Safety and Efficacy Study of Enzalutamide Versus Bicalutamide in Men With Prostate Cancer
STRIVE
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
2 other identifiers
interventional
396
1 country
109
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_2 prostate-cancer
Started Aug 2012
Typical duration for phase_2 prostate-cancer
109 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
August 1, 2012
CompletedFirst Submitted
Initial submission to the registry
August 10, 2012
CompletedFirst Posted
Study publicly available on registry
August 14, 2012
CompletedPrimary Completion
Last participant's last visit for primary outcome
February 1, 2015
CompletedResults Posted
Study results publicly available
May 23, 2016
CompletedStudy Completion
Last participant's last visit for all outcomes
January 1, 2018
CompletedJanuary 30, 2019
January 1, 2019
2.5 years
August 10, 2012
February 22, 2016
January 7, 2019
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Progression Free Survival (PFS)
PFS was defined as time from randomization to earliest objective evidence of prostate specific-antigen (PSA) progression, radiographic progression, or death on study. PSA progression was defined as ≥ 25% increase in PSA with an absolute increase ≥ 2 ng/mL above the nadir and was to be confirmed by a second consecutive assessment. Radiographic progression in bone was based on The Prostate Cancer Clinical Trials Working Group (PCWG2) guidelines defined as at least 2 new lesions on bone scan. Radiographic progression in soft tissue on Computerized Tomography/Magnetic Resonance Imaging (CT/MRI) was based on Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST 1.1). CT/MRI and bone scans were read locally by the same radiologist (or nuclear medicine physician for interpretation of bone scans) whenever possible. Participants not known to have had a PFS event at the time of the analysis data cutoff were censored at the date of last assessment.
From randomization until the data cut-off date of 09 February 2015, median duration of treatment was 14.7 months in the enzalutamide arm and 8.4 months in the bicalutamide arm.
Secondary Outcomes (6)
Time to PSA Progression
From randomization until the data cut-off date of 09 February 2015, median duration of treatment was 14.7 months in the enzalutamide arm and 8.4 months in the bicalutamide arm.
Percentage of Participants With a PSA Response ≥ 50%
From randomization until the data cut-off date of 09 February 2015, median duration of treatment was 14.7 months in the enzalutamide arm and 8.4 months in the bicalutamide arm.
Duration of Radiographic PFS
From randomization until the data cut-off date of 09 February 2015, median duration of treatment was 14.7 months in the enzalutamide arm and 8.4 months in the bicalutamide arm.
Quality of Life: Time to Degradation of Functional Assessment of Cancer Therapy - Prostate (FACT-P)
From randomization until the data cut-off date of 09 February 2015, median duration of treatment was 14.7 months in the enzalutamide arm and 8.4 months in the bicalutamide arm.
Best Overall Soft Tissue Response
From randomization until the data cut-off date of 09 February 2015, median duration of treatment was 14.7 months in the enzalutamide arm and 8.4 months in the bicalutamide arm.
- +1 more secondary outcomes
Study Arms (2)
Enzalutamide
EXPERIMENTALEnzalutamide 160 mg/day orally
Bicalutamide
ACTIVE COMPARATOR50 mg/day orally
Interventions
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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;
- +20 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Pfizerlead
- Astellas Pharma Inccollaborator
- Medivation LLC, a wholly owned subsidiary of Pfizer Inc.collaborator
Study Sites (109)
University of Alabama at Birmingham
Birmingham, Alabama, 35233, United States
University of Alabama at Birmingham，IDS Pharmacy
Birmingham, Alabama, 35249, United States
University of Alabama at Birmingham
Birmingham, Alabama, 35294, United States
Desert Springs Cancer Care
Scottsdale, Arizona, 85255, United States
Arizona Oncology Associates, PC - HOPE
Tucson, Arizona, 85704, United States
Arizona Oncology Associates, PC - HOPE
Tucson, Arizona, 85710, United States
Urological Associates of Southern Arizona, PC
Tucson, Arizona, 85715, United States
Urological Associates of Southern Arizona, PC
Tucson, Arizona, 85741, United States
Southern California Permanente Medical Group
Anaheim, California, 92806, United States
Kaiser Permanente Medical Center Lab Drawing Station
Antioch, California, 94509, United States
Kaiser Permanente Medical Center Lab Drawing Station
Antioch, California, 94531, United States
Kaiser Permanente Medical Center Lab Drawing Station
Fairfield, California, 94533-6901, United States
Kaiser Permanente Medical Center Lab Drawing Station
Gilroy, California, 95020, United States
Southern California Permanente Medical Group
Los Angeles, California, 90027, United States
Tower Urology
Los Angeles, California, 90048, United States
UCLA Clark Urology Clinic
Los Angeles, California, 90095, United States
UCLA Department of Pharmaceutical Services
Los Angeles, California, 90095, United States
Kaiser Permanente Medical Center Lab Drawing Station
Martinez, California, 94553, United States
Kaiser Permanente Medical Center Lab Drawing Station
Milpitas, California, 95035-5491, United States
Kaiser Permanente Medical Center Lab Drawing Station
Modesto, California, 95356, United States
Kaiser Permanente Medical Center Lab Drawing Station
Moutain View, California, 94041, United States
Kaiser Permanente Medical Center Lab Drawing Station
Napa, California, 94558-3313, United States
Kaiser Permanente Medical Center
Oakland, California, 94611, United States
Kaiser Permanente Medical Center Lab Drawing Station
Pleasanton, California, 94558, United States
Kaiser Permanente Medical Center Lab Drawing Station
Redwood City, California, 94063, United States
Kaiser Permanente Medical Center
Roseville, California, 95661, United States
UC Davis Comprehensive Cancer Center
Sacramento, California, 95817, United States
UC Davis Medical Center
Sacramento, California, 95817, United States
Kaiser Permanente Medical Center
Sacramento, California, 95825, United States
San Bernardino Urological Associates Medical Group
San Bernardino, California, 92404, United States
Southern California Permanente Medical Group
San Diego, California, 92120, United States
Kaiser Permanente Medical Center
San Francisco, California, 94115, United States
Kaiser Permanente Medical Center
San Jose, California, 95119, United States
Kaiser Permanente Medical Center
San Leandro, California, 94577, United States
Southern California Permanente Medical Group
San Marcos, California, 92078, United States
Kaiser Permanente Medical Center
Santa Clara, California, 95051, United States
Skyline Urology
Sherman Oaks, California, 91411, United States
Kaiser Permanente Medical Center
South San Francisco, California, 94080, United States
Standford Health Care
Stanford, California, 94305, United States
Skyline Urology
Torrance, California, 90505, United States
Kaiser Permanente Medical Center
Vallejo, California, 94589, United States
Kaiser Permanente Medical Center
Walnut Creek, California, 94596, United States
Anschutz Cancer Center Pavilion Pharmacy
Aurora, Colorado, 80045, United States
Anschutz Inpatient Pavilion
Aurora, Colorado, 80045, United States
University of Colorado Cancer Center, Anschutz Cancer Pavilion
Aurora, Colorado, 80045, United States
The Urology Center of Colorado
Denver, Colorado, 80211, United States
George Washington University - Medical Faculty Associates
Washington D.C., District of Columbia, 20037, United States
Advanced Urology institute
Daytona Beach, Florida, 32114, United States
East Coast Institute for Research, LLC
Jacksonville, Florida, 32207, United States
East Coast Institute for Research, LLC
Jacksonville, Florida, 32216, United States
Specialists In Urology
Naples, Florida, 34102, United States
First Urology, PSC
Jeffersonville, Indiana, 47130, United States
Metairie Oncologist, LLC
Metairie, Louisiana, 70006, United States
Ochsner Clinic Foundation
New Orleans, Louisiana, 70121, United States
Regional Urology, LLC
Shreveport, Louisiana, 71106, United States
Chesapeake Urology Research Associates
Towson, Maryland, 21204, United States
Michigan Institute of Urology
Troy, Michigan, 48084, United States
Minnesota Oncology Hematology, P.A.
Edina, Minnesota, 55435-2150, United States
Minnesota Oncology Hematology, P.A.
