Ignite Creation Date:
2025-12-24 @ 11:16 PM
Ignite Modification Date:
2026-01-02 @ 7:22 PM
Study NCT ID:
NCT05458856
Status:
COMPLETED
Last Update Posted:
2025-07-25
First Post:
2022-06-17
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Effects of Triptorelin When Given Every 6-months Under the Skin to Adult Males With Cancer in the Prostate
Sponsor:
Organization:
Raw JSON
{'hasResults': True, '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'}], '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'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'clinical.trials@ipsen.com', 'phone': 'see email', 'title': 'Medical Director', 'organization': 'Ipsen'}, 'certainAgreement': {'piSponsorEmployee': False, 'restrictiveAgreement': True}}, 'adverseEventsModule': {'timeFrame': 'Serious AEs, non-serious AEs and all-cause mortality (deaths) were collected from screening (Day -28) up to end of study visit (Day 337), up to maximum of 365 days', 'description': 'The safety set included all participants who received at least 1 dose of study treatment.', 'eventGroups': [{'id': 'EG000', 'title': 'Triptorelin Embonate 22.5 mg', 'description': 'Participants received triptorelin embonate 22.5 mg SC injection on Days 1 and 169.', 'otherNumAtRisk': 145, 'deathsNumAtRisk': 145, 'otherNumAffected': 38, 'seriousNumAtRisk': 145, 'deathsNumAffected': 4, 'seriousNumAffected': 26}], 'otherEvents': [{'term': 'Hot flush', 'stats': [{'groupId': 'EG000', 'numAtRisk': 145, 'numEvents': 18, 'numAffected': 17}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 27.0'}, {'term': 'Hypertension', 'stats': [{'groupId': 'EG000', 'numAtRisk': 145, 'numEvents': 15, 'numAffected': 14}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 27.0'}, {'term': 'Fall', 'stats': [{'groupId': 'EG000', 'numAtRisk': 145, 'numEvents': 9, 'numAffected': 9}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 27.0'}, {'term': 'Fatigue', 'stats': [{'groupId': 'EG000', 'numAtRisk': 145, 'numEvents': 8, 'numAffected': 8}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 27.0'}], 'seriousEvents': [{'term': 'COVID-19', 'stats': [{'groupId': 'EG000', 'numAtRisk': 145, 'numEvents': 4, 'numAffected': 4}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 27.0'}, {'term': 'Anal abscess', 'stats': [{'groupId': 'EG000', 'numAtRisk': 145, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 27.0'}, {'term': 'Appendicitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 145, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 27.0'}, {'term': 'Lyme disease', 'stats': [{'groupId': 'EG000', 'numAtRisk': 145, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 27.0'}, {'term': 'Pneumonia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 145, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 27.0'}, {'term': 'Foot fracture', 'stats': [{'groupId': 'EG000', 'numAtRisk': 145, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 27.0'}, {'term': 'Head injury', 'stats': [{'groupId': 'EG000', 'numAtRisk': 145, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 27.0'}, {'term': 'Peroneal nerve injury', 'stats': [{'groupId': 'EG000', 'numAtRisk': 145, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 27.0'}, {'term': 'Road traffic accident', 'stats': [{'groupId': 'EG000', 'numAtRisk': 145, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 27.0'}, {'term': 'Skin laceration', 'stats': [{'groupId': 'EG000', 'numAtRisk': 145, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 27.0'}, {'term': 'Disease progression', 'stats': [{'groupId': 'EG000', 'numAtRisk': 145, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 27.0'}, {'term': 'Death', 'stats': [{'groupId': 'EG000', 'numAtRisk': 145, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 27.0'}, {'term': 'General physical health deterioration', 'stats': [{'groupId': 'EG000', 'numAtRisk': 145, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 27.0'}, {'term': 'Squamous cell carcinoma of skin', 'stats': [{'groupId': 'EG000', 'numAtRisk': 145, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 27.0'}, {'term': 'Clear cell renal cell carcinoma', 'stats': [{'groupId': 'EG000', 'numAtRisk': 145, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 27.0'}, {'term': 'Metastases to central nervous system', 'stats': [{'groupId': 'EG000', 'numAtRisk': 145, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 27.0'}, {'term': 'Cerebral haematoma', 'stats': [{'groupId': 'EG000', 'numAtRisk': 145, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 27.0'}, {'term': 'Cerebral ischaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 145, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 27.0'}, {'term': 'Generalised tonic-clonic seizure', 'stats': [{'groupId': 'EG000', 'numAtRisk': 145, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 27.0'}, {'term': 'Syncope', 'stats': [{'groupId': 'EG000', 'numAtRisk': 145, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 27.0'}, {'term': 'Abdominal pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 145, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 27.0'}, {'term': 'Inguinal hernia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 145, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 27.0'}, {'term': 'Anaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 145, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 27.0'}, {'term': 'Acute myocardial infarction', 'stats': [{'groupId': 'EG000', 'numAtRisk': 145, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 27.0'}, {'term': 'Osteonecrosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 145, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 27.0'}, {'term': 'Nephrolithiasis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 145, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 27.0'}, {'term': 'Pneumothorax spontaneous', 'stats': [{'groupId': 'EG000', 'numAtRisk': 145, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 27.0'}, {'term': 'Hypertension', 'stats': [{'groupId': 'EG000', 'numAtRisk': 145, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 27.0'}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Percentage of Participants Who Maintained Castrate Levels of Serum Testosterone During the Study', 'denoms': [{'units': 'Participants', 'counts': [{'value': '120', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Triptorelin Embonate 22.5 mg', 'description': 'Participants received triptorelin embonate 22.5 mg SC injection on Days 1 and 169.'}], 'classes': [{'categories': [{'measurements': [{'value': '95.0', 'groupId': 'OG000', 'lowerLimit': '89.4', 'upperLimit': '98.1'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Up to Day 337', 'description': 'Blood samples were collected for the measurement of serum testosterone concentrations using a validated, specific and sensitive liquid chromatography tandem mass spectrometry method. Maintenance of castration during the study was defined as testosterone \\<1.735 nanomoles per liter (nmol/L) (\\<50 nanograms/deciliter \\[ng/dL\\]) at Days 29, 85, 141, 169, 253, 309 and 337.', 'unitOfMeasure': 'percentage of participants', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'The full analysis set (FAS) included all participants who signed an informed consent form (ICF) and received 2 administrations of study treatment and completed all visits for testosterone measurement (Days 29, 85, 141, 169, 253, 309 and 337).'}, {'type': 'SECONDARY', 'title': 'Percentage of Participants Castrated on Days 29, 85, 141, 169, 253, 309 and 337', 'denoms': [{'units': 'Participants', 'counts': [{'value': '120', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Triptorelin Embonate 22.5 mg', 'description': 'Participants received triptorelin embonate 22.5 mg SC injection on Days 1 and 169.'}], 'classes': [{'title': 'Day 29', 'categories': [{'measurements': [{'value': '100.0', 'groupId': 'OG000', 'lowerLimit': '97.0', 'upperLimit': '100.0'}]}]}, {'title': 'Day 85', 'categories': [{'measurements': [{'value': '100.0', 'groupId': 'OG000', 'lowerLimit': '97.0', 'upperLimit': '100.0'}]}]}, {'title': 'Day 141', 'categories': [{'measurements': [{'value': '98.3', 'groupId': 'OG000', 'lowerLimit': '94.1', 'upperLimit': '99.8'}]}]}, {'title': 'Day 169', 'categories': [{'measurements': [{'value': '97.5', 'groupId': 'OG000', 'lowerLimit': '92.9', 'upperLimit': '99.5'}]}]}, {'title': 'Day 253', 'categories': [{'measurements': [{'value': '100.0', 'groupId': 'OG000', 'lowerLimit': '97.0', 'upperLimit': '100.0'}]}]}, {'title': 'Day 309', 'categories': [{'measurements': [{'value': '99.2', 'groupId': 'OG000', 'lowerLimit': '95.4', 'upperLimit': '100.0'}]}]}, {'title': 'Day 337', 'categories': [{'measurements': [{'value': '99.2', 'groupId': 'OG000', 'lowerLimit': '95.4', 'upperLimit': '100.0'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Days 29, 85, 141, 169, 253, 309 and 337', 'description': 'Blood samples were collected for the measurement of serum testosterone concentrations using a validated, specific and sensitive liquid chromatography tandem mass spectrometry method. Castration was defined as testosterone \\<1.735 nmol/L (\\<50 ng/dL).', 'unitOfMeasure': 'percentage of participants', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'The FAS included all participants who signed an ICF and received 2 administrations of study treatment and completed all visits for testosterone measurement (Days 29, 85, 141, 169, 253, 309 and 337).'