Ignite Creation Date:
2025-12-25 @ 12:43 AM
Ignite Modification Date:
2025-12-25 @ 10:56 PM
Study NCT ID:
NCT01630967
Status:
UNKNOWN
Last Update Posted:
2012-06-28
First Post:
2012-06-25
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Efficacy Study of Switching to a Lutenizing Hormone-releasing Hormone (LHRH) Antagonist From a LHRH Agonist to Treat Progressive Castrate Resistant Prostate Cancer (CRPC)
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'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 40}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2012-08'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2012-06', 'completionDateStruct': {'date': '2013-12', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2012-06-27', 'studyFirstSubmitDate': '2012-06-25', 'studyFirstSubmitQcDate': '2012-06-27', 'lastUpdatePostDateStruct': {'date': '2012-06-28', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2012-06-28', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2013-12', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': '50% fall in PSA', 'timeFrame': '8 weekly', 'description': 'Proportion of patients with castrate resistant prostate cancer (CRPC) who have a PSA decline of ≥50% from baseline when switched from an LHRH agonist to an LHRH antagonist'}], 'secondaryOutcomes': [{'measure': 'Luteinizing hormone (LH)', 'timeFrame': '8 weekly', 'description': 'Circulating androgen and pituitary hormones will be measured during the course of the study (8 weekly).'}, {'measure': 'Follicle stimulating hormone (FSH)', 'timeFrame': '8 weekly', 'description': 'Circulating androgen and pituitary hormones will be measured during the course of the study (8 weekly).'}, {'measure': 'Testosterone (TT)', 'timeFrame': '8 weekly', 'description': 'Circulating androgen and pituitary hormones will be measured during the course of the study (8 weekly).'}, {'measure': 'dehydroepiandrosterone (DHEA)', 'timeFrame': '8 weekly', 'description': 'Circulating androgen and pituitary hormones will be measured during the course of the study (8 weekly).'}, {'measure': 'dehydroepiandrosterone-sulfate (DHEA-S)', 'timeFrame': '8 weekly', 'description': 'Circulating androgen and pituitary hormones will be measured during the course of the study (8 weekly).'}, {'measure': 'androstenedione (AED)', 'timeFrame': '8 weekly', 'description': 'Circulating androgen and pituitary hormones will be measured during the course of the study (8 weekly).'}, {'measure': 'dihydrotestosterone (DHT)', 'timeFrame': '8 weekly', 'description': 'Circulating androgen and pituitary hormones will be measured during the course of the study (8 weekly).'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['castrate resistance', 'PSA progression', 'LHRH antagonism'], 'conditions': ['Prostate Neoplasm']}, 'referencesModule': {'references': [{'pmid': '21788033', 'type': 'RESULT', 'citation': 'Crawford ED, Tombal B, Miller K, Boccon-Gibod L, Schroder F, Shore N, Moul JW, Jensen JK, Olesen TK, Persson BE. A phase III extension trial with a 1-arm crossover from leuprolide to degarelix: comparison of gonadotropin-releasing hormone agonist and antagonist effect on prostate cancer. J Urol. 2011 Sep;186(3):889-97. doi: 10.1016/j.juro.2011.04.083. Epub 2011 Jul 23.'}]}, 'descriptionModule': {'briefSummary': 'Men with castrate resistant prostate cancer who are switched from a luteinizing hormone-releasing hormone (LHRH) antagonists from a LHRH agonist will experience a fall in prostate-specific antigen (PSA).', 'detailedDescription': 'To determine the proportion of patients with castrate resistant Prostate Cancer who have a PSA decline of ≥50% from baseline PSA when switched from an LHRH agonist to an LHRH antagonist.'}, 'eligibilityModule': {'sex': 'MALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* histologically confirmed adenocarcinoma of the prostate\n* currently receiving LHRH agonist\n* Anti-androgen oral therapy is permitted but will be discontinued upon enrollment\n* PSA \\> 2 ng/ml\n* rising PSA despite LHRH agonist\n* patients may or may not have clinical evidence off metastases. If metastases are present, they must be asymptomatic and in bone or lymph node only\n* Prior chemotherapy allowed\n* ECOG performance status 0-1\n\nExclusion Criteria:\n\n* Patients with a history of other active malignancies, except: adequately treated non-melanoma skin cancer, superficial bladder cancer, or other solid tumours curatively treated with no evidence of disease for ≥ 3 years.\n* Other serious illness, psychiatric or medical condition that would not permit the patient to be managed according to the protocol including: i)Significant cardiovascular condition including but not limited to: uncontrolled hypertension, unstable angina, significant congestive heart failure or myocardial infarction, deep venous thrombosis, pulmonary embolus or cerebrovascular attack within the last 6 months. ii) History of significant neurological disorder that would impair the ability to obtain consent'}, 'identificationModule': {'nctId': 'NCT01630967', 'briefTitle': 'Efficacy Study of Switching to a Lutenizing Hormone-releasing Hormone (LHRH) Antagonist From a LHRH Agonist to Treat Progressive Castrate Resistant Prostate Cancer (CRPC)', 'organization': {'class': 'OTHER', 'fullName': 'British Columbia Cancer Agency'}, 'officialTitle': 'A Phase II Single Arm Study of Degarelix in Men With Castrate Resistant Prostate Cancer With a Rising Prostate-Specific Antigen (PSA) Despite LHRH Agonist Therapy.', 'orgStudyIdInfo': {'id': 'BCCA_Deg01'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Degarelix', 'description': 'Degarelix 240mg subcutaneously loading dose, then 80mg sc every month until disease progression.', 'interventionNames': ['Drug: Degarelix']}], 'interventions': [{'name': 'Degarelix', 'type': 'DRUG', 'otherNames': ['Firmagon'], 'description': 'Standard dosing and schedule for administration of degarelix will be used. 240mg s.c. loading dose, 80mg s.c. monthly maintenance dose.', 'armGroupLabels': ['Degarelix']}]}, 'contactsLocationsModule': {'locations': [{'zip': 'V5Z4E6', 'city': 'Vancouver', 'state': 'British Columbia', 'country': 'Canada', 'facility': 'British Columbia Cancer Agency', 'geoPoint': {'lat': 49.24966, 'lon': -123.11934}}], 'centralContacts': [{'name': 'Kim N Chi, MD', 'role': 'CONTACT', 'email': 'kim.chi@bccancer.bc.ca', 'phone': '+1 604 877 6000', 'phoneExt': '2746'}], 'overallOfficials': [{'name': 'Kim N Chi, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'British Columbia Cancer Agency, Univeristy of British Columbia'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'British Columbia Cancer Agency', 'class': 'OTHER'}, 'collaborators': [{'name': 'Ferring Pharmaceuticals', 'class': 'INDUSTRY'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Associate Professor of Medicine, University of British Columbia', 'investigatorFullName': 'Kim Chi', 'investigatorAffiliation': 'British Columbia Cancer Agency'}}}}