Ignite Creation Date:
2025-12-25 @ 3:21 AM
Ignite Modification Date:
2026-03-11 @ 6:06 PM
Study NCT ID:
NCT02446405
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2025-02-06
First Post:
2015-05-04
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Enzalutamide in First Line Androgen Deprivation Therapy for Metastatic Prostate Cancer
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': 'C540278', 'term': 'enzalutamide'}, {'id': 'D002369', 'term': 'Castration'}], 'ancestors': [{'id': 'D013507', 'term': 'Endocrine Surgical Procedures'}, {'id': 'D013514', 'term': 'Surgical Procedures, Operative'}, {'id': 'D013519', 'term': 'Urogenital Surgical Procedures'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'Stratification factors:\n\n1. High volume disease (yes versus no), characterised as:\n\n * 4 or more bone metastases, one of which is outside the vertebral column and pelvis AND/OR\n * Visceral metastases (e.g. lung, pleura, liver, adrenal and others) Lymph node involvement or bladder invasion do NOT qualify as visceral disease.\n2. Study site\n3. Concomitant "anti-resorptive" therapy to delay skeletal related events when commencing ADT\n4. Co-morbidities according to the Adult Co-morbidity Evaluation (ACE-27: 0-1 vs 2-3)\n5. Early use of docetaxel defined as use of docetaxel in conjunction with initiation of ADT.'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 1125}}, 'statusModule': {'overallStatus': 'ACTIVE_NOT_RECRUITING', 'startDateStruct': {'date': '2014-03'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-02', 'completionDateStruct': {'date': '2027-06-30', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-02-03', 'studyFirstSubmitDate': '2015-05-04', 'studyFirstSubmitQcDate': '2015-05-13', 'lastUpdatePostDateStruct': {'date': '2025-02-06', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2015-05-18', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2026-12-31', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Overall Survival Time', 'timeFrame': '3 years', 'description': 'the interval from the date of randomisation to date of death.'}], 'secondaryOutcomes': [{'measure': 'Prostate specific antigen progression free survival time', 'timeFrame': '3 years', 'description': 'the interval from the date of randomisation to the date of first evidence of PSA progression, clinical progression, or death from any cause, whichever occurs first, or the date of last known follow-up without PSA progression\n\nPSA progression is defined as: a rise in PSA by more than 25% AND more than 2ng/mL'}, {'measure': 'Clinical progression free survival time', 'timeFrame': '3 years', 'description': 'the interval from the date of randomisation to the date of first clinical evidence of disease progression or death from any cause, whichever occurs first, or the date of last known follow-up without clinical progression'}, {'measure': 'Adverse events', 'timeFrame': '3 years', 'description': 'The NCI Common Terminology Criteria for Adverse Events version 4 (CTCAE v4.03) will be used to classify and grade the intensity of adverse events during study treatment'}, {'measure': 'Health-related quality of life (EORTC Core Quality of Life Questionnaire (QLQ C-30), Quality of Life Questionnaire for Prostate Cancer (PR-25), Euroqol 5 item preference-based measure of health (EQ-5 D-5L))', 'timeFrame': '3 years', 'description': 'HRQL will be reported by participants using the EORTC core quality of life questionnaire (QLQ C-30) and prostate cancer specific module (PR-25). The EQ-5D-5L will be used to derive utility scores suitable for quality adjusted survival analyses'}, {'measure': 'Healthcare resource cost-effectiveness (incremental cost effectiveness ratio)', 