}, {'type': 'SECONDARY', 'title': 'Percentage of Participants With a Serum Testosterone Level <0.694 Nmol/L (<20 ng/dL) During the Study', 'denoms': [{'units': 'Participants', 'counts': [{'value': '120', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Triptorelin Embonate 22.5 mg', 'description': 'Participants received triptorelin embonate 22.5 mg SC injection on Days 1 and 169.'}], 'classes': [{'categories': [{'measurements': [{'value': '83.3', 'groupId': 'OG000', 'lowerLimit': '75.4', 'upperLimit': '89.5'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Up to Day 337', 'description': 'Blood samples were collected for the measurement of serum testosterone concentrations using a validated, specific and sensitive liquid chromatography tandem mass spectrometry method.', 'unitOfMeasure': 'percentage of participants', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'The FAS included all participants who signed an ICF and received 2 administrations of study treatment and completed all visits for testosterone measurement (Days 29, 85, 141, 169, 253, 309 and 337).'}, {'type': 'SECONDARY', 'title': 'Percentage of Participants With a Serum Testosterone Level <0.694 Nmol/L (<20 ng/dL) on Days 29, 85, 141, 169, 253, 309 and 337', 'denoms': [{'units': 'Participants', 'counts': [{'value': '120', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Triptorelin Embonate 22.5 mg', 'description': 'Participants received triptorelin embonate 22.5 mg SC injection on Days 1 and 169.'}], 'classes': [{'title': 'Day 29', 'categories': [{'measurements': [{'value': '92.5', 'groupId': 'OG000', 'lowerLimit': '86.2', 'upperLimit': '96.5'}]}]}, {'title': 'Day 85', 'categories': [{'measurements': [{'value': '92.5', 'groupId': 'OG000', 'lowerLimit': '86.2', 'upperLimit': '96.5'}]}]}, {'title': 'Day 141', 'categories': [{'measurements': [{'value': '92.5', 'groupId': 'OG000', 'lowerLimit': '86.2', 'upperLimit': '96.5'}]}]}, {'title': 'Day 169', 'categories': [{'measurements': [{'value': '94.2', 'groupId': 'OG000', 'lowerLimit': '88.4', 'upperLimit': '97.6'}]}]}, {'title': 'Day 253', 'categories': [{'measurements': [{'value': '95.8', 'groupId': 'OG000', 'lowerLimit': '90.5', 'upperLimit': '98.6'}]}]}, {'title': 'Day 309', 'categories': [{'measurements': [{'value': '95.8', 'groupId': 'OG000', 'lowerLimit': '90.5', 'upperLimit': '98.6'}]}]}, {'title': 'Day 337', 'categories': [{'measurements': [{'value': '98.3', 'groupId': 'OG000', 'lowerLimit': '94.1', 'upperLimit': '99.8'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Days 29, 85, 141, 169, 253, 309 and 337', 'description': 'Blood samples were collected for the measurement of serum testosterone concentrations using a validated, specific and sensitive liquid chromatography tandem mass spectrometry method.', 'unitOfMeasure': 'percentage of participants', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'The FAS included all participants who signed an ICF and received 2 administrations of study treatment and completed all visits for testosterone measurement (Days 29, 85, 141, 169, 253, 309 and 337).'}, {'type': 'SECONDARY', 'title': 'Percentage of Participants Castrated on Days 3 and 7 After Each Injection Administered on Days 1 and 169', 'denoms': [{'units': 'Participants', 'counts': [{'value': '120', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Triptorelin Embonate 22.5 mg', 'description': 'Participants received triptorelin embonate 22.5 mg SC injection on Days 1 and 169.'}], 'classes': [{'title': 'Day 3', 'categories': [{'measurements': [{'value': '92.5', 'groupId': 'OG000', 'lowerLimit': '86.2', 'upperLimit': '96.5'}]}]}, {'title': 'Day 7', 'categories': [{'measurements': [{'value': '98.3', 'groupId': 'OG000', 'lowerLimit': '94.1', 'upperLimit': '99.8'}]}]}, {'title': 'Day 171', 'categories': [{'measurements': [{'value': '95.0', 'groupId': 'OG000', 'lowerLimit': '89.4', 'upperLimit': '98.1'}]}]}, {'title': 'Day 175', 'categories': [{'measurements': [{'value': '95.8', 'groupId': 'OG000', 'lowerLimit': '90.5', 'upperLimit': '98.6'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'On Days 3, 7, 171, and 175', 'description': 'Blood samples were collected for the measurement of serum testosterone concentrations using a validated, specific and sensitive liquid chromatography tandem mass spectrometry method. Castration was defined as testosterone \\<1.735 nmol/L (\\<50 ng/dL).', 'unitOfMeasure': 'percentage of participants', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'The FAS included all participants who signed an ICF and received 2 administrations of study treatment and completed all visits for testosterone measurement (Days 29, 85, 141, 169, 253, 309 and 337).'