title: Enzalutamide Versus Bicalutamide in Castration-Resistant Prostate Cancer: The STRIVE Trial.
abstract: Enzalutamide, a potent oral androgen receptor inhibitor, improves survival in men with metastatic castration-resistant prostate cancer (CRPC) before and after chemotherapy. Bicalutamide, a nonsteroidal antiandrogen, is widely used to treat men with nonmetastatic or metastatic CRPC. The efficacy and safety of these drugs were compared in this randomized, double-blind, phase II study of men with CRPC.
  
  
  
  A total of 396 men with nonmetastatic (n = 139) or metastatic (n = 257) CRPC were randomly assigned to enzalutamide 160 mg per day (n = 198) or bicalutamide 50 mg per day (n = 198). Androgen deprivation therapy was continued in both arms. The primary end point was progression-free survival (PFS).
  
  
  
  Enzalutamide reduced the risk of progression or death by 76% compared with bicalutamide (hazard ratio [HR], 0.24; 95% CI, 0.18 to 0.32; P < .001). Median PFS was 19.4 months with enzalutamide versus 5.7 months with bicalutamide. Enzalutamide resulted in significant improvements in all key secondary end points: time to prostate-specific antigen progression (HR, 0.19; 95% CI, 0.14 to 0.26; P < .001); proportion of patients with a ≥ 50% prostate-specific antigen response (81% v 31%; P < .001); and radiographic PFS in metastatic patients (HR, 0.32; 95% CI, 0.21 to 0.50; P < .001). Beneficial effects with enzalutamide were observed in both nonmetastatic and metastatic subgroups. The observed adverse event profile was consistent with that from phase III enzalutamide trials.
  
  
  
  Enzalutamide significantly reduced risk of prostate cancer progression or death compared with bicalutamide in patients with nonmetastatic or metastatic CRPC.
authors.affiliation: David F. Penson, Vanderbilt University Medical Center and Tennessee Valley Veterans Administration Medical Center Geriatric Research, Education, and Clinical Center; Raoul Concepcion, Urology Associates PC, Nashville, TN; Andrew J. Armstrong, Duke Cancer Institute, Duke University, Durham, NC; Neeraj Agarwal, Huntsman Cancer Institute, University of Utah, Salt Lake City, UT; Carl Olsson, Icahn School of Medicine at Mount Sinai, New York, NY; Lawrence Karsh, The Urology Center of Colorado, Denver, CO; Curtis Dunshee, Urological Associates of Southern Arizona, Tucson, AZ; Fong Wang and Kenneth Wu, Medivation, San Francisco, CA; Andrew Krivoshik, Astellas Pharma Global Development, Northbrook, IL; De Phung, Astellas Pharma Global Development, Leiden, The Netherlands; and Celestia S. Higano, Fred Hutchinson Cancer Research Center, University of Washington, Seattle, WA. david.penson@vanderbilt.edu.
authors.forename: David F
authors.initials: DF
authors.lastname: Penson
authors.affiliation: David F. Penson, Vanderbilt University Medical Center and Tennessee Valley Veterans Administration Medical Center Geriatric Research, Education, and Clinical Center; Raoul Concepcion, Urology Associates PC, Nashville, TN; Andrew J. Armstrong, Duke Cancer Institute, Duke University, Durham, NC; Neeraj Agarwal, Huntsman Cancer Institute, University of Utah, Salt Lake City, UT; Carl Olsson, Icahn School of Medicine at Mount Sinai, New York, NY; Lawrence Karsh, The Urology Center of Colorado, Denver, CO; Curtis Dunshee, Urological Associates of Southern Arizona, Tucson, AZ; Fong Wang and Kenneth Wu, Medivation, San Francisco, CA; Andrew Krivoshik, Astellas Pharma Global Development, Northbrook, IL; De Phung, Astellas Pharma Global Development, Leiden, The Netherlands; and Celestia S. Higano, Fred Hutchinson Cancer Research Center, University of Washington, Seattle, WA.
