Safety Study of Continued Enzalutamide Treatment In Prostate Cancer Patients

NCT01995513

Last updated date
Study Location
Beth Israel Deaconess Medical Center
Boston, Massachusetts, 02115, United States
Contact
1-800-718-1021

FOR MORE INFORMATION

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

By phone

Pfizer Clinical Trials Contact Center

1-800-718-1021

By email

Contact

[email protected]

Call Now

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

- Men with metastatic castration-resistant prostate cancer

- Progressive disease on androgen deprivation therapy

- Patients must agree to continue androgen deprivation therapy with a GnRH agonist/antagonist throughout the study or have had a prior bilateral orchiectomy

- ECOG performance score ≤ 1

- Estimated life expectancy of ≥ 12 months

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


- Prior cytotoxic chemotherapy, aminoglutethimide, ketoconazole, abiraterone, or
enzalutamide for the treatment of prostate cancer


- Prior participation in a clinical trial of an investigational agent that inhibits the
androgen receptor or androgen synthesis (unless the treatment was placebo)


- History of brain metastasis, active leptomeningeal disease or seizure


- Severe cardiovascular or hepatic disease


- Pituitary or adrenal dysfunction

NEED INFO?

Questions about a trial? Call or email to reach a Pfizer Clinical Trial Contact Center Representative

Pfizer Clinical Trials Contact Center

1-800-718-1021

[email protected]

TRY A NEW SEARCH

Search for Clinical Trials by condition, keyword or trial number. Share your location or enter your city or zip code to find studies near you.

