Ignite Creation Date:
2025-12-24 @ 1:18 PM
Ignite Modification Date:
2025-12-29 @ 8:21 AM
Study NCT ID:
NCT05110495
Status:
COMPLETED
Last Update Posted:
2025-02-17
First Post:
2021-08-23
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
IGF Inhibition With Xentuzumab Prior to Radical Prostatectomy
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': 'C588089', 'term': 'xentuzumab'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'simon.lord@oncology.ox.ac.uk', 'phone': '01865 227212', 'title': 'Dr Simon Lord', 'organization': 'University of Oxford'}, 'certainAgreement': {'piSponsorEmployee': True}}, 'adverseEventsModule': {'timeFrame': 'From consent to end of study visit (up to 19 weeks).', 'description': 'Adverse Event data was collected during trial visits from investigator-led assessments as specified in the protocol.', 'eventGroups': [{'id': 'EG000', 'title': 'Xentuzumab', 'description': 'All patients were allocated to receive the study IMP, Xentuzumab. Xentuzumab is a humanised IgG1 monoclonal antibody that neutralises the IGF ligands to inhibit activation of IGF-1R and INSR-A, suppressing IGF-mediated proliferation, invasion and therapy resistance.', 'otherNumAtRisk': 27, 'deathsNumAtRisk': 27, 'otherNumAffected': 24, 'seriousNumAtRisk': 27, 'deathsNumAffected': 0, 'seriousNumAffected': 0}], 'otherEvents': [{'term': 'Blood & Lymphatic System Disorders', 'stats': [{'groupId': 'EG000', 'numAtRisk': 27, 'numEvents': 10, 'numAffected': 5}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.0'}, {'term': 'Eye disorders', 'stats': [{'groupId': 'EG000', 'numAtRisk': 27, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.0'}, {'term': 'Gastrointestinal Disorders', 'stats': [{'groupId': 'EG000', 'numAtRisk': 27, 'numEvents': 12, 'numAffected': 8}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.0'}, {'term': 'General Disorders & Administration Site Conditions', 'stats': [{'groupId': 'EG000', 'numAtRisk': 27, 'numEvents': 15, 'numAffected': 11}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.0'}, {'term': 'Infections & Infestations', 'stats': [{'groupId': 'EG000', 'numAtRisk': 27, 'numEvents': 6, 'numAffected': 5}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.0'}, {'term': 'Injury; poisoning and procedural complications', 'stats': [{'groupId': 'EG000', 'numAtRisk': 27, 'numEvents': 3, 'numAffected': 3}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.0'}, {'term': 'Metabolism & Nutrition Disorders', 'stats': [{'groupId': 'EG000', 'numAtRisk': 27, 'numEvents': 5, 'numAffected': 4}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.0'}, {'term': 'Musculoskeletal & Connective Tissue Disorders', 'stats': [{'groupId': 'EG000', 'numAtRisk': 27, 'numEvents': 7, 'numAffected': 7}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.0'}, {'term': 'Nervous System Disorders', 'stats': [{'groupId': 'EG000', 'numAtRisk': 27, 'numEvents': 8, 'numAffected': 6}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.0'}, {'term': 'Renal and urinary disorders', 'stats': [{'groupId': 'EG000', 'numAtRisk': 27, 'numEvents': 13, 'numAffected': 11}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.0'}, {'term': 'Reproductive system and breast disorders', 'stats': [{'groupId': 'EG000', 'numAtRisk': 27, 'numEvents': 3, 'numAffected': 3}], 'organSystem': 'Reproductive system and breast disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.0'}, {'term': 'Respiratory, thoracic and mediastinal disorders', 'stats': [{'groupId': 'EG000', 'numAtRisk': 27, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.0'}, {'term': 'Skin and subcutaneous tissue disorders', 'stats': [{'groupId': 'EG000', 'numAtRisk': 27, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.0'}, {'term': 'Surgical and medical procedures', 'stats': [{'groupId': 'EG000', 'numAtRisk': 27, 'numEvents': 3, 'numAffected': 3}], 'organSystem': 'Surgical and medical procedures', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.0'}, {'term': 'Vascular disorders', 'stats': [{'groupId': 'EG000', 'numAtRisk': 27, 'numEvents': 6, 'numAffected': 3}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.0'}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Percentage Change of Phospho-IGF-1R Positive Tumour Cells Following Treatment With Xentuzumab', 'denoms': [{'units': 'Participants', 'counts': [{'value': '21', 'groupId': 'OG000'}]}, {'units': 'Tissue samples', 'counts': [{'value': '42', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Xentuzumab', 