Ignite Creation Date:
2025-12-25 @ 1:34 AM
Ignite Modification Date:
2025-12-25 @ 11:48 PM
Study NCT ID:
NCT03990194
Status:
WITHDRAWN
Last Update Posted:
2024-10-31
First Post:
2019-06-13
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Real-life Study of Patients After 3-months of Leuprorelin 5mg Implant in 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': 'D016729', 'term': 'Leuprolide'}], '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'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 0}, 'patientRegistry': False}, 'statusModule': {'whyStopped': 'Internal decision', 'overallStatus': 'WITHDRAWN', 'startDateStruct': {'date': '2020-03-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-09', 'completionDateStruct': {'date': '2020-03-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2024-10-29', 'studyFirstSubmitDate': '2019-06-13', 'studyFirstSubmitQcDate': '2019-06-17', 'lastUpdatePostDateStruct': {'date': '2024-10-31', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2019-06-18', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2020-03-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'The percentage of prostate cancer patients at 3 months who attained a testosteronemia threshold of ≤ 0.5 ng/mL following a 3-month treatment with leuprorelin 5 mg implant', 'timeFrame': '3 months', 'description': 'The percentage of prostate cancer patients who attained a testosteronemia threshold of ≤ 0.5 ng/mL following a 3-month treatment with leuprorelin 5 mg implant will be evaluated at 3 months and at 6 months of follow-up'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Prostate Cancer']}, 'descriptionModule': {'briefSummary': 'To improve the management of patients suffering from prostate cancer, Laboratoires BOUCHARA-RECORDATI wish to set up an observational study to document, in daily practice, and over a large population, the profile and clinical and biological follow-up of patients undergoing leuprorelin 5 mg implant as well as the conditions for implant placement. The evolution of these prostate cancer patients will be monitored on the basis of data available in daily practice, including testosterone values, PSA values, and factors that may influence disease progression, in order to objectify whether the observed results are consistent with those described in the clinical studies.', 'detailedDescription': "To improve the management of patients suffering from prostate cancer, Laboratoires BOUCHARA-RECORDATI wish to set up an observational study to document, in daily practice, and over a large population, the profile and clinical and biological follow-up of patients undergoing leuprorelin 5 mg implant as well as the conditions for implant placement. The evolution of these prostate cancer patients will be monitored on the basis of data available in daily practice, including testosterone values, PSA values, and factors that may influence disease progression, in order to objectify whether the observed results are consistent with those described in the clinical studies.\n\nThe psychological dimension of the management of patients with prostate cancer will also be addressed by evaluating the strategies used by patients to cope with their prostate cancer \\[(Prostate Cancer Patients' Coping Strategies Questionnaire (PCPCSQ)\\]."}, 'eligibilityModule': {'sex': 'MALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Patients with prostate cancer for whom the physician has decided to prescribe hormone therapy by subcutaneous leuprorelin implant 5 mg (Leptoprol®).', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients with prostate cancer for whom the physician has decided to prescribe hormone therapy by subcutaneous leuprorelin implant 5 mg (Leptoprol®).\n\nExclusion Criteria:\n\n* Patient who have already participated in another study or those who do not wish to participate in this study.'}, 'identificationModule': {'nctId': 'NCT03990194', 'acronym': 'LEPTO', 'briefTitle': 'Real-life Study of Patients After 3-months of Leuprorelin 5mg Implant in Prostate Cancer', 'organization': {'class': 'INDUSTRY', 'fullName': 'RECORDATI GROUP'}, 'officialTitle': 'Real-life Observational Study of Patients After 3-months of Leuprorelin 5mg Implant and Evaluation of Coping Strategies Among Patients With Prostate Cancer: LEPTO STUDY', 'orgStudyIdInfo': {'id': 'Leptoprol- FR-NIS 0023'}}, 'armsInterventionsModule': {'interventions': [{'name': 'Leuprolide Acetate', 'type': 'DRUG', 'otherNames': ['Leptoprol 5 mg'], 'description': 'Administration of Leptoprol implant every 3 months'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'RECORDATI GROUP', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}