Safety and Efficacy Study of Enzalutamide Versus Bicalutamide in Men With Prostate Cancer

NCT01664923

Last updated date
Study Location
University of Alabama at Birmingham
Birmingham, Alabama, 35233, 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

- Males age 18 or older;

- Histologically or cytologically confirmed adenocarcinoma of the prostate;

- Ongoing androgen deprivation therapy;

- Serum testosterone level ≤ 50 ng/dL (1.73 nmol/L) at the Screening visit;

- Progressive disease at study entry defined by prostate-specific antigen (PSA) progression and/or radiographic progression that occurred while the patient was on primary androgen deprivation therapy;

- Asymptomatic or mildly symptomatic from prostate cancer;

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

- Estimated life expectancy of ≥ 12 months;

- Able to swallow the study drug and comply with study requirements.

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


- Is currently or has taken commercially available enzalutamide (Xtandi) prior to
participation in this open-label extension;


- Discontinued enzalutamide during the double-blind portion of the study prior to
unblinding;


- Has any clinically significant cardiovascular, dermatologic, endocrine,
gastrointestinal, hematologic, hepatic, infectious, metabolic, neurologic,
psychiatric, psychologic, pulmonary, or renal disorder or any other condition,
including excessive alcohol or drug abuse, or secondary malignancy, that may interfere
with study participation in the opinion of the investigator or medical monitor;


- Has a current or previously treated brain metastasis or leptomeningeal disease;


- Has a history of seizure or any condition that may predispose to seizure (eg, prior
cortical stroke or significant brain trauma);


- Has a history of loss of consciousness or transient ischemic attack within 12 months
of open label day 1;


- Has taken cytotoxic chemotherapy or investigational therapy within 4 weeks before
enrollment (open label day 1).

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Advanced Information
Descriptive Information
Brief Title  ICMJE Safety and Efficacy Study of Enzalutamide Versus Bicalutamide in Men With Prostate Cancer
Official Title  ICMJE STRIVE: A MULTICENTER PHASE 2, RANDOMIZED, DOUBLE-BLIND, EFFICACY AND SAFETY STUDY OF ENZALUTAMIDE VS. BICALUTAMIDE IN MEN WITH PROSTATE CANCER WHO HAVE FAILED PRIMARY ANDROGEN DEPRIVATION THERAPY
Brief Summary The purpose of this study is to determine the safety and efficacy of enzalutamide vs bicalutamide in asymptomatic or mildly symptomatic patients with prostate cancer who have disease progression despite primary androgen deprivation therapy.
Detailed Description

This study is a multicenter phase 2, randomized, double-blind, efficacy and safety study of enzalutamide (160 mg/day) vs. bicalutamide (50 mg/day) in patients with recurrent prostate cancer who have serologic and/or radiographic disease progression despite primary androgen deprivation therapy.

Throughout the study, safety and tolerability will be assessed by the recording of adverse events, monitoring of vital signs, physical examinations, and safety laboratory evaluations.

Following study unblinding, study patients receiving enzalutamide or bicalutamide at the time of unblinding and qualifying patients randomized to bicalutamide who discontinued prior to unblinding will be offered the opportunity to receive open label enzalutamide treatment.

Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
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
    160 mg, daily, by mouth.
    Other Names:
    • MDV3100
    • Xtandi
  • Drug: Bicalutamide
    50 mg, daily, by mouth
    Other Name: Casodex
Study Arms  ICMJE
  • Experimental: Enzalutamide
    Enzalutamide 160 mg/day orally
    Intervention: Drug: Enzalutamide
  • Active Comparator: Bicalutamide
    50 mg/day orally
    Intervention: Drug: Bicalutamide
Publications * Penson DF, Armstrong AJ, Concepcion R, Agarwal N, Olsson C, Karsh L, Dunshee C, Wang F, Wu K, Krivoshik A, Phung D, Higano CS. Enzalutamide Versus Bicalutamide in Castration-Resistant Prostate Cancer: The STRIVE Trial. J Clin Oncol. 2016 Jun 20;34(18):2098-106. doi: 10.1200/JCO.2015.64.9285. Epub 2016 Jan 25.