'description': 'All patients will be allocated to receive Xentuzumab\n\nXentuzumab: The study IMP is xentuzumab, a humanised IgG1 monoclonal antibody that neutralises the IGF ligands to inhibit activation of IGF-1R and INSR-A, suppressing IGF-mediated proliferation, invasion and therapy resistance'}], 'classes': [{'categories': [{'measurements': [{'value': '-8.28', 'groupId': 'OG000', 'lowerLimit': '-97.94', 'upperLimit': '481.68'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'From first xentuzumab infusion at week 1 (pre-treatment) to surgery at week 4-13 (post-treatment). Up to 13 weeks total.', 'description': 'Diagnostic biopsies (pre-treatment) and in-theatre cores (post-treatment) were stained with phospho-IGF-1R. Percentage of positively stained tumour cells in each sample were compared and the percentage change between timepoints was quantified. A negative percentage change indicates a reduction in phospho-IGF-1R in post-treatment samples. This endpoint was designed to assess the amount of IGF pathway inhibition induced by xentuzumab.', 'unitOfMeasure': 'Percentage change Phospho-IGF-1R+ cells', 'dispersionType': 'Full Range', 'reportingStatus': 'POSTED', 'typeUnitsAnalyzed': 'Tissue samples', 'denomUnitsSelected': 'Tissue samples', 'populationDescription': 'Units given accounts for a pre-treatment and post-treatment sample per participant. Number analysed excludes samples from 6 participants that were missing either the pre-treatment or post-treatment sample, or could not be analysed for other reasons.'}, {'type': 'PRIMARY', 'title': 'Percentage Change of Phospho-S6 Positive Tumour Cells Following Treatment With Xentuzumab', 'denoms': [{'units': 'Participants', 'counts': [{'value': '17', 'groupId': 'OG000'}]}, {'units': 'Tissue samples', 'counts': [{'value': '34', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Xentuzumab', 'description': 'All patients will be allocated to receive Xentuzumab\n\nXentuzumab: The study IMP is xentuzumab, a humanised IgG1 monoclonal antibody that neutralises the IGF ligands to inhibit activation of IGF-1R and INSR-A, suppressing IGF-mediated proliferation, invasion and therapy resistance'}], 'classes': [{'categories': [{'measurements': [{'value': '-52.55', 'groupId': 'OG000', 'lowerLimit': '-87.61', 'upperLimit': '60.11'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'From first xentuzumab infusion at week 1 (pre-treatment) to surgery at week 4-13 (post-treatment). Up to 13 weeks total.', 'description': 'Diagnostic biopsies (pre-treatment) and in-theatre cores (post-treatment) were stained by phospho-S6. Percentage of positively stained tumour cells in each sample were compared and the percentage change between timepoints was quantified. A negative percentage change indicates a reduction in phospho-S6 in post-treatment samples. This endpoint was designed to assess the amount of IGF pathway inhibition induced by xentuzumab.', 'unitOfMeasure': 'Percentage change of Phospho-S6+ cells', 'dispersionType': 'Full Range', 'reportingStatus': 'POSTED', 'typeUnitsAnalyzed': 'Tissue samples', 'denomUnitsSelected': 'Tissue samples', 'populationDescription': 'Units analysed describes pre-treatment and post-treatment sample for each participant. Number analysed excludes 10 participants that were missing either the pre-treatment or post-treatment sample, or could not be analysed for other reasons.'}, {'type': 'SECONDARY', 'title': 'Number of Participants Who Had at Least 4 Doses of Xentuzumab and Proceeded to Have Surgery Per the Protocol Schedule', 'denoms': [{'units': 'Participants', 'counts': [{'value': '26', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Xentuzumab', 'description': 'All patients will be allocated to receive Xentuzumab\n\nXentuzumab: The study IMP is xentuzumab, a humanised IgG1 monoclonal antibody that neutralises the IGF ligands to inhibit activation of IGF-1R and INSR-A, suppressing IGF-mediated proliferation, invasion and therapy resistance'}], 'classes': [{'categories': [{'title': 'Surgery performed on schedule', 'measurements': [{'value': '26', 'groupId': 'OG000'}]}, {'title': 'Surgery delayed by trial treatment', 'measurements': [{'value': '0', 'groupId': 'OG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'From first xentuzumab infusion at week 1 (pre-treatment) to surgery at week 4-13 (post-treatment). Up to 13 weeks total.', 'description': 'This endpoint was a measure of feasibility of the treatment schedule in the pre-operative setting.