Based on your search, you may also be interested in

Prostate CancerMitoxantrone and Prednisone With or Without Leflunomide in Treating Patients With Stage IV Prostate Cancer NCT00004071
  1. Boca Raton, Florida
  2. Fort Myers, Florida
  3. New York, New York
Male
18 Years+
years
MULTIPLE SITES
Prostate CancerChemotherapy in Treating Patients Who Have Metastatic Prostate Cancer NCT00003343
  1. La Jolla, California
Male
18 Years+
years
MULTIPLE SITES
Prostate CancerStudy of Enzalutamide (Formerly MDV3100) as a Neoadjuvant Therapy for Patients Undergoing Prostatectomy for Localized Prostate Cancer NCT01547299
  1. Boston, Massachusetts
  2. Seattle, Washington
  3. Vancouver, British Columbia
  4. Toronto, Ontario
Male
18 Years+
years
MULTIPLE SITES
Prostate CancerA Safety and Efficacy Study of Oral MDV3100 in Chemotherapy-Naive Patients With Progressive Metastatic Prostate Cancer NCT01212991
  1. Birmingham, Alabama
  2. Birmingham, Alabama
  3. Tucson, Arizona
  4. Tucson, Arizona
  5. La Mesa, California
  6. Los Angeles, California
  7. Los Angeles, California
  8. Los Angeles, California
  9. Los Angeles, California
  10. Los Angeles, California
  11. Los Angeles, California
  12. Oceanside, California
  13. Sacramento, California
  14. Sacramento, California
  15. San Diego, California
  16. San Diego, California
  17. San Diego, California
  18. Stanford, California
  19. Aurora, Colorado
  20. Aurora, Colorado
  21. Boca Raton, Florida
  22. Chicago, Illinois
  23. Chicago, Illinois
  24. Louisville, Kentucky
  25. Boston, Massachusetts
  26. Boston, Massachusetts
  27. Boston, Massachusetts
  28. Detroit, Michigan
  29. Farmington Hills, Michigan
  30. Rochester, Minnesota
  31. Creve Coeur, Missouri
  32. Saint Louis, Missouri
  33. Saint Louis, Missouri
  34. Saint Louis, Missouri
  35. Saint Peters, Missouri
  36. Omaha, Nebraska
  37. New York, New York
  38. New York, New York
  39. Cary, North Carolina
  40. Charlotte, North Carolina
  41. Charlotte, North Carolina
  42. Charlotte, North Carolina
  43. Charlotte, North Carolina
  44. Charlotte, North Carolina
  45. Durham, North Carolina
  46. Durham, North Carolina
  47. Raleigh, North Carolina
  48. Portland, Oregon
  49. Philadelphia, Pennsylvania
  50. Pittsburgh, Pennsylvania
  51. Pittsburgh, Pennsylvania
  52. Charleston, South Carolina
  53. Charleston, South Carolina
  54. Charleston, South Carolina
  55. Charleston, South Carolina
  56. Mount Pleasant, South Carolina
  57. Mount Pleasant, South Carolina
  58. Dallas, Texas
  59. Hampton, Virginia
  60. Newport News, Virginia
  61. Norfolk, Virginia
  62. Virginia Beach, Virginia
  63. Seattle, Washington
  64. Seattle, Washington
  65. Madison, Wisconsin
  66. Concord, New South Wales
  67. Kogarah, New South Wales
  68. Lismore, New South Wales
  69. Liverpool, New South Wales
  70. Port Macquarie, New South Wales
  71. Randwick, New South Wales
  72. St Leonards, New South Wales
  73. Sydney, New South Wales
  74. Wahroonga, New South Wales
  75. Wahroonga, New South Wales
  76. Wahroonga, New South Wales
  77. Waratah, New South Wales
  78. Westmead, New South Wales
  79. Auchenflower, Queensland
  80. Auchenflower, Queensland
  81. Auchenflower, Queensland
  82. Chermside, Queensland
  83. Herston, Queensland
  84. Herston, Queensland
  85. South Brisbane, Queensland
  86. South Brisbane, Queensland
  87. South Brisbane, Queensland
  88. Kurralta Park, South Australia
  89. Kurralta Park, South Australia
  90. Kurralta park, South Australia
  91. Kurralta Park, South Australia
  92. Bendigo, Victoria
  93. Bendigo, Victoria
  94. Box Hill, Victoria
  95. Box Hill, Victoria
  96. Box Hill, Victoria
  97. Box Hill, Victoria
  98. Brighton, Victoria
  99. Clayton, Victoria
  100. East Melbourne, Victoria
  101. Geelong, Victoria
  102. Heidelberg, Victoria
  103. Malvern,, Victoria
  104. Malvern, Victoria
  105. Malvern, Victoria
  106. Melbourne, Victoria
  107. St Albans, Victoria
  108. Linz,
  109. Salzburg,
  110. Salzburg,
  111. Wien,
  112. Brussels,
  113. Ghent,
  114. Hasselt,
  115. Kortrijk,
  116. Leuven,
  117. Liege,
  118. Calgary, Alberta
  119. Calgary, Alberta
  120. Edmonton, Alberta
  121. Kelowna, British Columbia
  122. Vancouver, British Columbia
  123. Victoria, British Columbia
  124. Victoria, British Columbia
  125. Winnipeg, Manitoba
  126. Halifax, Nova Scotia
  127. Halifax, Nova Scotia
  128. Halifax, Nova Scotia
  129. Hamilton, Ontario
  130. London, Ontario
  131. Ottawa, Ontario
  132. Ottawa, Ontario
  133. Toronto, Ontario
  134. Toronto, Ontario
  135. Montreal, Quebec
  136. Quebec,
  137. Quebec,
  138. Aalborg,
  139. Aarhus N,
  140. Copenhagen,
  141. Frederiksberg,
  142. Herlev,
  143. Roskilde,
  144. Helsinki,
  145. Helsinki,
  146. Oulu,
  147. Tampere,
  148. Strasbourg, Alsace
  149. Rennes cedex, Bretagne
  150. Bordeaux, Nouvelle Aquitaine
  151. Angers,
  152. Avignon,
  153. Bordeaux,
  154. La Roche sur Yon Cedex,
  155. Le Mans,
  156. Lyon,
  157. Paris Cedex 15,
  158. Paris,
  159. Paris,
  160. Saint Herblain Cedex,
  161. Saint-Mande,
  162. Saint-Priest en Jarez,
  163. Toulouse,
  164. Villejuif,
  165. Hannover, Niedersachsen
  166. Berlin,
  167. Braunschweig,
  168. Dresden,
  169. Hamburg,
