage 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'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'RETROSPECTIVE', 'observationalModel': 'ECOLOGIC_OR_COMMUNITY'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 200}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2008-10'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2012-12', 'completionDateStruct': {'date': '2012-10', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2012-12-26', 'studyFirstSubmitDate': '2008-10-15', 'studyFirstSubmitQcDate': '2008-10-15', 'lastUpdatePostDateStruct': {'date': '2012-12-28', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2008-10-16', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2010-11', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'To determine the efficacy of prostate brachytherapy for local control of early stage prostate cancer at Summa Health System', 'timeFrame': 'Pre-op through 4 follow-up visits', 'description': 'A retrospective chart review of PSA values on 85 patients from 2001-2008 with prostate cancer stage T1c-T2a NX MO, who were treated with permanent prostate brachytherapy using conventional transrectal ultrasound guided placement of Iodine-125 seeds delivering 145 Gy or 110 Gy, depending on whether mono or combination therapy with external beam radiotherapy (EBRT) was used. Those who had EBRT received 45 Gy prior to seed implants. Some patients also received hormonal therapy.'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['seed implantation'], 'conditions': ['Prostate Cancer']}, 'descriptionModule': {'briefSummary': 'The primary goal of this project is to evaluate the efficacy of prostate seed implantation for the treatment of early stage prostate cancer for patients treated at Summa Health System/Akron City Hospital and Salem Community Hospital.', 'detailedDescription': 'Charts of early stage prostate cancer patients receiving prostate seed implants with or without external beam radiotherapy and/or hormonal therapy will be reviewed and abstracted. The abstracted data will include pathology reports including Gleason score and T stage, PSA, treatment assignment and dosimetry parameters including dose and percent compliant with established criteria based on guidelines established by the American Brachytherapy Society.\n\nA database will be developed for capture of the abstracted data. Outcomes will be determined based on PSA levels at 2 and 5 years after prostate seed implantation. The role of hormonal therapy with prostate seed implantation and outcomes will be evaluated. The outcomes will be compared to national statistics.'}, 'eligibilityModule': {'sex': 'MALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '80 Years', 'minimumAge': '18 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'Prostate seed implantation for the treatment of early stage prostate cancer', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Prostate seed implantation for the treatment of early stage prostate cancer'}, 'identificationModule': {'nctId': 'NCT00773305', 'briefTitle': 'Efficacy of Prostate Seed Implantation for Local Control of Early Stage Prostate Cancer', 'organization': {'class': 'OTHER', 'fullName': 'Summa Health System'}, 'officialTitle': 'Chart Review of the Efficacy of Prostate Seed Implantation for Local Control of Early Stage Prostate Cancer', 'orgStudyIdInfo': {'id': 'Prostate Seed Implantation'}}, 'contactsLocationsModule': {'overallOfficials': [{'name': 'William Demas, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Summa Health System'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Summa Health System', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Study Principal Investigator', 'investigatorFullName': 'William Demas', 'investigatorAffiliation': 'Summa Health System'}}}}