Ignite Creation Date:
2025-12-24 @ 4:11 PM
Ignite Modification Date:
2026-01-22 @ 5:14 PM
Study NCT ID:
NCT01744366
Status:
COMPLETED
Last Update Posted:
2015-06-23
First Post:
2012-12-05
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
One Month Degarelix/Comparator Treatment for Prostate Cancer in Chinese Population
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': 'C431566', 'term': 'acetyl-2-naphthylalanyl-3-chlorophenylalanyl-1-oxohexadecyl-seryl-4-aminophenylalanyl(hydroorotyl)-4-aminophenylalanyl(carbamoyl)-leucyl-ILys-prolyl-alaninamide'}, {'id': 'D017273', 'term': 'Goserelin'}], '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': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 285}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2013-01'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2015-06', 'completionDateStruct': {'date': '2015-05', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2015-06-22', 'studyFirstSubmitDate': '2012-12-05', 'studyFirstSubmitQcDate': '2012-12-05', 'lastUpdatePostDateStruct': {'date': '2015-06-23', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2012-12-06', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2015-05', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Cumulative probability of testosterone at castrate level (≤0.5 ng/mL)', 'timeFrame': 'Day 28 to Day 364'}], 'secondaryOutcomes': [{'measure': 'Proportion of patients with testosterone levels ≤0.5 ng/mL', 'timeFrame': 'at Day 3'}, {'measure': 'Percentage change in prostate-specific antigen (PSA)', 'timeFrame': 'from baseline to Day 28'}, {'measure': 'Changes in testosterone and PSA levels', 'timeFrame': 'Day 0 to 364'}, {'measure': 'Significant changes in laboratory values', 'timeFrame': 'Day 0 to Day 364'}, {'measure': 'Significant changes in vital signs', 'timeFrame': 'Day 0 to Day 364'}, {'measure': 'Significant changes in body weight', 'timeFrame': 'Day 0 to Day 364'}, {'measure': 'Frequency and severity of adverse events', 'timeFrame': 'Day 0 to Day 364'}, {'measure': 'Cumulative probability of no PSA failure', 'timeFrame': 'Day 0 to Day 364', 'description': 'PSA failure defined as two consecutive (at least two weeks apart) increase of 50 percentage and at least 5ng/mL increase compared to nadir'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Prostate Cancer']}, 'referencesModule': {'references': [{'pmid': '34350976', 'type': 'DERIVED', 'citation': 'Zengerling F, Jakob JJ, Schmidt S, Meerpohl JJ, Blumle A, Schmucker C, Mayer B, Kunath F. Degarelix for treating advanced hormone-sensitive prostate cancer. Cochrane Database Syst Rev. 2021 Aug 5;8(8):CD012548. doi: 10.1002/14651858.CD012548.pub2.'}]}, 'descriptionModule': {'briefSummary': 'One month degarelix/comparator treatment for prostate cancer in Chinese population'}, 'eligibilityModule': {'sex': 'MALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Chinese male over 18 years\n* Adenocarcinoma of the prostate\n* Relevant disease status based on lab values and as judged by the physician\n* Life expectancy of at least a year\n\nExclusion Criteria:\n\n* Previous hormonal treatment for prostate cancer\n* Considered to be candidate for curative therapy\n* Risk or history of any serious or significant health condition\n* Has received an investigational drug within the last 28 days and no previous treatment with degarelix'}, 'identificationModule': {'nctId': 'NCT01744366', 'acronym': 'PANDA', 'briefTitle': 'One Month Degarelix/Comparator Treatment for Prostate Cancer in Chinese Population', 'organization': {'class': 'INDUSTRY', 'fullName': 'Ferring Pharmaceuticals'}, 'officialTitle': 'An Open-label, Multi-centre, Randomised, Parallel-group Trial, Comparing Efficacy and Safety of Degarelix One-month Dosing Regimen With Goserelin in Chinese Patients With Prostate Cancer Requiring Androgen Ablation Therapy', 'orgStudyIdInfo': {'id': '000006'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Degarelix', 'description': 'Degarelix 240/80 mg', 'interventionNames': ['Drug: Degarelix']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Goserelin', 'description': 'Goserelin 3.6 mg', 'interventionNames': ['Drug: Goserelin']}], 'interventions': [{'name': 'Degarelix', 'type': 'DRUG', 'armGroupLabels': ['Degarelix']}, {'name': 'Goserelin', 'type': 'DRUG', 'armGroupLabels': ['Goserelin']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Beijing', 'state': 'Beijing Municipality', 'country': 'China', 'facility': 'Cancer Institute & Hospital. Chinese Academy of Medical Sciences', 'geoPoint': {'lat': 39.9075, 'lon': 116.39723}}, {'city': 