Spots Global Cancer Trial Database for A Study of Enzalutamide Versus Bicalutamide in Castrate Men With Metastatic Prostate Cancer
The following info and data is provided "as is" to help patients around the globe.
We do not endorse or review these studies in any way.
Trial Identification
Brief Title: A Study of Enzalutamide Versus Bicalutamide in Castrate Men With Metastatic Prostate Cancer
Official Title: A Randomized, Double-Blind, Phase II, Efficacy and Safety Study of MDV3100 Versus Bicalutamide in Castrate Men With Metastatic Prostate Cancer
Study ID: NCT01288911
Conditions
Study Description
Brief 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.
Detailed 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
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: MALE
Healthy Volunteers: No
Locations
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, Gent, , Belgium
Site BE3018, Kortrijk, , Belgium
Site BE3288, Leuven, , Belgium
Site BE3289, Liege, , 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, Creteil, , France
Site FR3009, Lille, , France
Site FR442, Lyon Cedex 3, , France
Site FR3002, Paris Cedex 10, , France
Site FR3003, Poitiers Cedex, , France
Site FR3000, Rennes Cedex, , France
Site FR3007, Rouen, , France
Site FR3005, Suresnes Cedex, , France
Site DE4000, Nuertingen, Baden-Wuerttemberg, 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, Hannover, , 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
Contact Details
Name: Principal Investigator
Affiliation: Carolina Urologic Research Center
Role: PRINCIPAL_INVESTIGATOR
Name: Associate Medical Science Director
Affiliation: Astellas Pharma Global Development
Role: STUDY_DIRECTOR
Take Control of Your Skin and Body Changes Today.
Try out Spots for free, set up only takes 2 mins.
Join others from around the world:
