Ignite Creation Date:
2025-12-25 @ 1:27 AM
Ignite Modification Date:
2026-02-26 @ 12:36 AM
Study NCT ID:
NCT02366494
Status:
COMPLETED
Last Update Posted:
2024-11-25
First Post:
2015-02-12
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Micro RNAs to Predict Response to Androgen Deprivation Therapy
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': 'C053541', 'term': 'bicalutamide'}, {'id': 'D016729', 'term': 'Leuprolide'}, {'id': 'D017273', 'term': 'Goserelin'}, {'id': 'D017329', 'term': 'Triptorelin Pamoate'}, {'id': 'D000077143', 'term': 'Docetaxel'}, {'id': 'C089740', 'term': 'abiraterone'}, {'id': 'D000069501', 'term': 'Abiraterone Acetate'}, {'id': 'C572045', 'term': 'apalutamide'}, {'id': 'C540278', 'term': 'enzalutamide'}], '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'}, {'id': 'D043823', 'term': 'Taxoids'}, {'id': 'D043822', 'term': 'Cyclodecanes'}, {'id': 'D003516', 'term': 'Cycloparaffins'}, {'id': 'D006840', 'term': 'Hydrocarbons, Alicyclic'}, {'id': 'D006844', 'term': 'Hydrocarbons, Cyclic'}, {'id': 'D006838', 'term': 'Hydrocarbons'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D004224', 'term': 'Diterpenes'}, {'id': 'D013729', 'term': 'Terpenes'}, {'id': 'D000736', 'term': 'Androstenes'}, {'id': 'D000731', 'term': 'Androstanes'}, {'id': 'D013256', 'term': 'Steroids'}, {'id': 'D000072473', 'term': 'Fused-Ring Compounds'}, {'id': 'D011083', 'term': 'Polycyclic Compounds'}]}}, 'protocolSection': {'designModule': {'bioSpec': {'retention': 'SAMPLES_WITH_DNA', 'description': 'Whole blood collection at pre treatment (at enrollment), 3 months post treatment, and at the time of disease progression (or at 2 years post treatment).'}, 'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'OTHER'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 42}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2015-04-29', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-11', 'completionDateStruct': {'date': '2021-05-11', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2024-11-21', 'studyFirstSubmitDate': '2015-02-12', 'studyFirstSubmitQcDate': '2015-02-12', 'lastUpdatePostDateStruct': {'date': '2024-11-25', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2015-02-19', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2021-05-11', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Identify five most prevalent exosomal microRNAs that predict response to androgen deprivation therapy based treatment.', 'timeFrame': 'Up to two years', 'description': 'Two hundred to 300 microRNAs will be identified by RNA sequencing. This outcome measure will report the read count per million of the top-five most prevalent microRNAs that correlate with responses.'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': True, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['prostate cancer', 'treatment response', 'androgen deprivation therapy'], 'conditions': ['Prostate Cancer']}, 'referencesModule': {'references': [{'pmid': '18309951', 'type': 'BACKGROUND', 'citation': 'Scher HI, Halabi S, Tannock I, Morris M, Sternberg CN, Carducci MA, Eisenberger MA, Higano C, Bubley GJ, Dreicer R, Petrylak D, Kantoff P, Basch E, Kelly WK, Figg WD, Small EJ, Beer TM, Wilding G, Martin A, Hussain M; Prostate Cancer Clinical Trials Working Group. Design and end points of clinical trials for patients with progressive prostate cancer and castrate levels of testosterone: recommendations of the Prostate Cancer Clinical Trials Working Group. J Clin Oncol. 2008 Mar 1;26(7):1148-59. doi: 10.1200/JCO.2007.12.4487.'}, {'pmid': '4625049', 'type': 'BACKGROUND', 'citation': 'Huggins C, Hodges CV. Studies on prostatic cancer. I. The effect of castration, of estrogen and androgen injection on serum phosphatases in metastatic carcinoma of the prostate. CA Cancer J Clin. 1972 Jul-Aug;22(4):232-40. doi: 10.3322/canjclin.22.4.232. No abstract available.'}, {'pmid': '17135641', 'type': 'BACKGROUND', 'citation': 'Taplin ME, Xie W, Bubley GJ, Ernstoff MS, Walsh W, Morganstern DE, Regan MM. Docetaxel, estramustine, and 15-month androgen deprivation for men with prostate-specific antigen progression after definitive local therapy for prostate cancer. J Clin Oncol. 2006 Dec 1;24(34):5408-13. doi: 10.1200/JCO.2006.06.6589.'}]}, 'descriptionModule': {'briefSummary': 'Identify exosomal micro RNA that predict responses to ADT', 'detailedDescription': '1. Identify novel exosomal RNA signatures at pretreatment that predict response to ADT.\n\n The study team will collect blood samples from patients with systemic disease pretreatment (at enrollment), three months post-treatment and at the time of progression of disease (or at two years post-ADT for patients still in remission at that time point) and then perform next-generation sequencing using serum exosomal RNAs derived from these patients.