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

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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

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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 September 2020

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