A Safety and Efficacy Study of Oral MDV3100 in Chemotherapy-Naive Patients With Progressive Metastatic Prostate Cancer

NCT01212991

Last updated date
Study Location
University of Alabama at Birmingham
Birmingham, Alabama, 35249, United States
Contact
1-800-718-1021

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By email

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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

- Histologically confirmed adenocarcinoma of the prostate without neuroendocrine differentiation or small cell features

- Ongoing androgen deprivation therapy with a GnRH analogue or bilateral orchiectomy

- Progressive disease despite androgen deprivation therapy as defined by rising PSA levels or progressive soft tissue or bony disease

- No prior treatment with cytotoxic chemotherapy

- Asymptomatic or mildly symptomatic from prostate cancer

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


- Severe concurrent disease, infection, or co-morbidity that, in the judgment of the
Investigator, would make the patient inappropriate for enrollment


- Known or suspected brain metastasis or active leptomeningeal disease


- History of another malignancy within the previous 5 years other than curatively
treated non-melanomatous skin cancer


Open-Label Treatment Period:


The following inclusion criteria apply to patients receiving enzalutamide or placebo during
double-blind treatment.


Eligible patients must meet all inclusion criteria.


- Received randomized double-blind treatment in PREVAIL;


- Open-label day 1 visit is within 6 months after this amendment is approved and becomes
effective at the study site;


- Is willing to maintain androgen deprivation therapy with a gonadotropin-releasing
hormone (GnRH) agonist/antagonist or has had a bilateral orchiectomy;


The exclusion criteria apply only to patients starting new treatment with enzalutamide
after receiving placebo as randomized treatment. Each patient must not meet any of the
following criteria:


- Has taken commercially available enzalutamide (Xtandi);


- Severe concurrent disease, infection, or co-morbidity that, in the judgment of the
Investigator, would make the patient inappropriate for enrollment


- Known or suspected brain metastasis or active leptomeningeal disease

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Advanced Information
Descriptive Information
Brief Title  ICMJE A Safety and Efficacy Study of Oral MDV3100 in Chemotherapy-Naive Patients With Progressive Metastatic Prostate Cancer
Official Title  ICMJE PREVAIL: A MULTINATIONAL PHASE 3, RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED EFFICACY AND SAFETY STUDY OF ORAL MDV3100 IN CHEMOTHERAPY-NAÏVE PATIENTS WITH PROGRESSIVE METASTATIC PROSTATE CANCER WHO HAVE FAILED ANDROGEN DEPRIVATION THERAPY
Brief Summary The purpose of this study is to determine the benefit of enzalutamide versus placebo as assessed by overall survival and progression-free survival in patients with progressive metastatic prostate cancer who have failed androgen deprivation therapy but not yet received chemotherapy.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE Prostate Cancer
Intervention  ICMJE
  • Drug: Enzalutamide
    Participants received enzalutamide 160 mg, administered as four 40-mg capsules, once per day by mouth. Study drug treatment continued until disease progression (evidence of radiographic progression, a skeletal-related event, or clinical progression) and the initiation of a cytotoxic chemotherapy or an investigational agent, unacceptable toxicity, or withdrawal.
  • Drug: Placebo
    Participants received placebo, administered as four capsules, once per day by mouth. Study drug treatment continued until disease progression (evidence of radiographic progression, a skeletal-related event, or clinical progression) and the initiation of a cytotoxic chemotherapy or an investigational agent, unacceptable toxicity, or withdrawal.
Study Arms  ICMJE
  • Experimental: Enzalutamide
    Intervention: Drug: Enzalutamide
  • Placebo Comparator: Placebo
    Intervention: Drug: Placebo
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 Completed
Actual Enrollment  ICMJE
 (submitted: March 12, 2020)
1717
Original Enrollment  ICMJE Not Provided
Actual Study Completion Date  ICMJE February 14, 2019
Actual Primary Completion Date September 30, 2013   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Randomized, Double Blind Treatment Period:

Inclusion Criteria:

  • Histologically confirmed adenocarcinoma of the prostate without neuroendocrine differentiation or small cell features
  • Ongoing androgen deprivation therapy with a GnRH analogue or bilateral orchiectomy
  • Progressive disease despite androgen deprivation therapy as defined by rising PSA levels or progressive soft tissue or bony disease
  • No prior treatment with cytotoxic chemotherapy
  • Asymptomatic or mildly symptomatic from prostate cancer

Exclusion Criteria:

  • Severe concurrent disease, infection, or co-morbidity that, in the judgment of the Investigator, would make the patient inappropriate for enrollment
  • Known or suspected brain metastasis or active leptomeningeal disease
  • History of another malignancy within the previous 5 years other than curatively treated non-melanomatous skin cancer

Open-Label Treatment Period:

The following inclusion criteria apply to patients receiving enzalutamide or placebo during double-blind treatment.

Eligible patients must meet all inclusion criteria.

  • Received randomized double-blind treatment in PREVAIL;
  • Open-label day 1 visit is within 6 months after this amendment is approved and becomes effective at the study site;
  • Is willing to maintain androgen deprivation therapy with a gonadotropin-releasing hormone (GnRH) agonist/antagonist or has had a bilateral orchiectomy;

The exclusion criteria apply only to patients starting new treatment with enzalutamide after receiving placebo as randomized treatment. Each patient must not meet any of the following criteria:

  • Has taken commercially available enzalutamide (Xtandi);
  • Severe concurrent disease, infection, or co-morbidity that, in the judgment of the Investigator, would make the patient inappropriate for enrollment
  • Known or suspected brain metastasis or active leptomeningeal disease
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,   Austria,   Belgium,   Canada,   Denmark,   Finland,   France,   Germany,   Israel,   Italy,   Japan,   Korea, Republic of,   Lithuania,   Netherlands,   Poland,   Russian Federation,   Singapore,   Slovakia,   Spain,   Sweden,   United Kingdom,   United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01212991
Other Study ID Numbers  ICMJE MDV3100-03
2010-020821-41 ( EudraCT Number )
C3431003 ( Other Identifier: Alias Study Number )
Has Data Monitoring Committee Yes
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
PRS Account Pfizer
Verification Date March 2020

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