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Castration-sensitive systemic therapy Observation (preferred)1 or Footnotes 1 NCCN 2020. NCCN Clinical Practice Guidelines in Oncology. Prostate Cancer. Version 3. 2020. Updated 11/17/20. Accessed 11/18/20
Castration-resistant systemic therapy Footnotes 1 NCCN 2020. NCCN Clinical Practice Guidelines in Oncology. Prostate Cancer. Version 3. 2020. Updated 11/17/20. Accessed 11/18/20
2 Lowrance WT, et al. Advanced Prostate Cancer: AUA/ASTRO/SUO Guideline PART II. J Urol. 2020;101097JU0000000000001376. Online ahead of print.
3 Smith MR, et al. Apalutamide Treatment and Metastasis-Free Survival in Prostate Cancer. N Engl J Med. 2018;378(15):1408-18.
4 Fizazi K, et al. Darolutamide in Nonmetastatic, Castration-Resistant Prostate Cancer. N Engl J Med. 2019;380(13):1235-46.
5 Hussain M, et al. Enzalutamide in Men With Nonmetastatic, Castration-Resistant Prostate Cancer. N Engl J Med. 2018;378(26):2465-74.
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Castration-sensitive systemic therapy Footnotes 1 NCCN 2020. NCCN Clinical Practice Guidelines in Oncology. Prostate Cancer. Version 3. 2020. Updated 11/17/20. Accessed 11/18/20
2 Lowrance WT, et al. Advanced Prostate Cancer: AUA/ASTRO/SUO Guideline PART I. J Urol. 2020;101097JU0000000000001375. Online Ahead Of Print. Online Accessed 11/20/20.
3 Fizazi K, et al. Abiraterone Plus Prednisone in Metastatic, Castration-Sensitive Prostate Cancer. N Engl J Med. 2017;377(4):352-60.
4 James ND, et al. Abiraterone for Prostate Cancer Not Previously Treated With Hormone Therapy. N Engl J Med. 2017;377(4):338-51.
5 Stein CA, et al. Randomized Phase 2 Therapeutic Equivalence Study of Abiraterone Acetate Fine Particle Formulation vs. Originator Abiraterone Acetate in Patients With Metastatic Castration-Resistant Prostate Cancer: The STAAR Study. Urol Oncol. 2018;36(2):81e9-e16.
6 Chi KN, et al. Apalutamide for Metastatic, Castration-Sensitive Prostate Cancer. N Engl J Med. 2019;381(1):13-24.
7 James ND, et al. Addition of Docetaxel, Zoledronic Acid, or Both to First-Line Long-Term Hormone Therapy in Prostate Cancer (STAMPEDE): Survival Results From an Adaptive, Multiarm, Multistage, Platform Randomised Controlled Trial. Lancet (London, England). 2016;387(10024):1163-77.
8 Sweeney CJ, et al. Chemohormonal Therapy in Metastatic Hormone-Sensitive Prostate Cancer. N Engl J Med. 2015;373(8):737-46.
9 Davis ID, et al. Enzalutamide With Standard First-Line Therapy in Metastatic Prostate Cancer. N Engl J Med. 2019;381(2):121-31.
Castration-resistant systemic therapy - abiraterone acetate + prednisone3-5
abiraterone 1000 mg PO qd + prednisone 5 mg PO bid
- abiraterone acetate micronized + methylprednisolone6
abiraterone 500 mg PO qd + methylprednisolone 4 mg PO bid
- docetaxel + prednisone7,8
Day 1: docetaxel 75 mg/m2/dose IV x1
Cycled q21 days for up to 10 cycles
+ prednisone 5 mg PO bid continuously
- enzalutamide9,10
enzalutamide 160 mg PO qd
- mitoxantrone + prednisone (for palliation in symptomatic pts w/ visceral metastases)7,8
Day 1: mitoxantrone 12 mg/m2/dose IV x1
Cycled q21 days for up to 10 cycles
+ prednisone 5 mg PO bid continuously
- radium Ra 223 dichloride (for symptomatic bone metastases)11
Day 1: radium Ra 223 dichloride 55 kBq/kg/dose IV x1
Cycled q28 days x6 cycles
- sipuleucel-T (for pts w/ no or minimal sx, no liver metastases, life expectancy >6mo, and an ECOG score of 0–1)12
Day 1: sipuleucel-T dose (≥50 million autologous CD54+ cells) IV x1
Cycled q14 days x3 cycles
Footnotes 1 NCCN 2020. NCCN Clinical Practice Guidelines in Oncology. Prostate Cancer. Version 3. 2020. Updated 11/17/20. Accessed 11/18/20
2 Lowrance WT, et al. Advanced Prostate Cancer: AUA/ASTRO/SUO Guideline PART II. J Urol. 2020;101097JU0000000000001376. Online ahead of print.