'timeFrame': '3 years', 'description': 'Information on the following areas of health-care resource usage will be collected: hospitalisations, visits to health professionals, and medications Australian unit costs will be applied to the resource usage data to estimate the incremental cost of the addition of enzalutamide to standard treatment'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['metastatic prostate cancer', 'prostate cancer', 'prostate cancer treatment', 'enzalutamide'], 'conditions': ['Prostatic Neoplasms']}, 'referencesModule': {'references': [{'pmid': '39404227', 'type': 'DERIVED', 'citation': 'Armstrong AJ, Azad AA, Conduit C, Haas GP, Bland C, Davis ID. Enzalutamide in metastatic hormone-sensitive prostate cancer: A plain language summary of the ARCHES and ENZAMET follow-up studies. Future Oncol. 2025 Jan;21(1):15-24. doi: 10.1080/14796694.2024.2408101. Epub 2024 Oct 15.'}, {'pmid': '36990608', 'type': 'DERIVED', 'citation': 'Sweeney CJ, Martin AJ, Stockler MR, Begbie S, Cheung L, Chi KN, Chowdhury S, Frydenberg M, Horvath LG, Joshua AM, Lawrence NJ, Marx G, McCaffrey J, McDermott R, McJannett M, North SA, Parnis F, Parulekar W, Pook DW, Reaume MN, Sandhu SK, Tan A, Tan TH, Thomson A, Vera-Badillo F, Williams SG, Winter D, Yip S, Zhang AY, Zielinski RR, Davis ID; ENZAMET trial investigators and Australian and New Zealand Urogenital and Prostate Cancer Trials Group. Testosterone suppression plus enzalutamide versus testosterone suppression plus standard antiandrogen therapy for metastatic hormone-sensitive prostate cancer (ENZAMET): an international, open-label, randomised, phase 3 trial. Lancet Oncol. 2023 Apr;24(4):323-334. doi: 10.1016/S1470-2045(23)00063-3.'}, {'pmid': '34928708', 'type': 'DERIVED', 'citation': 'Stockler MR, Martin AJ, Davis ID, Dhillon HM, Begbie SD, Chi KN, Chowdhury S, Coskinas X, Frydenberg M, Hague WE, Horvath LG, Joshua AM, Lawrence NJ, Marx GM, McCaffrey J, McDermott R, McJannett M, North SA, Parnis F, Parulekar WR, Pook DW, Reaume MN, Sandhu S, Tan A, Tan TH, Thomson A, Vera-Badillo F, Williams SG, Winter DG, Yip S, Zhang AY, Zielinski RR, Sweeney CJ; ENZAMET Trial Investigators and the Australian and New Zealand Urogenital and Prostate Cancer Trials Group (ANZUP). Health-Related Quality of Life in Metastatic, Hormone-Sensitive Prostate Cancer: ENZAMET (ANZUP 1304), an International, Randomized Phase III Trial Led by ANZUP. J Clin Oncol. 2022 Mar 10;40(8):837-846. doi: 10.1200/JCO.21.00941. Epub 2021 Dec 20.'}, {'pmid': '31157964', 'type': 'DERIVED', 'citation': 'Davis ID, Martin AJ, Stockler MR, Begbie S, Chi KN, Chowdhury S, Coskinas X, Frydenberg M, Hague WE, Horvath LG, Joshua AM, Lawrence NJ, Marx G, McCaffrey J, McDermott R, McJannett M, North SA, Parnis F, Parulekar W, Pook DW, Reaume MN, Sandhu SK, Tan A, Tan TH, Thomson A, Tu E, Vera-Badillo F, Williams SG, Yip S, Zhang AY, Zielinski RR, Sweeney CJ; ENZAMET Trial Investigators and the Australian and New Zealand Urogenital and Prostate Cancer Trials Group. Enzalutamide with Standard First-Line Therapy in Metastatic Prostate Cancer. N Engl J Med. 2019 Jul 11;381(2):121-131. doi: 10.1056/NEJMoa1903835. Epub 2019 Jun 2.'}, {'pmid': '29525541', 'type': 'DERIVED', 'citation': 'Davis ID. Answering Questions and Questioning Answers: More Evidence To Guide Decision-making About Chemohormonal Therapy in Metastatic Prostate Cancer. Eur Urol. 2018 Jun;73(6):856-858. doi: 10.1016/j.eururo.2018.02.020. Epub 2018 Mar 7. No abstract available.'}], 'seeAlsoLinks': [{'url': 'https://www.anzup.org.au/', 'label': 'Australian and New Zealand Urogenital and Prostate (ANZUP) Cancer Trials Group.'}, {'url': 'http://ctc.usyd.edu.au/', 'label': 'University of Sydney, National Health and Medical Research Council (NHMRC) Clinical Trials Centre.'