Ignite Creation Date:
2025-12-24 @ 11:40 PM
Ignite Modification Date:
2026-02-23 @ 8:08 PM
Study NCT ID:
NCT00992251
Status:
COMPLETED
Last Update Posted:
2016-12-22
First Post:
2009-10-07
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Eligard Observational Registry for Patients With 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': 'PROSPECTIVE', 'observationalModel': 'CASE_ONLY'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 354}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2009-08'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2016-12', 'completionDateStruct': {'date': '2014-03', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2016-12-21', 'studyFirstSubmitDate': '2009-10-07', 'studyFirstSubmitQcDate': '2009-10-08', 'lastUpdatePostDateStruct': {'date': '2016-12-22', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2009-10-09', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2014-03', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Determine the percentage of patients that will achieve a hormone refractory status at 3 years after initiation of Androgen Deprivation Treatment with Eligard®.', 'timeFrame': '3 Years'}], 'secondaryOutcomes': [{'measure': 'Determine what baseline patient characteristics are associated with becoming hormone refractory at 3 years.', 'timeFrame': '3 years'}, {'measure': 'Collect data on patient demographics, medical history, and change in prostate-, bone- and overall health of the patients receiving androgen ablation treatment using Eligard®.', 'timeFrame': '3 years'}, {'measure': 'Collect referral data if the patient was referred to a medical oncologist during treatment.', 'timeFrame': '3 years'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['prostate cancer'], 'conditions': ['Cancer of the Prostate']}, 'descriptionModule': {'briefSummary': 'The objective of this registry is to collect data on patient demographics, medical history, change in prostate, bone and overall health of the patients receiving androgen ablation treatment using Eligard. Data collected through this national registry program provides an opportunity to increase knowledge of efficacy and safety of the long term treatment with Eligard, provide a platform to better identify patient segments for the therapy with Eligard®. Furthermore registries are the only tools to accurately capture rare adverse events.', 'detailedDescription': '354 patients were enrolled in this study. Only 88 patients completed the study.\n\nFor those patients completing the three years of data collection, 10% were considered Castrate Resistant and remained on Eligard®. For those patients not completing 3 years of follow-up, 8.8% were considered Castrate Resistant and did not continue in the study.'}, 'eligibilityModule': {'sex': 'MALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Patients \\> 18 years of age. Histologically confirmed diagnosis of locally Advanced or Metastatic Prostate Cancer Patient starting an androgen deprivation therapy with Eligard at 3 or 4 month treatment frequency per standard of care.', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Patients \\> 18 years of age.\n* Histologically confirmed diagnosis of locally Advanced or Metastatic Prostate Cancer.\n* Patient starting an androgen deprivation therapy with Eligard at 3 or 4 month treatment frequency per standard of care.\n* Signed written informed consent.\n\nExclusion Criteria:\n\n* Prior ADT (within 6 months).