Ignite Creation Date:
2025-12-24 @ 12:59 PM
Ignite Modification Date:
2025-12-28 @ 11:46 AM
Study NCT ID:
NCT01376661
Status:
TERMINATED
Last Update Posted:
2021-04-02
First Post:
2011-06-03
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Outcome Assessment of an Active Surveillance Program for Low Risk Prostate Cancer: An Observational Study
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': 'PROSPECTIVE', 'observationalModel': 'CASE_ONLY'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 8}, 'patientRegistry': False}, 'statusModule': {'whyStopped': "Early termination due to PI's decision to discontinue research activities.", 'overallStatus': 'TERMINATED', 'startDateStruct': {'date': '2009-05', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-03', 'completionDateStruct': {'date': '2016-09-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2021-03-30', 'studyFirstSubmitDate': '2011-06-03', 'studyFirstSubmitQcDate': '2011-06-16', 'lastUpdatePostDateStruct': {'date': '2021-04-02', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2011-06-20', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2016-09-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Percentage of enrolled subjects who remain compliant free until disease progression.', 'timeFrame': '10 years', 'description': 'This measurement will monitor the feasibility of the Active Surveillance Program for men with low risk prostate cancer'}], 'secondaryOutcomes': [{'measure': 'Percentage of enrolled subjects who require definitive therapy', 'timeFrame': '10 years'}, {'measure': 'Quality of Life as measured by patient survey.', 'timeFrame': '10 Years'}, {'measure': 'Overall survival', 'timeFrame': '10 years', 'description': 'This will be a measurement of the treatment outcome.'}, {'measure': 'Cost/Benefit Analysis', 'timeFrame': '10 Years', 'description': 'This measure will determine the feasibility of the Active Surveillance Program.'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Prostate Cancer', 'Active Surveillance', 'Low risk prostate cancer'], 'conditions': ['Prostate Cancer']}, 'descriptionModule': {'briefSummary': 'The purpose of this research study is to monitor the feasibility and outcome of the Active Surveillance Program for men with low risk prostate cancer.', 'detailedDescription': 'The purpose of this observational study is to prospectively monitor the outcome associated with men who meet the eligibility criteria for low risk prostate cancer and elected to participate in the active surveillance program at The Center for Cancer Prevention and Treatment at St. Joseph Hospital. We hope to demonstrate that men who are compliant with a closely monitored active surveillance program for low risk prostate cancer will achieve favorable outcomes by: 1) avoiding the side effects of definitive therapy that may not be necessary; 2) retaining quality of life (QOL) and normal activities; 3) avoiding unnecessary treatment; and 4) decreased health care costs. In addition, we will monitor the possible adverse outcomes that may be associated with the active surveillance program including suboptimal response and/or greater side effects due to delayed initiation of therapy; psychological impact on the patients and caregivers due to anxiety of living with an untreated cancer and/or the requirement for frequent medical examination and periodic prostate biopsies.'}, 'eligibilityModule': {'sex': 'MALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '90 Years', 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Men with low risk prostate cancer.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* At least 18 years of age\n* Histological documented adenocarcinoma of the prostate either newly diagnosed or previously diagnosed. Subjects who are diagnosed more than 3 months prior to time of enrollment in the active surveillance program must have biopsy repeated.\n* PSA \\< 10 ng/ml within 1 month of program enrollment\n* Clinical stage less than or equal to T2a\n* Biopsy sampling with at least 10-12 cores\n* Gleason score less than or equal to 3 + 3\n* No more than 2 cores involved\n* No core more than 50% involved\n* Eligible for definitive therapy\n* Able to provide informed consent\n* Able to complete a QOL questionnaire\n* Able to comply with the scheduled follow-up appointments\n\nExclusion Criteria:\n\n* See inclusion criteria for eligibility'}, 'identificationModule': {'nctId': 'NCT01376661', 'briefTitle': 'Outcome Assessment of an Active Surveillance Program for Low Risk Prostate Cancer: An Observational Study', 'organization': {'class': 'OTHER', 'fullName': 'St. Joseph Hospital of Orange'}, 'officialTitle': 'Outcome Assessment of an Active Surveillance Program for Low Risk Prostate Cancer: An Observational Study', 'orgStudyIdInfo': {'id': '09-009 Active Surveillance'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Active Surveillance/ Prostate Cancer'}]}, 'contactsLocationsModule': {'locations': [{'zip': '92868', 'city': 'Orange', 'state': 'California', 'country': 'United States', 'facility': 'St. Joseph Hospital of Orange', 'geoPoint': {'lat': 33.78779, 'lon': -117.85311}}], 'overallOfficials': [{'name': 'Matthew Greenberger, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'St. Joseph Hospital of Orange'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'St. Joseph Hospital of Orange', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}