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.

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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.

View Eligibility Criteria

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

Study is for people with:

Prostate Cancer

Phase:

Phase 2

Estimated Enrollment:

375

Study ID:

NCT01288911

Recruitment Status:

Completed

Sponsor:

Astellas Pharma Inc

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There are 86 Locations for this study

See Locations Near You

Site US1934
Homewood Alabama, 35209, United States
Site US1527
Anchorage Alaska, 99503, United States
Site US3026
Tucson Arizona, 85715, United States
Site US2977
Highland California, 92346, United States
Site US3630
San Diego California, 92123, United States
Site US2935
Denver Colorado, 80211, United States
Site US2945
Middlebury Connecticut, 06762, United States
Site US2014
Melrose Park Illinois, 60160, United States
Site US2067
Springfield Illinois, 62703, United States
Site US2027
Jeffersonville Indiana, 47130, United States
Site US1838
West Des Moines Iowa, 50266, United States
Site US62
Kansas City Kansas, 66160, United States
Site US2976
Baltimore Maryland, 21201, United States
Site US3182
Bethesda Maryland, 20889, United States
Site US2975
Ann Arbor Michigan, 48109, United States
Site US892
Grand Rapids Michigan, 49546, United States
Site US20
Minneapolis Minnesota, 55455, United States
Site US3078
Billings Montana, 59101, United States
Site US2968
Lawrenceville New Jersey, 08648, United States
Site US3025
Poughkeepsie New York, 12601, United States
Site US1675
Rochester New York, 14642, United States
Site US2934
Staten Island New York, 10304, United States
Site US81
Chapel Hill North Carolina, 27599, United States
Site US2104
Greensboro North Carolina, 27403, United States
Site US44
Cincinnati Ohio, 45267, United States
Site US2185
Columbus Ohio, 43221, United States
Site US1598
Bala-Cynwyd Pennsylvania, 19004, United States
Site US1680
Lancaster Pennsylvania, 17604, United States
Site US2926
Myrtle Beach South Carolina, 29572, United States
Site US1657
Nashville Tennessee, 37209, United States
Site US464
Houston Texas, 77030, United States
Site US2978
San Antonio Texas, 78229, United States
Site US1653
Virginia Beach Virginia, 23462, United States
Site US1580
Burien Washington, 98166, United States
Site US1709
Wenatchee Washington, 98801, United States
Site US51
Milwaukee Wisconsin, 53226, United States
Site BE3015
Brussels , 1090, Belgium
Site BE1322
Gent , 9000, Belgium
Site BE3018
Kortrijk , 8500, Belgium
Site BE3288
Leuven , 3000, Belgium
Site BE3289
Liege , , Belgium
Site BE3013
Turnhout , 2300, Belgium
Site CA3104
Calgary Alberta, T2V 1, Canada
Site CA3242
Abbotsford British Columbia, V2S 3, Canada
Site CA2646
Kingston Ontario, K7L 2, Canada
Site CA166
Toronto Ontario, M4N 3, Canada
Site CA3084
Toronto Ontario, M5G 2, Canada
Site CA2984
Granby Quebec, J2G 8, Canada
Site CA170
Montreal Quebec, H3G 1, Canada
Site DK3354
Aalborg , 9000, Denmark
Site DK3356
Aarhus , 8200, Denmark
Site DK1857
Copenhagen , 2200, Denmark
Site DK1263
Herlev , 2730, Denmark
Site FR1091
Creteil , 94010, France
Site FR3009
Lille , 59037, France
Site FR442
Lyon Cedex 3 , 69437, France
Site FR3002
Paris Cedex 10 , 75020, France
Site FR3003
Poitiers Cedex , 86000, France
Site FR3000
Rennes Cedex , 35033, France
Site FR3007
Rouen , 76031, France
Site FR3005
Suresnes Cedex , 92151, France
Site DE4000
Nuertingen Baden-Wuerttemberg, 72622, Germany
Site DE2989
Aachen , 51074, Germany
Site DE3287
Bergisch Gladbach , D-514, Germany
Site DE2993
Bonn , 53105, Germany
Site DE2995
Bonn , 53111, Germany
Site DE2994
Bonn , 53117, Germany
Site DE2990
Hamburg , 22081, Germany
Site DE3270
Hannover , 30625, Germany
Site DE2992
Reutlingen , 72764, Germany
Site DE3286
Waldshut-Tiengen , 29761, Germany
Site DE2988
Wuppertal , 42103, Germany
Site RO3042
Bucharest RO, 02232, Romania
Site RO3039
Bucharest RO, 05065, Romania
Site RO3035
Bucharest , 04134, Romania
Site GB3029
Bristol UK, BS2 8, United Kingdom
Site GB3027
London UK, SE19R, United Kingdom
Site GB3030
London UK, SW17 , United Kingdom
Site GB3028
Cardiff Wales, CF14 , United Kingdom
Site GB3244
Belfast , BT9 7, United Kingdom
Site GB2702
Cambridge , CB2 0, United Kingdom
Site GB3166
Glasgow , G12 0, United Kingdom
Site GB1862
Leicher , LE5 4, United Kingdom
Site GB3163
London , NW1 2, United Kingdom
Site GB2624
Manchester , M20 4, United Kingdom
Site GB3355
Merseyside , CH63 , United Kingdom
Site GB3245
Northwood, Middlesex , HA6 2, United Kingdom
Site GB3290
Preston , PR2 9, United Kingdom

How clear is this clinincal trial information?

Study is for people with:

Prostate Cancer

Phase:

Phase 2

Estimated Enrollment:

375

Study ID:

NCT01288911

Recruitment Status:

Completed

Sponsor:


Astellas Pharma Inc

How clear is this clinincal trial information?

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