Safety and Efficacy Study of Enzalutamide Versus Bicalutamide in Men With Prostate Cancer
NCT ID: NCT01664923
Last Updated: 2019-01-30
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE2
396 participants
INTERVENTIONAL
2012-08-31
2018-01-31
Brief Summary
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Detailed Description
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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.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
TRIPLE
Study Groups
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Enzalutamide
Enzalutamide 160 mg/day orally
Enzalutamide
160 mg, daily, by mouth.
Bicalutamide
50 mg/day orally
Bicalutamide
50 mg, daily, by mouth
Interventions
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Enzalutamide
160 mg, daily, by mouth.
Bicalutamide
50 mg, daily, by mouth
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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.
* 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
* 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:
* 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).
18 Years
MALE
No
Sponsors
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Astellas Pharma Inc
INDUSTRY
Medivation LLC, a wholly owned subsidiary of Pfizer Inc.
INDUSTRY
Pfizer
INDUSTRY
Responsible Party
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Principal Investigators
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Pfizer Pfizer CT.gov Call Center
Role: STUDY_DIRECTOR
Pfizer
Locations
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University of Alabama at Birmingham
Birmingham, Alabama, United States
University of Alabama at Birmingham，IDS Pharmacy
Birmingham, Alabama, United States
University of Alabama at Birmingham
Birmingham, Alabama, United States
Desert Springs Cancer Care
Scottsdale, Arizona, United States
Arizona Oncology Associates, PC - HOPE
Tucson, Arizona, United States
Arizona Oncology Associates, PC - HOPE
Tucson, Arizona, United States
Urological Associates of Southern Arizona, PC
Tucson, Arizona, United States
Urological Associates of Southern Arizona, PC
Tucson, Arizona, United States
Southern California Permanente Medical Group
Anaheim, California, United States
Kaiser Permanente Medical Center Lab Drawing Station
Antioch, California, United States
Kaiser Permanente Medical Center Lab Drawing Station
Antioch, California, United States
Kaiser Permanente Medical Center Lab Drawing Station
Fairfield, California, United States
Kaiser Permanente Medical Center Lab Drawing Station
Gilroy, California, United States
Southern California Permanente Medical Group
Los Angeles, California, United States
Tower Urology
Los Angeles, California, United States
UCLA Clark Urology Clinic
Los Angeles, California, United States
UCLA Department of Pharmaceutical Services
Los Angeles, California, United States
Kaiser Permanente Medical Center Lab Drawing Station
Martinez, California, United States
Kaiser Permanente Medical Center Lab Drawing Station
Milpitas, California, United States
Kaiser Permanente Medical Center Lab Drawing Station
Modesto, California, United States
Kaiser Permanente Medical Center Lab Drawing Station
Moutain View, California, United States
Kaiser Permanente Medical Center Lab Drawing Station
Napa, California, United States
Kaiser Permanente Medical Center
Oakland, California, United States
Kaiser Permanente Medical Center Lab Drawing Station
Pleasanton, California, United States
Kaiser Permanente Medical Center Lab Drawing Station
Redwood City, California, United States
Kaiser Permanente Medical Center
Roseville, California, United States
UC Davis Comprehensive Cancer Center
Sacramento, California, United States
UC Davis Medical Center
Sacramento, California, United States
Kaiser Permanente Medical Center
Sacramento, California, United States
San Bernardino Urological Associates Medical Group
San Bernardino, California, United States
Southern California Permanente Medical Group
San Diego, California, United States
Kaiser Permanente Medical Center
San Francisco, California, United States
Kaiser Permanente Medical Center
San Jose, California, United States
Kaiser Permanente Medical Center
San Leandro, California, United States
Southern California Permanente Medical Group
San Marcos, California, United States
Kaiser Permanente Medical Center
Santa Clara, California, United States
Skyline Urology
Sherman Oaks, California, United States
Kaiser Permanente Medical Center
South San Francisco, California, United States
Standford Health Care
Stanford, California, United States
Skyline Urology
Torrance, California, United States
Kaiser Permanente Medical Center
Vallejo, California, United States
Kaiser Permanente Medical Center
Walnut Creek, California, United States
Anschutz Cancer Center Pavilion Pharmacy
Aurora, Colorado, United States
Anschutz Inpatient Pavilion
Aurora, Colorado, United States
University of Colorado Cancer Center, Anschutz Cancer Pavilion
Aurora, Colorado, United States
The Urology Center of Colorado
Denver, Colorado, United States
George Washington University - Medical Faculty Associates
Washington D.C., District of Columbia, United States
Advanced Urology institute
Daytona Beach, Florida, United States
East Coast Institute for Research, LLC
Jacksonville, Florida, United States
East Coast Institute for Research, LLC
Jacksonville, Florida, United States
Specialists In Urology
Naples, Florida, United States
First Urology, PSC
Jeffersonville, Indiana, United States
Metairie Oncologist, LLC
Metairie, Louisiana, United States
Ochsner Clinic Foundation
New Orleans, Louisiana, United States
Regional Urology, LLC
Shreveport, Louisiana, United States
Chesapeake Urology Research Associates
Towson, Maryland, United States
Michigan Institute of Urology
Troy, Michigan, United States
Minnesota Oncology Hematology, P.A.