}, {'type': 'SECONDARY', 'title': 'Percent Change From Baseline in Prostate Specific Antigen (PSA) at Days 169 and 337', 'denoms': [{'units': 'Participants', 'counts': [{'value': '118', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Triptorelin Embonate 22.5 mg', 'description': 'Participants received triptorelin embonate 22.5 mg SC injection on Days 1 and 169.'}], 'classes': [{'title': 'Day 169', 'denoms': [{'units': 'Participants', 'counts': [{'value': '115', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '0.00', 'groupId': 'OG000', 'lowerLimit': '-35.60', 'upperLimit': '0.00'}]}]}, {'title': 'Day 337', 'denoms': [{'units': 'Participants', 'counts': [{'value': '118', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '0.00', 'groupId': 'OG000', 'lowerLimit': '-46.90', 'upperLimit': '14.30'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'Baseline (prior to injection on Day 1), Days 169 and 337', 'description': 'Blood samples were collected for the measurement of plasma PSA concentrations. Percent change in PSA was defined as the absolute value of the difference between the PSA values at Days 169 and 337 and the baseline value divided by the baseline value. The baseline value was the last sample prior to the first injection.', 'unitOfMeasure': 'percent change', 'dispersionType': 'Inter-Quartile Range', 'reportingStatus': 'POSTED', 'populationDescription': 'The FAS included all participants who signed an ICF and received 2 administrations of study treatment and completed all visits for testosterone measurement (Days 29, 85, 141, 169, 253, 309 and 337). Only those participants with data collected at specified timepoints are reported.'}, {'type': 'SECONDARY', 'title': 'Number of Participants With Treatment-Emergent Adverse Events (TEAEs) and TEAEs of Local Intolerance', 'denoms': [{'units': 'Participants', 'counts': [{'value': '145', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Triptorelin Embonate 22.5 mg', 'description': 'Participants received triptorelin embonate 22.5 mg SC injection on Days 1 and 169.'}], 'classes': [{'title': 'TEAEs', 'categories': [{'measurements': [{'value': '88', 'groupId': 'OG000'}]}]}, {'title': 'TEAEs of Local Intolerance', 'categories': [{'measurements': [{'value': '19', 'groupId': 'OG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'From first dose of study treatment (Day 1) up to end of study visit (Day 337)', 'description': 'An adverse event (AE) was any untoward medical occurrence in clinical study participant, temporally associated with use of study treatment, whether or not considered related to study treatment. TEAEs were AEs that started or worsened on or after the first study treatment administration and within 168 days after the last dose of study treatment, or up to Day 337, whichever was later. Local tolerance was assessed 2 hours after each injection by examination of injection site for signs such as but not limited to tenderness, redness, bruising, erythema, swelling, rash, pain, itching, induration, hematoma, ulceration or necrosis.', 'calculatePct': False, 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'The safety set included all participants who received at least 1 dose of study treatment.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Triptorelin Embonate 22.5 mg', 'description': 'Participants received triptorelin embonate 22.5 milligrams (mg) subcutaneous (SC) injection on Days 1 and 169.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '147'}]}, {'type': 'Received Treatment', 'achievements': [{'groupId': 'FG000', 'numSubjects': '145'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '134'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '13'}]}], 'dropWithdraws': [{'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '5'}]}, {'type': 'Death', 'reasons': [{'groupId': 'FG000', 'numSubjects': '4'}]}, {'type': 'Protocol Deviation', 'reasons': [{'groupId': 'FG000', 'numSubjects': '3'}]}, {'type': 'Physician Decision', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}]}]}], 'recruitmentDetails': 'This Phase III, multicenter, open-label, single arm study was conducted at 26 investigational sites in 6 countries from 30-Aug-2022 to 08-Jul-2024 in participants with locally advanced and/or metastatic prostate cancer previously treated and castrated with a gonadotropin-releasing hormone (GnRH) analogue.', 'preAssignmentDetails': 'The study consisted of a screening period (Day -28 to Day -1), study treatment administration on Days 1 and 169 (with visits on Days 3, 7, 29, 85, 141, 171, 175, 253, 309) and an end of study/early discontinuation visit on Day 337. A total of 147 participants were enrolled in the study.