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Total number of participants who had at least 4 doses of xentuzumab. Excludes one registered patient who progressed prior to surgery and came off trial.'}, {'type': 'SECONDARY', 'title': 'Median Delay in Surgery in Participants Who Had More Than 4 Doses of Xentuzumab (and Whose Surgery Was Delayed by Factors Other Than Trial Treatment)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '15', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Xentuzumab', 'description': 'All patients will be allocated to receive Xentuzumab\n\nXentuzumab: The study IMP is xentuzumab, a humanised IgG1 monoclonal antibody that neutralises the IGF ligands to inhibit activation of IGF-1R and INSR-A, suppressing IGF-mediated proliferation, invasion and therapy resistance'}], 'classes': [{'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000', 'lowerLimit': '2', 'upperLimit': '9'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'From first xentuzumab infusion at week 1 (pre-treatment) to surgery at week 4-13 (post-treatment). Up to 13 weeks total.', 'description': 'All participants who had more than 4 doses of xentuzumab were considered to have had their surgery delayed by factors other than trial treatment. Per protocol, all participants who had delayed surgery received additional weekly doses of xentuzumab. Reason for delay was not recorded as part of the study dataset. This endpoint was a measure of feasibility of the treatment schedule in the pre-operative setting.', 'unitOfMeasure': 'weeks', 'dispersionType': 'Full Range', 'reportingStatus': 'POSTED', 'populationDescription': 'Number of participants who had more than 4 Doses of xentuzumab.'}, {'type': 'SECONDARY', 'title': 'Number of Patients Experiencing an Adverse Event (AE) or Serious Adverse Event (SAE) While On-trial', 'denoms': [{'units': 'Participants', 'counts': [{'value': '27', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Xentuzumab', 'description': 'All patients will be allocated to receive Xentuzumab\n\nXentuzumab: The study IMP is xentuzumab, a humanised IgG1 monoclonal antibody that neutralises the IGF ligands to inhibit activation of IGF-1R and INSR-A, suppressing IGF-mediated proliferation, invasion and therapy resistance'}], 'classes': [{'categories': [{'title': 'Any AE, Highest Grade 1 or 2 (CTCAE v5.0)', 'measurements': [{'value': '23', 'groupId': 'OG000'}]}, {'title': 'Any AE, Highest Grade 3,4,5 (CTCAE v5.0)', 'measurements': [{'value': '1', 'groupId': 'OG000'}]}, {'title': 'Any SAE, Highest Grade 1 or 2 (CTCAE v5.0)', 'measurements': [{'value': '0', 'groupId': 'OG000'}]}, {'title': 'Any SAE, Highest Grade 3,4,5 (CTCAE v5.0)', 'measurements': [{'value': '0', 'groupId': 'OG000'}]}, {'title': 'No AEs or SAEs reported', 'measurements': [{'value': '3', 'groupId': 'OG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'From consent at week -1 to the end of study visit at up to 19 weeks', 'description': 'This endpoint was designed to assess safety and tolerability of xentuzumab administered in the pre-prostatectomy setting. AEs \\& SAEs were graded using CTCAE v5.0, with higher grades considered to be worse outcomes.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'All participants registered to take part in the WINGMEN trial. All participants received xentuzumab.'}, {'type': 'SECONDARY', 'title': 'Number of Patients With Any Adverse Event Assessed as Treatment-Related (TRAE) While On-trial', 'denoms': [{'units': 'Participants', 'counts': [{'value': '27', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Xentuzumab', 'description': 'All patients will be allocated to receive Xentuzumab\n\nXentuzumab: The study IMP is xentuzumab, a humanised IgG1 monoclonal antibody that neutralises the IGF ligands to inhibit activation of IGF-1R and INSR-A, suppressing IGF-mediated proliferation, invasion and therapy resistance'}], 'classes': [{'categories': [{'title': 'Any TRAE, Highest Grade 1 or 2 (CTCAE v5.0)', 'measurements': [{'value': '17', 'groupId': 'OG000'}]}, {'title': 'Any TRAE, Highest Grade 3,4,5 (CTCAE v5.0)', 'measurements': [{'value': '0', 'groupId': 'OG000'}]}, {'title': 'No TRAE', 'measurements': [{'value': '10', 'groupId': 'OG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'From consent at week -1 to the end of study visit at up to 19 weeks', 'description': 'Number of patients with any TRAE from the time of consent to the end of study visit. TRAEs are AEs that are investigator-determined to be definitely, probably or possibly related to treatment with xentuzumab and graded using CTCAE v5.0, with higher grades considered to be worse outcomes.