Long-Term Specified Drug Use-Results Survey for Xtandi Capsule

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NCT02669771

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Study Location
Aichi, , , Japan
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Contact
1-800-718-1021
[email protected]
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FOR MORE INFORMATION

Contact a representative by phone, email, or visiting the study website. Please see the references below:

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1-800-718-1021

By email

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[email protected]

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Eligibility Criteria
condition
The disease, disorder, syndrome, illness, or injury that is being studied.
Castration-resistant Prostate Cancer
Sex
Male
Age
Pediatric Trials: 0-17 Years
Adult Trials: 18+ Years
0 +
Inclusion Criteria
The factors, or reasons, that allow a person to participate in a clinical study.
Show details

- no history of treatment with enzalutamide

Exclusion Criteria
The factors, or reasons, that prevent a person from participating in a clinical study.
Show details


-

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Castration-resistant Prostate CancerLong-Term Specified Drug Use-Results Survey for Xtandi Capsule
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  2. Akita,
  3. Aomori,
  4. Chiba,
  5. Ehime,
  6. Fukui,
  7. Fukuoka,
  8. Fukushima,
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  10. Gunma,
  11. Hiroshima,
  12. Hokkaido,
  13. Hyogo,
  14. Ibaraki,
  15. Ishikawa,
  16. Iwate,
  17. Kagawa,
  18. Kagoshima,
  19. Kanagawa,
  20. Kochi,
  21. Kumamoto,
  22. Kyoto,
  23. Mie,
  24. Miyagi,
  25. Miyazaki,
  26. Nagano,
  27. Nagasaki,
  28. Nara,
  29. Niigata,
  30. Oita,
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  32. Okinawa,
  33. Osaka,
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  36. Shiga,
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  9. La Mesa, California
  10. Los Angeles, California
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  12. Los Angeles, California
  13. Los Angeles, California
  14. Marina Del Rey, California
  15. Oceanside, California
  16. San Diego, California
  17. San Diego, California
  18. San Diego, California
  19. San Francisco, California
  20. South Pasadena, California
  21. Stanford, California
  22. Stanford, California
  23. Aurora, Colorado
  24. Aurora, Colorado
  25. New Haven, Connecticut
  26. New Haven, Connecticut
  27. Washington, District of Columbia
  28. Atlantis, Florida
  29. Palm Beach Gardens, Florida
  30. Wellington, Florida
  31. West Palm Beach, Florida
  32. Atlanta, Georgia
  33. Chicago, Illinois
  34. Chicago, Illinois
  35. Baltimore, Maryland
  36. Baltimore, Maryland
  37. Boston, Massachusetts
  38. Boston, Massachusetts
  39. Boston, Massachusetts
  40. Boston, Massachusetts
  41. Detroit, Michigan
  42. Farmington Hills, Michigan
  43. Rochester, Minnesota
  44. Creve Coeur, Missouri
  45. Saint Louis, Missouri
  46. Saint Louis, Missouri
  47. Saint Peters, Missouri
  48. Las Vegas, Nevada
  49. Las Vegas, Nevada
  50. Las Vegas, Nevada
  51. Albuquerque, New Mexico
  52. Buffalo, New York
  53. New York, New York
  54. New York, New York
  55. New York, New York
  56. Durham, North Carolina
  57. Durham, North Carolina
  58. Portland, Oregon
  59. McKeesport, Pennsylvania
  60. Philadelphia, Pennsylvania
  61. Philadelphia, Pennsylvania
  62. Pittsburgh, Pennsylvania
  63. Pittsburgh, Pennsylvania
  64. Pittsburgh, Pennsylvania
  65. Charleston, South Carolina
  66. Charleston, South Carolina
  67. Myrtle Beach, South Carolina
  68. Myrtle Beach, South Carolina
  69. Chattanooga, Tennessee
  70. Dickson, Tennessee
  71. Franklin, Tennessee
  72. Gallatin, Tennessee
  73. Hermitage, Tennessee
  74. Lebanon, Tennessee
  75. Murfreesboro, Tennessee
  76. Nashville, Tennessee
  77. Nashville, Tennessee
  78. Nashville, Tennessee
  79. Nashville, Tennessee
  80. Nashville, Tennessee
  81. Nashville, Tennessee
  82. Smyrna, Tennessee
  83. Dallas, Texas
  84. Dallas, Texas
  85. Dallas, Texas
  86. Chesapeake, Virginia
  87. Hampton, Virginia
  88. Mechanicsville, Virginia
  89. Midlothian, Virginia
  90. Newport News, Virginia
  91. Norfolk, Virginia
  92. Richmond, Virginia
  93. Richmond, Virginia
  94. Virginia Beach, Virginia
  95. Williamsburg, Virginia
  96. Seattle, Washington
  97. Seattle, Washington
  98. Madison, Wisconsin