\n* Any concurrent condition that would make it undesirable, in the physician's opinion, for the subject to participate in the study or would jeopardize compliance with the protocol.\n* Life expectancy less than 2 years."}, 'identificationModule': {'nctId': 'NCT00992251', 'briefTitle': 'Eligard Observational Registry for Patients With Prostate Cancer', 'organization': {'class': 'OTHER', 'fullName': 'CMX Research'}, 'officialTitle': 'A Prospective, Single Product, Observational Registry Involving Patients Presenting With Locally Advanced or Metastatic Prostate Cancer Receiving Eligard as Androgen Deprivation Treatment.', 'orgStudyIdInfo': {'id': 'LEUPR_L_04620'}}, 'contactsLocationsModule': {'locations': [{'zip': 'V2S 3N5', 'city': 'Abbotsford', 'state': 'British Columbia', 'country': 'Canada', 'facility': 'Dr. George Vrabec', 'geoPoint': {'lat': 49.05798, 'lon': -122.25257}}, {'zip': 'V1Y 2H4', 'city': 'Kelowna', 'state': 'British Columbia', 'country': 'Canada', 'facility': 'Southern Interior Medical Research Corporation', 'geoPoint': {'lat': 49.88307, 'lon': -119.48568}}, {'zip': 'V3V 1N1', 'city': 'Surrey', 'state': 'British Columbia', 'country': 'Canada', 'facility': 'Dr. Cal Andreou', 'geoPoint': {'lat': 49.10635, 'lon': -122.82509}}, {'zip': 'V3V 1N1', 'city': 'Surrey', 'state': 'British Columbia', 'country': 'Canada', 'facility': 'Dr. Nazif Omar', 'geoPoint': {'lat': 49.10635, 'lon': -122.82509}}, {'zip': 'V4A 4N7', 'city': 'Surrey', 'state': 'British Columbia', 'country': 'Canada', 'facility': 'Dr. Herman Kwan', 'geoPoint': {'lat': 49.10635, 'lon': -122.82509}}, {'zip': 'L4M 7G1', 'city': 'Barrie', 'state': 'Ontario', 'country': 'Canada', 'facility': 'Dr. Joseph Zadra', 'geoPoint': {'lat': 44.40011, 'lon': -79.66634}}, {'zip': 'L6T 4S5', 'city': 'Brampton', 'state': 'Ontario', 'country': 'Canada', 'facility': 'Dr. Jonathan Giddens', 'geoPoint': {'lat': 43.68341, 'lon': -79.76633}}, {'zip': 'N3R 4N3', 'city': 'Brantford', 'state': 'Ontario', 'country': 'Canada', 'facility': 'Brantford Urology Research, Medical Arts Building', 'geoPoint': {'lat': 43.1334, 'lon': -80.26636}}, {'zip': 'L7N 3V2', 'city': 'Burlington', 'state': 'Ontario', 'country': 'Canada', 'facility': 'G. Kenneth Jansz Medicine Professional Corporation', 'geoPoint': {'lat': 43.38621, 'lon': -79.83713}}, {'zip': 'P3E 4T3', 'city': 'Greater Sudbury', 'state': 'Ontario', 'country': 'Canada', 'facility': 'Dr. Bisshwajit Bora', 'geoPoint': {'lat': 46.49, 'lon': -80.99001}}, {'zip': 'N1H 5J1', 'city': 'Guelph', 'state': 'Ontario', 'country': 'Canada', 'facility': 'Dr. Eric Hirshberg', 'geoPoint': {'lat': 43.54594, 'lon': -80.25599}}, {'zip': 'L8N 4A6', 'city': 'Hamilton', 'state': 'Ontario', 'country': 'Canada', 'facility': 'Dr. Anil Dapoor', 'geoPoint': {'lat': 43.25011, 'lon': -79.84963}}, {'zip': 'L6B 1A1', 'city': 'Markham', 'state': 'Ontario', 'country': 'Canada', 'facility': 'Dr. Giovanni A. DiCostanzo', 'geoPoint': {'lat': 43.86682, 'lon': -79.2663}}, {'zip': 'L3X 1W1', 'city': 'Newmarket', 'state': 'Ontario', 'country': 'Canada', 'facility': 'Dr. Morrie Liquornik', 'geoPoint': {'lat': 44.05011, 'lon': -79.46631}}, {'zip': 'M2J 1V1', 'city': 'North York', 'state': 'Ontario', 'country': 'Canada', 'facility': 'Dr. Roger Buckley'}, {'zip': 'M3B 3S6', 'city': 'North York', 'state': 'Ontario', 'country': 'Canada', 'facility': 'Dr. Stanley Flax'}, {'zip': 'M6A 3B5', 'city': 'North York', 'state': 'Ontario', 'country': 'Canada', 'facility': 