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '147', 'groupId': 'BG000'}]}], 'groups': [{'id': 'BG000', 'title': 'Triptorelin Embonate 22.5 mg', 'description': 'Participants received triptorelin embonate 22.5 mg SC injection on Days 1 and 169.'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '71.8', 'spread': '8.43', 'groupId': 'BG000'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'Male', 'measurements': [{'value': '147', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'calculatePct': False, 'unitOfMeasure': 'Participants'}, {'title': 'Ethnicity (NIH/OMB)', 'classes': [{'categories': [{'title': 'Hispanic or Latino', 'measurements': [{'value': '4', 'groupId': 'BG000'}]}, {'title': 'Not Hispanic or Latino', 'measurements': [{'value': '104', 'groupId': 'BG000'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '39', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'calculatePct': False, 'unitOfMeasure': 'Participants'}, {'title': 'Race/Ethnicity, Customized', 'classes': [{'categories': [{'title': 'White', 'measurements': [{'value': '109', 'groupId': 'BG000'}]}, {'title': 'Other', 'measurements': [{'value': '2', 'groupId': 'BG000'}]}, {'title': 'Not Reported', 'measurements': [{'value': '36', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'calculatePct': False, 'unitOfMeasure': 'Participants'}], 'populationDescription': 'The enrolled set included all participants who were enrolled to study treatment.'}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2023-12-05', 'size': 6764391, 'label': 'Study Protocol', 'hasIcf': False, 'hasSap': False, 'filename': 'Prot_000.pdf', 'typeAbbrev': 'Prot', 'uploadDate': '2025-06-27T01:47', 'hasProtocol': True}, {'date': '2023-02-09', 'size': 4753159, 'label': 'Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'SAP_001.pdf', 'typeAbbrev': 'SAP', 'uploadDate': '2025-06-27T01:47', 'hasProtocol': False}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 147}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2022-08-30', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-07', 'completionDateStruct': {'date': '2024-07-08', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-07-24', 'studyFirstSubmitDate': '2022-06-17', 'resultsFirstSubmitDate': '2025-07-04', 'studyFirstSubmitQcDate': '2022-07-13', 'lastUpdatePostDateStruct': {'date': '2025-07-25', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2025-07-04', 'studyFirstPostDateStruct': {'date': '2022-07-14', 'type': 'ACTUAL'}, 'resultsFirstPostDateStruct': {'date': '2025-07-23', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-07-08', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Percentage of Participants Who Maintained Castrate Levels of Serum Testosterone During the Study', 'timeFrame': 'Up to Day 337', 'description': 'Blood samples were collected for the measurement of serum testosterone concentrations using a validated, specific and sensitive liquid chromatography tandem mass spectrometry method. Maintenance of castration during the study was defined as testosterone \\<1.735 nanomoles per liter (nmol/L) (\\<50 nanograms/deciliter \\[ng/dL\\]) at Days 29, 85, 141, 169, 253, 309 and 337.'}], 'secondaryOutcomes': [{'measure': 'Percentage of Participants Castrated on Days 29, 85, 141, 169, 253, 309 and 337', 'timeFrame': 'Days 29, 85, 141, 169, 253, 309 and 337', 'description': 'Blood samples were collected for the measurement of serum testosterone concentrations using a validated, specific and sensitive liquid chromatography tandem mass spectrometry method. Castration was defined as testosterone \\<1.735 nmol/L (\\<50 ng/dL).'}, {'measure': 'Percentage of Participants With a Serum Testosterone Level <0.694 Nmol/L (<20 ng/dL) During the Study', 'timeFrame': 'Up to Day 337', 'description': 'Blood samples were collected for the measurement of serum testosterone concentrations using a validated, specific and sensitive liquid chromatography tandem mass spectrometry method.'