A Study of Enzalutamide Versus Bicalutamide in Castrate Men With Metastatic Prostate Cancer
NCT ID: NCT01288911
Last Updated: 2024-12-06
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE2
375 participants
INTERVENTIONAL
2011-03-22
2017-11-08
Brief Summary
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Detailed Description
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Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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Enzalutamide
Participants received enzalutamide 160 mg orally once daily until confirmed radiographic disease progression, skeletal-related event or the initiation of a new antineoplastic therapy.
enzalutamide
capsules
Bicalutamide
Participants received bicalutamide 50 mg orally once daily until confirmed radiographic disease progression, skeletal-related event or the initiation of a new antineoplastic therapy.
bicalutamide
tablets
Interventions
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enzalutamide
capsules
bicalutamide
tablets
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Ongoing androgen deprivation therapy with a Luteinizing Hormone Receptor Hormone (LHRH) agonist or antagonist at a stable dose and schedule within 4 weeks of randomization or bilateral orchiectomy (i.e., surgical or medical castration)
* Metastatic disease documented by one of the following:
* At least two bone lesions on bone scan, or
* Soft tissue disease documented by computed tomography (CT)/ magnetic resonance imaging (MRI), or
* Unequivocal pelvic adenopathy short axis \> 2.0 cm in diameter by CT/MRI
* Progressive disease at study entry defined as one or more of the following three criteria occurring in the setting of castrate levels of testosterone:
* Prostate Specific Antigen (PSA) progression defined by a minimum of three rising PSA levels with an interval of ≥ 1 week between each determination. The PSA value should be ≥ 2 µg/L (2 ng/mL);
* Soft tissue disease progression defined by Response Evaluation Criteria in Solid Tumors (RECIST) 1.1;
* Bone disease progression defined by two or more new lesions on bone scan
* Asymptomatic or mildly symptomatic from prostate cancer (i.e. the score on the Brief Pain Inventory-Short Form (BPI-SF) Question #3 must be \< 4); no use of opiate analgesics for prostate cancer-related pain currently or anytime within 4 weeks prior to randomization
* Eastern Cooperative Oncology Group (ECOG) performance status of 0-1, including subjects with decreased performance status not attributed to progressive and symptomatic prostate cancer
* Estimated life expectancy of ≥ 12 months
* Able to swallow the study drug and comply with study requirements
* A male subject and his female spouse/partner who is of childbearing potential must use two acceptable methods of birth control (one of which must include a condom as a barrier method of contraception) starting at Screening and continuing throughout the study period, and for 3 months after final study drug administration. Two acceptable forms of birth control include:
1. Condom (barrier method of contraception), AND
2. In addition to a condom, one of the following acceptable forms of contraception is required:
* Established use of oral, injected or implanted hormonal methods of contraception.
* Placement of an intrauterine device (IUD) or intrauterine system (IUS).
* Barrier methods of contraception: Occlusive cap (diaphragm or cervical/vault caps) with spermicidal foam/gel/film/cream/suppository.
* Tubal ligation for at least 6 months prior to Screening
* Vasectomy or other surgical castration at least 6 months prior to Screening
Exclusion Criteria
* Severe concurrent disease, infection, or comorbidity that would make the subject inappropriate for enrollment
* Known or suspected brain and/or skull metastasis or active epidural disease
* History of another malignancy within the previous 5 years other than curatively treated non-melanomatous skin cancer
* Current or prior treatment with estrogens and/or drugs with anti-androgenic properties such as spironolactone \> 50 mg/day, or progestational agents for the treatment of prostate cancer within 6 months prior to randomization
* Current or prior use of ketoconazole for the treatment of prostate cancer
* Use of antiandrogens within 6 weeks prior to randomization
* Documented prior disease progression while receiving antiandrogens. Disease progression defined as PSA progression, radiographic progression and/or clinical deterioration.
* Current or prior treatment with 5-α reductase inhibitors or anabolic steroids within 6 months prior to randomization
* Prior use of systemic glucocorticoids (the equivalent of 10 mg of prednisone) within 3 months prior to randomization or expectation of their use during the study
* Radiation therapy to bone lesions or prostatic bed within 4 weeks prior to randomization
* Major surgery within 2 months prior to randomization
* History of seizure including febrile seizure or any condition that may predispose to seizure (e.g., prior stroke, brain arteriovenous malformation, head trauma with loss of consciousness requiring hospitalization). Also, current or prior treatment with anti-epileptic medications for the treatment of seizures or history of loss of consciousness or transient ischemic attack within 12 months prior to randomization
* Clinically significant cardiovascular disease including myocardial infarction within past six months or uncontrolled angina within past three months
18 Years
MALE
No
Sponsors
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Medivation LLC, a wholly owned subsidiary of Pfizer Inc.