authors.forename: Andrew J
authors.initials: AJ
authors.lastname: Armstrong
authors.affiliation: David F. Penson, Vanderbilt University Medical Center and Tennessee Valley Veterans Administration Medical Center Geriatric Research, Education, and Clinical Center; Raoul Concepcion, Urology Associates PC, Nashville, TN; Andrew J. Armstrong, Duke Cancer Institute, Duke University, Durham, NC; Neeraj Agarwal, Huntsman Cancer Institute, University of Utah, Salt Lake City, UT; Carl Olsson, Icahn School of Medicine at Mount Sinai, New York, NY; Lawrence Karsh, The Urology Center of Colorado, Denver, CO; Curtis Dunshee, Urological Associates of Southern Arizona, Tucson, AZ; Fong Wang and Kenneth Wu, Medivation, San Francisco, CA; Andrew Krivoshik, Astellas Pharma Global Development, Northbrook, IL; De Phung, Astellas Pharma Global Development, Leiden, The Netherlands; and Celestia S. Higano, Fred Hutchinson Cancer Research Center, University of Washington, Seattle, WA.
authors.forename: Raoul
authors.initials: R
authors.lastname: Concepcion
authors.affiliation: David F. Penson, Vanderbilt University Medical Center and Tennessee Valley Veterans Administration Medical Center Geriatric Research, Education, and Clinical Center; Raoul Concepcion, Urology Associates PC, Nashville, TN; Andrew J. Armstrong, Duke Cancer Institute, Duke University, Durham, NC; Neeraj Agarwal, Huntsman Cancer Institute, University of Utah, Salt Lake City, UT; Carl Olsson, Icahn School of Medicine at Mount Sinai, New York, NY; Lawrence Karsh, The Urology Center of Colorado, Denver, CO; Curtis Dunshee, Urological Associates of Southern Arizona, Tucson, AZ; Fong Wang and Kenneth Wu, Medivation, San Francisco, CA; Andrew Krivoshik, Astellas Pharma Global Development, Northbrook, IL; De Phung, Astellas Pharma Global Development, Leiden, The Netherlands; and Celestia S. Higano, Fred Hutchinson Cancer Research Center, University of Washington, Seattle, WA.
authors.forename: Neeraj
authors.initials: N
authors.lastname: Agarwal
authors.affiliation: David F. Penson, Vanderbilt University Medical Center and Tennessee Valley Veterans Administration Medical Center Geriatric Research, Education, and Clinical Center; Raoul Concepcion, Urology Associates PC, Nashville, TN; Andrew J. Armstrong, Duke Cancer Institute, Duke University, Durham, NC; Neeraj Agarwal, Huntsman Cancer Institute, University of Utah, Salt Lake City, UT; Carl Olsson, Icahn School of Medicine at Mount Sinai, New York, NY; Lawrence Karsh, The Urology Center of Colorado, Denver, CO; Curtis Dunshee, Urological Associates of Southern Arizona, Tucson, AZ; Fong Wang and Kenneth Wu, Medivation, San Francisco, CA; Andrew Krivoshik, Astellas Pharma Global Development, Northbrook, IL; De Phung, Astellas Pharma Global Development, Leiden, The Netherlands; and Celestia S. Higano, Fred Hutchinson Cancer Research Center, University of Washington, Seattle, WA.
authors.forename: Carl
authors.initials: C
authors.lastname: Olsson
authors.affiliation: David F. Penson, Vanderbilt University Medical Center and Tennessee Valley Veterans Administration Medical Center Geriatric Research, Education, and Clinical Center; Raoul Concepcion, Urology Associates PC, Nashville, TN; Andrew J. Armstrong, Duke Cancer Institute, Duke University, Durham, NC; Neeraj Agarwal, Huntsman Cancer Institute, University of Utah, Salt Lake City, UT; Carl Olsson, Icahn School of Medicine at Mount Sinai, New York, NY; Lawrence Karsh, The Urology Center of Colorado, Denver, CO; Curtis Dunshee, Urological Associates of Southern Arizona, Tucson, AZ; Fong Wang and Kenneth Wu, Medivation, San Francisco, CA; Andrew Krivoshik, Astellas Pharma Global Development, Northbrook, IL; De Phung, Astellas Pharma Global Development, Leiden, The Netherlands; and Celestia S. Higano, Fred Hutchinson Cancer Research Center, University of Washington, Seattle, WA.
