Prostate Cancer Clinical Trial
A Study of Enzalutamide Versus Bicalutamide in Castrate Men With Metastatic Prostate Cancer
Summary
The purpose of this study was to determine the efficacy and safety of oral enzalutamide compared to bicalutamide in castrate men with metastatic prostate cancer who have progressed while on Luteinizing Hormone Receptor Hormone (LHRH) agonist/antagonist or after receiving a bilateral orchiectomy.
Full Description
An open-label period was added to the main protocol. Following unblinding at the end of the double-blind period and demonstration of a statistically significant advantage of enzalutamide over bicalutamide as assessed by the primary endpoint, all ongoing enzalutamide treated participants and ongoing or previous bicalutamide treated participants that met entry criteria were offered open-label enzalutamide at the discretion of the participant and study investigators.
Eligibility Criteria
Inclusion Criteria:
Histologically confirmed adenocarcinoma of the prostate without neuroendocrine differentiation or small cell features
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:
Condom (barrier method of contraception), AND
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:
Prior cytotoxic chemotherapy for prostate cancer
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
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There are 86 Locations for this study
Homewood Alabama, 35209, United States
Anchorage Alaska, 99503, United States
Tucson Arizona, 85715, United States
Highland California, 92346, United States
San Diego California, 92123, United States
Denver Colorado, 80211, United States
Middlebury Connecticut, 06762, United States
Melrose Park Illinois, 60160, United States
Springfield Illinois, 62703, United States
Jeffersonville Indiana, 47130, United States
West Des Moines Iowa, 50266, United States
Kansas City Kansas, 66160, United States
Baltimore Maryland, 21201, United States
Bethesda Maryland, 20889, United States
Ann Arbor Michigan, 48109, United States
Grand Rapids Michigan, 49546, United States
Minneapolis Minnesota, 55455, United States
Billings Montana, 59101, United States
Lawrenceville New Jersey, 08648, United States
Poughkeepsie New York, 12601, United States
Rochester New York, 14642, United States
Staten Island New York, 10304, United States
Chapel Hill North Carolina, 27599, United States
Greensboro North Carolina, 27403, United States
Cincinnati Ohio, 45267, United States
Columbus Ohio, 43221, United States
Bala-Cynwyd Pennsylvania, 19004, United States
Lancaster Pennsylvania, 17604, United States
Myrtle Beach South Carolina, 29572, United States
Nashville Tennessee, 37209, United States
Houston Texas, 77030, United States
San Antonio Texas, 78229, United States
Virginia Beach Virginia, 23462, United States
Burien Washington, 98166, United States
Wenatchee Washington, 98801, United States
Milwaukee Wisconsin, 53226, United States
Brussels , 1090, Belgium
Gent , 9000, Belgium
Kortrijk , 8500, Belgium
Leuven , 3000, Belgium
Liege , , Belgium
Turnhout , 2300, Belgium
Calgary Alberta, T2V 1, Canada
Abbotsford British Columbia, V2S 3, Canada
Kingston Ontario, K7L 2, Canada
Toronto Ontario, M4N 3, Canada
Toronto Ontario, M5G 2, Canada
Granby Quebec, J2G 8, Canada
Montreal Quebec, H3G 1, Canada
Aalborg , 9000, Denmark
Aarhus , 8200, Denmark
Copenhagen , 2200, Denmark
Herlev , 2730, Denmark
Creteil , 94010, France
Lille , 59037, France
Lyon Cedex 3 , 69437, France
Paris Cedex 10 , 75020, France
Poitiers Cedex , 86000, France
Rennes Cedex , 35033, France
Rouen , 76031, France
Suresnes Cedex , 92151, France
Nuertingen Baden-Wuerttemberg, 72622, Germany
Aachen , 51074, Germany
Bergisch Gladbach , D-514, Germany
Bonn , 53105, Germany
Bonn , 53111, Germany
Bonn , 53117, Germany
Hamburg , 22081, Germany
Hannover , 30625, Germany
Reutlingen , 72764, Germany
Waldshut-Tiengen , 29761, Germany
Wuppertal , 42103, Germany
Bucharest RO, 02232, Romania
Bucharest RO, 05065, Romania
Bucharest , 04134, Romania
Bristol UK, BS2 8, United Kingdom
London UK, SE19R, United Kingdom
London UK, SW17 , United Kingdom
Cardiff Wales, CF14 , United Kingdom
Belfast , BT9 7, United Kingdom
Cambridge , CB2 0, United Kingdom
Glasgow , G12 0, United Kingdom
Leicher , LE5 4, United Kingdom
London , NW1 2, United Kingdom
Manchester , M20 4, United Kingdom
Merseyside , CH63 , United Kingdom
Northwood, Middlesex , HA6 2, United Kingdom
Preston , PR2 9, United Kingdom
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