INDUSTRY
Astellas Pharma Inc
INDUSTRY
Responsible Party
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Principal Investigators
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Principal Investigator
Role: PRINCIPAL_INVESTIGATOR
Carolina Urologic Research Center
Associate Medical Science Director
Role: STUDY_DIRECTOR
Astellas Pharma Global Development
Locations
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Site US1934
Homewood, Alabama, United States
Site US1527
Anchorage, Alaska, United States
Site US3026
Tucson, Arizona, United States
Site US2977
Highland, California, United States
Site US3630
San Diego, California, United States
Site US2935
Denver, Colorado, United States
Site US2945
Middlebury, Connecticut, United States
Site US2014
Melrose Park, Illinois, United States
Site US2067
Springfield, Illinois, United States
Site US2027
Jeffersonville, Indiana, United States
Site US1838
West Des Moines, Iowa, United States
Site US62
Kansas City, Kansas, United States
Site US2976
Baltimore, Maryland, United States
Site US3182
Bethesda, Maryland, United States
Site US2975
Ann Arbor, Michigan, United States
Site US892
Grand Rapids, Michigan, United States
Site US20
Minneapolis, Minnesota, United States
Site US3078
Billings, Montana, United States
Site US2968
Lawrenceville, New Jersey, United States
Site US3025
Poughkeepsie, New York, United States
Site US1675
Rochester, New York, United States
Site US2934
Staten Island, New York, United States
Site US81
Chapel Hill, North Carolina, United States
Site US2104
Greensboro, North Carolina, United States
Site US44
Cincinnati, Ohio, United States
Site US2185
Columbus, Ohio, United States
Site US1598
Bala-Cynwyd, Pennsylvania, United States
Site US1680
Lancaster, Pennsylvania, United States
Site US2926
Myrtle Beach, South Carolina, United States
Site US1657
Nashville, Tennessee, United States
Site US464
Houston, Texas, United States
Site US2978
San Antonio, Texas, United States
Site US1653
Virginia Beach, Virginia, United States
Site US1580
Burien, Washington, United States
Site US1709
Wenatchee, Washington, United States
Site US51
Milwaukee, Wisconsin, United States
Site BE3015
Brussels, , Belgium
Site BE1322
Ghent, , Belgium
Site BE3018
Kortrijk, , Belgium
Site BE3288
Leuven, , Belgium
Site BE3289
Liège, , Belgium
Site BE3013
Turnhout, , Belgium
Site CA3104
Calgary, Alberta, Canada
Site CA3242
Abbotsford, British Columbia, Canada
Site CA2646
Kingston, Ontario, Canada
Site CA166
Toronto, Ontario, Canada
Site CA3084
Toronto, Ontario, Canada
Site CA2984
Granby, Quebec, Canada
Site CA170
Montreal, Quebec, Canada
Site DK3354
Aalborg, , Denmark
Site DK3356
Aarhus, , Denmark
Site DK1857
Copenhagen, , Denmark
Site DK1263
Herlev, , Denmark
Site FR1091
Créteil, , France
Site FR3009
Lille, , France
Site FR442
Lyon, , France
Site FR3002
Paris, , France
Site FR3003
Poitiers, , France
Site FR3000
Rennes, , France
Site FR3007
Rouen, , France
Site FR3005
Suresnes, , France
Site DE4000
Nürtingen, Baden-Wurttemberg, Germany
Site DE2989
Aachen, , Germany
Site DE3287
Bergisch Gladbach, , Germany
Site DE2993
Bonn, , Germany
Site DE2995
Bonn, , Germany
Site DE2994
Bonn, , Germany
Site DE2990
Hamburg, , Germany
Site DE3270
Hanover, , Germany
Site DE2992
Reutlingen, , Germany
Site DE3286
Waldshut-Tiengen, , Germany
Site DE2988
Wuppertal, , Germany
Site RO3042
Bucharest, RO, Romania
Site RO3039
Bucharest, RO, Romania
Site RO3035
Bucharest, , Romania
Site GB3029
Bristol, UK, United Kingdom
Site GB3027
London, UK, United Kingdom
Site GB3030
London, UK, United Kingdom
Site GB3028
Cardiff, Wales, United Kingdom
Site GB3244
Belfast, , United Kingdom
Site GB2702
Cambridge, , United Kingdom
Site GB3166
Glasgow, , United Kingdom
Site GB1862
Leicher, , United Kingdom
Site GB3163
London, , United Kingdom
Site GB2624
Manchester, , United Kingdom
Site GB3355
Merseyside, , United Kingdom
Site GB3245
Northwood, Middlesex, , United Kingdom
Site GB3290
Preston, , United Kingdom
Countries
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References
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Schultz NM, Shore ND, Chowdhury S, Klotz LH, Concepcion RS, Penson DF, Karsh LI, Yang H, Brown BA, Barlev A, Flanders SC. Number-needed-to-treat analysis of clinical progression in patients with metastatic castration-resistant prostate cancer in the STRIVE and TERRAIN trials. BMC Urol. 2018 Sep 6;18(1):77. doi: 10.1186/s12894-018-0387-7.
Heidenreich A, Chowdhury S, Klotz L, Siemens DR, Villers A, Ivanescu C, Holmstrom S, Baron B, Wang F, Lin P, Shore ND. Impact of Enzalutamide Compared with Bicalutamide on Quality of Life in Men with Metastatic Castration-resistant Prostate Cancer: Additional Analyses from the TERRAIN Randomised Clinical Trial. Eur Urol. 2017 Apr;71(4):534-542. doi: 10.1016/j.eururo.2016.07.027. Epub 2016 Aug 3.
Shore ND, Chowdhury S, Villers A, Klotz L, Siemens DR, Phung D, van Os S, Hasabou N, Wang F, Bhattacharya S, Heidenreich A. Efficacy and safety of enzalutamide versus bicalutamide for patients with metastatic prostate cancer (TERRAIN): a randomised, double-blind, phase 2 study. Lancet Oncol. 2016 Feb;17(2):153-163. doi: 10.1016/S1470-2045(15)00518-5. Epub 2016 Jan 14.
Related Links
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Link to results on the Astellas Clinical Study Results website
Other Identifiers
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2010-021868-15
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
9785-CL-0222
Identifier Type: -
Identifier Source: org_study_id