3 de Bono JS, et al. Abiraterone and Increased Survival in Metastatic Prostate Cancer. N Engl J Med. 2011 May 26;364(21):1995-2005.
4 Fizazi K, et al. Abiraterone Acetate for Treatment of Metastatic Castration-Resistant Prostate Cancer: Final Overall Survival Analysis of the COU-AA-301 Randomised, Double-blind, Placebo-controlled Phase 3 Study. Lancet Oncol. 2012 Oct;13(10):983-92.
5 Logothetis CJ, et al. Effect of Abiraterone Acetate and Prednisone Compared With Placebo and Prednisone on Pain Control and Skeletal-related Events in Patients With Metastatic Castration-resistant Prostate Cancer: Exploratory Analysis of Data from the COU-AA-301 Randomised Trial. Lancet Oncol. 2012 Dec;13(12):1210-7.
6 Stein CA, et al. Randomized Phase 2 Therapeutic Equivalence Study of Abiraterone Acetate Fine Particle Formulation vs. Originator Abiraterone Acetate in Patients With Metastatic Castration-resistant Prostate Cancer: The STAAR Study. Urol Oncol. 2018 Feb;36(2):81e9-81e16.
7 Tannock IF, et al. Docetaxel Plus Prednisone or Mitoxantrone Plus Prednisone for Advanced Prostate Cancer. N Engl J Med. 2004 Oct 7;351(15):1502-12.
8 Berthold DR, et al. Docetaxel Plus Prednisone or Mitoxantrone Plus Prednisone for Advanced Prostate Cancer: Updated Survival in the TAX 327 Study. J Clin Oncol. 2008 Jan 10;26(2):242-5.
9 Beer TM, et al. Enzalutamide in Metastatic Prostate Cancer Before Chemotherapy. N Engl J Med. 2014 Jul 31;371(5):424-33.
10 Scher HI, et al. Increased Survival With Enzalutamide in Prostate Cancer After Chemotherapy. N Engl J Med. 2012 Sep 27;367(13):1187-97.
11 Saad F, et al. Radium-223 and Concomitant Therapies in Patients With Metastatic Castration-Resistant Prostate Cancer: An International, Early Access, Open-Label, Single-Arm Phase 3b Trial. Lancet Oncol. 2016;17(9):1306-16.
12 Kantoff PW, et al. Sipuleucel-T Immunotherapy for Castration-Resistant Prostate Cancer. N Engl J Med. 2010;363(5):411-22.
Prior abiraterone/enzalutamide tx Choose 1 of the following:1 - abiraterone acetate + prednisone (if not previously received)2-4
abiraterone 1000 mg PO qd + prednisone 5 mg PO bid - abiraterone acetate micronized + methylprednisolone (if not previously received)5
abiraterone 500 mg PO qd + methylprednisolone 4 mg PO bid - cabazitaxel + prednisone6-8
Day 1: cabazitaxel 20-25 mg/m2/dose IV x1
Cycled q21 days
+ prednisone 10 mg PO qd continuously
- docetaxel + prednisone9,10
Day 1: docetaxel 75 mg/m2/dose IV x1
Cycled q21 days for up to 10 cycles
+ prednisone 5 mg PO bid continuously - enzalutamide (if not previously received)11,12
enzalutamide 160 mg PO qd - olaparib (for pts w/ mutation in HRR)8,13
olaparib 300 mg PO bid
- pembrolizumab (for MSI-H or dMMR)8,14
pembrolizumab 200 mg IV x1
Cycled q21 days for up to 24mo - radium Ra 223 dichloride (for symptomatic bone metastases)15
Day 1: radium Ra 223 dichloride 55 kBq/kg/dose IV x1
Cycled q28 days x6 cycles - rucaparib (for pts w/ mutation in BRCA)8,16
rucaparib 600 mg PO bid
- sipuleucel-T (for pts w/ no or minimal sx, no liver metastases, life expectancy >6mo, and an ECOG score of 0–1)17
Day 1: sipuleucel-T dose (≥50 million autologous CD54+ cells) IV x1
Cycled q14 days x3 cycles
Footnotes 1 NCCN 2020. NCCN Clinical Practice Guidelines in Oncology. Prostate Cancer. Version 3. 2020. Updated 11/17/20. Accessed 11/18/20
2 de Bono JS, et al. Abiraterone and Increased Survival in Metastatic Prostate Cancer. N Engl J Med. 2011;364(21):1995-2005.
