Ignite Creation Date:
2025-12-24 @ 4:24 PM
Ignite Modification Date:
2026-01-01 @ 11:20 AM
Study NCT ID:
NCT02290366
Status:
WITHDRAWN
Last Update Posted:
2022-08-29
First Post:
2014-11-05
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Prospective Evaluation of Focal Brachytherapy Using Cesium-131 For Patients With Low 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': 'C000614985', 'term': 'Cesium-131'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP', 'interventionModelDescription': 'Brachytherapy, using Cesium 131'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 0}}, 'statusModule': {'whyStopped': 'Principal Investigator decision', 'overallStatus': 'WITHDRAWN', 'startDateStruct': {'date': '2014-11', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-08', 'completionDateStruct': {'date': '2022-07-31', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2022-08-23', 'studyFirstSubmitDate': '2014-11-05', 'studyFirstSubmitQcDate': '2014-11-10', 'lastUpdatePostDateStruct': {'date': '2022-08-29', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2014-11-14', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2022-07-31', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'biochemical disease free survival', 'timeFrame': 'five years'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Prostate Cancer']}, 'descriptionModule': {'briefSummary': 'The standard options for men with very low risk prostate cancer include active surveillance and the standard treatment options for low risk disease, i.e. radical prostatectomy, external beam radiotherapy, and whole gland prostate brachytherapy. The present study seeks to evaluate focal brachytherapy using the isotope Cesium 131 to treat patients with low risk prostate cancer. The goals of the study are to determine the biochemical disease free survival at five years in these patients, as well as to determine the acute and late urinary, bowel, and sexual toxicity associated with focal prostate brachytherapy using Cesium 131. Patients eligible for the study will be men with histologically confirmed adenocarcinoma of the prostate with clinical stage T1c-T2aN0M0, Gleason score ≤3+3=6, prostate specific antigen(PSA) \\<10 ng/ml or a PSA density ≤ 0.15 ng/cc, and ≤ 2 cores positive out of a minimum of 12 cores sampled. Additionally, patients must have a single, dominant index lesion on MRI. The study is a phase II study. Patients will be followed prospectively. Dosimetry will be evaluated post-procedure, and PSAs will be obtained every three months in year one and every six months from year two through year five. Urinary, bowel, and sexual morbidity will be assessed by patient survey prior to treatment , two weeks, after treatment, at three month intervals in year one and at six month intervals in years two through five.'}, 'eligibilityModule': {'sex': 'MALE', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Histologically confirmed adenocarcinoma of the prostate\n* Clinical stage T1c-T2aN0M0\n* Gleason score \\<= 3+3=6\n* prostate specific antigen (PSA) \\<10 ng/ml\n* \\<= 2 cores positive out of a minimum of 12 cores sampled'}, 'identificationModule': {'nctId': 'NCT02290366', 'briefTitle': 'Prospective Evaluation of Focal Brachytherapy Using Cesium-131 For Patients With Low Risk Prostate Cancer', 'organization': {'class': 'OTHER', 'fullName': 'University of Pittsburgh'}, 'officialTitle': 'Prospective Evaluation of Focal Brachytherapy Using Cesium-131 For Patients With Low Risk Prostate Cancer', 'orgStudyIdInfo': {'id': 'PRO14020322'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Focal Therapy', 'interventionNames': ['Radiation: Focal prostate brachytherapy with Cesium-131']}], 'interventions': [{'name': 'Focal prostate brachytherapy with Cesium-131', 'type': 'RADIATION', 'armGroupLabels': ['Focal Therapy']}]}, 'contactsLocationsModule': {'locations': [{'zip': '15219', 'city': 'Pittsburgh', 'state': 'Pennsylvania', 'country': 'United States', 'facility': 'UPMC Mercy', 'geoPoint': {'lat': 40.44062, 'lon': -79.99589}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Ronald M. Benoit, MD', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR_INVESTIGATOR', 'investigatorTitle': 'Associate Professor', 'investigatorFullName': 'Ronald M. Benoit, MD', 'investigatorAffiliation': 'University of Pittsburgh'}}}}