  170. Hamburg,
  171. Heidelberg,
  172. Homburg/Saar,
  173. Mannheim,
  174. Muenster,
  175. Tuebingen,
  176. Ulm,
  177. Weiden In Der Oberpfalz,
  178. Beer Sheva,
  179. Beer Yaakov,
  180. Haifa,
  181. Petach Tikva,
  182. Ramat Gan,
  183. Cremona, CR
  184. Meldola, FC
  185. Orbassano, TO
  186. Arezzo,
  187. Forli,
  188. Rome,
  189. Fukuoka-shi, Fukuoka
  190. Yokohama-shi, Kanagawa-ken
  191. Sendai-Shi, Miyagi
  192. Nagasaki-shi, Nagasaki
  193. Osaka-sayama, Osaka
  194. Osaka-shi, Osaka
  195. Suita-shi, Osaka
  196. Tokushima-shi, Tokushima
  197. Bunkyo-ku, Tokyo
  198. Itabashi-ku, Tokyo
  199. Koutou-ku, Tokyo
  200. Mitaka-shi, Tokyo
  201. Shinagawa-ku, Tokyo
  202. Shinjyuku-ku, Tokyo
  203. Ube-shi, Yamaguchi
  204. Chiba,
  205. Kyoto,
  206. Niigata,
  207. Osaka,
  208. Tokyo,
  209. Yamagata,
  210. Goyang, Gyeonggi-do
  211. Seongnam-si, Gyeonggi-do
  212. Hwasun-eup, Hwasun-gun, Jeonnam
  213. Gangnam-gu, Seoul
  214. Songpa-gu, Seoul
  215. Seoul,
  216. Seoul,
  217. Klaipeda,
  218. Vilnius,
  219. Amsterdam,
  220. Eindhoven,
  221. Groningen,
  222. Nijmegen,
  223. Wroclaw, Dolnoslaskie
  224. Lodz, Lodzkie
  225. Gdansk, Pomorskie
  226. Gdansk, Pomorskie
  227. Myslowice, Slaskie
  228. Poznan, Wielkopolskie
  229. Moscow,
  230. St-Petersburg,
  231. St-Petersburg,
  232. St.-Petersburg,
  233. Singapore,
  234. Singapore,
  235. Banska Bystrica,
  236. Bratislava,
  237. Martin,
  238. Nitra,
  239. Presov,
  240. Presov,
  241. Badalona, Barcelona
  242. Manresa, Barcelona
  243. Palma de Mallorca, Islas Baleares
  244. Pamplona, Navarra
  245. A Coruna,
  246. Barcelona,
  247. Barcelona,
  248. Barcelona,
  249. Madrid,
  250. Madrid,
  251. Sabadell(Barcelona),
  252. Gothenburg,
  253. Malmo,
  254. Orebro,
  255. Stockholm,
  256. Umea,
  257. Northwood, Middlesex
  258. Northwood, Middlesex
  259. Oxford, Oxfordshire
  260. Sutton, Surrey
  261. Newcastle Upon Tyne, Tyne and Wear
  262. Cardiff, Wales
  263. Bebington, Wirral, Merseyside
  264. Brighton, East Sussex,
  265. Bristol,
  266. Edinburgh,
  267. London,
  268. London,
  269. London,
Male
18 Years+
years
MULTIPLE SITES
Advanced Information
Descriptive Information
Brief Title  ICMJE Safety Study of Continued Enzalutamide Treatment In Prostate Cancer Patients
Official Title  ICMJE A PHASE 4, RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED STUDY OF CONTINUED ENZALUTAMIDE TREATMENT BEYOND PROGRESSION IN PATIENTS WITH CHEMOTHERAPY-NAÏVE METASTATIC CASTRATION-RESISTANT PROSTATE CANCER
Brief Summary The purpose of this study is to determine if continued treatment with Enzalutamide is effective in patients with metastatic prostate cancer.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 4
Study Design  ICMJE Allocation: Randomized
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE Prostate Cancer
Intervention  ICMJE
  • Drug: Enzalutamide
    160 mg by mouth once daily
    Other Names:
    • MDV3100
    • Xtandi
  • Drug: Abiraterone
    1000 mg by mouth once daily
    Other Names:
    • Abiraterone acetate
    • Zytiga
  • Drug: Placebo for Enzalutamide
    Sugar pill manufactured to mimic Enzalutamide 40 mg capsule
  • Drug: Prednisone
    5 mg by mouth twice daily
    Other Name: prednisolone
Study Arms  ICMJE
  • Experimental: Enzalutamide & Abiraterone/prednisone
    Enzalutamide (160 mg) administered as four 40-mg capsules by mouth once daily in combination with abiraterone (1000 mg) administered as four 250-mg tablets by mouth once daily and prednisone (10 mg) administered as one 5-mg tablet by mouth twice daily
    Interventions:
    • Drug: Enzalutamide
    • Drug: Abiraterone
    • Drug: Prednisone
  • Active Comparator: Enzalutamide placebo & Abiraterone/prednisone
    Enzalutamide placebo (placebo) capsules (identical in appearance to enzalutamide) administered as 4 capsules by mouth once daily in combination with abiraterone (1000 mg) administered as four 250-mg tablets by mouth once daily and prednisone (10 mg) administered as one 5-mg tablet by mouth twice daily.
    Interventions:
    • Drug: Abiraterone
    • Drug: Placebo for Enzalutamide
    • Drug: Prednisone
Publications * Attard G, Borre M, Gurney H, Loriot Y, Andresen-Daniil C, Kalleda R, Pham T, Taplin ME; PLATO collaborators. Abiraterone Alone or in Combination With Enzalutamide in Metastatic Castration-Resistant Prostate Cancer With Rising Prostate-Specific Antigen During Enzalutamide Treatment. J Clin Oncol. 2018 Sep 1;36(25):2639-2646. doi: 10.1200/JCO.2018.77.9827. Epub 2018 Jul 20.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Active, not recruiting
Actual Enrollment  ICMJE
 (submitted: October 17, 2017)
509
Original Estimated Enrollment  ICMJE
 (submitted: November 21, 2013)
500
Estimated Study Completion Date  ICMJE May 31, 2024
Actual Primary Completion Date November 15, 2016   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Men with metastatic castration-resistant prostate cancer
  • Progressive disease on androgen deprivation therapy
  • Patients must agree to continue androgen deprivation therapy with a GnRH agonist/antagonist throughout the study or have had a prior bilateral orchiectomy
  • ECOG performance score ? 1
  • Estimated life expectancy of ? 12 months