3 Fizazi K, et al. Abiraterone Acetate for Treatment of Metastatic Castration-Resistant Prostate Cancer: Final Overall Survival Analysis of the COU-AA-301 Randomised, Double-Blind, Placebo-Controlled Phase 3 Study. Lancet Oncol. 2012;13(10):983-92.
4 Logothetis CJ, et al. Effect of Abiraterone Acetate and Prednisone Compared With Placebo and Prednisone on Pain Control and Skeletal-Related Events in Patients With Metastatic Castration-Resistant Prostate Cancer: Exploratory Analysis of Data From the COU-AA-301 Randomised Trial. Lancet Oncol. 2012;13(12):1210-7.
5 Stein CA, et al. Randomized Phase 2 Therapeutic Equivalence Study of Abiraterone Acetate Fine Particle Formulation vs. Originator Abiraterone Acetate in Patients With Metastatic Castration-Resistant Prostate Cancer: The STAAR Study. Urol Oncol. 2018;36(2):81 e9- e16.
6 de Bono JS, et al. Prednisone Plus Cabazitaxel or Mitoxantrone for Metastatic Castration-Resistant Prostate Cancer Progressing After Docetaxel Treatment: A Randomised Open-Label Trial. Lancet (London, England). 2010;376(9747):1147-54.
7 Bahl A, et al. Impact of Cabazitaxel on 2-Year Survival and Palliation of Tumour-Related Pain in Men With Metastatic Castration-Resistant Prostate Cancer Treated in the TROPIC Trial. Ann Oncol. 2013;24(9):2402-8.
8 Lowrance WT, et al. Advanced Prostate Cancer: AUA/ASTRO/SUO Guideline PART II. J Urol. 2020;101097JU0000000000001376. Online ahead of print.
9 Tannock IF, et al. Docetaxel Plus Prednisone or Mitoxantrone Plus Prednisone for Advanced Prostate Cancer. N Engl J Med. 2004;351(15):1502-12.
10 Berthold DR, et al. Docetaxel Plus Prednisone or Mitoxantrone Plus Prednisone for Advanced Prostate Cancer: Updated Survival in the TAX 327 Study. J Clin Oncol. 2008;26(2):242-5.
11 Beer TM, et al. Enzalutamide in Metastatic Prostate Cancer Before Chemotherapy. N Engl J Med. 2014;371(5):424-33.
12 Scher HI, et al. Increased Survival With Enzalutamide in Prostate Cancer After Chemotherapy. N Engl J Med. 2012;367(13):1187-97.
13 de Bono JS, et al. Olaparib for Metastatic Castration-Resistant Prostate Cancer. NEJM. 2020;382(22):2091-102.
14 Antonarakis ES, et al. Pembrolizumab for Treatment-Refractory Metastatic Castration-Resistant Prostate Cancer: Multicohort, Open-Label Phase II KEYNOTE-199 Study. J Clin Oncol. 2019:Jco1901638.
15 Saad F, et al. Radium-223 and Concomitant Therapies in Patients With Metastatic Castration-Resistant Prostate Cancer: An International, Early Access, Open-Label, Single-Arm Phase 3b Trial. Lancet Oncol. 2016;17(9):1306-16.
16 Abida W, et al. Rucaparib in Men With Metastatic Castration-Resistant Prostate Cancer Harboring a BRCA1 or BRCA2 Gene Alteration. J Clin Oncol. 2020;38(32):3763-72.
17 Kantoff PW, et al. Sipuleucel-T Immunotherapy for Castration-Resistant Prostate Cancer. N Engl J Med. 2010;363(5):411-22.
Choose 1 of the following:1 - abiraterone acetate + prednisone2-4
abiraterone 1000 mg PO qd + prednisone 5 mg PO bid - abiraterone acetate micronized + methylprednisolone5
abiraterone 500 mg PO qd + methylprednisolone 4 mg PO bid - cabazitaxel + prednisone6-8
Day 1: cabazitaxel 20-25 mg/m2/dose IV x1
Cycled q21 days
+ prednisone 10 mg PO qd continuously - docetaxel + prednisone (rechallenge)9,10
Day 1: docetaxel 75 mg/m2/dose IV x1
Cycled q21 days for up to 10 cycles
+ prednisone 5 mg PO bid continuously - enzalutamide11,12
enzalutamide 160 mg PO qd - mitoxantrone + prednisone (for palliation in symptomatic pts w/ visceral metastases)9,10
Day 1: mitoxantrone 12 mg/m2/dose IV x1
Cycled q21 days for up to 10 cycles
+ prednisone 5 mg PO bid continuously
- olaparib (for pts w/ mutation in HRR)8,13
olaparib 300 mg PO bid
- pembrolizumab (for MSI-H or dMMR)8,14
pembrolizumab 200 mg IV x1
Cycled q21 days for up to 24mo - radium Ra 223 dichloride (for symptomatic bone metastases)15
Day 1: radium Ra 223 dichloride 55 kBq/kg/dose IV x1
Cycled q28 days x6 cycles
- rucaparib (for pts w/ mutation in BRCA)8,16
rucaparib 600 mg PO bid
- sipuleucel-T (for pts w/ no or minimal sx, no liver metastases, life expectancy >6mo, and an ECOG score of 0–1)17
Day 1: sipuleucel-T dose (≥50 million autologous CD54+ cells) IV x1
Cycled q14 days x3 cycles
Footnotes 1 NCCN 2020. NCCN Clinical Practice Guidelines in Oncology. Prostate Cancer. Version 3. 2020. Updated 11/17/20. Accessed 11/18/20
2 de Bono JS, et al. Abiraterone and Increased Survival in Metastatic Prostate Cancer. N Engl J Med. 2011;364(21):1995-2005.