}, {'measure': 'Percentage of Participants With a Serum Testosterone Level <0.694 Nmol/L (<20 ng/dL) on Days 29, 85, 141, 169, 253, 309 and 337', 'timeFrame': 'Days 29, 85, 141, 169, 253, 309 and 337', 'description': 'Blood samples were collected for the measurement of serum testosterone concentrations using a validated, specific and sensitive liquid chromatography tandem mass spectrometry method.'}, {'measure': 'Percentage of Participants Castrated on Days 3 and 7 After Each Injection Administered on Days 1 and 169', 'timeFrame': 'On Days 3, 7, 171, and 175', 'description': 'Blood samples were collected for the measurement of serum testosterone concentrations using a validated, specific and sensitive liquid chromatography tandem mass spectrometry method. Castration was defined as testosterone \\<1.735 nmol/L (\\<50 ng/dL).'}, {'measure': 'Percent Change From Baseline in Prostate Specific Antigen (PSA) at Days 169 and 337', 'timeFrame': 'Baseline (prior to injection on Day 1), Days 169 and 337', 'description': 'Blood samples were collected for the measurement of plasma PSA concentrations. Percent change in PSA was defined as the absolute value of the difference between the PSA values at Days 169 and 337 and the baseline value divided by the baseline value. The baseline value was the last sample prior to the first injection.'}, {'measure': 'Number of Participants With Treatment-Emergent Adverse Events (TEAEs) and TEAEs of Local Intolerance', 'timeFrame': 'From first dose of study treatment (Day 1) up to end of study visit (Day 337)', 'description': 'An adverse event (AE) was any untoward medical occurrence in clinical study participant, temporally associated with use of study treatment, whether or not considered related to study treatment. TEAEs were AEs that started or worsened on or after the first study treatment administration and within 168 days after the last dose of study treatment, or up to Day 337, whichever was later. Local tolerance was assessed 2 hours after each injection by examination of injection site for signs such as but not limited to tenderness, redness, bruising, erythema, swelling, rash, pain, itching, induration, hematoma, ulceration or necrosis.'}]}, 'oversightModule': {'isUsExport': True, 'oversightHasDmc': False, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Prostate Cancer']}, 'referencesModule': {'seeAlsoLinks': [{'url': 'https://www.ipsen.com/websites/ipsen_com_v2/wp-content/uploads/2025/07/04145025/D-FR-52014-245_Lay-Summary_Final_04Jul2025.pdf', 'label': 'Lay language results summary'}]}, 'descriptionModule': {'briefSummary': 'The aim of the study is to determine if triptorelin formulated for use every 6 months (given twice during the study) is effective and safe for when given by injection under the skin for the treatment of adult males with cancer in the prostate.'}, 'eligibilityModule': {'sex': 'MALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'genderBased': True, 'genderDescription': 'Participant is male as indication is prostate cancer', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria :\n\n* Participant is male and must be 18 years of age inclusive, at the time of signing the informed consent\n* Participant has histologically or cytologically proven prostate cancer with rising PSA after failed local therapy or metastatic disease, or requiring radiotherapy, and be a candidate for long-term (i.e. \\>1 year) androgen deprivation therapy\n* Participant requires a GnRH analogue treatment for a minimum of 18 months, of which a minimum of 3 months of GnRH analogue treatment has already been provided prior to screening. (Note: participants must receive study intervention on Day 1 in accordance with the treatment schedule of their previously received GnRH analogue therapy).\n* Has serum testosterone levels \\<1.735 nmol/L (50 ng/dL) at screening\n* Has Eastern Cooperative Oncology Group (ECOG) performance status score of 0 to 1\n* Has a life expectancy of \\>18 months\n* Male participants must agree that, if their partner is at risk of becoming pregnant (although highly unlikely in this study population), they will use an effective method of contraception. The participant must agree to use the contraception during the whole of the study and for 9 months after the last dose of study intervention\n* Capable of giving signed informed consent which includes compliance with the requirements and restrictions listed in the informed consent form (ICF) and in the protocol\n\nExclusion Criteria :\n\n* Presence