Ignite Creation Date:
2025-12-24 @ 4:35 PM
Ignite Modification Date:
2026-02-25 @ 5:53 PM
Study NCT ID:
NCT02238366
Status:
COMPLETED
Last Update Posted:
2019-07-25
First Post:
2014-09-02
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Study To Assess Renewal Of Treatment In Patients Recently Diagnosed 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'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D017329', 'term': 'Triptorelin Pamoate'}, {'id': 'D007273', 'term': 'Injections, Intramuscular'}, {'id': 'D007267', 'term': 'Injections'}], 'ancestors': [{'id': 'D007987', 'term': 'Gonadotropin-Releasing Hormone'}, {'id': 'D010906', 'term': 'Pituitary Hormone-Releasing Hormones'}, {'id': 'D007028', 'term': 'Hypothalamic Hormones'}, {'id': 'D036361', 'term': 'Peptide Hormones'}, {'id': 'D006728', 'term': 'Hormones'}, {'id': 'D006730', 'term': 'Hormones, Hormone Substitutes, and Hormone Antagonists'}, {'id': 'D009479', 'term': 'Neuropeptides'}, {'id': 'D010455', 'term': 'Peptides'}, {'id': 'D000602', 'term': 'Amino Acids, Peptides, and Proteins'}, {'id': 'D009842', 'term': 'Oligopeptides'}, {'id': 'D009419', 'term': 'Nerve Tissue Proteins'}, {'id': 'D011506', 'term': 'Proteins'}, {'id': 'D004333', 'term': 'Drug Administration Routes'}, {'id': 'D004358', 'term': 'Drug Therapy'}, {'id': 'D013812', 'term': 'Therapeutics'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 368}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2013-11'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2019-07', 'completionDateStruct': {'date': '2019-06-06', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2019-07-24', 'studyFirstSubmitDate': '2014-09-02', 'studyFirstSubmitQcDate': '2014-09-10', 'lastUpdatePostDateStruct': {'date': '2019-07-25', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2014-09-12', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2019-06-06', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Percentage of patients for whom the initial Gonadotropin-releasing Hormone (GnRH) analogue formulation has been renewed.', 'timeFrame': '1 month', 'description': 'To evaluate the percentage of patients for whom the initial GnRH analogue formulation has been renewed at 1-month +/- 7 days for Diphereline 3.75mg.'}, {'measure': 'Percentage of patients for whom the initial GnRH analogue formulation has been renewed.', 'timeFrame': '3 months', 'description': 'To evaluate the percentage of patients for whom the initial GnRH analogue formulation has been renewed at at 3-months +/- 10 days for Diphereline PR 11.25mg (Visit 2).'}], 'secondaryOutcomes': [{'measure': 'Percentage of patients for whom the initial GnRH analogue formulation has been renewed at each follow up visit', 'timeFrame': '6 and 12 months', 'description': 'To evaluate the percentage of patients for whom the initial GnRH formulation (triptorelin-Diphereline®) had been renewed at each follow up visit \\[Visit 3 (at 6-months +/- 3 weeks), Visit 4 (at 12-months +/- 6 weeks)\\].'}, {'measure': 'Percentage of patients that switched from a 1-month to a 3-months formulation', 'timeFrame': '3, 6, 12 months', 'description': 'To evaluate the percentage of patients having switched from a 1-month to a 3-months formulation at each visit \\[Visit 2 (at 1 month or 3 months), Visit 3 (at 6 months +/- 3 weeks), Visit 4 (at 12 months +/- 6 weeks)\\].'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Prostate Cancer']}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to collect some parameters which may help to provide guidance on how Androgen Deprivation Therapy (ADT) drugs are renewed and physician satisfaction.'}, 'eligibilityModule': {'sex': 'MALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Men recently diagnosed with locally advanced or metastatic prostate cancer receiving ADT.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Adult men, ≥18 years old, with recently diagnosed locally advanced or metastatic prostate cancer scheduled to receive androgen deprivation therapy as monotherapy or as concomitant and adjuvant therapy in association with radiation therapy, with a 1 or 3 month GnRH analogue triptorelin formulation\n* Expected survival \\> 12 months.\n* Patients having provided written informed consent.\n* Patients mentally fit for completing a questionnaire.\n\nExclusion Criteria:\n\n* Treatment with any investigational drug within the last 3 months before study entry or planning to participate in a study.\n* Patients who already have been treated with a GnRH analogue within the last year.\n* Patients with hypersensitivity to GnRH, GnRH analogue, triptorelin or its excipients.\n* Patients with a contraindication according to SmPC.'}, 'identificationModule': {'nctId': 'NCT02238366', 'acronym': 'CHRONOS3', 'briefTitle': 'Study To Assess Renewal Of Treatment In Patients Recently Diagnosed With Prostate Cancer', 'organization': {'class': 'INDUSTRY', 'fullName': 'Ipsen'}, 'officialTitle': 'A Non-interventional, Multi-centric, Observational, Prospective Study to Collect the Criteria on Which Renewal of GnRH Analogue Treatment With Triptorelin (Diphereline 3.75mg or Diphereline pr 11.25mg) is Made in Patients Recently Diagnosed With Prostate Cancer Requiring Androgen Deprivation Therapy', 'orgStudyIdInfo': {'id': 'A-38-52014-213'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Prostate cancer patients', 'description': 'Patients recently diagnosed with prostate cancer requiring ADT.', 'interventionNames': ['Drug: triptorelin']}], 'interventions': [{'name': 'triptorelin', 'type': 'DRUG', 'otherNames': ['Diphereline 3.75mg or Diphereline PR (prolonged release) 11.25mg intramuscular (IM.) Injection'], 'description': "This is an observational study. Thus, the treatment selection with triptorelin (Diphereline® or Diphereline PR®) is at investigator's discretion based on the current practice principles and guidelines/protocols, in accordance with the Summary of Product Characteristics (SmPC) approved in Romania by the National Medicines Agency.", 'armGroupLabels': ['Prostate cancer patients']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Arad', 'country': 'Romania', 'geoPoint': {'lat': 46.18333, 'lon': 21.31667}}, {'city': 'Bucharest', 'country': 'Romania', 'geoPoint': {'lat': 44.43225, 'lon': 26.10626}}, {'city': 'Cluj-Napoca', 'country': 'Romania', 'geoPoint': {'lat': 46.76667, 'lon': 23.6}}, {'city': 'Constanța', 'country': 'Romania', 'geoPoint': {'lat': 44.18073, 'lon': 28.63432}}, {'city': 'Craiova', 'country': 'Romania', 'geoPoint': {'lat': 44.31667, 'lon': 23.8}}, {'city': 'Iași', 'country': 'Romania', 'geoPoint': {'lat': 47.16667, 'lon': 27.6}}, {'city': 'Timișoara', 'country': 'Romania', 'geoPoint': {'lat': 45.75372, 'lon': 21.22571}}], 'overallOfficials': [{'name': 'Ipsen Medical Director', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Ipsen'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Ipsen', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}