Safety and Efficacy Study of Enzalutamide in Patients With Nonmetastatic Castration-Resistant Prostate Cancer

Back to Search
Print
Bookmark Trial

NCT02003924

Last updated date
Back to Search
Print
Bookmark Trial
FOR MORE INFORMATION
Study Location
Urological Associates of Southern Arizona, PC
Tucson, Arizona, 85741, United States
See other locations
Contact
1-800-718-1021
[email protected]
Related Links

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.
Nonmetastatic Castration-Resistant Prostate Cancer, Prostate Cancer, Cancer of the Prostate
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

- Histologically or cytologically confirmed adenocarcinoma of the prostate without neuroendocrine differentiation, signet cell, or small cell features;

- Ongoing androgen deprivation therapy with a gonadotropin-releasing hormone (GnRH) agonist/antagonist or prior bilateral orchiectomy (medical or surgical castration);

- Testosterone ≤ 50 ng/dL (≤ 1.73 nmol/L) at screening;

- Progressive disease on androgen deprivation therapy at enrollment;

- PSA and the screening PSA assessed by the central laboratory (central PSA) should be ≥ 2 µg/L (2 ng/mL:

- PSA doubling time ≤ 10 months;

- No prior or present evidence of metastatic disease;

- Asymptomatic prostate cancer;

- Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1;

- Estimated life expectancy ≥ 12 months.

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


- Prior cytotoxic chemotherapy;


- Use of hormonal therapy or biologic therapy for prostate cancer (other than approved
bone targeting agents and GnRH agonist/antagonist therapy) or use of an
investigational agent within 4 weeks of randomization;


- Known or suspected brain metastasis or active leptomeningeal disease;


- History of another invasive cancer within 3 years of randomization;


- Absolute neutrophil count < 1000/μL, platelet count < 100,000/μL, or hemoglobin < 10
g/dL (6.2 mmol/L) at screening;


- Total bilirubin ≥ 1.5 times the upper limit of normal;


- Creatinine > 2 mg/dL (177 µmol/L) at screening;


- Albumin < 3.0 g/dL (30 g/L) at screening;


- History of seizure or any condition that may predispose to seizure;


- Clinically significant cardiovascular disease;


- Gastrointestinal disorder affecting absorption;


- Major surgery within 4 weeks of randomization;


- Hypersensitivity reaction to the active pharmaceutical ingredient or any of the
capsule components, including Labrasol, butylated hydroxyanisole, and butylated
hydroxytoluene;


- Any concurrent disease, infection, or comorbid condition that interferes with the
ability of the patient to participate in the trial, which places the patient at undue
risk, or complicates the interpretation of data, in the opinion of the investigator or
medical monitor.

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]

Call Now

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.

Advanced Search

Based on your search, you may also be interested in

Nonmetastatic Castration-Resistant Prostate Cancer, Prostate Cancer, Cancer of the ProstateSafety and Efficacy Study of Enzalutamide in Patients With Nonmetastatic Castration-Resistant Prostate Cancer
NCT02003924
  1. Tucson, Arizona
  2. Los Angeles, California
  3. Los Angeles, California
  4. Orange, California
  5. San Luis Obispo, California
  6. Englewood, Colorado
  7. New Haven, Connecticut
  8. New Haven, Connecticut
  9. New Haven, Connecticut
  10. New Haven, Connecticut
  11. New Haven, Connecticut
  12. Lakeland, Florida
  13. Carmel, Indiana
  14. Jeffersonville, Indiana
  15. Lafayette, Indiana
  16. Overland Park, Kansas
  17. Wichita, Kansas
  18. Baltimore, Maryland
  19. Ann Arbor, Michigan
  20. Troy, Michigan
  21. Omaha, Nebraska
  22. Brooklyn, New York
  23. Newburgh, New York
  24. Cary, North Carolina
  25. Charlotte, North Carolina
  26. Gastonia, North Carolina
  27. Gastonia, North Carolina
  28. Huntersville, North Carolina
  29. Raleigh, North Carolina
  30. Middleburg Heights, Ohio
  31. Springfield, Oregon
  32. Lancaster, Pennsylvania
  33. Myrtle Beach, South Carolina
  34. Nashville, Tennessee
  35. Nashville, Tennessee
  36. San Antonio, Texas
  37. Virginia Beach, Virginia
  38. Berazategui, Buenos Aires
  39. Caba, Buenos Aires
  40. Caba, Buenos Aires
  41. Caba, Buenos Aires
  42. Rosario, Santa FE
  43. Rosario, Santa FE
  44. Cordoba,
  45. Cordoba,
  46. La Rioja,
  47. Garran, Australian Capital Territory
  48. Albury, New South Wales
  49. Albury, New South Wales
  50. Albury, New South Wales
  51. Concord, New South Wales
  52. Lismore, New South Wales
  53. Lismore, New South Wales
  54. North Ryde, New South Wales
  55. North Ryde, New South Wales
  56. Port Macquarie, New South Wales
  57. Port Macquarie, New South Wales
  58. St Leonards, New South Wales
  59. Tweed Heads, New South Wales
  60. Wahroonga, New South Wales
  61. Wahroonga, New South Wales
  62. Waratah, New South Wales
  63. Westmead, New South Wales
  64. Auchenflower, Queensland
  65. Auchenflower, Queensland
  66. Chermside, Queensland
  67. South Brisbane, Queensland
  68. South Brisbane, Queensland
  69. Southport, Queensland
  70. Southport, Queensland
  71. Woolloongabba, Queensland
  72. Kurralta Park, South Australia
  73. Kurralta park, South Australia
  74. Kurralta Park, South Australia
  75. Kurralta Park, South Australia
  76. Box Hill, Victoria
  77. Box Hill, Victoria
  78. Brighton, Victoria
  79. Clayton, Victoria
  80. Heidelberg, Victoria
  81. Malvern, Victoria
  82. Malvern, Victoria
  83. Melbourne, Victoria
  84. St Albans, Victoria
  85. Linz, Upper Austria
  86. Linz, Upper Austria
  87. Linz, Upper Austria
  88. Vienna,
  89. Vienna,
  90. Vienna,
  91. Kortrijk, West-vlaanderen
  92. Bruxelles,
  93. Gent,
  94. Leuven,
  95. Liege,
  96. Salvador, Bahia
  97. Curitiba, Parana
  98. Ijui, RIO Grande DO SUL
  99. Passo Fundo, RIO Grande DO SUL
  100. Porto Alegre, RIO Grande DO SUL
  101. Porto Alegre, RIO Grande DO SUL
  102. Porto Alegre, RIO Grande DO SUL
  103. Rio de Janeiro, RJ
  104. Jau, SAO Paulo
  105. Jau, SAO Paulo
  106. Jau, SAO Paulo
  107. Sao Paulp, SAO Paulo
  108. Campinas, SP
  109. Santo Andre, SP
  110. Sao Paulo, SP
  111. Rio de Janeiro,
  112. Rio de Janeiro,
  113. Calgary, Alberta
  114. Edmonton, Alberta
  115. Vancouver, British Columbia
  116. Winnipeg, Manitoba
  117. Halifax, Nova Scotia
  118. Barrie, Ontario
  119. Hamilton, Ontario
  120. Kitchener, Ontario
  121. London, Ontario
  122. London, Ontario
  123. Toronto, Ontario
  124. Toronto, Ontario
  125. Greenfield Park, Quebec
  126. Montreal, Quebec
  127. Montreal, Quebec
  128. Quebec,
  129. Santiago,
  130. Santiago,
  131. Temuco,
  132. Vina del Mar,
  133. Vina del Mar,
  134. Beijing, Beijing
  135. Beijing, Beijing
  136. Beijing, Beijing
  137. Beijing, Beijing
  138. Beijing, Beijing
  139. Chongqing, Chongqing
  140. Guangzhou, Guangdong
  141. Wuhan, Hubei
  142. Nanjing, Jiangsu
  143. Nanjing, Jiangsu
  144. Nanjing, Jiangsu
  145. Suzhou, Jiangsu
  146. Wuxi, Jiangsu
  147. Qingdao, Shandong
  148. Shanghai, Shanghai
  149. Shanghai, Shanghai
  150. Shanghai, Shanghai
  151. Shanghai, Shanghai
  152. Shanghai, Shanghai
  153. Xi'an, Shanxi
  154. Hangzhou, Zhejiang
  155. Wenzhou, Zhejiang
  156. Hong Kong,
  157. Tianjin,
  158. Copenhagen, Norrebro
  159. Copenhagen, N
  160. Arhus N,
  161. Copenhagen,
  162. Frederiksberg,
  163. Herlev,
  164. Odense C,
  165. Vejle,
  166. Helsinki,
  167. Helsinki,
  168. Oulu,
  169. Pori,
  170. Tampere,
  171. STRASBOURG Cedex, Alsace
  172. Strasbourg, Bas-rhin
  173. Strasbourg, Bas-rhin
  174. Strasbourg, Bas-rhin
  175. Paris Cedex, Paris
  176. Pierre Benite Cedex, Rhone
  177. Villejuif Cedex, VAL DE Marne
  178. Angers Cedex 2,
  179. Avignon, Cedex 9,
  180. Bordeaux Cedex,
  181. Bordeaux Cedex,
  182. Brest,
  183. Brest,
  184. Brest,
  185. Brest,
  186. Brest,
  187. Colmar Cedex,
  188. Colmar,
  189. Dijon,
  190. Le Mans,Cedex,
  191. Lille,
  192. Lyon Cedex 03,
  193. Lyon Cedex,
  194. Lyon,
  195. Marseille,
  196. Montpellier Cedex,
  197. Paris, Cedex 15,
  198. Pierre Benite,
  199. Poitiers, Cedex,
  200. Saint-Herblain Cedex,
  201. Toulouse Cedex 3,
  202. Toulouse Cedex 3,
  203. Toulouse Cedex 3,
  204. Toulouse Cedex 9,
  205. Toulouse,
  206. Nuertingen, Baden-wuerttemberg
  207. Mannheim, Baden-wurttemberg
  208. Braunschweig, Niedersachsen
  209. Braunschweig, Niedersachsen
  210. Hannover, Niedersachsen
  211. Hannover, Niedersachsen
  212. Aachen, Nordrhein-westfalen
  213. Aachen, Nordrhein-westfalen
  214. Aachen, Nordrhein-westfalen
  215. Dresden, Saxony
  216. Berlin,
  217. Berlin,
  218. Hamburg,
  219. Kirchheim,
  220. Heraklion, Crete
  221. Athens,
  222. Athens,
  223. Larissa,
  224. Patra,
  225. Thessaloniki,
  226. Hong Kong,
  227. Hong Kong,
  228. Shatin,
  229. Forli, FC
  230. Cremona,
  231. Cremona,
  232. Cremona,
  233. Cremona,
  234. Faenza (RA),
  235. Faenza (RA),
  236. Lugo (RA),
  237. Lugo (RA),
  238. Meldola (FC),
  239. Meldola (FC),
  240. Meldola (FC),
  241. Milano,
  242. Milano,
  243. Milano,
  244. Milano,
  245. Milano,
  246. Milano,
  247. Milano,
  248. Milano,
  249. Milano,
  250. Milano,
  251. Modena,
  252. Modena,
  253. Modena,
  254. Napoli,
  255. Orbassano (TO),
  256. Orbassano (TO),
  257. Orbassano (TO),
  258. Orbassano (TO),
  259. Padova,
  260. Padova,
  261. Padova,
  262. Padova,
  263. Ravenna,
  264. Ravenna,
  265. Ravenna,
  266. Roma,
  267. Trento,
  268. Trento,
  269. Trento,
  270. Goyang-si, Gyeonggi-do
  271. Hwasun-gun, Jeonnam
  272. Incheon,
  273. Seoul,
  274. Seoul,
  275. Seoul,
  276. Seoul,
  277. Seoul,
  278. Cheras, Kuala Lumpur
  279. Kuching, Sarawak
  280. Subang Jaya, Selangor Darul Ehsan
  281. Kuala Lumpur,
  282. Kuala Lumpur,
  283. Maastricht, AZ
  284. Eindhoven, Noord-brabant
  285. Amsterdam,
  286. Dordrecht,
  287. Groningen,
  288. Nijmegen,
  289. Christchurch, Canterbury
  290. Palmerston North, Manawatu
  291. Hamilton, Waikato
  292. Auckland,
  293. Auckland,
  294. Gdansk,
  295. Kielce,
  296. Krakow,
  297. Lublin,
  298. Slupsk,
  299. Wroclaw,
  300. Wroclaw,
  301. Wroclaw,
  302. Wroclaw,
  303. Moscow,
  304. Moscow,
  305. Saint-Petersburg,
  306. Saint-Petersburg,
  307. Saint-Petersburg,
  308. Saint-Petersburg,
  309. Saint-Petersburg,
  310. Ufa,
  311. Belgrade,
  312. Belgrade,
  313. Belgrade,
  314. Belgrade,
  315. Singapore,
  316. Singapore,
  317. Banska Bystrica,
  318. Banska Bystrica,
  319. Bratislava,
  320. Bratislava,
  321. Kosice,
  322. Kosice,
  323. Kosice,
  324. Martin,
  325. Nitra,
  326. Nitra,
  327. Nitra,
  328. Presov,
  329. Presov,
  330. Presov,
  331. Ruzomberok,
  332. Skalica,
  333. Trnava,
  334. Trnava,
  335. Zilina,
  336. Zilina,
  337. Santiago de Compostela, A Coruna
  338. Palma de Mallorca, Baleares
  339. Badalona, Barcelona
  340. Manresa, Barcelona
  341. Sabadell, Barcelona
  342. Gerona, Cataluna
  343. Pamplona, Navarra
  344. A Coruna,
  345. Barcelona,
  346. Barcelona,
  347. Barcelona,
  348. Madrid,
  349. Madrid,
  350. Madrid,
  351. Goteborg,
  352. Malmo,
  353. Malmo,
  354. Molnlycke,
  355. Solna,
  356. Stockholm,
  357. Umea,
  358. Örebro,
  359. Chiayi County,
  360. Kaohsiung,
  361. Kaohsiung,
  362. Kaohsiung,
  363. Keelung City,
  364. Taichung,
  365. Taichung,
  366. Tainan City,
  367. Taipei,
  368. Taipei,
  369. Taoyuan County,
  370. Muang, Chiang MAI
  371. Hat Yai, Songkla
  372. Bangkok,
  373. Bangkok,
  374. Adana,
  375. Ankara,
  376. Istanbul,
  377. Izmir,
  378. Manisa,
  379. Chernivtsi,
  380. Dnipropetrovsk,
  381. Kharkiv,
  382. Kyiv,
  383. Uzhgorod,
  384. Zaporizhzhia,
  385. Northwood, Middlesex
  386. Belfast, Northern Ireland
  387. Sutton, Surrey
  388. Newcastle upon Tyne, Tyne and Wear
  389. Birmingham,
  390. Birmingham,
  391. Bristol,
  392. Bristol,
  393. Cambridge,
  394. London,
  395. London,
  396. London,
  397. Manchester,
  398. Oxford,
Male
18 Years+
years
MULTIPLE SITES
Advanced Information
Descriptive Information
Brief Title  ICMJE Safety and Efficacy Study of Enzalutamide in Patients With Nonmetastatic Castration-Resistant Prostate Cancer
Official Title  ICMJE PROSPER: A MULTINATIONAL, PHASE 3, RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED, EFFICACY AND SAFETY STUDY OF ENZALUTAMIDE IN PATIENTS WITH NONMETASTATIC CASTRATION-RESISTANT PROSTATE CANCER
Brief Summary The purpose of this study is to assess the safety and efficacy of enzalutamide in patients with non metastatic prostate cancer.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE
  • Nonmetastatic Castration-Resistant Prostate Cancer
  • Prostate Cancer
  • Cancer of the Prostate
Intervention  ICMJE
  • Drug: Enzalutamide
    160 mg by mouth once daily
    Other Names:
    • MDV3100
    • Xtandi
  • Drug: Placebo
    Sugar pill to mimic enzalutamide
Study Arms  ICMJE
  • Sham Comparator: Placebo
    Sugar pill manufactured to mimic enzalutamide 40 mg capsule
    Intervention: Drug: Placebo
  • Experimental: Enzalutamide
    160 mg by mouth once daily
    Intervention: Drug: Enzalutamide
Publications *

*   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: November 16, 2017)		1401
Original Estimated Enrollment  ICMJE
 (submitted: December 3, 2013)		1560
Estimated Study Completion Date  ICMJE December 31, 2023
Actual Primary Completion Date June 28, 2017   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Histologically or cytologically confirmed adenocarcinoma of the prostate without neuroendocrine differentiation, signet cell, or small cell features;
  • Ongoing androgen deprivation therapy with a gonadotropin-releasing hormone (GnRH) agonist/antagonist or prior bilateral orchiectomy (medical or surgical castration);
  • Testosterone ? 50 ng/dL (? 1.73 nmol/L) at screening;
  • Progressive disease on androgen deprivation therapy at enrollment;
  • PSA and the screening PSA assessed by the central laboratory (central PSA) should be ? 2 µg/L (2 ng/mL:
  • PSA doubling time ? 10 months;
  • No prior or present evidence of metastatic disease;
  • Asymptomatic prostate cancer;
  • Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1;
  • Estimated life expectancy ? 12 months.

Exclusion Criteria:

  • Prior cytotoxic chemotherapy;
  • Use of hormonal therapy or biologic therapy for prostate cancer (other than approved bone targeting agents and GnRH agonist/antagonist therapy) or use of an investigational agent within 4 weeks of randomization;
  • Known or suspected brain metastasis or active leptomeningeal disease;
  • History of another invasive cancer within 3 years of randomization;
  • Absolute neutrophil count < 1000/?L, platelet count < 100,000/?L, or hemoglobin < 10 g/dL (6.2 mmol/L) at screening;
  • Total bilirubin ? 1.5 times the upper limit of normal;
  • Creatinine > 2 mg/dL (177 µmol/L) at screening;
  • Albumin < 3.0 g/dL (30 g/L) at screening;
  • History of seizure or any condition that may predispose to seizure;
  • Clinically significant cardiovascular disease;
  • Gastrointestinal disorder affecting absorption;
  • Major surgery within 4 weeks of randomization;
  • Hypersensitivity reaction to the active pharmaceutical ingredient or any of the capsule components, including Labrasol, butylated hydroxyanisole, and butylated hydroxytoluene;
  • Any concurrent disease, infection, or comorbid condition that interferes with the ability of the patient to participate in the trial, which places the patient at undue risk, or complicates the interpretation of data, in the opinion of the investigator or medical monitor.
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 Argentina,   Australia,   Austria,   Belgium,   Brazil,   Canada,   Chile,   China,   Denmark,   Finland,   France,   Germany,   Greece,   Hong Kong,   Italy,   Korea, Republic of,   Malaysia,   Netherlands,   New Zealand,   Poland,   Russian Federation,   Serbia,   Singapore,   Slovakia,   Spain,   Sweden,   Taiwan,   Thailand,   Turkey,   Ukraine,   United Kingdom,   United States
Removed Location Countries Ireland
 
Administrative Information
NCT Number  ICMJE NCT02003924
Other Study ID Numbers  ICMJE MDV3100-14
C3431005 ( Other Identifier: Alias Study Number )
2012-005665-12 ( EudraCT 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 Pfizer CT.gov Call CenterPfizer
PRS Account Pfizer
Verification Date September 2020

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