authors.forename: Lawrence
authors.initials: L
authors.lastname: Karsh
authors.affiliation: David F. Penson, Vanderbilt University Medical Center and Tennessee Valley Veterans Administration Medical Center Geriatric Research, Education, and Clinical Center; Raoul Concepcion, Urology Associates PC, Nashville, TN; Andrew J. Armstrong, Duke Cancer Institute, Duke University, Durham, NC; Neeraj Agarwal, Huntsman Cancer Institute, University of Utah, Salt Lake City, UT; Carl Olsson, Icahn School of Medicine at Mount Sinai, New York, NY; Lawrence Karsh, The Urology Center of Colorado, Denver, CO; Curtis Dunshee, Urological Associates of Southern Arizona, Tucson, AZ; Fong Wang and Kenneth Wu, Medivation, San Francisco, CA; Andrew Krivoshik, Astellas Pharma Global Development, Northbrook, IL; De Phung, Astellas Pharma Global Development, Leiden, The Netherlands; and Celestia S. Higano, Fred Hutchinson Cancer Research Center, University of Washington, Seattle, WA.
authors.forename: Curtis
authors.initials: C
authors.lastname: Dunshee
authors.affiliation: David F. Penson, Vanderbilt University Medical Center and Tennessee Valley Veterans Administration Medical Center Geriatric Research, Education, and Clinical Center; Raoul Concepcion, Urology Associates PC, Nashville, TN; Andrew J. Armstrong, Duke Cancer Institute, Duke University, Durham, NC; Neeraj Agarwal, Huntsman Cancer Institute, University of Utah, Salt Lake City, UT; Carl Olsson, Icahn School of Medicine at Mount Sinai, New York, NY; Lawrence Karsh, The Urology Center of Colorado, Denver, CO; Curtis Dunshee, Urological Associates of Southern Arizona, Tucson, AZ; Fong Wang and Kenneth Wu, Medivation, San Francisco, CA; Andrew Krivoshik, Astellas Pharma Global Development, Northbrook, IL; De Phung, Astellas Pharma Global Development, Leiden, The Netherlands; and Celestia S. Higano, Fred Hutchinson Cancer Research Center, University of Washington, Seattle, WA.
authors.forename: Fong
authors.initials: F
authors.lastname: Wang
authors.affiliation: David F. Penson, Vanderbilt University Medical Center and Tennessee Valley Veterans Administration Medical Center Geriatric Research, Education, and Clinical Center; Raoul Concepcion, Urology Associates PC, Nashville, TN; Andrew J. Armstrong, Duke Cancer Institute, Duke University, Durham, NC; Neeraj Agarwal, Huntsman Cancer Institute, University of Utah, Salt Lake City, UT; Carl Olsson, Icahn School of Medicine at Mount Sinai, New York, NY; Lawrence Karsh, The Urology Center of Colorado, Denver, CO; Curtis Dunshee, Urological Associates of Southern Arizona, Tucson, AZ; Fong Wang and Kenneth Wu, Medivation, San Francisco, CA; Andrew Krivoshik, Astellas Pharma Global Development, Northbrook, IL; De Phung, Astellas Pharma Global Development, Leiden, The Netherlands; and Celestia S. Higano, Fred Hutchinson Cancer Research Center, University of Washington, Seattle, WA.