3 Fizazi K, et al. Abiraterone Acetate for Treatment of Metastatic Castration-Resistant Prostate Cancer: Final Overall Survival Analysis of the COU-AA-301 Randomised, Double-Blind, Placebo-Controlled Phase 3 Study. Lancet Oncol. 2012;13(10):983-92.
4 Logothetis CJ, et al. Effect of Abiraterone Acetate and Prednisone Compared With Placebo and Prednisone on Pain Control and Skeletal-Related Events in Patients With Metastatic Castration-Resistant Prostate Cancer: Exploratory Analysis of Data From the COU-AA-301 Randomised Trial. Lancet Oncol. 2012;13(12):1210-7.
5 Stein CA, et al. Randomized Phase 2 Therapeutic Equivalence Study of Abiraterone Acetate Fine Particle Formulation vs. Originator Abiraterone Acetate in Patients With Metastatic Castration-Resistant Prostate Cancer: The STAAR Study. Urol Oncol. 2018;36(2):81 e9- e16.
6 de Bono JS, et al. Prednisone Plus Cabazitaxel or Mitoxantrone for Metastatic Castration-Resistant Prostate Cancer Progressing After Docetaxel Treatment: A Randomised Open-Label Trial. Lancet (London, England). 2010;376(9747):1147-54.
7 Bahl A, et al. Impact of Cabazitaxel on 2-Year Survival and Palliation of Tumour-Related Pain in Men With Metastatic Castration-Resistant Prostate Cancer Treated in the TROPIC Trial. Ann Oncol. 2013;24(9):2402-8.
8 Lowrance WT, et al. Advanced Prostate Cancer: AUA/ASTRO/SUO Guideline PART II. J Urol. 2020;101097JU0000000000001376. Online ahead of print.
9 Tannock IF, et al. Docetaxel Plus Prednisone or Mitoxantrone Plus Prednisone for Advanced Prostate Cancer. N Engl J Med. 2004;351(15):1502-12.
10 Berthold DR, et al. Docetaxel Plus Prednisone or Mitoxantrone Plus Prednisone for Advanced Prostate Cancer: Updated Survival in the TAX 327 Study. J Clin Oncol. 2008;26(2):242-5.
11 Beer TM, et al. Enzalutamide in Metastatic Prostate Cancer Before Chemotherapy. N Engl J Med. 2014;371(5):424-33.
12 Scher HI, et al. Increased Survival With Enzalutamide in Prostate Cancer After Chemotherapy. N Engl J Med. 2012;367(13):1187-97.
13 de Bono JS, et al. Olaparib for Metastatic Castration-Resistant Prostate Cancer. N Engl J Med.. 2020;382(22):2091-102.
14 Antonarakis ES, et al. Pembrolizumab for Treatment-Refractory Metastatic Castration-Resistant Prostate Cancer: Multicohort, Open-Label Phase II KEYNOTE-199 Study. J Clin Oncol. 2019:Jco1901638.
15 Saad F, et al. Radium-223 and Concomitant Therapies in Patients With Metastatic Castration-Resistant Prostate Cancer: An International, Early Access, Open-Label, Single-Arm Phase 3b Trial. Lancet Oncol. 2016;17(9):1306-16.
16 Abida W, et al. Rucaparib in Men With Metastatic Castration-Resistant Prostate Cancer Harboring a BRCA1 or BRCA2 Gene Alteration. J Clin Oncol. 2020;38(32):3763-72.
17 Kantoff PW, et al. Sipuleucel-T Immunotherapy for Castration-Resistant Prostate Cancer. N Engl J Med. 2010;363(5):411-22.
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