\n\nThis endpoint was designed to assess safety and tolerability of xentuzumab administered in the pre-prostatectomy setting.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'All participants registered to take part in the WINGMEN trial. All participants received xentuzumab.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Xentuzumab', 'description': 'All patients will be allocated to receive Xentuzumab\n\nXentuzumab: The study IMP is xentuzumab, a humanised IgG1 monoclonal antibody that neutralises the IGF ligands to inhibit activation of IGF-1R and INSR-A, suppressing IGF-mediated proliferation, invasion and therapy resistance'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '27'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '25'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '2'}]}], 'dropWithdraws': [{'type': 'Lost to Follow-up', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}]}, {'type': 'Completed treatment with IMP but disease progressed prior to surgery.', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '27', 'groupId': 'BG000'}]}], 'groups': [{'id': 'BG000', 'title': 'Xentuzumab', 'description': 'All patients will be allocated to receive Xentuzumab\n\nXentuzumab: The study IMP is xentuzumab, a humanised IgG1 monoclonal antibody that neutralises the IGF ligands to inhibit activation of IGF-1R and INSR-A, suppressing IGF-mediated proliferation, invasion and therapy resistance'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '66', 'groupId': 'BG000', 'lowerLimit': '50', 'upperLimit': '74'}]}]}], 'paramType': 'MEDIAN', 'unitOfMeasure': 'years', 'dispersionType': 'FULL_RANGE'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'Male', 'measurements': [{'value': '27', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Ethnicity (NIH/OMB)', 'classes': [{'categories': [{'title': 'Hispanic or Latino', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'Not Hispanic or Latino', 'measurements': [{'value': '27', 'groupId': 'BG000'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'United Kingdom', 'categories': [{'measurements': [{'value': '27', 'groupId': 'BG000'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}]}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2022-11-21', 'size': 880839, 'label': 'Study Protocol', 'hasIcf': False, 'hasSap': False, 'filename': 'Prot_000.pdf', 'typeAbbrev': 'Prot', 'uploadDate': '2024-08-21T09:00', 'hasProtocol': True}, {'date': '2024-06-24', 'size': 662114, 'label': 'Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'SAP_001.pdf', 'typeAbbrev': 'SAP', 'uploadDate': '2024-08-21T09:01', 'hasProtocol': False}]}}, 'protocolSection': {'designModule': {'phases': ['EARLY_PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP', 'interventionModelDescription': "This is a phase 0 'window of opportunity' study testing whether xentuzumab blocks IGF signalling and markers of growth in men with localised prostate cancer scheduled for radical prostatectomy"}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 27}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2021-12-17', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-07', 'completionDateStruct': {'date': '2023-05-27', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-01-30', 'studyFirstSubmitDate': '2021-08-23', 'resultsFirstSubmitDate': '2024-08-22', 'studyFirstSubmitQcDate': '2021-11-05', 'lastUpdatePostDateStruct': {'date': '2025-02-17', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2025-01-30', 'studyFirstPostDateStruct': {'date': '2021-11-08', 'type': 'ACTUAL'}, 'resultsFirstPostDateStruct': {'date': '2025-02-17', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-03-20', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Percentage Change of Phospho-IGF-1R Positive Tumour Cells Following Treatment With Xentuzumab', 'timeFrame': 'From first xentuzumab infusion at week 1 (pre-treatment) to surgery at week 4-13 (post-treatment). Up to 13 weeks total.', 'description': 'Diagnostic biopsies (pre-treatment) and in-theatre cores (post-treatment) were stained with phospho-IGF-1R. Percentage of positively stained tumour cells in each sample were compared and the percentage change between timepoints was quantified. A negative percentage change indicates a reduction in phospho-IGF-1R in post-treatment samples. This endpoint was designed to assess the amount of IGF pathway inhibition induced by xentuzumab.'}, {'measure': 'Percentage Change of Phospho-S6 Positive Tumour Cells Following Treatment With Xentuzumab', 'timeFrame': 'From first xentuzumab infusion at week 1 (pre-treatment) to surgery at week 4-13 (post-treatment). Up to 13 weeks total.', 'description': 'Diagnostic biopsies (pre-treatment) and in-theatre cores (post-treatment) were stained by phospho-S6. Percentage of positively stained tumour cells in each sample were compared and the percentage change between timepoints was quantified. A negative percentage change indicates a reduction in phospho-S6 in post-treatment samples. This endpoint was designed to assess the amount of IGF pathway inhibition induced by xentuzumab.'}], 'secondaryOutcomes': [{'measure': 'Number of Participants Who Had at Least 4 Doses of Xentuzumab and Proceeded to Have Surgery Per the Protocol Schedule', 'timeFrame': 'From first xentuzumab infusion at week 1 (pre-treatment) to surgery at week 4-13 (post-treatment). Up to 13 weeks total.', 'description': 'This endpoint was a measure of feasibility of the treatment schedule in the pre-operative setting.'}, {'measure': 'Median Delay in Surgery in Participants Who Had More Than 4 Doses of Xentuzumab (and Whose Surgery Was Delayed by Factors Other Than Trial Treatment)', 'timeFrame': 'From first xentuzumab infusion at week 1 (pre-treatment) to surgery at week 4-13 (post-treatment). Up to 13 weeks total.', 'description': 'All participants who had more than 4 doses of xentuzumab were considered to have had their surgery delayed by factors other than trial treatment. Per protocol, all participants who had delayed surgery received additional weekly doses of xentuzumab. Reason for delay was not recorded as part of the study dataset. This endpoint was a measure of feasibility of the treatment schedule in the pre-operative setting.'}, {'measure': 'Number of Patients Experiencing an Adverse Event (AE) or Serious Adverse Event (SAE) While On-trial', 'timeFrame': 'From consent at week -1 to the end of study visit at up to 19 weeks', 'description': 'This endpoint was designed to assess safety and tolerability of xentuzumab administered in the pre-prostatectomy setting. AEs \\& SAEs were graded using CTCAE v5.0, with higher grades considered to be worse outcomes.'}, {'measure': 'Number of Patients With Any Adverse Event Assessed as Treatment-Related (TRAE) While On-trial', 'timeFrame': 'From consent at week -1 to the end of study visit at up to 19 weeks', 'description': 'Number of patients with any TRAE from the time of consent to the end of study visit. TRAEs are AEs that are investigator-determined to be definitely, probably or possibly related to treatment with xentuzumab and graded using CTCAE v5.0, with higher grades considered to be worse outcomes.\n\nThis endpoint was designed to assess safety and tolerability of xentuzumab administered in the pre-prostatectomy setting.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Prostate Cancer']}, 'descriptionModule': {'briefSummary': 'The WINGMEN trial aims to understand how a hormone-like protein called insulin-like growth factor (IGF) helps prostate cancers grow and become aggressive. IGF is required for normal development, and also helps cancers grow and spread. Men with high blood IGF are at increased risk of developing prostate cancer, and tall men are more likely to get aggressive prostate cancer. The WINGMEN trial will recruit 30 men with prostate cancer who have been offered an operation to remove the prostate. Most men have to wait 4-5 weeks between a decision to have prostate removal surgery, and actually having the operation. In this 4-5 week window we will offer treatment with a new IGF-blocker drug called xentuzumab. The drug is provided by Boehringer Ingelheim and the trial is funded by Prostate Cancer UK.