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  101. Cordoba, Provincia DE Cordoba
  102. Neuquen, Provincia DE Neuquen
  103. Cipolletti, Provincia DE RIO Negro
  104. Cipolletti, Provincia DE RIO Negro
  105. Rosario, Provincia DE Santa FE
  106. Rosario, Provincia DE Santa FE
  107. Rosario, Provincia DE Santa FE
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  109. Ciudad Autonoma de Buenos Aires,
  110. Coffs Harbour, New South Wales
  111. Concord, New South Wales
  112. Port Macquarie, New South Wales
  113. Port Macquarie, New South Wales
  114. Port Macquarie, New South Wales
  115. Randwick, New South Wales
  116. Tweed Heads, New South Wales
  117. Wentworthville, New South Wales
  118. Westmead, New South Wales
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  120. Auchenflower, Queensland
  121. Auchenflower, Queensland
  122. Chermside, Queensland
  123. Chermside, Queensland
  124. Herston, Queensland
  125. Milton, Queensland
  126. South Brisbane, Queensland
  127. South Brisbane, Queensland
  128. South Brisbane, Queensland
  129. Toowong, Queensland
  130. Adelaide, South Australia
  131. Hobart, Tasmania
  132. Fitzroy, Victoria
  133. Frankston, Victoria
  134. Heidelberg, Victoria
  135. Nedlands, Western Australia
  136. Footscray,
  137. Footscray,
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  145. Kortrijk,
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  150. Calgary, Alberta
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  152. Kelowna, British Columbia
  153. Vancouver, British Columbia
  154. Victoria, British Columbia
  155. Halifax, Nova Scotia
  156. Halifax, Nova Scotia
  157. Halifax, Nova Scotia
  158. Hamilton, Ontario
  159. London, Ontario
  160. Toronto, Ontario
  161. Montreal, Quebec
  162. Montreal, Quebec
  163. Quebec,
  164. Quebec,
  165. Quebec,
  166. Santiago,
  167. Santiago,
  168. Temuco,
  169. Vina del Mar,
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  172. Caen Cedex,
  173. Cannes Cedex,
  174. Creteil,
  175. Frejus Cedex,
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  177. Le Mans,
  178. Lyon Cedex 08,
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  182. Paris,
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  185. Reims Cedex,
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  189. SAINT-HERBLAIN Cedex,
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  192. Aachen,
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  240. Bristol,
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18 Years+
years
MULTIPLE SITES
Advanced Information
Descriptive Information
Brief Title Long-Term Specified Drug Use-Results Survey for Xtandi Capsule
Official Title Xtandi® Capsules 40 mg Protocol for Long-Term Specified Drug Use-Results Survey
Brief Summary The purpose of this study is to confirm the long term safety and efficacy of enzalutamide in patients.
Detailed Description Not Provided
Study Type Observational
Study Design Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
Sampling Method Non-Probability Sample
Study Population Patients with castration-resistant prostate cancer
Condition Castration-resistant Prostate Cancer
Intervention Drug: enzalutamide
oral
Other Names:
  • Xtandi
  • MDV3100
Study Groups/Cohorts Enzalutamide group
oral
Intervention: Drug: enzalutamide
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Completed
Actual Enrollment
 (submitted: January 17, 2017)		1018
Original Estimated Enrollment
 (submitted: January 28, 2016)		900
Actual Study Completion Date November 30, 2018
Actual Primary Completion Date November 30, 2018   (Final data collection date for primary outcome measure)
Eligibility Criteria

Inclusion Criteria:

  • no history of treatment with enzalutamide

Exclusion Criteria:

-

Sex/Gender
Sexes Eligible for Study:Male
Ages Child, Adult, Older Adult
Accepts Healthy Volunteers No
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries Japan
Removed Location Countries  
 
Administrative Information
NCT Number NCT02669771
Other Study ID Numbers 9785-MA-1018
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement
Plan to Share IPD:No
Plan Description:Access to anonymized individual participant level data will not be provided for this trial as it meets one or more of the exceptions described on www.clinicalstudydatarequest.com under "Sponsor Specific Details for Astellas."
Responsible Party Astellas Pharma Inc
Study Sponsor Astellas Pharma Inc
Collaborators Pfizer
Investigators
Study Director:Medical DirectorAstellas Pharma Inc
PRS Account Astellas Pharma Inc
Verification Date December 2020