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Castration-Resistant Prostate Cancer Reference Guide

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i3 Health is pleased to make the clinician's resource guide available for use as a nonaccredited self-study or teaching resource.

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Castration-Resistant Prostate Cancer Reference Guide

  1. 1. Clinical Tools and Resources for Self-Study and Patient Education CASTRATION-RESISTANT PROSTATE CANCER REFERENCE GUIDE The clinical tools and resources contained herein are provided as educational adjuncts to the CME/CE-certified online activity Current Trends in the Management of Castration-Resistant Prostate Cancer. To access the activity and earn CME/CE credit, visit: https://www.i3Health.com/ CONTENTS I: TNM Staging of Prostate Tumors..................................................................................2 II: NCCN Guidelines for Systemic Therapy: M0 CRPC.....................................................4 III: NCCN Guidelines for Systemic Therapy: M1 CRPC....................................................5 IV: NCCN Guidelines for Subsequent Systemic Therapy: M1 CRPC ...............................6 V: NCCN Guidelines for Systemic Therapy: Additional Options for M1 CRPC................7 VI: Principles of Androgen Deprivation Therapy..............................................................8 VII: Glossary of Systemic Treatments for Prostate Cancer .............................................10 VIII: Common Terminology Criteria for Adverse Events (CTCAE): Osteoporosis ..........11 IX: Managing Treatment-Related Adverse Events: Osteoporosis..................................12
  2. 2. 087CRPC Reference Guide I Page 2 of 12 www.i3Health.com I: TNM STAGING OF PROSTATE TUMORS TNM Clinical Classifications TNM Stage Definition T1 Tumor cannot be felt or seen with imaging tests. Found in tissue removed by biopsies or surgical treatments (incidental finding) T1a Incidental cancer found in £5% of removed tissue T1b Incidental cancer found in >5% of removed tissue T1c Tumors found by needle biopsy done as a result of high PSA level T2 Tumors felt during digital rectal exams. Cancer growth within the lobes (left and right halves of the prostate); hasn’t grown outside the prostate gland T2a Tumors have not grown beyond half of one lobe T2b Tumors have grown beyond half of one lobe but not to the other lobe T2c Tumors have grown into both lobes T3 Tumors have spread outside the prostate, reaching connective tissue around the prostate, the seminal vesicles, or the neck of the bladder T3a Tumors have grown outside the prostate but not into the seminal vesicles T3b Tumors have grown outside the prostate and into the seminal vesicles T4 Tumors have fixed or invaded other nearby tissues such as the external sphincter, rectum, bladder, levator muscles, or pelvic wall TNM = tumor/nodes/metastases; PSA = prostate-specific antigen.
  3. 3. 087CRPC Reference Guide I Page 3 of 12 www.i3Health.com TNM Clinical Classifications (Cont.) TNM Stage Definition NX Unknown if cancer is in lymph nodes N0 No cancer within nearby lymph nodes N1 Cancer has spread into nearby lymph nodes MX Unknown if cancer has spread to distant sites M0 No growth to distant sites M1 Cancer has spread to distant sites M1a Cancer has spread to non-regional lymph nodes M1b Cancer has spread to distant bones M1c Cancer has spread to distant organs National Comprehensive Cancer Network (2018). Clinical Practice Guidelines in Oncology: prostate cancer. Version 4.2018. Available at http://www.nccn.org
  4. 4. 087CRPC Reference Guide I Page 4 of 12 www.i3Health.com II: NCCN GUIDELINES FOR SYSTEMIC THERAPY: M0 CRPC All recommendations are category 2A unless otherwise indicated. CRPC = Castration-resistant prostate cancer; PSADT = prostate-specific antigen doubling time; mo = months. National Comprehensive Cancer Network (2018). Clinical Practice Guidelines in Oncology: prostate cancer. Version 4.2018. Available at http://www.nccn.org
  5. 5. 087CRPC Reference Guide I Page 5 of 12 www.i3Health.com III: NCCN GUIDELINES FOR SYSTEMIC THERAPY: M1 CRPC All recommendations are category 2A unless otherwise indicated. MSI-H = microsatellite instability high; dMMR = deficient mismatch repair; RT = radiotherapy. National Comprehensive Cancer Network (2018). Clinical Practice Guidelines in Oncology: prostate cancer. Version 4.2018. Available at http://www.nccn.org
  6. 6. 087CRPC Reference Guide I Page 6 of 12 www.i3Health.com IV: NCCN GUIDELINES FOR SUBSEQUENT SYSTEMIC THERAPY: M1 CRPC All recommendations are category 2A unless otherwise indicated. National Comprehensive Cancer Network (2018). Clinical Practice Guidelines in Oncology: prostate cancer. Version 4.2018. Available at http://www.nccn.org
  7. 7. 087CRPC Reference Guide I Page 7 of 12 www.i3Health.com V: NCCN GUIDELINES FOR SYSTEMIC THERAPY: ADDITIONAL OPTIONS FOR M1 CRPC All recommendations are category 2A unless otherwise indicated. MRI = magnetic resonance imaging. National Comprehensive Cancer Network (2018). Clinical Practice Guidelines in Oncology: prostate cancer. Version 4.2018. Available at http://www.nccn.org