Woodbury, Minnesota, 55125, United States
Barnes-Jewish West County Hospital
Creve Coeur, Missouri, 63141, United States
Barnes-Jewish Hospital
St Louis, Missouri, 63110, United States
Washington University Infusion Center Pharmacy
St Louis, Missouri, 63110, United States
Washington University, School of Medicine, 7th Floor, Center for Advanced Medicine
St Louis, Missouri, 63110, United States
Siteman Cancer Center - South County
St Louis, Missouri, 63129, United States
GU Research network,LLC / Urology Cancer Center
Omaha, Nebraska, 68130, United States
Hackensack University Medical Center
Hackensack, New Jersey, 07601, United States
John Theurer Cancer Center at Hackensack University Medical Center
Hackensack, New Jersey, 07601, United States
AccuMed Research Associates
Garden City, New York, 11530, United States
Premier Medical Group of the Hudson Valley PC
Poughkeepsie, New York, 12601, United States
Associated Medical Professionals of NY, PLLC
Syracuse, New York, 13210, United States
Carolinas Medical Center-Steelcreek
Charlotte, North Carolina, 28278, United States
Carolina Clinical Trials, LLC
Concord, North Carolina, 28025, United States
Carolina Urology Partners, PLLC
Concord, North Carolina, 28025, United States
Duke University Medical Center
Durham, North Carolina, 27710, United States
Investigational Chemotherapy Services
Durham, North Carolina, 27710, United States
Alliance Urology Specialists, PA
Greensboro, North Carolina, 27403, United States
Rowan Regional Medical Center
Salisbury, North Carolina, 28144, United States
Wake Forest Baptist Health Urology
Winston-Salem, North Carolina, 27103, United States
Wake Forest Baptist Health
Winston-Salem, North Carolina, 27157, United States
TriState Urologic Services PSC Inc., dba The Urology Group
Cincinnati, Ohio, 45212, United States
Cleveland Clinic Taussig Cancer Institute
Cleveland, Ohio, 44195, United States
Peace Harbor Hospital
Florence, Oregon, 97439, United States
Salem Hospital
Salem, Oregon, 97301, United States
Oregon Urology Institute
Springfield, Oregon, 97477, United States
Sacred Heart Nuclear Medicine
Springfield, Oregon, 97477, United States
Lancaster Urology
Lancaster, Pennsylvania, 17604, United States
Jefferson Medical Oncology
Philadelphia, Pennsylvania, 19107, United States
Jefferson Urology Associates
Philadelphia, Pennsylvania, 19107, United States
Thomas Jefferson University Hospital
Philadelphia, Pennsylvania, 19107, United States
UPMC Cancer Center Hillman Cancer Center
Pittsburgh, Pennsylvania, 15232, United States
Mount Nittany Physician Group
State College, Pennsylvania, 16801, United States
Mount Nittany Health
State College, Pennsylvania, 16803, United States
Charleston Hematology Oncology Associates, PA
Charleston, South Carolina, 29414, United States
Carolina Urologic Research Center
Myrtle Beach, South Carolina, 29572, United States
Urology Associates P.C.
Nashville, Tennessee, 37209, United States
Vanderbilt University Medical Center
Nashville, Tennessee, 37232, United States
Urology Clinics of North Texas
Dallas, Texas, 75231, United States
Texas Oncology - Baylor Charles A. Sammons Cancer Center
Dallas, Texas, 75246, United States
Texas Oncology-Memorial City
Houston, Texas, 77024, United States
Urology San Antonio Research
San Antonio, Texas, 78229, United States
University of Utah/Huntsman Cancer Hospital
Salt Lake City, Utah, 84112, United States
University of Utah/Huntsman Cancer Institute
Salt Lake City, Utah, 84112, United States
Virginia Oncology Associates
Hampton, Virginia, 23666, United States
Virginia Oncology Associates
Norfolk, Virginia, 23502, United States
Urology of Virginia, PLLC.
Virginia Beach, Virginia, 23462, United States
Virginia Mason Medical Center
Seattle, Washington, 98101, United States
Seattle Cancer Care Alliance
Seattle, Washington, 98109, United States
University of Washington Medical Center
Seattle, Washington, 98195, United States
University of Wisconsin Clinical Sciences Center
Madison, Wisconsin, 53792, United States
Related Publications (3)
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.
PMID: 34621011DERIVEDSchultz 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.
PMID: 30189902DERIVEDPenson 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.
PMID: 26811535DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Results Point of Contact
- Title
- Pfizer ClinicalTrials.gov Call Center
- Organization
- Pfizer Inc.
Study Officials
- STUDY DIRECTOR
Pfizer Pfizer CT.gov Call Center
Pfizer
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- OTHER
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- TRIPLE
- Who Masked
- PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
August 10, 2012
First Posted
August 14, 2012
Study Start
August 1, 2012
Primary Completion
February 1, 2015
Study Completion
January 1, 2018
Last Updated
January 30, 2019
Results First Posted
May 23, 2016
Record last verified: 2019-01
Data Sharing
- IPD Sharing
- Will share
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/data\_requests.