authors.forename: Kenneth
authors.initials: K
authors.lastname: Wu
authors.affiliation: David F. Penson, Vanderbilt University Medical Center and Tennessee Valley Veterans Administration Medical Center Geriatric Research, Education, and Clinical Center; Raoul Concepcion, Urology Associates PC, Nashville, TN; Andrew J. Armstrong, Duke Cancer Institute, Duke University, Durham, NC; Neeraj Agarwal, Huntsman Cancer Institute, University of Utah, Salt Lake City, UT; Carl Olsson, Icahn School of Medicine at Mount Sinai, New York, NY; Lawrence Karsh, The Urology Center of Colorado, Denver, CO; Curtis Dunshee, Urological Associates of Southern Arizona, Tucson, AZ; Fong Wang and Kenneth Wu, Medivation, San Francisco, CA; Andrew Krivoshik, Astellas Pharma Global Development, Northbrook, IL; De Phung, Astellas Pharma Global Development, Leiden, The Netherlands; and Celestia S. Higano, Fred Hutchinson Cancer Research Center, University of Washington, Seattle, WA.
authors.forename: Andrew
authors.initials: A
authors.lastname: Krivoshik
authors.affiliation: David F. Penson, Vanderbilt University Medical Center and Tennessee Valley Veterans Administration Medical Center Geriatric Research, Education, and Clinical Center; Raoul Concepcion, Urology Associates PC, Nashville, TN; Andrew J. Armstrong, Duke Cancer Institute, Duke University, Durham, NC; Neeraj Agarwal, Huntsman Cancer Institute, University of Utah, Salt Lake City, UT; Carl Olsson, Icahn School of Medicine at Mount Sinai, New York, NY; Lawrence Karsh, The Urology Center of Colorado, Denver, CO; Curtis Dunshee, Urological Associates of Southern Arizona, Tucson, AZ; Fong Wang and Kenneth Wu, Medivation, San Francisco, CA; Andrew Krivoshik, Astellas Pharma Global Development, Northbrook, IL; De Phung, Astellas Pharma Global Development, Leiden, The Netherlands; and Celestia S. Higano, Fred Hutchinson Cancer Research Center, University of Washington, Seattle, WA.
authors.forename: De
authors.initials: D
authors.lastname: Phung
authors.affiliation: David F. Penson, Vanderbilt University Medical Center and Tennessee Valley Veterans Administration Medical Center Geriatric Research, Education, and Clinical Center; Raoul Concepcion, Urology Associates PC, Nashville, TN; Andrew J. Armstrong, Duke Cancer Institute, Duke University, Durham, NC; Neeraj Agarwal, Huntsman Cancer Institute, University of Utah, Salt Lake City, UT; Carl Olsson, Icahn School of Medicine at Mount Sinai, New York, NY; Lawrence Karsh, The Urology Center of Colorado, Denver, CO; Curtis Dunshee, Urological Associates of Southern Arizona, Tucson, AZ; Fong Wang and Kenneth Wu, Medivation, San Francisco, CA; Andrew Krivoshik, Astellas Pharma Global Development, Northbrook, IL; De Phung, Astellas Pharma Global Development, Leiden, The Netherlands; and Celestia S. Higano, Fred Hutchinson Cancer Research Center, University of Washington, Seattle, WA.
authors.forename: Celestia S
authors.initials: CS
authors.lastname: Higano
mesh_terms: D000328:Adult; D000368:Aged; D000726:Androgen Antagonists / Q000627:therapeutic use*; D000813:Anilides / Q000009:adverse effects / Q000627:therapeutic use*; D000970:Antineoplastic Agents / Q000627:therapeutic use*; D001549:Benzamides; D004311:Double-Blind Method; D006801:Humans; D008297:Male; D008875:Middle Aged; D009570:Nitriles / Q000009:adverse effects / Q000627:therapeutic use*; D010669:Phenylthiohydantoin / Q000009:adverse effects / Q000031:analogs & derivatives* / Q000627:therapeutic use; D017430:Prostate-Specific Antigen / Q000097:blood; D064129:Prostatic Neoplasms, Castration-Resistant / Q000188:drug therapy* / Q000401:mortality; D014105:Tosyl Compounds / Q000009:adverse effects / Q000627:therapeutic use*
chemical_list: D000726:Androgen Antagonists; D000813:Anilides; D000970:Antineoplastic Agents; D001549:Benzamides; D009570:Nitriles; D014105:Tosyl Compounds; D010669:Phenylthiohydantoin; C540278:enzalutamide; C053541:bicalutamide; D017430:Prostate-Specific Antigen