Prostate Cancer Treatment Regimens

SEE BELOW THE CHART TO SEE GENITOURINARY CANCER DRUG MONOGRAPHS.

Prostate Cancer Treatment Regimens

Clinical Trials: The NCCN recommends cancer patient participation in clinical trials as the gold standard for treatment.

Cancer therapy selection, dosing, administration, and the management of related adverse events can be a complex process that should be handled by an experienced healthcare team. Clinicians must choose and verify treatment options based on the individual patient; drug dose modifications and supportive care interventions should be administered accordingly. The cancer treatment regimens below may include both U.S. Food and Drug Administration-approved and unapproved indications/regimens. These regimens are only provided to supplement the latest treatment strategies.

These Guidelines are a work in progress that may be refined as often as new significant data becomes available. The National Comprehensive Cancer Network Guidelines® are a consensus statement of its authors regarding their views of currently accepted approaches to treatment. Any clinician seeking to apply or consult any 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 NCCN makes no warranties of any kind whatsoever regarding their content, use, or application and disclaims any responsibility for their application or use in any way.

Note: All recommendations are Category 2A unless otherwise indicated.

▶Androgen Deprivation Therapy (ADT)1,a-e

REGIMEN

DOSING

LHRH Agonists

Goserelin2-4

Day 1: Goserelin 3.6mg subcutaneous implant.

Repeat cycle every 4 weeks.f

OR

Day 1: Goserelin 10.8mg subcutaneous implant.

Repeat cycle every 3 months.f

Histrelin4-6

Day 1: Histrelin 50mg subcutaneous implant.

Repeat cycle every 1 year.f

Leuprolide2,3,7

Day 1: Leuprolide 7.5mg IM or subcutaneous.

Repeat cycle every 4 weeks.f

OR

Day 1: Leuprolide 22.5mg IM or subcutaneous.

Repeat cycle every 3 months.f

OR

Day 1: Leuprolide 30mg IM or subcutaneous.

Repeat cycle every 4 months.f

OR

Day 1: Leuprolide 45mg IM or subcutaneous.

Repeat cycle every 6 months.f

Triptorelin4,8

Day 1: Triptorelin 3.75mg IM.

Repeat cycle every 1 month.f

OR

Day 1: Triptorelin 11.25mg IM.

Repeat cycle every 3 months.f

OR

Day 1: Triptorelin 22.5mg IM.

Repeat cycle every 6 months.f

First-Generation Antiandrogeng

Bicalutamide3,4,9,10

Days 1-28: Bicalutamide 150mg orally once daily.

Repeat cycle every 4 weeks for 2 years (clinically localized disease).

OR

Days 1-28: Bicalutamide 50mg orally once daily.

Repeat cycle every 4 weeks.f

Flutamide3,4

Days 1-28: Flutamide 250mg orally three times daily.

Repeat cycle every 4 weeks.f

Nilutamide4,11

Days 1-30: Nilutamide 300mg orally once daily.

Administer for one 30-day cycle, followed by:

Days 1-28: Nilutamide 150mg orally once daily.

Repeat cycle every 4 weeks.f

LHRH Antagonist

Degarelix4,12,13

Day 1: Degarelix 240mg (administered as 2 subcutaneous injections of 120mg) in one 4-week cycle, followed by:

Day 1: Degarelix 80mg (administered as 1 subcutaneous 4mL injection).

Repeat cycle every 4 weeks.f

▶Clinically Localized Disease (N0M0)1,a

ADT2-13,b-h

▶Regional Disease (N1M0)1,a

ADT2-13,b-g

Abiraterone + Methyprednisolone (Category 2B)14-20,i-k

Days 1-28: Abiraterone (micronized formulation) 500mg orally once daily

Days 1-28: Methylprednisolone 4mg orally twice daily.

Repeat cycle every 4 weeks for 2 years.

Abiraterone + Prednisone14-20,i-k

Days 1-28: Abiraterone (conventional formulation) 1,000mg orally daily

Days 1-28: Prednisone 5mg orally once daily.

Repeat cycle every 4 weeks for 2 years.

▶Castration-Naïve M01

ADT2-13,b-g

▶Castration-Naïve M11,a

ADT2,13,b-g,l

Abiraterone + Methylprednisolone (Category 2B)14-20,i-l

Days 1-28: Abiraterone (micronized formulation) 500mg orally once daily

Days 1-28: Methylprednisolone 4mg orally twice daily.