\n\n The investigators plan to identify exosomal RNAs signatures that change between pretreatment (at enrollment) and during treatment (at three months) and further explore the effect of these changes on disease response. The investigators also plan to compare exosomal RNA levels between patients relapse within the first two years versus those in remission at two years. Among patients with progression, the investigators plan to compare exosomal RNA signatures at progression of disease to signatures at pretreatment and during treatment.\n2. Validate exosomal RNA markers that predict response to ADT by real-time RT-PCR.\n\nSecondary objectives: Selected RNAs, identified through the above process will be validated using real-time RT-PCR assay to test reproducibility of RNA sequencing results. The investigators expect to select and validate approximate five RNA markers that predict duration of response to ADT.'}, 'eligibilityModule': {'sex': 'MALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '85 Years', 'minimumAge': '21 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'Men with systemic disease ( with biochemical relpase or metastaic disease)', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Histologically proven prostate cancer.\n* Testosterone level \\>30ng/ml and at least 6 months since last dose of hormonal therapy.\n* History/physical examination including a detailed description of the stage of prostate cancer within 8 weeks prior to registration.\n* CT scan of abdomen and pelvis with IV contrast and bone scan should be performed within 8 weeks prior to registration.\n* Eastern Cooperative Oncology Group (ECOG) Performance Status 0-2.\n* Age ≥ 18.\n* Patients must provide study-specific informed consent prior to study entry for this project and mandatory blood specimen for banking for future studies (future studies may include genetic testing).\n\nExclusion Criteria:\n\n* Received hormonal therapy less than 6 months prior to registration.\n* History of active secondary malignancy.\n* Decline hormone therapy for prostate cancer.\n* Current or previous treatment with 5-alpha reductase inhibitors within 6 months prior to enrollment.'}, 'identificationModule': {'nctId': 'NCT02366494', 'briefTitle': 'Micro RNAs to Predict Response to Androgen Deprivation Therapy', 'organization': {'class': 'OTHER', 'fullName': 'Medical College of Wisconsin'}, 'officialTitle': 'Utility of Exosomal MicroRNAs to Predict Response to Androgen Deprivation Therapy in Prostate Cancer Patients', 'orgStudyIdInfo': {'id': '23842'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Androgen blockade', 'description': 'Androgen DeprivationTherapy or Complete Androgen Blockade', 'interventionNames': ['Drug: Bicalutamide', 'Drug: Leuprolide', 'Drug: Goserelin', 'Drug: Triptorelin']}, {'label': 'Hormonal Therapy and Chemotherapy', 'description': 'Hormonal therapy, novel oral hormonal therapy (abiraterone/apalutamide/enzalutamide) and chemotherapy (docetaxel)', 'interventionNames': ['Drug: Bicalutamide', 'Drug: Leuprolide', 'Drug: Goserelin', 'Drug: Triptorelin', 'Drug: Docetaxel', 'Drug: Abiraterone', 'Drug: Apalutamide', 'Drug: Enzalutamide']}], 'interventions': [{'name': 'Bicalutamide', 'type': 'DRUG', 'otherNames': ['Casodex'], 'description': 'ANDROGEN BLOCKADE', 'armGroupLabels': ['Androgen blockade', 'Hormonal Therapy and Chemotherapy']}, {'name': 'Leuprolide', 'type': 'DRUG', 'otherNames': ['Lupron'], 'description': 'ANDROGEN BLOCKADE', 'armGroupLabels': ['Androgen blockade', 'Hormonal Therapy and Chemotherapy']}, {'name': 'Goserelin', 'type': 'DRUG', 'otherNames': ['Zoladex'], 'description': 'ANDROGEN BLOCKADE', 'armGroupLabels': ['Androgen blockade', 'Hormonal Therapy and Chemotherapy']}, {'name': 'Triptorelin', 'type': 'DRUG', 'otherNames': ['Trelstar'], 'description': 'ANDROGEN BLOCKADE', 'armGroupLabels': ['Androgen blockade', 'Hormonal Therapy and Chemotherapy']}, {'name': 'Docetaxel', 'type': 'DRUG', 'otherNames': ['Taxotere'], 'description': 'Chemo hormonal therapy', 'armGroupLabels': ['Hormonal Therapy and Chemotherapy']}, {'name': 'Abiraterone', 'type': 'DRUG', 'otherNames': ['Zytiga'], 'description': 'Chemo hormonal therapy', 'armGroupLabels': ['Hormonal Therapy and Chemotherapy']}, {'name': 'Apalutamide', 'type': 'DRUG', 'otherNames': ['Erleada'], 'description': 'Nonsteroidal antiandrogen medication', 'armGroupLabels': ['Hormonal Therapy and Chemotherapy']}, {'name': 'Enzalutamide', 'type': 'DRUG', 'otherNames': ['Xtandi'], 'description': 'Nonsteroidal antiandrogen medication', 'armGroupLabels': ['Hormonal Therapy and Chemotherapy']}]}, 'contactsLocationsModule': {'locations': [{'zip': '53226', 'city': 'Milwaukee', 'state': 'Wisconsin', 'country': 'United States', 'facility': 'Froedtert Hospital', 'geoPoint': {'lat': 43.0389, 'lon': -87.90647}}], 'overallOfficials': [{'name': 'Deepak Kilari, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'The Medical College of Wisconsin'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Medical College of Wisconsin', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Associate Professor', 'investigatorFullName': 'Deepak Kilari', 'investigatorAffiliation': 'Medical College of Wisconsin'}}}}