Edina, Minnesota, United States
Minnesota Oncology Hematology, P.A.
Woodbury, Minnesota, United States
Barnes-Jewish West County Hospital
Creve Coeur, Missouri, United States
Barnes-Jewish Hospital
St Louis, Missouri, United States
Washington University Infusion Center Pharmacy
St Louis, Missouri, United States
Washington University, School of Medicine, 7th Floor, Center for Advanced Medicine
St Louis, Missouri, United States
Siteman Cancer Center - South County
St Louis, Missouri, United States
GU Research network,LLC / Urology Cancer Center
Omaha, Nebraska, United States
Hackensack University Medical Center
Hackensack, New Jersey, United States
John Theurer Cancer Center at Hackensack University Medical Center
Hackensack, New Jersey, United States
AccuMed Research Associates
Garden City, New York, United States
Premier Medical Group of the Hudson Valley PC
Poughkeepsie, New York, United States
Associated Medical Professionals of NY, PLLC
Syracuse, New York, United States
Carolinas Medical Center-Steelcreek
Charlotte, North Carolina, United States
Carolina Clinical Trials, LLC
Concord, North Carolina, United States
Carolina Urology Partners, PLLC
Concord, North Carolina, United States
Duke University Medical Center
Durham, North Carolina, United States
Investigational Chemotherapy Services
Durham, North Carolina, United States
Alliance Urology Specialists, PA
Greensboro, North Carolina, United States
Rowan Regional Medical Center
Salisbury, North Carolina, United States
Wake Forest Baptist Health Urology
Winston-Salem, North Carolina, United States
Wake Forest Baptist Health
Winston-Salem, North Carolina, United States
TriState Urologic Services PSC Inc., dba The Urology Group
Cincinnati, Ohio, United States
Cleveland Clinic Taussig Cancer Institute
Cleveland, Ohio, United States
Peace Harbor Hospital
Florence, Oregon, United States
Salem Hospital
Salem, Oregon, United States
Oregon Urology Institute
Springfield, Oregon, United States
Sacred Heart Nuclear Medicine
Springfield, Oregon, United States
Lancaster Urology
Lancaster, Pennsylvania, United States
Jefferson Medical Oncology
Philadelphia, Pennsylvania, United States
Jefferson Urology Associates
Philadelphia, Pennsylvania, United States
Thomas Jefferson University Hospital
Philadelphia, Pennsylvania, United States
UPMC Cancer Center Hillman Cancer Center
Pittsburgh, Pennsylvania, United States
Mount Nittany Physician Group
State College, Pennsylvania, United States
Mount Nittany Health
State College, Pennsylvania, United States
Charleston Hematology Oncology Associates, PA
Charleston, South Carolina, United States
Carolina Urologic Research Center
Myrtle Beach, South Carolina, United States
Urology Associates P.C.
Nashville, Tennessee, United States
Vanderbilt University Medical Center
Nashville, Tennessee, United States
Urology Clinics of North Texas
Dallas, Texas, United States
Texas Oncology - Baylor Charles A. Sammons Cancer Center
Dallas, Texas, United States
Texas Oncology-Memorial City
Houston, Texas, United States
Urology San Antonio Research
San Antonio, Texas, United States
University of Utah/Huntsman Cancer Hospital
Salt Lake City, Utah, United States
University of Utah/Huntsman Cancer Institute
Salt Lake City, Utah, United States
Virginia Oncology Associates
Hampton, Virginia, United States
Virginia Oncology Associates
Norfolk, Virginia, United States
Urology of Virginia, PLLC.
Virginia Beach, Virginia, United States
Virginia Mason Medical Center
Seattle, Washington, United States
Seattle Cancer Care Alliance
Seattle, Washington, United States
University of Washington Medical Center
Seattle, Washington, United States
University of Wisconsin Clinical Sciences Center
Madison, Wisconsin, United States
Countries
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References
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Penson DF, Armstrong AJ, Concepcion RS, Agarwal N, Olsson CA, Karsh LI, Dunshee CJ, Duggan W, Shen Q, Sugg J, Haas GP, Higano CS. Enzalutamide versus bicalutamide in patients with nonmetastatic castration-resistant prostate cancer: a prespecified subgroup analysis of the STRIVE trial. Prostate Cancer Prostatic Dis. 2022 Feb;25(2):363-365. doi: 10.1038/s41391-021-00465-7. Epub 2021 Oct 7.
Schultz NM, Shore ND, Chowdhury S, Klotz LH, Concepcion RS, Penson DF, Karsh LI, Yang H, Brown BA, Barlev A, Flanders SC. Number-needed-to-treat analysis of clinical progression in patients with metastatic castration-resistant prostate cancer in the STRIVE and TERRAIN trials. BMC Urol. 2018 Sep 6;18(1):77. doi: 10.1186/s12894-018-0387-7.
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.
Other Identifiers
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C3431014
Identifier Type: OTHER
Identifier Source: secondary_id
MDV3100-09
Identifier Type: -
Identifier Source: org_study_id
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