of another neoplastic lesion or brain metastases\n* Metastatic hormone-sensitive prostate cancer with high tumour burden\n* Metastatic castration-resistant prostate cancer\n* Any concomitant disorder or resulting therapy that is likely to interfere with participant compliance or with the study in the opinion of the investigator\n* Use of finasteride (Proscar®) or dutasteride (Avodart®/Avolve®) within the past 6 months\n* Planned intermittent scheme of GnRH analogue\n* At the time of screening, planned use of any chemotherapy for prostate cancer during the study\n* Prior hypophysectomy or adrenalectomy\n* Participation in another study with an experimental drug within 3 months before signing informed consent or within five half-lives of the investigational drug (whichever was the longer), or any other type of medical research\n* Severe kidney or liver failure (creatinine \\>2 times the normal range, aspartate aminotransferase and alanine aminotransferase \\>3 times the normal range)\n* Any concomitant disorder or resulting therapy that is likely to interfere with participant's compliance, the subcutaneous administration of the drug or with the study in the opinion of the investigator\n* Previous history of QT prolongation or concomitant use of medicinal products known to prolong the QT interval or with a known risk of torsades de pointes\n* Known hypersensitivity to triptorelin or any of its excipients, GnRH, other GnRH agonist/analogues\n* Known active use of recreational drug or alcohol dependence in the opinion of the investigator\n* Inability to give informed consent or to comply fully with the protocol"}, 'identificationModule': {'nctId': 'NCT05458856', 'acronym': 'TriptoSwitch', 'briefTitle': 'Effects of Triptorelin When Given Every 6-months Under the Skin to Adult Males With Cancer in the Prostate', 'organization': {'class': 'INDUSTRY', 'fullName': 'Ipsen'}, 'officialTitle': 'An Open-label, Multicentre, Single Arm Study to Assess the Efficacy and Safety of Triptorelin 6-month Formulation Administered Subcutaneously in Participants With Locally Advanced and/or Metastatic Prostate Cancer Previously Treated and Castrated With a GnRH Analogue', 'orgStudyIdInfo': {'id': 'D-FR-52014-245'}, 'secondaryIdInfos': [{'id': '2021-005719-29', 'type': 'EUDRACT_NUMBER'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Triptorelin embonate', 'description': 'All participants will receive triptorelin embonate 22.5 mg', 'interventionNames': ['Drug: Triptorelin embonate 22.5 mg']}], 'interventions': [{'name': 'Triptorelin embonate 22.5 mg', 'type': 'DRUG', 'otherNames': ['Decapeptyl'], 'description': 'A prolonged release formulation of triptorelin pamoate 22.5 mg 6-month formulation in D, L-lactide-co-glycolide polymers for single subcutaneous injection on Day 1 and Day 169', 'armGroupLabels': ['Triptorelin embonate']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Brussels', 'country': 'Belgium', 'facility': 'Cliniques Universitaires Saint-Luc', 'geoPoint': {'lat': 50.85045, 'lon': 4.34878}}, {'city': 'Edegem', 'country': 'Belgium', 'facility': 'UZ Antwerpen', 'geoPoint': {'lat': 51.15662, 'lon': 4.44504}}, {'zip': '8500', 'city': 'Kortrijk', 'country': 'Belgium', 'facility': 'AZGroeninge', 'geoPoint': {'lat': 50.82803, 'lon': 3.26487}}, {'city': 'Liège', 'country': 'Belgium', 'facility': 'CHU de Liège - Domaine Universitaire du Sart Tilman - Urologie', 'geoPoint': {'lat': 50.63373, 'lon': 5.56749}}, {'city': 'Brno', 'country': 'Czechia', 'facility': 'Fakultni nemocnice u sv. 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Polyclinique Du Bois', 'geoPoint': {'lat': 50.63391, 'lon': 3.05512}}, {'zip': '69437', 'city': 'Lyon', 'country': 'France', 'facility': 'CHU Hopital Edouard Herriot', 'geoPoint': {'lat': 45.74906, 'lon': 4.84789}}, {'zip': '75014', 'city': 'Paris', 'country': 'France', 'facility': "L'Institut Mutualiste Montsouris", 'geoPoint': {'lat': 48.85341, 'lon': 2.3488}}, {'zip': '75018', 'city': 'Paris', 'country': 'France', 'facility': 'Hopital Bichat', 'geoPoint': {'lat': 48.85341, 'lon': 2.3488}}, {'zip': '69495', 'city': 'Pierre-Bénite', 'country': 'France', 'facility': 'Centre hospitalier Lyon Sud', 'geoPoint': {'lat': 45.70359, 'lon': 4.82424}}, {'zip': '92151', 'city': 'Suresnes', 'country': 'France', 'facility': 'Hopital Foch - Urologie et Transplantation Ré', 'geoPoint': {'lat': 48.87143, 'lon': 2.22929}}, {'zip': '31400', 'city': 'Toulouse', 'country': 'France', 'facility': 'Saint Jean Languedoc and La Croix du Sud Hospital', 'geoPoint': {'lat': 