}, {'url': 'http://www.anzctr.org.au/', 'label': 'Australian New Zealand Clinical Trials Registry (ANZCTR)'}]}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to determine the effectiveness of enzalutamide, versus a conventional non-steroidal anti androgen (NSAA), when combined with a luteinizing hormone releasing hormone analog (LHRHA) or surgical castration, as first line androgen deprivation therapy (ADT) for newly diagnosed metastatic prostate cancer.'}, 'eligibilityModule': {'sex': 'MALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Men starting first line androgen deprivation therapy for metastatic prostate cancer.\n\nInclusion criteria:\n\n1. Male aged 18 or older with metastatic adenocarcinoma of the prostate\n2. Target or non-target lesions according to Response Evaluation Criteria in Solid Tumours (RECIST) 1.1\n3. Adequate bone marrow function: Haemoglobin (Hb) ≥100g/L and White Cell Count (WCC) ≥ 4.0 x 109/L and platelets ≥100 x 109/L.\n4. Adequate liver function: Alanine transaminase (ALT) \\< 2 x Upper Limit of Normal (ULN) and bilirubin \\< 1.5 x ULN, (or if bilirubin is between 1.5-2 x ULN, they must have a normal conjugated bilirubin). If liver metastases are present ALT must be \\< 5 x ULN\n5. Adequate renal function: calculated creatinine clearance \\> 30 ml/min (Cockcroft-Gault)\n6. Eastern Cooperative Oncology Group (ECOG) performance status of 0-2. Patients with performance status 2 are only eligible if the decline in performance status is due to metastatic prostate cancer.\n7. Study treatment both planned and able to start within 7 days after randomisation.\n8. Willing and able to comply with all study requirements, including treatment and required assessments\n9. Has completed baseline Health-Related Quality of Life (HRQL) questionnaires UNLESS is unable to complete because of limited literacy or vision\n10. Signed, written, informed consent\n\nExclusion Criteria:\n\n1. Prostate cancer with significant sarcomatoid or spindle cell or neuroendocrine small cell components\n2. History of\n\n * seizure or any condition that may predispose to seizure (e.g., prior cortical stroke or significant brain trauma).\n * loss of consciousness or transient ischemic attack within 12 months of randomization\n * significant cardiovascular disease within the last 3 months including: myocardial infarction, unstable angina, congestive heart failure, ongoing arrhythmias of Grade \\>2 \\[National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE), version 4.03\\], thromboembolic events (e.g., deep vein thrombosis, pulmonary embolism). Chronic stable atrial fibrillation on stable anticoagulant therapy is allowed.\n3. Life expectancy of less than 12 months.\n4. History of another malignancy within 5 years prior to randomisation, except for either non- melanomatous carcinoma of the skin or, adequately treated, non-muscle-invasive urothelial carcinoma of the bladder (Tis, Ta and low grade T1 tumours).\n5. Concurrent illness, including severe infection that might jeopardize the ability of the patient to undergo the procedures outlined in this protocol with reasonable safety\n\n a. Human Immunodeficiency Virus (HIV)-infection is not an exclusion criterion if it is controlled with anti-retroviral drugs that are unaffected by concomitant enzalutamide.\n6. Presence of any psychological, familial, sociological or geographical condition potentially hampering compliance with the study protocol and follow-up schedule, including alcohol dependence or drug abuse;\n7. Patients who are sexually active and not willing/able to use medically acceptable forms of barrier contraception.