Ignite Creation Date:
2025-12-24 @ 11:48 PM
Ignite Modification Date:
2025-12-30 @ 10:13 AM
Study NCT ID:
NCT01275651
Status:
WITHDRAWN
Last Update Posted:
2019-01-24
First Post:
2011-01-11
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Biomarkers in Bone Marrow and Blood Samples From Patients With Prostate Cancer Treated With Ketoconazole
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'}]}}, 'protocolSection': {'designModule': {'bioSpec': {'retention': 'SAMPLES_WITH_DNA', 'description': 'Tissue, bone marrow, and blood'}, 'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'RETROSPECTIVE', 'observationalModel': 'CASE_ONLY'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 0}}, 'statusModule': {'whyStopped': 'Trial closure for NCI NCTN Transition', 'overallStatus': 'WITHDRAWN', 'startDateStruct': {'date': '2010-12'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2019-01', 'completionDateStruct': {'date': '2015-08', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2019-01-22', 'studyFirstSubmitDate': '2011-01-11', 'studyFirstSubmitQcDate': '2011-01-11', 'lastUpdatePostDateStruct': {'date': '2019-01-24', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2011-01-12', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2015-08', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Progression-free survival (PFS)', 'timeFrame': 'Baseline'}], 'secondaryOutcomes': [{'measure': 'Equal to or greater than 30% decline in PSA', 'timeFrame': 'Baseline'}, {'measure': 'Overall survival', 'timeFrame': 'Baseline'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['adenocarcinoma of the prostate', 'recurrent prostate cancer'], 'conditions': ['Prostate Cancer']}, 'descriptionModule': {'briefSummary': 'This research trial studies biomarkers in bone marrow and blood samples from patients with prostate cancer treated with ketoconazole. Studying samples of bone marrow and blood from patients with prostate cancer in the laboratory may help doctors learn more about changes that occur in deoxyribonucleic acid (DNA) and identify biomarkers related to cancer.', 'detailedDescription': 'PRIMARY OBJECTIVES:\n\nI. To determine whether pre-treatment androgen receptor (AR) activity correlates with progression-free survival (PFS) of men with castration-resistant prostate cancer (CRPC) treated with ketoconazole.\n\nSECONDARY OBJECTIVES:\n\nI. To determine if expression of androgen transport/synthesis/metabolism genes (including cytochrome P450, family 17, subfamily A, polypeptide 1 \\[CYP17A1\\], aldo-keto reductase family 1 \\[AKR1\\]C3, hydroxy-delta-5-steroid dehydrogenase, 3 beta- and steroid delta-isomerase 2 \\[HSD3B2\\], hydroxysteroid \\[17-beta\\] dehydrogenase \\[HSD17B\\]3, HSD17B6, AKR1C2, AKR1C1, UGTB15, UGTB17, steroid-5-alpha-reductase, alpha polypeptide 1 \\[3-oxo-5 alpha-steroid delta 4-dehydrogenase alpha\\] \\[SRD5A\\]1, SRD5A2, SRD5A3, and solute carrier organic anion transporter family, member 2B1 \\[SLCO2B1\\]) correlate with detected AR activity, time to progression (progression free survival \\[PFS\\]) following treatment with ketoconazole, and overall survival.\n\nII. To determine if semi-quantitative immunohistochemical analysis of AR and AKR1C3 protein levels correlate with PFS following treatment with ketoconazole.\n\nIII. To determine if specific AR splice variations correlate with PFS in response to ketoconazole.\n\nIV. To determine if detected activity of signaling pathways that interact with AR pathway activity (e.g., phosphatidylinositol-4,5-bisphosphate 3-kinase, catalytic subunit alpha \\[PI3K\\] and downstream effectors, SRC proto-oncogene, non-receptor tyrosine kinase \\[SRC\\], others) correlate with detected AR activity, PFS, and OS.\n\nV. To determine if AR gene amplification correlates with detected AR activity and PFS on ketoconazole.\n\nVI. To determine if levels of testosterone and dihydrotestosterone (DHT) from tumor tissue correlate with AR activity and PFS on ketoconazole.\n\nVII. To determine the presence of specific prostate cancer-associated gene translocations in each sample of CRPC.\n\nVIII. To provide an unbiased data set of gene expression in CRPC that will markedly expand the currently available public domain data.\n\nIX. To provide a library of amplified ribonucleic acid (RNA) and complementary (c)DNA for further analysis by other investigators.\n\nOUTLINE:\n\nPreviously collected bone marrow, tissue, and blood samples are analyzed for AR activity, AR splice variations, expression of androgen transport/synthesis/metabolism genes, AKR1C3 protein levels, and testosterone and dihydrotestosterone levels via reverse transcription (RT)-polymerase chain reaction (PCR), single nucleotide polymorphisms (SNP) microarrays, immunohistochemistry (IHC), gene expression analysis, and mass spectrometry methods.'}, 'eligibilityModule': {'sex': 'MALE', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Patients with prostate cancer registered to Cancer and Leukemia Group B (CALGB) 9583 and CALGB 9663', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusioin Criteria:\n\n* Patients must have been registered to CALGB 9583 and CALGB 9663\n* Adequate tissue specimen available for analysis'}, 'identificationModule': {'nctId': 'NCT01275651', 'briefTitle': 'Biomarkers in Bone Marrow and Blood Samples From Patients With Prostate Cancer Treated With Ketoconazole', 'organization': {'class': 'OTHER', 'fullName': 'Alliance for Clinical Trials in Oncology'}, 'officialTitle': 'Androgen Receptor (AR) Activity in Castration-Resistant Prostate Cancer (CRPC) and Response to Ketoconazole', 'orgStudyIdInfo': {'id': 'CALGB-151004'}, 'secondaryIdInfos': [{'id': 'CDR0000688286', 'type': 'REGISTRY', 'domain': 'NCI Physician Data Query'}, {'id': 'NCI-2011-02835', 'type': 'REGISTRY', 'domain': 'NCI Clinical Trial Reporting Program'}]}, 'armsInterventionsModule': {'armGroups': [{'label': 'Ancillary-Correlative (AR activity in CRPC)', 'description': 'Previously collected bone marrow tissue and blood samples are analyzed for AR activity, AR splice variations, expression of androgen transport/synthesis/metabolism genes, AKR1C3 protein levels, and testosterone and dihydrotestosterone levels via RT-PCR, SNP microarrays, IHC, gene expression analysis, and mass spectrometry methods.', 'interventionNames': ['Other: laboratory biomarker analysis']}], 'interventions': [{'name': 'laboratory biomarker analysis', 'type': 'OTHER', 'description': 'Correlative studies', 'armGroupLabels': ['Ancillary-Correlative (AR activity in CRPC)']}]}, 'contactsLocationsModule': {'locations': [{'zip': '02115', 'city': 'Boston', 'state': 'Massachusetts', 'country': 'United States', 'facility': 'Alliance for Clinical Trials in Oncology', 'geoPoint': {'lat': 42.35843, 'lon': -71.05977}}], 'overallOfficials': [{'name': 'Mary-Ellen Taplin, MD', 'role': 'STUDY_CHAIR', 'affiliation': 'Dana-Farber Cancer Institute'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Alliance for Clinical Trials in Oncology', 'class': 'OTHER'}, 'collaborators': [{'name': 'National Cancer Institute (NCI)', 'class': 'NIH'}], 'responsibleParty': {'type': 'SPONSOR'}}}}