Ignite Creation Date:
2025-12-25 @ 1:46 AM
Ignite Modification Date:
2026-03-05 @ 6:04 PM
Study NCT ID:
NCT00681694
Status:
UNKNOWN
Last Update Posted:
2010-04-28
First Post:
2008-05-19
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Long-Term Outcomes of Alternative Brachytherapy Techniques for Early 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': 'D001918', 'term': 'Brachytherapy'}], 'ancestors': [{'id': 'D011878', 'term': 'Radiotherapy'}, {'id': 'D013812', 'term': 'Therapeutics'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 414}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2002-03'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2010-04', 'completionDateStruct': {'date': '2011-03', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2010-04-27', 'studyFirstSubmitDate': '2008-05-19', 'studyFirstSubmitQcDate': '2008-05-20', 'lastUpdatePostDateStruct': {'date': '2010-04-28', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2008-05-21', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2011-03', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'To assess changes in generic and disease specific quality of life over time after treatment with brachytherapy for early prostate cancer', 'timeFrame': '10 years'}], 'secondaryOutcomes': [{'measure': 'To compare these outcomes after two alternative brachytherapy techniques, standard ultrasound guided brachytherapy and MRI guided prostate brachytherapy (MRIGPB)', 'timeFrame': '10 years'}, {'measure': 'To identify factors associated with specific adverse outcomes.', 'timeFrame': '10 years'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['brachytherapy', 'radioactive seed implants'], 'conditions': ['Prostate Cancer']}, 'descriptionModule': {'briefSummary': 'The purpose of this research study is to assess outcomes of treatment for early prostate cancer. Current treatments for early (non-metastatic) cancer may cause long-term impairments in the patients quality of life. In this study we will compare the outcomes of patients treated with two alternative brachytherapy (seed implants) techniques using a series of questionnaires.', 'detailedDescription': 'Participants will be asked to complete a questionnaire about their health prior to treatment, at 1, 3 and 12 months after treatment and then once a year 4 more times.'}, 'eligibilityModule': {'sex': 'MALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Patients who have indicated their intention to receive brachytherapy at one of the four accrual sites.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Pathological diagnosis of an adenocarcinoma of the prostate\n* 18 years of age or older\n* Prior choice of either standard brachytherapy or MRIGPB as primary treatment\n\nExclusion Criteria:\n\n* Prior primary therapy (surgery or external beam radiation) for prostate cancer\n* Current hormone ablation therapy'}, 'identificationModule': {'nctId': 'NCT00681694', 'briefTitle': 'Long-Term Outcomes of Alternative Brachytherapy Techniques for Early Prostate Cancer', 'organization': {'class': 'OTHER', 'fullName': 'Massachusetts General Hospital'}, 'officialTitle': 'Long-Term Outcomes of Alternative Brachytherapy Techniques for Early Prostate Cancer', 'orgStudyIdInfo': {'id': '01-264'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'MRBT', 'description': 'MRI-assisted brachytherapy, the experimental arm', 'interventionNames': ['Radiation: brachytherapy']}, {'label': 'USBT1', 'description': 'Standard ultrasound-guided brachytherapy performed by group 1 (control arm 1)', 'interventionNames': ['Radiation: brachytherapy']}, {'label': 'USBT2', 'description': 'Standard ultrasound-guided brachytherapy performed by group 2 (control group 2)', 'interventionNames': ['Radiation: brachytherapy']}], 'interventions': [{'name': 'brachytherapy', 'type': 'RADIATION', 'description': 'An experimental arm using MRI imaging and excluding the transition zone from the target volume', 'armGroupLabels': ['MRBT']}, {'name': 'brachytherapy', 'type': 'RADIATION', 'description': 'Standard ultrasound-guided brachytherapy with standard target volumes', 'armGroupLabels': ['USBT1']}, {'name': 'brachytherapy', 'type': 'RADIATION', 'description': 'Standard ultrasound-guided brachytherapy with standard target volumes', 'armGroupLabels': ['USBT2']}]}, 'contactsLocationsModule': {'locations': [{'zip': '02114', 'city': 'Boston', 'state': 'Massachusetts', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'James Talcott, MD, SM', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Massachusetts General Hospital', 'geoPoint': {'lat': 42.35843, 'lon': -71.05977}}, {'zip': '02115', 'city': 'Boston', 'state': 'Massachusetts', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': "Anthony D'Amico, MD", 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': "Dana-Farber Cancer Institute/Brigham and Women's Hospital", 'geoPoint': {'lat': 42.35843, 'lon': -71.05977}}, {'zip': '02215', 'city': 'Boston', 'state': 'Massachusetts', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Irving Kaplan, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Beth Israel Deaconess Medical Center', 'geoPoint': {'lat': 42.35843, 'lon': -71.05977}}], 'centralContacts': [{'name': 'James Talcott, MD, SM', 'role': 'CONTACT', 'email': 'jtalcott@partners.org', 'phone': '617-724-5451'}, {'name': 'Anita Rodrigues', 'role': 'CONTACT', 'email': 'aerodrigues@partners.org'}], 'overallOfficials': [{'name': 'James Talcott, MD, SM', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Massachusetts General Hospital'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Massachusetts General Hospital', 'class': 'OTHER'}, 'collaborators': [{'name': 'Dana-Farber Cancer Institute', 'class': 'OTHER'}, {'name': "Brigham and Women's Hospital", 'class': 'OTHER'}, {'name': 'Beth Israel Deaconess Medical Center', 'class': 'OTHER'}, {'name': 'Metro West Medical Center', 'class': 'OTHER'}, {'name': 'United States Department of Defense', 'class': 'FED'}], 'responsibleParty': {'oldNameTitle': 'James Talcott, MD, SM', 'oldOrganization': 'Massachusetts General Hospital'}}}}