ARCHES: A Randomized, Phase III Study of Androgen Deprivation Therapy With Enzalutamide or Placebo in Men With Metastatic Hormone-Sensitive Prostate Cancer

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Andrew J. Armstrong, MD, ScM; Russell Z. Szmulewitz, MD; Daniel P. Petrylak, MD; Jeffrey Holzbeierlein, MD; Arnauld Villers, MD; Arun Azad, MBBS, PhD; Antonio Alcaraz, MD, PhD; Boris Alekseev, MD; Taro Iguchi, MD, PhD; Neal D. Shore, MD; Brad Rosbrook, MS; Jennifer Sugg, MS; Benoit Baron, MS; Lucy Chen, MD; and Arnulf Stenzl, MD

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Evaluation of Clinically Relevant Drug–Drug Interactions and Population Pharmacokinetics of Darolutamide

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Full Title: Evaluation of Clinically Relevant Drug–Drug Interactions and Population Pharmacokinetics of Darolutamide in Patients with Nonmetastatic Castration-Resistant Prostate Cancer: Results of Pre-Specified and Post Hoc Analyses of the Phase III ARAMIS Trial

Neal Shore, Christian Zurth, Robert Fricke, Hille Gieschen, Kristina Graudenz, Mikko Koskinen, Bart Ploeger, Jonathan Moss, Olaf Prien, Gustavo Borghesi, Oana Petrenciuc, Teuvo L. Tammela, Iris Kuss, Frank Verholen, Matthew R. Smith, Karim Fizazi

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Real-World Outcomes of Sipuleucel-T Treatment in PROCEED, a Prospective Registry of Men With Metastatic Castration-Resistant Prostate Cancer

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Celestia S. Higano, MD1; Andrew J. Armstrong, MD, ScM2,3; A. Oliver Sartor, MD4; Nicholas J. Vogelzang, MD5; Philip W. Kantoff, MD6; David G. McLeod, MD, JD7; Christopher M. Pieczonka, MD8; David F. Penson, MD, MPH9,10; Neal D. Shore, MD11; Jeffrey Vacirca, MD12; Raoul S. Concepcion, MD13; Ronald F. Tutrone, MD14; Luke T. Nordquist, MD15; David I. Quinn, MBBS, PhD16; Vahan Kassabian, MD17; Mark C. Scholz, MD18; Matt Harmon, JD19; Robert C. Tyler, PhD20; Nancy N. Chang, PharmD20; Hong Tang, MD20; and Matthew R. Cooperberg, MD, MPH21,22

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Results of a Real-world Study of Enzalutamide and Abiraterone Acetate with Prednisone Tolerability (REAAcT)

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Neal D. Shore, Daniel Saltzstein, Paul Sieber, Bryan Mehlhaff, Lawrence Gervasi, Jennifer Phillips, Yu-Ning Wong, Huiling Peig, Tracy McGowan

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Three-year Active Surveillance Outcomes in a Contemporary Community Urology Cohort in the United States

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Jeremy B. Shelton, Thomas A. Paivanas, Phil Buffington, Stephen R. Ruyle, Edward S. Cohen, Richard Natale II, Bryan Mehlhaff, Ronald Suh, Timothy J. Bradford, Alec S. Koo, Lorna Kwan, Neal Shore

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Contemporary Management of Incident Prostate Cancer in Large Community Urology Practices in the United States

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Jeremy B. Shelton, Phil Buffington, Richard Augspurger, Franklin Gaylis, Todd Cohen, Bryan Mehlhaff, Ronald Suh, Timothy J. Bradford, Lorna Kwan, Alec S. Koo,  Neal Shore

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Darolutamide in Nonmetastatic, Castration-Resistant Prostate Cancer

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  • Karim Fizazi, M.D.,
  • Neal Shore, M.D.,
  • Teuvo L. Tammela, M.D., Ph.D.,
  • Albertas Ulys, M.D.,
  • Egils Vjaters, M.D.,
  • Sergey Polyakov, M.D.,
  • Mindaugas Jievaltas, M.D.,
  • Murilo Luz, M.D.,
  • Boris Alekseev, M.D.,
  • Iris Kuss, M.D.,
  • Christian Kappeler, Ph.D.,
  • Amir Snapir, M.D., Ph.D.,
  • Toni Sarapohja, M.Sc.,
  • and Matthew R. Smith, M.D., Ph.D.
  • for the ARAMIS Investigators*

    Background- Darolutamide is a structurally unique androgen-receptor antagonist that is under development for the treatment of prostate cancer. We evaluated the efficacy of darolutamide for delaying metastasis and death in men with nonmetastatic, castration-resistant prostate cancer.

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Managing Nonmetastatic Castration-resistant Prostate Cancer

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Joaquin Mateo, Karim Fizazi, Silke Gillessen, Axel Heidenreich, Raquel Perez-Lopez, Wim J.G. Oyen, Neal Shore, Matthew Smith, Christopher Sweeney, Bertrand Tombal, Scott A. Tomlins, Johann S. de Bono. Correspondence information about the author Johann S. de Bono
Associate Editor: Giacomo Novara

Context

Patients with nonmetastatic castration-resistant prostate cancer (nmCRPC) have rising prostate-specific antigen (PSA) and castrate testosterone levels, with no radiological findings of metastatic disease on computed tomography and bone scan. Given recent drug approvals for nmCRPC, with many other therapeutics and imaging modalities being developed, management of nmCRPC is a rapidly evolving field that merits detailed investigation.

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A New Sustained-Release, 3-Month Leuprolide Acetate Formulation Achieves and Maintains Castrate Concentrations of Testosterone in Patients With Prostate Cancer

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Neal D.Shore, MD, SílviaGuerrero, PhD, Rosa MaSanahuja, MS, GemmaGambús, MD, PhD, AntonioParente, Ph

Purpose

This clinical trial investigated the effectiveness, pharmacokinetic properties, and safety profile of leuprolide acetate 22.5-mg depot, a new 3-month leuprolide depot formulation, as androgen deprivation therapy for patients with prostate cancer.

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