Exclusion Criteria:

  • Prior cytotoxic chemotherapy, aminoglutethimide, ketoconazole, abiraterone, or enzalutamide for the treatment of prostate cancer
  • Prior participation in a clinical trial of an investigational agent that inhibits the androgen receptor or androgen synthesis (unless the treatment was placebo)
  • History of brain metastasis, active leptomeningeal disease or seizure
  • Severe cardiovascular or hepatic disease
  • Pituitary or adrenal dysfunction
Sex/Gender  ICMJE
Sexes Eligible for Study:Male
Gender Based Eligibility:Yes
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Australia,   Belgium,   Denmark,   Finland,   France,   Italy,   Slovakia,   Spain,   Sweden,   United Kingdom,   United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01995513
Other Study ID Numbers  ICMJE MDV3100-10
2013-000722-54 ( EudraCT Number )
C3431013 ( Other Identifier: Alias Study Number )
PLATO, C3431013 ( Other Identifier: Alias Study Number )
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE
Plan to Share IPD:Yes
Plan Description:Pfizer will provide access to individual de-identified participant data and related study documents (e.g. protocol, Statistical Analysis Plan (SAP), Clinical Study Report (CSR)) upon request from qualified researchers, and subject to certain criteria, conditions, and exceptions. Further details on Pfizer's data sharing criteria and process for requesting access can be found at: https://www.pfizer.com/science/clinical_trials/trial_data_and_results/d….
URL:https://www.pfizer.com/science/clinical_trials/trial_data_and_results/d…
Responsible Party Pfizer
Study Sponsor  ICMJE Pfizer
Collaborators  ICMJE
  • Astellas Pharma Inc
  • Medivation LLC, a wholly owned subsidiary of Pfizer Inc.
Investigators  ICMJE
Study Director:Pfizer CT.gov Call CenterPfizer
Study Director:Medical DirectorMedviation, Inc.
PRS Account Pfizer
Verification Date December 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP