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 CancerA Study of Salvage Radiotherapy With or Without Enzalutamide in Recurrent Prostate Cancer Following Surgery
NCT03809000
  1. Clarkston, Michigan
  2. Farmington Hills, Michigan
  3. Macomb, Michigan
  4. Madison Heights, Michigan
  5. Troy, Michigan
  6. Gilbert, Arizona
  7. Peoria, Arizona
  8. Phoenix, Arizona
  9. Scottsdale, Arizona
  10. Scottsdale, Arizona
  11. Surprise, Arizona
  12. Greenbrae, California
  13. Greenbrae, California
  14. Roseville, California
  15. Roseville, California
  16. Sacramento, California
  17. Glenwood Springs, Colorado
  18. Savannah, Georgia
  19. Decatur, Illinois
  20. Effingham, Illinois
  21. Bath, Maine
  22. Belfast, Maine
  23. Biddeford, Maine
  24. Norway, Maine
  25. Portland, Maine
  26. Rockport, Maine
  27. Sanford, Maine
  28. Sanford, Maine
  29. Scarborough, Maine
  30. South Portland, Maine
  31. Bloomfield, Michigan
  32. Clarkston, Michigan
  33. Dearborn, Michigan
  34. Detroit, Michigan
  35. Flint, Michigan
  36. Flint, Michigan
  37. Lansing, Michigan
  38. Lansing, Michigan
  39. Lapeer, Michigan
  40. Mount Clemens, Michigan
  41. Mount Pleasant, Michigan
  42. Owosso, Michigan
  43. Petoskey, Michigan
  44. Port Huron, Michigan
  45. Royal Oak, Michigan
  46. Sterling Heights, Michigan
  47. Saint Louis, Missouri
  48. Lebanon, New Hampshire
  49. Oneida, New York
  50. Oneida, New York
  51. Oswego, New York
  52. Oswego, New York
  53. Syracuse, New York
  54. Syracuse, New York
  55. Ephrata, Pennsylvania
  56. Gettysburg, Pennsylvania
  57. Lebanon, Pennsylvania
  58. York, Pennsylvania
  59. Dallas, Texas
  60. Saint Johnsbury, Vermont
  61. Québec City, Quebec
  62. Sherbrooke,
Male
18 Years+
years
MULTIPLE SITES
Prostate CancerA Randomized Study of Enzalutamide in Patients With Localized Prostate Cancer Undergoing Active Surveillance
NCT02799745
  1. Birmingham, Alabama
  2. Homewood, Alabama
  3. Tucson, Arizona
  4. Tucson, Arizona
  5. Los Angeles, California
  6. Sacramento, California
  7. San Diego, California
  8. Aurora, Colorado
  9. Denver, Colorado
  10. Denver, Colorado
  11. Bradenton, Florida
  12. Lakeland, Florida
  13. Chicago, Illinois
  14. Chicago, Illinois
  15. Chicago, Illinois
  16. Glenview, Illinois
  17. Lake Barrington, Illinois
  18. Carmel, Indiana
  19. Jeffersonville, Indiana
  20. New Orleans, Louisiana
  21. Shreveport, Louisiana
  22. Towson, Maryland
  23. Boston, Massachusetts
  24. Troy, Michigan
  25. Lincoln, Nebraska
  26. Omaha, Nebraska
  27. Omaha, Nebraska
  28. Lebanon, New Hampshire
  29. Morristown, New Jersey
  30. Voorhees, New Jersey
  31. Brooklyn, New York
  32. Cheektowaga, New York
  33. Garden City, New York
  34. Poughkeepsie, New York
  35. Syracuse, New York
  36. Syracuse, New York
  37. Gastonia, North Carolina
  38. Cleveland, Ohio
  39. Middleburg Heights, Ohio
  40. Oklahoma City, Oklahoma
  41. Bala-Cynwyd, Pennsylvania
  42. Lancaster, Pennsylvania
  43. Warwick, Rhode Island
  44. Myrtle Beach, South Carolina
  45. Nashville, Tennessee
  46. Dallas, Texas
  47. Houston, Texas
  48. San Antonio, Texas
  49. Richmond, Virginia
  50. Milwaukee, Wisconsin
  51. Abbotsford, British Columbia
  52. Halifax, Nova Scotia
  53. Toronto, Ontario
  54. Toronto, Ontario
Male
18 Years+
years
MULTIPLE SITES
Prostate CancerA Study for Subjects With Prostate Cancer Who Previously Participated in an Enzalutamide Clinical Study
NCT02960022
  1. Göteborg,
  2. Umeå,
  3. Anchorage, Alaska
  4. Tucson, Arizona
  5. Los Angeles, California
  6. San Diego, California
  7. Aurora, Colorado
  8. Denver, Colorado
  9. Daytona Beach, Florida
  10. Chicago, Illinois
  11. Jeffersonville, Indiana
  12. Towson, Maryland
  13. Saint Louis, Missouri
  14. Omaha, Nebraska
  15. Hackensack, New Jersey
  16. Garden City, New York
  17. New York, New York
  18. New York, New York
  19. Syracuse, New York
  20. Charlotte, North Carolina
  21. Greensboro, North Carolina
  22. Winston-Salem, North Carolina
  23. Springfield, Oregon
  24. Lancaster, Pennsylvania
  25. Pittsburgh, Pennsylvania
  26. Charleston, South Carolina
  27. Dallas, Texas
  28. Houston, Texas
  29. Virginia Beach, Virginia
  30. Seattle, Washington
  31. Madison, Wisconsin
  32. Cordorba,
  33. Tucuman,
  34. Ashford,
  35. Malvern,
  36. Kortrijk, West-Vlaanderen
  37. Brussels,
  38. Leuven,
  39. Liege,
  40. Turnhout,
  41. Kingston, Ontario
  42. Granby, Quebec
  43. Montreal,
  44. IX Region,
  45. Santiago,
  46. Vina del Mar,
  47. Olomouc,
  48. Praha 2,
  49. Praha 6,
  50. Aalborg, Nordjylland
  51. Aarhus,
  52. Copenhagen,
  53. Herlev,
  54. Tampere,
  55. Lyon Cedex 3,
  56. Paris,
  57. Villejuif,
  58. Nürtingen, Baden-Württemberg
  59. Mannheim, DE
  60. Duisburg, NRW
  61. Bonn,
  62. Hamburg,
  63. Hamburg,
  64. Peth Tikva,
  65. Ramat-Gan,
  66. Arezzo,
  67. Cremona,
  68. Forli,
  69. Roma,
  70. Seongnam-si,
  71. Seoul,
  72. Seoul,
  73. Seoul,
  74. Seoul,
  75. Chisinau,
  76. Hamilton,
  77. Gdansk,
  78. Myslowice,
  79. Pozman,
  80. St. Petersburg,
  81. Bratislava,
  82. George,
  83. Barcelona,
  84. Pamplona,
  85. Bebington,
  86. Belfast,
  87. Bristol,
  88. Cardiff,
  89. London,
  90. Manchester,
  91. Northwood,
  92. Sutton,
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