*   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: January 7, 2019)
396
Original Estimated Enrollment  ICMJE
 (submitted: August 13, 2012)
400
Actual Study Completion Date  ICMJE January 2018
Actual Primary Completion Date February 2015   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Males age 18 or older;
  • Histologically or cytologically confirmed adenocarcinoma of the prostate;
  • Ongoing androgen deprivation therapy;
  • Serum testosterone level ? 50 ng/dL (1.73 nmol/L) at the Screening visit;
  • Progressive disease at study entry defined by prostate-specific antigen (PSA) progression and/or radiographic progression that occurred while the patient was on primary androgen deprivation therapy;
  • Asymptomatic or mildly symptomatic from prostate cancer;
  • Eastern Cooperative Oncology Group (ECOG) performance status of 0-1;
  • Estimated life expectancy of ? 12 months;
  • Able to swallow the study drug and comply with study requirements.

Exclusion Criteria:

  • Severe concurrent disease, infection, or co-morbidity;
  • Known or suspected brain metastasis or active leptomeningeal disease;
  • History of another invasive malignancy within the previous 5 years other than treated non-melanomatous skin cancer and American Joint Committee on Cancer (AJCC) Stage 0 or Stage 1 cancers that have a remote probability of recurrence;
  • Absolute neutrophil count < 1,500/µL, or platelet count < 100,000/µL, or hemoglobin < 9 g/dL at the Screening visit;
  • Total bilirubin, alanine aminotransferase (ALT) or aspartate aminotransferase (AST) > 2.5 times the upper limit of normal (ULN) at the Screening visit;
  • Creatinine > 2 mg/dL at the Screening visit;
  • Albumin < 3.0 g/dL at the Screening visit;
  • History of seizure or any condition that may predispose to seizure;
  • Clinically significant cardiovascular disease;
  • Gastrointestinal disorder affecting absorption (e.g., gastrectomy, active peptic ulcer disease within last 3 months);
  • Major surgery within 4 weeks of enrollment;
  • Use of opiate analgesics for pain from prostate cancer within 4 weeks of enrollment;
  • Radiation therapy for treatment of the primary tumor within 3 weeks of enrollment;
  • Prior radiation or radionuclide therapy for treatment of distant metastases;
  • Prior ketoconazole, abiraterone, or cytotoxic chemotherapy for prostate cancer;
  • Treatment with hormonal therapy or biologic therapy for prostate cancer within 4 weeks of enrollment;
  • Use of antiandrogens within 4 weeks prior to enrollment;
  • Prior disease progression, as assessed by the Investigator, while receiving bicalutamide;
  • Participation in a previous clinical trial of enzalutamide or an investigational agent that inhibits the androgen receptor or androgen synthesis (patients who received placebo are acceptable);
  • Use of an investigational agent within 4 weeks of enrollment;
  • Use of herbal products that may have hormonal anti-prostate cancer activity and/or are known to decrease PSA levels (e.g., saw palmetto) or systemic corticosteroids for prostate cancer within 4 weeks of enrollment;
  • Any condition or reason that, in the opinion of the Investigator, interferes with the ability of the patient to participate in the trial, which places the patient at undue risk, or complicates the interpretation of safety data.

Open-Label Treatment Period:

Inclusion Criteria:

  • Received randomized double blind treatment in MDV3100-09 as follows:

    • Randomized to enzalutamide and receiving enzalutamide at the time of study unblinding;
    • Randomized to bicalutamide and receiving bicalutamide at the time of study unblinding;
    • Randomized to bicalutamide and discontinued bicalutamide before study unblinding;
  • Willing to maintain androgen deprivation therapy with a gonadotropin releasing hormone (GnRH) agonist/antagonist or has had a bilateral orchiectomy.

Exclusion Criteria:

  • Is currently or has taken commercially available enzalutamide (Xtandi) prior to participation in this open-label extension;
  • Discontinued enzalutamide during the double-blind portion of the study prior to unblinding;
  • Has any clinically significant cardiovascular, dermatologic, endocrine, gastrointestinal, hematologic, hepatic, infectious, metabolic, neurologic, psychiatric, psychologic, pulmonary, or renal disorder or any other condition, including excessive alcohol or drug abuse, or secondary malignancy, that may interfere with study participation in the opinion of the investigator or medical monitor;
  • Has a current or previously treated brain metastasis or leptomeningeal disease;
  • Has a history of seizure or any condition that may predispose to seizure (eg, prior cortical stroke or significant brain trauma);
  • Has a history of loss of consciousness or transient ischemic attack within 12 months of open label day 1;
  • Has taken cytotoxic chemotherapy or investigational therapy within 4 weeks before enrollment (open label day 1).
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 United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01664923
Other Study ID Numbers  ICMJE MDV3100-09
C3431014 ( Other Identifier: Alias Study Number )
Has Data Monitoring Committee Not Provided
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 January 2019

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