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Prostate Cancer NCCN Clinical Practice Guidelines in Oncology (NCCN Guidelines®) Prostate Cancer Version 4.2018 — August 15, 2018 NCCN.org NCCN Guidelines for Patients® available at www.nccn.org/patients Continue Version 4.2018, 08/15/18 © National Comprehensive Cancer Network, Inc. 2018, All rights reserved. The NCCN Guidelines® and this illustration may not be reproduced in any form without the express written permission of NCCN®. NCCN Guidelines Index NCCN Guidelines Version 4.2018 Table of Contents Prostate Cancer Discussion *James L. Mohler, MD/Chair ω Celestia S. Higano, MD † ω Sylvia Richey, MD † Roswell Park Cancer Institute Fred Hutchinson Cancer Research Center/ St. Jude Children’s Research Hospital/ Seattle Cancer Care Alliance University of Tennessee Health Science Center *Richard J. Lee, MD, PhD/Vice-Chair † Dana-Farber/Brigham and Women’s Cancer Eric Mark Horwitz, MD § Mack Roach, III, MD § Center | Massachusetts General Hospital Fox Chase Cancer Center UCSF Helen Diller Family Cancer Center Comprehensive Cancer Center Michael Hurwitz, MD, PhD † *Emmanuel S. Antonarakis, MD † Yale Cancer Center/Smilow Cancer Hospital Stan Rosenfeld ¥ The Sidney Kimmel Comprehensive University of California San Francisco Cancer Center at Johns Hopkins Joseph E. Ippolito, MD, PhD ф Patient Services Committee Chair Siteman Cancer Center at Barnes-Jewish *Andrew J. Armstrong, MD † Hospital and Washington University School of *Edward Schaeffer, MD, PhD ω Duke Cancer Institute Medicine Robert H. Lurie Comprehensive Cancer Center of Northwestern University Anthony Victor D’Amico, MD, PhD § Christopher J. Kane, MD ω Dana-Farber/Brigham and Women’s Cancer UC San Diego Moores Cancer Center Ahmad Shabsigh, MD ω Center | Massachusetts General Hospital The Ohio State University Comprehensive Cancer Center Michael Kuettel, MD, MBA, PhD § Cancer Center - James Cancer Hospital and Roswell Park Cancer Institute Solove Research Institute Brian J. Davis, MD, PhD § Mayo Clinic Cancer Center Joshua M. Lang, MD † Ted A. Skolarus, MD ω University of Wisconsin Carbone Cancer Center University of Michigan Tanya Dorff, MD † Comprehensive Cancer Center City of Hope Comprehensive Cancer Center George Netto, MD ≠ University of Alabama at Birmingham Eric J. Small, MD † James A. Eastham, MD ω Comprehensive Cancer Center UCSF Helen Diller Family Memorial Sloan Kettering Cancer Center Comprehensive Cancer Center David F. Penson, MD, MPH ω Rodney Ellis, MD § Vanderbilt-Ingram Cancer Center Sandy Srinivas, MD † Case Comprehensive Cancer Center/ Stanford Cancer Institute University Hospitals Seidman Cancer Center Elizabeth R. Plimack, MD, MS † Þ and Cleveland Clinic Taussig Cancer Institute Fox Chase Cancer Center *Jonathan Tward, MD, PhD § Huntsman Cancer Institute at the University of ω Charles A. Enke, MD § Julio M. Pow-Sang, MD Utah Fred & Pamela Buffett Cancer Center Moffitt Cancer Center Przemyslaw Twardowski, MD † ¥ Thomas A. Farrington ¥ Thomas J. Pugh, MD § City of Hope Comprehensive Cancer Center Prostate Health Education Network (PHEN) University of Colorado Cancer Center NCCN Deborah Freedman-Cass, PhD † Medical oncology ф Diagnostic/Interventional radiology Dorothy A. Shead, MS § Radiotherapy/Radiation oncology ≠ Pathology Continue Þ Internal medicine ¥ Patient advocate NCCN Guidelines Panel Disclosures ω Urology *Discussion Section Writing Committee Version 4.2018, 08/15/18 © National Comprehensive Cancer Network, Inc. 2018, All rights reserved. The NCCN Guidelines® and this illustration may not be reproduced in any form without the express written permission of NCCN®. NCCN Guidelines Index NCCN Guidelines Version 4.2018 Table of Contents Prostate Cancer Discussion NCCN Prostate Cancer Panel Members NCCN believes that Summary of Guidelines Updates Clinical Trials: the best management for any patient Initial Prostate Cancer Diagnosis (PROS-1) with cancer is in a clinical trial. Risk Stratification and Staging Workup (PROS-2) Participation in clinical trials is Very Low Risk Group (PROS-4) especially encouraged. Low Risk Group (PROS-5) To find clinical trials online at NCCN Favorable Intermediate Risk Group (PROS-6) Member Institutions, click here: Unfavorable Intermediate Risk Group (PROS-7) nccn.org/clinical_trials/clinicians.aspx. High or Very High Risk Group (PROS-8) Regional Risk Group (PROS-9) NCCN Categories of Evidence and Consensus: All recommendations Monitoring (PROS-10) are category 2A unless otherwise Radical Prostatectomy PSA Persistence/Recurrence (PROS-11) indicated. Radiation Therapy Recurrence (PROS-12) Systemic Therapy for Castration-Naive Disease (PROS-13) See NCCN Categories of Evidence and Consensus. Systemic Therapy for M0 Castration Resistant Prostate Cancer (CRPC) (PROS-14) Systemic Therapy for M1 CRPC (PROS-15) Subsequent