Ignite Creation Date:
2025-12-24 @ 5:42 PM
Ignite Modification Date:
2026-01-05 @ 5:34 PM
Study NCT ID:
NCT00703768
Status:
UNKNOWN
Last Update Posted:
2009-02-17
First Post:
2008-06-19
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Quality of Life for Subjects Receiving Androgen Deprivation Therapy and Have a Doubling in PSA of Either Less Than or Greater Than 1 Year
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': 'ESTIMATED', 'count': 300}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2006-06'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2009-02', 'completionDateStruct': {'date': '2010-07', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2009-02-13', 'studyFirstSubmitDate': '2008-06-19', 'studyFirstSubmitQcDate': '2008-06-19', 'lastUpdatePostDateStruct': {'date': '2009-02-17', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2008-06-23', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2010-06', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Significant difference in FACT-P scores after 12 months between the 2 groups', 'timeFrame': '12 months'}], 'secondaryOutcomes': [{'measure': 'PSA response', 'timeFrame': '12 months'}, {'measure': 'To evaluate the ease of use of FACT-P to measure Quality of Life', 'timeFrame': '12 months'}, {'measure': 'QOL, side effect profile and evaluate the safety and tolerability of Androgen Deprivation Therapy', 'timeFrame': '12 months'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Quality of Life', 'Androgen Deprivation Therapy', 'Goserelin'], 'conditions': ['Prostate Cancer']}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to evaluate if there is a difference in quality of life (as measured by FACT-P) in patients treated with androgen deprivation therapy (ADT) for biochemical failure (PSA recurrence) following surgery or radiation for prostate cancer depending on when ADT is initiated.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Male subjects aged 18 years or older with histologically-confirmed prostate cancer, showing biochemical failure (defined as a rising PSA) following definitive therapy (surgery or radiation) and indicated to receive hormone therapy.', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* 18 years or older\n* Received therapy of curative intent (surgery or radiotherapy)\n* Have a rising PSA which has doubled from a nadir value.\n* Histologically proven prostate cancer requiring androgen deprivation therapy for at least 12 months\n* Written informed consent to participate in the trial.\n\nExclusion Criteria:\n\n* Known hypersensitivity to Zoladex, Casodex, ar any component of these products\n* Prior treatment with LHRH agonist or anti-androgens in the past 12 months\n* Any concomitant condition that would make it undesirable, in the physician's opinion, for the subject to participate in the trial or would jeopardize compliance with the protocol."}, 'identificationModule': {'nctId': 'NCT00703768', 'briefTitle': 'Quality of Life for Subjects Receiving Androgen Deprivation Therapy and Have a Doubling in PSA of Either Less Than or Greater Than 1 Year', 'organization': {'class': 'OTHER', 'fullName': 'Urology South Shore Research Inc.'}, 'officialTitle': 'An Open-Label, Phase ll Trial Comparing FACT-P Scores For Subjects Who Are Indicated To Receive Androgen Deprivation Therapy And Have A Doubling In PSA Post Curative Therapy Of Either Less Than Or Greater Than One Year', 'orgStudyIdInfo': {'id': 'D8664L00006'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'A', 'description': 'Patients who have been identified as having a doubling in PSA from nadir of greater than one year'}, {'label': 'B', 'description': 'Patients who have been identified as having a doubling in PSA from nadir of less than one year.'}]}, 'contactsLocationsModule': {'locations': [{'zip': 'J4V 2H3', 'city': 'Greenfield Park', 'state': 'Quebec', 'status': 'RECRUITING', 'country': 'Canada', 'contacts': [{'name': 'Lorne Aaron, MD', 'role': 'CONTACT', 'email': 'ussr@bellnet.ca', 'phone': '450-671-2945'}, {'name': 'Carol Paris', 'role': 'CONTACT', 'email': 'ussr@bellnet.ca', 'phone': '450-671-2945'}, {'name': 'Lorne Aaron, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Urology South Shore Research Inc.', 'geoPoint': {'lat': 45.48649, 'lon': -73.46223}}], 'centralContacts': [{'name': 'Lorne Aaron', 'role': 'CONTACT', 'email': 'ussr@bellnet.ca', 'phone': '450-671-2945'}, {'name': 'Carol Paris', 'role': 'CONTACT', 'email': 'ussr@bellnet.ca', 'phone': '450-671-2945'}], 'overallOfficials': [{'name': 'Lorne Aaron, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Urology South Shore Research Inc.', 'class': 'OTHER'}, 'collaborators': [{'name': 'AstraZeneca', 'class': 'INDUSTRY'}], 'responsibleParty': {'oldNameTitle': 'Dr. Lorne Aaron', 'oldOrganization': 'Urology South Shore Research Inc.'}}}}