43.60426, 'lon': 1.44367}}, {'zip': '01307', 'city': 'Dresden', 'country': 'Germany', 'facility': 'Universitätsklinikum Carl Gustav Carus', 'geoPoint': {'lat': 51.05089, 'lon': 13.73832}}, {'city': 'Jena', 'country': 'Germany', 'facility': 'University Hospital Jena KöR', 'geoPoint': {'lat': 50.92878, 'lon': 11.5899}}, {'zip': '48149', 'city': 'Münster', 'country': 'Germany', 'facility': 'Universitaetsklinikum Muenster', 'geoPoint': {'lat': 51.96236, 'lon': 7.62571}}, {'zip': '72622', 'city': 'Nürtingen', 'country': 'Germany', 'facility': 'Studienpraxis Urologie', 'geoPoint': {'lat': 48.62565, 'lon': 9.34203}}, {'city': 'Tübingen', 'country': 'Germany', 'facility': 'Universität Tuebingen - Urology', 'geoPoint': {'lat': 48.52266, 'lon': 9.05222}}, {'city': 'Kaunas', 'country': 'Lithuania', 'facility': 'Hospital of Lithuanian University of Health Sciences Kaunas', 'geoPoint': {'lat': 54.90156, 'lon': 23.90909}}, {'zip': 'LT92288', 'city': 'Klaipėda', 'country': 'Lithuania', 'facility': 'Klaipeda University Hospital', 'geoPoint': {'lat': 55.7068, 'lon': 21.13912}}, {'zip': 'LT-08660', 'city': 'Vilnius', 'country': 'Lithuania', 'facility': 'National Cancer Institute', 'geoPoint': {'lat': 54.68916, 'lon': 25.2798}}, {'city': 'Vilnius', 'country': 'Lithuania', 'facility': 'Vilniaus Universiteto ligonines Santariskiu Klinikos', 'geoPoint': {'lat': 54.68916, 'lon': 25.2798}}, {'city': 'Amsterdam', 'country': 'Netherlands', 'facility': 'The Netherlands Cancer Institute - Oncology', 'geoPoint': {'lat': 52.37403, 'lon': 4.88969}}, {'zip': '5623 EJ', 'city': 'Eindhoven', 'country': 'Netherlands', 'facility': 'Catharina Ziekenhuis - Urology', 'geoPoint': {'lat': 51.44083, 'lon': 5.47778}}, {'zip': '6532 SZ', 'city': 'Nijmegen', 'country': 'Netherlands', 'facility': 'CWZ', 'geoPoint': {'lat': 51.8425, 'lon': 5.85278}}, {'city': 'The Hague', 'country': 'Netherlands', 'facility': 'Haga Ziekenhuis', 'geoPoint': {'lat': 52.07667, 'lon': 4.29861}}, {'zip': '08035', 'city': 'Barcelona', 'country': 'Spain', 'facility': "Hospital Universitario Vall d'Hebron", 'geoPoint': {'lat': 41.38879, 'lon': 2.15899}}, {'zip': '08041', 'city': 'Barcelona', 'country': 'Spain', 'facility': 'Hospital de La Santa Creu i Sant Pau - Oncología Médica', 'geoPoint': {'lat': 41.38879, 'lon': 2.15899}}, {'zip': '48013', 'city': 'Bilbao', 'country': 'Spain', 'facility': 'H. de Basurto - Urología', 'geoPoint': {'lat': 43.26271, 'lon': -2.92528}}, {'zip': '27004', 'city': 'Lugo', 'country': 'Spain', 'facility': 'POLUSA - Policlínico Lucense - Oncología', 'geoPoint': {'lat': 43.00992, 'lon': -7.55602}}, {'zip': '28041', 'city': 'Madrid', 'country': 'Spain', 'facility': 'Hospital Universitario 12 de Octubre- Urology', 'geoPoint': {'lat': 40.4165, 'lon': -3.70256}}, {'zip': '33011', 'city': 'Oviedo', 'country': 'Spain', 'facility': 'Hospital Universitario Central de Asturias (HUCA)', 'geoPoint': {'lat': 43.36029, 'lon': -5.84476}}, {'zip': '41013', 'city': 'Seville', 'country': 'Spain', 'facility': 'Hospital Universitario Virgen del Rocio- Urología Pediátrica', 'geoPoint': {'lat': 37.38283, 'lon': -5.97317}}, {'zip': '46026', 'city': 'Valencia', 'country': 'Spain', 'facility': 'Hospital Universitari i Politecnic La Fe', 'geoPoint': {'lat': 39.47391, 'lon': -0.37966}}], 'overallOfficials': [{'name': 'Ipsen Medical Director', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Ipsen'}]}, 'ipdSharingStatementModule': {'url': 'https://vivli.org/members/ourmembers/', 'timeFrame': 'Where applicable, data from eligible studies are available 6 months after the studied medicine and indication have been approved in the US and EU or after the primary manuscript describing the results has been accepted for publication, whichever is later.', 'ipdSharing': 'YES', 'description': 'Qualified researchers may request access to patient level data and related study documents including the clinical study report, study protocol with any amendments, annotated case report form, statistical analysis plan, and dataset specifications. Patient level data will be anonymized and study documents will be redacted to protect the privacy of study participants.\n\nAny requests should be submitted to www.vivli.org for assessment by an independent scientific review board.', 'accessCriteria': "Access Criteria: Further details on Ipsen's sharing criteria, eligible studies and process for sharing are available here (https://vivli.org/members/ourmembers/)."}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Ipsen', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}