'Dr. Jack Barkin'}, {'zip': 'L6H 3P1', 'city': 'Oakville', 'state': 'Ontario', 'country': 'Canada', 'facility': 'Dr. Richard Casey', 'geoPoint': {'lat': 43.45011, 'lon': -79.68292}}, {'zip': 'L3V 7V1', 'city': 'Orillia', 'state': 'Ontario', 'country': 'Canada', 'facility': 'Orillia Urology Associates', 'geoPoint': {'lat': 44.60868, 'lon': -79.42068}}, {'zip': 'K9H 1T6', 'city': 'Peterborough', 'state': 'Ontario', 'country': 'Canada', 'facility': 'Kawartha Urology Associates', 'geoPoint': {'lat': 44.30012, 'lon': -78.31623}}, {'zip': 'K9J 7B3', 'city': 'Peterborough', 'state': 'Ontario', 'country': 'Canada', 'facility': 'Dr. Mohamed Elharram', 'geoPoint': {'lat': 44.30012, 'lon': -78.31623}}, {'zip': 'L4C 3X5', 'city': 'Richmond Hill', 'state': 'Ontario', 'country': 'Canada', 'facility': 'Dr. Emmanuel Abara', 'geoPoint': {'lat': 43.87111, 'lon': -79.43725}}, {'zip': 'P6A 2C3', 'city': 'Sault Ste. Marie', 'state': 'Ontario', 'country': 'Canada', 'facility': 'Dr. Vinod Mathur', 'geoPoint': {'lat': 46.51677, 'lon': -84.33325}}, {'zip': 'M1P 2T7', 'city': 'Scarborough Village', 'state': 'Ontario', 'country': 'Canada', 'facility': 'Dr. Edward Woods', 'geoPoint': {'lat': 43.73899, 'lon': -79.22124}}, {'zip': 'M1P 2T7', 'city': 'Toronto', 'state': 'Ontario', 'country': 'Canada', 'facility': 'Dr. Nick Logarakis', 'geoPoint': {'lat': 43.70643, 'lon': -79.39864}}, {'zip': 'M4X 1W4', 'city': 'Toronto', 'state': 'Ontario', 'country': 'Canada', 'facility': 'Dr. Harold Kwok', 'geoPoint': {'lat': 43.70643, 'lon': -79.39864}}, {'zip': 'M6S 4W4', 'city': 'Toronto', 'state': 'Ontario', 'country': 'Canada', 'facility': 'Dr. Ashis Chawla', 'geoPoint': {'lat': 43.70643, 'lon': -79.39864}}, {'zip': 'M6S 4W4', 'city': 'Toronto', 'state': 'Ontario', 'country': 'Canada', 'facility': 'Dr. Jain Umesh', 'geoPoint': {'lat': 43.70643, 'lon': -79.39864}}, {'zip': 'G7H 4J1', 'city': 'Chicoutimi', 'state': 'Quebec', 'country': 'Canada', 'facility': 'Dr. Louis-Rene Barrette', 'geoPoint': {'lat': 48.41963, 'lon': -71.06369}}, {'zip': 'J4V 2H3', 'city': 'Greenfield Park', 'state': 'Quebec', 'country': 'Canada', 'facility': 'Dr. Mahmoud Nachabe', 'geoPoint': {'lat': 45.48649, 'lon': -73.46223}}, {'zip': 'H7G 2E6', 'city': 'Laval', 'state': 'Quebec', 'country': 'Canada', 'facility': 'Polyclinique Med Concorde', 'geoPoint': {'lat': 45.56995, 'lon': -73.692}}, {'zip': 'H2L 4M1', 'city': 'Montreal', 'state': 'Quebec', 'country': 'Canada', 'facility': 'Dr. Thu Van Nguyen', 'geoPoint': {'lat': 45.50884, 'lon': -73.58781}}, {'zip': 'H2X 1N8', 'city': 'Montreal', 'state': 'Quebec', 'country': 'Canada', 'facility': 'Dr. Pierre Karakiewicz', 'geoPoint': {'lat': 45.50884, 'lon': -73.58781}}, {'zip': 'G5L 8W1', 'city': 'Rimouski', 'state': 'Quebec', 'country': 'Canada', 'facility': 'Dr. John Vary', 'geoPoint': {'lat': 48.44879, 'lon': -68.52396}}, {'zip': 'J9P 3Y1', 'city': "Val-d'Or", 'state': 'Quebec', 'country': 'Canada', 'facility': 'Dr. Thierry Tremblay', 'geoPoint': {'lat': 48.0974, 'lon': -77.79737}}, {'zip': 'H4A 1S9', 'city': 'Westmount', 'state': 'Quebec', 'country': 'Canada', 'facility': 'Westmount Med Bldg', 'geoPoint': {'lat': 45.48341, 'lon': -73.59918}}], 'overallOfficials': [{'name': 'Hélène Grassin', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Sanofi'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'CMX Research', 'class': 'OTHER'}, 'collaborators': [{'name': 'Sanofi', 'class': 'INDUSTRY'}], 'responsibleParty': {'type': 'SPONSOR'}}}}