  8. 8. 087CRPC Reference Guide I Page 8 of 12 www.i3Health.com VI: PRINCIPLES OF ANDROGEN DEPRIVATION THERAPY Indication Treatments ADT for regional disease, adjuvant treatment of lymph node metastases, or patients on observation who require treatment • Orchiectomy • LHRH agonist alone o Goserelin, histrelin, leuprolide, or triptorelin Neoadjuvant, concurrent, and/or adjuvant ADT as part of radiation therapy for clinically localized disease • LHRH agonist alone o Goserelin, histrelin, leuprolide, or triptorelin • LHRH agonist (as above) plus a first-generation antiandrogen o Nilutamide, flutamide, or bicalutamide ADT for M0 or M1 castration-naive disease • Orchiectomy • LHRH agonist alone (first-generation antiandrogen must be given for ³7 days to prevent testosterone flare if metastases are present in weight-bearing bone) • Goserelin, histrelin, leuprolide, or triptorelin • LHRH agonist (as above) plus first-generation antiandrogen • Nilutamide, flutamide, or bicalutamide • LHRH antagonist • Degarelix • Orchiectomy, LHRH agonist, or LHRH antagonist (as above) plus abiraterone plus prednisone or abiraterone with methylprednisolone (category 2B) (for M1)
  9. 9. 087CRPC Reference Guide I Page 9 of 12 www.i3Health.com Indication (Cont.) Treatments Secondary hormone therapy for M0 or M1 CRPC • Continue LHRH agonist or antagonist to maintain castrate serum levels of testosterone (<50 ng/dL) and add: o Second-generation antiandrogen o First-generation antiandrogen § Apalutamide (for M0) § Enzalutamide (for M0 or M1) o First-generation antiandrogen § Nilutamide, flutamide, or bicalutamide o Ketoconazole o Ketoconazole plus hydrocortisone o Corticosteroids § Hydrocortisone, prednisone, dexamethasone o DES or other estrogen All recommendations are category 2A unless otherwise indicated. DES = diethylstilbestrol. National Comprehensive Cancer Network (2018). Clinical Practice Guidelines in Oncology: prostate cancer. Version 4.2018. Available at http://www.nccn.org
  10. 10. 087CRPC Reference Guide I Page 10 of 12 www.i3Health.com VII: GLOSSARY OF SYSTEMIC TREATMENTS Agent Definition Abiraterone (Zytiga® ) Androgen biosynthesis inhibitor. Blocks CYP17 (enzyme that produces testosterone) Apalutamide (ErleadaÔ) Androgen receptor inhibitor; decreases testosterone. Used for M0 CRPC resistant to ADT Cabazitaxel (Jevtana® ) Microtubule inhibitor; interferes with the cell division Denosumab (Prolia® , Xgeva® ) Monoclonal antibody that binds to RANKL, a protein involved in the growth and survival of osteoclasts (cells that disintegrate bone). Stops osteoclasts from forming Docetaxel (Taxotere® , Docefrez® ) Stops or slows growth of cancer cells in the body Enzalutamide (Xtandi® ) Androgen receptor inhibitor for M0/M1 CRPC. Used in patients who no longer respond to hormone therapy to lower testosterone. Reduces risk of metastasis Leuprolide (Eligard® , Lupron Depot® , Viadur® ) Works as a gonadotropin-releasing hormone (GnRH) to reduce testosterone levels Mitoxantrone (Novantrone® ) Antitumor antibiotic Pembrolizumab (Keytruda® ) Monoclonal antibody; checkpoint inhibitor blocking the PD-1 pathway Prednisone, methylprednisolone Steroids used to treat pain, inflammation, and edema. Have been shown to decrease PSA levels in M1 CRPC Radium-223 (Xofigo® ) Alpha particle-emitting drug to treat bone metastases Sipuleucel-T (Provenge® ) Autologous active cellular immunotherapy M1 CRPC Chemotherapy combinations Cisplatin/etoposide Carboplatin/etoposide Docetaxel/carboplatin Cancer Treatment Centers of America (2017). Prostate cancer drug information. Available at https://www.cancercenter.com National Comprehensive Cancer Network (2018). Clinical Practice Guidelines in Oncology: prostate cancer. Version 4.2018. Available at http://www.nccn.org
  11. 11. 087CRPC Reference Guide I Page 11 of 12 www.i3Health.com VIII: COMMON TERMINOLOGY CRITERIA FOR ADVERSE EVENTS (CTCAE): OSTEOPOROSIS CTCAE Term Grade 1 Grade 2 Grade 3 Grade 4 Osteoporosis Radiologic evidence of osteoporosis or BMD T-score of - 1 to -2.5 (osteopenia) BMD T-score <-2.5; loss of height <2 cm; limited instrumental ADL. Therapy to improve BMD indicated. Loss of height ≥2 cm; limited self- care ADL. Hospitalization indicated. — National Cancer Institute (2017). Common terminology criteria for adverse events (CTCAE). Version 5.2017. Available at https://ctep.cancer.gov
  12. 12. 087CRPC Reference Guide I Page 12 of 12 www.i3Health.com IX: MANAGING TREATMENT-RELATED ADVERSE EVENTS: OSTEOPOROSIS Osteoporosis Risk Factors • Hormone deprivation therapy • Being thin or having a small frame • Having a family history of the disease • Using certain medications, such as glucocorticoids • Not getting enough calcium • Not getting enough physical activity • Smoking • Drinking too much alcohol Management • Medication • Alendronate (BinostoÒ, FosamaxÒ) • Pamidronate (ArediaÒ) and zoledronic acid (ZometaÒ) • Denosumab (Prolia®, Xgeva®) • Nutrition (diet high in vitamin D and calcium) • Exercise • Healthy lifestyle (no smoking, moderate drinking) • Bone mineral density (BMD) test • Central dual-energy x-ray absorptiometry (DEXA) American Society of Clinical Oncology (2012). Hormone deprivation symptoms in men. Available at http://www.cancer.net National Institute of Arthritis and Musculoskeletal and Skin Diseases (2016). What prostate cancer survivors need to know about osteoporosis. Available at http://www.bones.nih.gov

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