'Chongqing', 'state': 'Chongqing Municipality', 'country': 'China', 'facility': "Affiliated Southwest Hospital of 3rd Military Medical University of People's Liberation Army", 'geoPoint': {'lat': 29.56026, 'lon': 106.55771}}, {'city': 'Guangzhou', 'state': 'Guangdong', 'country': 'China', 'facility': '1st Afilliated Hospital of Guangzhou Medical College', 'geoPoint': {'lat': 23.11667, 'lon': 113.25}}, {'city': 'Wuhan', 'state': 'Hubei', 'country': 'China', 'facility': 'Renmin Hospital of Wuhan University', 'geoPoint': {'lat': 30.58333, 'lon': 114.26667}}, {'city': 'Xi’an', 'state': 'Shanxi', 'country': 'China', 'facility': "2nd.Affiliated Hospital of Xi'an Jiaotong University College of Medicine", 'geoPoint': {'lat': 35.99785, 'lon': 113.52486}}, {'city': 'Hangzhou', 'state': 'Zhejiang', 'country': 'China', 'facility': '1st Hospital Affiliated to Zhejiang University Medical School', 'geoPoint': {'lat': 30.29365, 'lon': 120.16142}}, {'city': 'Beijing', 'country': 'China', 'facility': 'Beijing Hospital of Ministry of Health', 'geoPoint': {'lat': 39.9075, 'lon': 116.39723}}, {'city': 'Beijing', 'country': 'China', 'facility': 'Peking Union Hospital', 'geoPoint': {'lat': 39.9075, 'lon': 116.39723}}, {'city': 'Beijing', 'country': 'China', 'facility': 'Peking University 3rd Hospital', 'geoPoint': {'lat': 39.9075, 'lon': 116.39723}}, {'city': 'Beijing', 'country': 'China', 'facility': "Peking University People's Hospital", 'geoPoint': {'lat': 39.9075, 'lon': 116.39723}}, {'city': 'Changchun', 'country': 'China', 'facility': '1st Hospital of Jilin University', 'geoPoint': {'lat': 43.88, 'lon': 125.32278}}, {'city': 'Changsha', 'country': 'China', 'facility': 'Hunan Cancer Hospital', 'geoPoint': {'lat': 28.19874, 'lon': 112.97087}}, {'city': 'Changsha', 'country': 'China', 'facility': "Hunan Province People's Hospital", 'geoPoint': {'lat': 28.19874, 'lon': 112.97087}}, {'city': 'Chengdu', 'country': 'China', 'facility': "People's Hospital of Sichuan", 'geoPoint': {'lat': 30.66667, 'lon': 104.06667}}, {'city': 'Hangzhou', 'country': 'China', 'facility': '2nd Hospital Affiliated to Zhejiang University Medical School', 'geoPoint': {'lat': 30.29365, 'lon': 120.16142}}, {'city': 'Lanzhou', 'country': 'China', 'facility': '1st Hospital of Lanzhou University', 'geoPoint': {'lat': 36.05701, 'lon': 103.83987}}, {'city': 'Nanchang', 'country': 'China', 'facility': '1st Affiliated Hospital of Nanchang University', 'geoPoint': {'lat': 28.68396, 'lon': 115.85306}}, {'city': 'Nanjing', 'country': 'China', 'facility': '1st Affiliated Hospital of Nanjing Medical University', 'geoPoint': {'lat': 32.06167, 'lon': 118.77778}}, {'city': 'Nanjing', 'country': 'China', 'facility': 'Drum Tower Hospital Affiliated to Nanjing University Medical School', 'geoPoint': {'lat': 32.06167, 'lon': 118.77778}}, {'city': 'Shanghai', 'country': 'China', 'facility': 'Fudan University Shanghai Cancer Center', 'geoPoint': {'lat': 31.22222, 'lon': 121.45806}}, {'city': 'Shanghai', 'country': 'China', 'facility': 'Huashan Hospital of Fudan University', 'geoPoint': {'lat': 31.22222, 'lon': 121.45806}}, {'city': 'Shanghai', 'country': 'China', 'facility': "Shanghai 5th People's Hospital affilicated to Fudan University", 'geoPoint': {'lat': 31.22222, 'lon': 121.45806}}, {'city': 'Shanghai', 'country': 'China', 'facility': 'Shanghai Changhai Hospital', 'geoPoint': {'lat': 31.22222, 'lon': 121.45806}}, {'city': 'Shenyang', 'country': 'China', 'facility': '1st Hospital Affiliated to China Medical University', 'geoPoint': {'lat': 41.79222, 'lon': 123.43278}}, {'city': 'Suzhou', 'country': 'China', 'facility': '2nd Hospital Affiliated to Suzhou University', 'geoPoint': {'lat': 31.30408, 'lon': 120.59538}}, {'city': 'Tianjin', 'country': 'China', 'facility': '2nd Hospital of Tianjin Medical University', 'geoPoint': {'lat': 39.14222, 'lon': 117.17667}}, {'city': 'Wuhan', 'country': 'China', 'facility': 'Tongji Hospital of Tongji Medical College, Huazhong University of Science and Technology', 'geoPoint': {'lat': 30.58333, 'lon': 114.26667}}, {'city': 'Wuhan', 'country': 'China', 'facility': 'Zhongnan Hospital of Wuhan University', 'geoPoint': {'lat': 30.58333, 'lon': 114.26667}}, {'city': 'Wuxi', 'country': 'China', 'facility': "1st People's Hospital of Wuxi", 'geoPoint': {'lat': 31.56887, 'lon': 120.28857}}], 'overallOfficials': [{'name': 'Clinical Development Support', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Ferring Pharmaceuticals'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Ferring Pharmaceuticals', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}