Safety and Efficacy Study of Enzalutamide Versus Bicalutamide in Men With Prostate Cancer
NCT01664923
ABOUT THIS STUDY
FOR MORE INFORMATION
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- 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.
- 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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Descriptive Information | |||||||
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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 |
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Study Arms ICMJE |
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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 | 396 | ||||||
Original Estimated Enrollment ICMJE | 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:
Exclusion Criteria:
Open-Label Treatment Period: Inclusion Criteria:
Exclusion Criteria:
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Sex/Gender ICMJE |
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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 |
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Responsible Party | Pfizer | ||||||
Study Sponsor ICMJE | Pfizer | ||||||
Collaborators ICMJE |
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Investigators ICMJE |
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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 |