\n\nXentuzumab will be given as an outpatient by once weekly intravenous infusion (drip) in the Early Phase Clinical Trials Unit, Oxford Cancer Centre, Churchill Hospital. In other trials, xentuzumab is being tested in patients with advanced cancer, and is proving to be well-tolerated. After the 4-week treatment, WINGMEN trial patients will have routine prostate removal surgery. Samples of blood and prostate cancer that are surplus to diagnostic need will be taken from the diagnostic prostate biopsy (pre-xentuzumab) and the cancer removed at surgery (after xentuzumab) for research tests. These samples will be compared to measure how effectively xentuzumab reduces signs of tumour growth, and identify which genes and proteins are switched on or off by xentuzumab, and which may therefore be important in helping IGF promote prostate cancer growth. The information we get from the WINGMEN trial may help us to improve treatment of men with prostate cancer, with the long-term aim of reducing the risk of aggressive prostate cancer'}, 'eligibilityModule': {'sex': 'MALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'genderBased': True, 'genderDescription': 'based on gender identity', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\nA patient will be eligible for inclusion in this study if all of the following criteria apply.\n\n1. Men with prostate adenocarcinoma confirmed on prostate biopsy and with sufficient cancer-containing biopsy tissue surplus to diagnostic need to provide 2 sections for primary endpoint analysis.\n2. Scheduled for open or robotic radical prostatectomy\n3. Age ≥ 18 years\n4. Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1 (Appendix 1)\n5. The patient is willing and able to comply with the protocol scheduled follow-up visits and examinations for the duration of the study\n6. Participant is willing and able to give informed consent.\n7. Participants whose partner is of child bearing potential must be willing to ensure that they or their partner use effective contraception during the trial and for 70 days thereafter.\n8. Adequate hematologic, renal and hepatic function, defined as follows:\n\nLaboratory Test Value required Hemoglobin (Hb) ≥90g/L White Blood Count (WBC) \\>2.5 x 10\\*9/L Absolute Neutrophil Count (ANC) ≥ 1.5 x10\\*9/L Platelet count ≥ 100 x 10\\*9/L AST, ALT, and alkaline phosphatase ≤ 2.5 x upper limit of normal eGFR\\* ≥30ml/min\n\n\\*eGFR calculated by Cockcroft \\& Gault formula,\n\nExclusion Criteria:\n\n* A patient will not be eligible for the trial if any of the following apply:\n\n 1. Treated with systemic corticosteroids, insulin, metformin, other oral hypoglycemic agent, or anti-androgens in the 28 days prior to first dose of study drug\n 2. Diabetes mellitus\n 3. Previous prostate radiotherapy\n 4. Current or previous treatment with xentuzumab or other IGF or GH -modifying therapy\n 5. Patients who are known to be serologically positive for Hepatitis B, Hepatitis C or HIV\n 6. Treatment with any other investigational agent, or treatment in another interventional clinical trial within 28 days prior to enrolment\n 7. Other psychological, social or medical condition, physical examination finding or a laboratory abnormality that the Investigator considers would make the patient a poor trial candidate or could interfere with protocol compliance or the interpretation of trial results'}, 'identificationModule': {'nctId': 'NCT05110495', 'acronym': 'WINGMEN', 'briefTitle': 'IGF Inhibition With Xentuzumab Prior to Radical Prostatectomy', 'organization': {'class': 'OTHER', 'fullName': 'University of Oxford'}, 'officialTitle': 'Windows Trial of INsulin-like Growth Factor Neutralising Antibody Xentuzumab in MEN Scheduled for Radical Prostatectomy (WINGMEN)', 'orgStudyIdInfo': {'id': 'OCTO-084'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Xentuzumab', 'description': 'All patients will be allocated to receive Xentuzumab', 'interventionNames': ['Drug: Xentuzumab']}], 'interventions': [{'name': 'Xentuzumab', 'type': 'DRUG', 'description': 'The study IMP is xentuzumab, a humanised IgG1 monoclonal antibody that neutralises the IGF ligands to inhibit activation of IGF-1R and INSR-A, suppressing IGF-mediated proliferation, invasion and therapy resistance', 'armGroupLabels': ['Xentuzumab']}]}, 'contactsLocationsModule': {'locations': [{'zip': 'OX3 7LE', 'city': 'Oxford', 'country': 'United Kingdom', 'facility': 'Churchill Hospital, Oxford University Hospitals', 'geoPoint': {'lat': 51.75222, 'lon': -1.25596}}], 'overallOfficials': [{'name': 'Simon Lord, Prof', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Oxford'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Oxford', 'class': 'OTHER'}, 'collaborators': [{'name': 'Prostate Cancer UK', 'class': 'OTHER'}, {'name': 'Boehringer Ingelheim', 'class': 'INDUSTRY'}], 'responsibleParty': {'type': 'SPONSOR'}}}}