\n8. Prior ADT for prostate cancer (including bilateral orchidectomy), except in the following settings:\n\n * Started less than 12 weeks prior to randomisation AND Prostate Specific Antigen (PSA) is stable or falling. The 12 weeks starts from whichever of the following occurs earliest: first dose of oral anti- androgen, LHRHA, or surgical castration.\n * In the adjuvant setting, where the completion of adjuvant hormonal therapy was more than 12 months prior to randomisation AND the total duration of hormonal treatment did not exceed 24 months. For depot preparations, hormonal therapy is deemed to have started with the first dose and to have been completed when the next dose would otherwise have been due, e.g. 12 weeks after the last dose of depot goserelin 10.8mg.\n9. Prior cytotoxic chemotherapy for prostate cancer, but up to 2 cycles of docetaxel chemotherapy for metastatic disease is permitted.\n10. Participation in other clinical trials of investigational agents for the treatment of prostate cancer or other diseases.'}, 'identificationModule': {'nctId': 'NCT02446405', 'acronym': 'ENZAMET', 'briefTitle': 'Enzalutamide in First Line Androgen Deprivation Therapy for Metastatic Prostate Cancer', 'organization': {'class': 'OTHER', 'fullName': 'University of Sydney'}, 'officialTitle': 'Randomised Phase 3 Trial of Enzalutamide in First Line Androgen Deprivation Therapy for Metastatic Prostate Cancer: ENZAMET', 'orgStudyIdInfo': {'id': 'ANZUP 1304'}, 'secondaryIdInfos': [{'id': 'ACTRN12614000110684', 'type': 'OTHER', 'domain': 'Australian New Zealand Clinical Trials Registry (ANZCTR)'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Enzalutamide', 'description': 'Enzalutamide is 160 mg daily, by mouth, until clinical disease progression or prohibitive toxicity.\n\nAll participants are to receive standard background therapy with a LHRHA or surgical castration, as per standard of care. The choice of the LHRHA or surgical castration is at the discretion of the treating clinician.', 'interventionNames': ['Drug: Enzalutamide', 'Drug: LHRHA or Surgical Castration']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Conventional NSAA', 'description': 'Conventional NSAA, by mouth until clinical disease progression or prohibitive toxicity.\n\nAll participants are to receive standard background therapy with a LHRHA or surgical castration, as per standard of care. The choice of the LHRHA or surgical castration is at the discretion of the treating clinician.', 'interventionNames': ['Drug: NSAA', 'Drug: LHRHA or Surgical Castration']}], 'interventions': [{'name': 'Enzalutamide', 'type': 'DRUG', 'armGroupLabels': ['Enzalutamide']}, {'name': 'NSAA', 'type': 'DRUG', 'armGroupLabels': ['Conventional NSAA']}, {'name': 'LHRHA or Surgical Castration', 'type': 'DRUG', 'armGroupLabels': ['Conventional NSAA', 'Enzalutamide']}]}, 'contactsLocationsModule': {'locations': [{'zip': '02115', 'city': 'Boston', 'state': 'Massachusetts', 'country': 'United States', 'facility': 'Dana Farber Cancer Institute', 'geoPoint': {'lat': 42.35843, 'lon': -71.05977}}, {'zip': '2050', 'city': 'Camperdown', 'state': 'New South Wales', 'country': 'Australia', 'facility': "Chris O'Brien Lifehouse", 'geoPoint': {'lat': -33.88965, 'lon': 151.17642}}, {'zip': '2450', 'city': 'Coffs Harbour', 'state': 'New South Wales', 'country': 'Australia', 'facility': 'Coffs Harbour Health Campus', 'geoPoint': {'lat': -30.29626, 'lon': 153.11351}}, {'zip': '2139', 'city': 'Concord', 'state': 'New South Wales', 'country': 'Australia', 'facility': 'Concord Cancer Centre - Concord Repatriation General Hospital', 'geoPoint': {'lat': -33.84722, 'lon': 151.10381}}, {'zip': '2010', 'city': 'Darlinghurst', 'state': 'New South Wales', 