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Brief Title: Adjuvant Apalutamide in Subjects With High-risk Localized or Locally Advanced Prostate Cancer After Radical Prostatectomy
Official Title: A Randomized, Open-label, Phase 2 Study of Adjuvant Apalutamide or Standard of Care in Subjects With High-risk, Localized or Locally Advanced Prostate Cancer After Radical Prostatectomy
Study ID: NCT04295447
Brief Summary: The primary objective of this trial is to determine if adjuvant apalutamide in prostate cancer patients at high risk of developing subsequent metastatic disease results in prolonged biochemically recurrence-free survival after radical prostatectomy (RPE) in comparison to standard of care (SOC).
Detailed Description:
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: MALE
Healthy Volunteers: No
Medizinische Universität Innsbruck, Innsbruck, , Austria
Ordensklinikum Linz GmbH Elisabethinen, Linz, , Austria
Kepler Universitätsklinikum GmbH, Linz, , Austria
Uniklinikum Salzburg, Landeskrankenhaus, Salzburg, , Austria
Salzkammergut Klinikum Vöcklabruck, Vöcklabruck, , Austria
Hanusch-Krankenhaus, Wien, , Austria
University Hospital Münster, Münster, North Rhine-Westfalia, Germany
GFO Kliniken Rhein-Berg, Bergisch Gladbach, , Germany
Städtisches Klinikum Braunschweig, Braunschweig, , Germany
Universitätsklinikum Carl Gustav Carus an der TU Dresden, Dresden, , Germany
Urologicum Duisburg, Duisburg, , Germany
Universitätsklinikum Düsseldorf, Düsseldorf, , Germany
Universitätsklinikum Essen, Essen, , Germany
Universitätsklinikum Frankfurt, Frankfurt, , Germany
Universitätsklinikum Hamburg-Eppendorf, Martini-Klinik, Hamburg, , Germany
Universitätsklinikum Jena, Jena, , Germany
Urologische Partnerschaft Köln, Köln, , Germany
Universitätsklinikum Schleswig-Holstein, Campus Lübeck, Lübeck, , Germany
Universitätsklinikum Magdeburg, Magdeburg, , Germany
Studienpraxis Urologie, Nürtingen, , Germany
Klinik für Urologie, Lehrstuhl Regensburg, Am Caritas Krankenhaus St. Josef, Regensburg, , Germany
Diakonie Klinikum Stuttgart, Stuttgart, , Germany
Universitätsklinikum Ulm, Ulm, , Germany
UroGynZentrum, Wuppertal, , Germany
Helios Universitätsklinikum Wuppertal, Universität Witten/Herdecke, Wuppertal, , Germany
Name: Martin Bögemann, Univ.-Prof. Dr. med.
Affiliation: Universitätsklinikum Münster, Klinik für Urologie und Kinderurologie
Role: PRINCIPAL_INVESTIGATOR