Systemic Therapy for M1 CRPC: No Visceral Metastases (PROS-16) Systemic Therapy for M1 CRPC: Visceral Metastases (PROS-17) Principles of Life Expectancy Estimation (PROS-A) Principles of Imaging (PROS-B) Principles of Active Surveillance and Observation (PROS-C) Principles of Radiation Therapy (PROS-D) Principles of Surgery (PROS-E) Principles of Androgen Deprivation Therapy (PROS-F) Principles of Immunotherapy and Chemotherapy (PROS-G) Staging (ST-1) The NCCN Guidelines® are a statement of evidence and consensus of the authors regarding their views of currently accepted approaches to treatment. Any clinician seeking to apply or consult the NCCN Guidelines is expected to use independent medical judgment in the context of individual clinical circumstances to determine any patient’s care or treatment. The National Comprehensive Cancer Network® (NCCN®) makes no representations or warranties of any kind regarding their content, use or application and disclaims any responsibility for their application or use in any way. The NCCN Guidelines are copyrighted by National Comprehensive Cancer Network®. All rights reserved. The NCCN Guidelines and the illustrations herein may not be reproduced in any form without the express written permission of NCCN. ©2018. Version 4.2018, 08/15/18 © National Comprehensive Cancer Network, Inc. 2018, All rights reserved. The NCCN Guidelines® and this illustration may not be reproduced in any form without the express written permission of NCCN®. NCCN Guidelines Index NCCN Guidelines Version 4.2018 Table of Contents Prostate Cancer Discussion Updates in Version 4.2018 of the NCCN Guidelines for Prostate Cancer from Version 3.2018 include: PROS-9 • ADT for M0 or M1 castration-naive disease, added "or abiraterone plus • Initial therapy, added "EBRT + ADT (2–3 y; category 1) ± abiraterone and methylprednisolone (category 2B)." methylprednisolone (category 2B)" to EBRT and ADT recommendations. • Secondary hormone therapy for M0 or M1 CRPC: • Initial therapy, added "ADT ± abiraterone and methylprednisolone (category Changed enzalutamide (for M1) to enzalutamide (for M0 or M1). 2B)" to ADT recommendations. Added a bullet "abiraterone plus methylprednisolone (for M1)." PROS-13 PROS-F (3 of 4) • M1, added "ADT and abiraterone with methylprednisolone (category 2B)." • Secondary hormone therapy PROS-14 Changed enzalutamide (for M1) to enzalutamide (for M0 or M1). • Added "Enzalutamide especially if PSADT ≤10 mo (category 1)." Added "abiraterone with methylprednisolone." PROS-15 Modified "A phase 3 study of patients with M0 CRPC and a PSADT ≤10 No visceral metastases, added a bullet "abiraterone + methylprednisolone" mo showed apalutamide (240 mg/day) improved the primary endpoint of PROS-16 metastasis-free survival over placebo (40.5 mo vs. 16.2 mo). No significant • Prior therapy abiraterone/enzalutamide: added a bullet: "abiraterone + difference was seen in overall survivalat the first interim analysis. methylprednisolone." Adverse events included rash (24% vs 5.5%), fracture (11% vs. 6.5%), • Prior therapy docetaxel: added a bullet: "abiraterone + and hypothyroidism (8% vs. 2%). Patients with M0 CRPC can be offered methylprednisolone." apalutamide after a discussion of the risks and benefits. Bone support • At progression: added a bullet: "abiraterone + methylprednisolone." should be used in patients receiving apalutamide." PROS-17 Added a new bullet, "A phase 3 study of patients with M0 CRPC and a • Adenocarcinoma, added "abiraterone + methylprednisolone." PSADT ≤10 mo showed enzalutamide (160 mg/day) improved the primary • Prior therapy abiraterone/enzalutamide: added a bullet: "abiraterone + endpoint of metastasis-free survival over placebo (36.6 mo vs. 14.7 mo). methylprednisolone." No significant difference was seen in overall survival at the first interim • Prior therapy docetaxel: added a bullet: "abiraterone + analysis. Adverse events included falls and nonpathologic fractures (17% methylprednisolone." vs. 8%), hypertension (12% vs. 5%), major adverse cardiovascular events PROS-D (1 of 3) (5% vs. 3%), and mental impairment disorders (5% vs. 2%). Bone support • Regional disease: Modified the first bullet by adding "or abiraterone and should be used in patients receiving enzalutamide." methylprednisolone (category 2B)." PROS-F (4 of 4) PROS-F (1 of 4) • Revised the bullet, "A phase 3 study of docetaxel-naive men with... M1 • Modified footnote 1 by removing "plus prednisone." CRPC showed that enzalutamide (160 mg daily)…" • Footnote 3 is new "Abiraterone should be given with concurrent steroid, • Added "M1" before CRPC in two bullets for clarification. either prednisone 5 mg orally twice daily or methylprednisolone 4 mg Discussion orally twice daily depending on the formulation of abiraterone used.
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