'country': 'Australia', 'facility': "St Vincent's Hospital Sydney", 'geoPoint': {'lat': -33.87939, 'lon': 151.21925}}, {'zip': '2747', 'city': 'Kingswood', 'state': 'New South Wales', 'country': 'Australia', 'facility': 'Nepean Cancer Care Centre', 'geoPoint': {'lat': -33.75614, 'lon': 150.72346}}, {'zip': '2217', 'city': 'Kogarah', 'state': 'New South Wales', 'country': 'Australia', 'facility': 'St. George Hospital', 'geoPoint': {'lat': -33.9681, 'lon': 151.13564}}, {'zip': '2800', 'city': 'Orange', 'state': 'New South Wales', 'country': 'Australia', 'facility': 'Central West Cancer Services', 'geoPoint': {'lat': -33.28397, 'lon': 149.10018}}, {'zip': '2444', 'city': 'Port Macquarie', 'state': 'New South Wales', 'country': 'Australia', 'facility': 'Port Macquarie Base Hospital', 'geoPoint': {'lat': -31.43084, 'lon': 152.90894}}, {'zip': '2031', 'city': 'Randwick', 'state': 'New South Wales', 'country': 'Australia', 'facility': 'Prince of Wales Hospital', 'geoPoint': {'lat': -33.91439, 'lon': 151.24895}}, {'zip': '2065', 'city': 'St Leonards', 'state': 'New South Wales', 'country': 'Australia', 'facility': 'Genesis Care North Shore', 'geoPoint': {'lat': -33.82344, 'lon': 151.19836}}, {'zip': '2340', 'city': 'Tamworth', 'state': 'New South Wales', 'country': 'Australia', 'facility': 'Tamworth Rural Referral Hospital', 'geoPoint': {'lat': -31.09048, 'lon': 150.92905}}, {'zip': '2485', 'city': 'Tweed Heads', 'state': 'New South Wales', 'country': 'Australia', 'facility': 'The Tweed Hospital', 'geoPoint': {'lat': -28.17671, 'lon': 153.5452}}, {'zip': '2650', 'city': 'Wagga Wagga', 'state': 'New South Wales', 'country': 'Australia', 'facility': 'Riverina Cancer Care Centre', 'geoPoint': {'lat': -35.12577, 'lon': 147.35375}}, {'zip': '2076', 'city': 'Wahroonga', 'state': 'New South Wales', 'country': 'Australia', 'facility': 'Sydney Adventist Hospital', 'geoPoint': {'lat': -33.71816, 'lon': 151.11561}}, {'zip': '2500', 'city': 'Wollongong', 'state': 'New South Wales', 'country': 'Australia', 'facility': 'Wollongong Hospital', 'geoPoint': {'lat': -34.424, 'lon': 150.89345}}, {'zip': '0810', 'city': 'Tiwi', 'state': 'Northern Territory', 'country': 'Australia', 'facility': 'Royal Darwin Hospital', 'geoPoint': {'lat': -12.35876, 'lon': 130.878}}, {'zip': '4575', 'city': 'Birtinya', 'state': 'Queensland', 'country': 'Australia', 'facility': 'Sunshine Coast University Hospital', 'geoPoint': {'lat': -26.74322, 'lon': 153.11913}}, {'zip': '4814', 'city': 'Douglas', 'state': 'Queensland', 'country': 'Australia', 'facility': 'Townsville Hospital', 'geoPoint': {'lat': -19.32394, 'lon': 146.75234}}, {'zip': '4006', 'city': 'Herston', 'state': 'Queensland', 'country': 'Australia', 'facility': "Royal Brisbane and Women's Hospital", 'geoPoint': {'lat': -27.44453, 'lon': 153.01852}}, {'zip': '4215', 'city': 'Southport', 'state': 'Queensland', 'country': 'Australia', 'facility': 'Gold Coast University Hospital', 'geoPoint': {'lat': -27.96724, 'lon': 153.39796}}, {'zip': '4102', 'city': 'Woolloongabba', 'state': 'Queensland', 'country': 'Australia', 'facility': 'Princess Alexandra Hospital', 'geoPoint': {'lat': -27.48855, 'lon': 153.03655}}, {'zip': '5000', 'city': 'Adelaide', 'state': 'South Australia', 'country': 'Australia', 'facility': 'Royal Adelaide Hospital', 'geoPoint': {'lat': -34.92866, 'lon': 138.59863}}, {'zip': '5042', 'city': 'Bedford Park', 'state': 'South Australia', 'country': 'Australia', 'facility': 'Flinders Medical Centre', 'geoPoint': {'lat': -35.02204, 'lon': 138.56815}}, {'zip': '5037', 'city': 'Kurralta Park', 'state': 'South Australia', 'country': 'Australia', 'facility': 'Adelaide Cancer Centre - 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