Repeat cycle every 4 weeks.

Abiraterone + Prednisone (Category 1)14-20,i-l

Days 1-28: Abiraterone (conventional formulation) 1,000mg orally daily

Days 1-28: Prednisone 5mg orally once daily.

Repeat cycle every 4 weeks.

Apalutamide (Category 1)21,22,l,m

Days 1-28: Apalutamide 240mg orally once daily.

Repeat cycle every 4 weeks.

Docetaxel + Prednisone (Category 1)23-26,l,n

Day 1: Docetaxel 75mg/m2 IV over 60 minutes

Days 1-21: Prednisone 5mg orally twice daily.

Repeat cycle every 3 weeks for 6 cycles.

Enzalutamide (Category 1)27-30,l,o

Days 1-28: Enzalutamide 160mg orally once daily.

Repeat cycle every 4 weeks.

▶Castration-Resistant M01,p

Apalutamide (Category 1)21,22,m,q

Days 1-28: Apalutamide 240mg orally once daily.

Repeat cycle every 4 weeks.

Darolutamide (Category 1)31,32,q,r

Days 1-28: Darolutamide 600mg orally twice daily.

Repeat cycle every 4 weeks.

Enzalutamide (Category 1)27-30,o,q

Days 1-28: Enzalutamide 160mg orally once daily.

Repeat cycle every 4 weeks.

▶Castration-Resistant M1 (Adenocarcinoma): First-Line1,a,p

No Visceral Metastases

Abiraterone + Methylprednisolone14-20,i-k,q

Days 1-28: Abiraterone (micronized formulation) 500mg orally once daily

Days 1-28: Methylprednisolone 4mg orally twice daily.

Repeat cycle every 4 weeks.

Abiraterone + Prednisone (Category 1)14-20,i-k,q

Days 1-28: Abiraterone (conventional formulation) 1,000mg orally daily

Days 1-28: Prednisone 5mg orally twice daily.

Repeat cycle every 4 weeks.

Docetaxel + Prednisone (Category 1)23-26,q

Day 1: Docetaxel 75mg/m2 IV over 60 minutes

Days 1-21: Prednisone 5mg orally twice daily.

Repeat cycle every 3 weeks.

Enzalutamide (Category 1)27-30,q

Days 1-28: Enzalutamide 160mg orally once daily.

Repeat cycle every 4 weeks.

Radium-223 (for symptomatic bone mets) (Category 1)33,34,q

See NCCN Prostate Cancer Guidelines.1

Visceral Metastases

Abiraterone + Methylprednisolone14-20,i-k,q

Days 1-28: Abiraterone (micronized formulation) 500mg orally once daily

Days 1-28: Methylprednisolone 4mg orally twice daily.

Repeat cycle every 4 weeks.

Abiraterone + Prednisone14-20,i-k,q

Days 1-28: Abiraterone (conventional formulation) 1,000mg orally daily

Days 1-28: Prednisone 5mg orally twice daily.

Repeat cycle every 4 weeks.

Docetaxel + Prednisone (Category 1)23-26,q

Day 1: Docetaxel 75mg/m2 IV over 60 minutes

Days 1-21: Prednisone 5mg orally twice daily.

Repeat cycle every 3 weeks.

Enzalutamide (Category 1)27-30,q

Days 1-28: Enzalutamide 160mg orally once daily.

Repeat cycle every 4 weeks.

Mitoxantrone + Prednisone24,35,q

Day 1: Mitoxantrone 12mg/m2 IV over 30 minutes.

Days 1-21: Prednisone 5mg orally twice daily.

Repeat cycle every 3 weeks.

▶Castration Resistant M1 (Adenocarcinoma): Second-Line1,p

No Visceral Metastases and Prior Therapy With Enzalutamide or Abiraterone

Abiraterone + Methylprednisolone (if not previously received)14-20,i-k,q

Days 1-28: Abiraterone (micronized formulation) 500mg orally once daily

Days 1-28: Methylprednisolone 4mg orally twice daily.

Repeat cycle every 4 weeks.

Abiraterone + Prednisone (if not previously received)14-20,i-k,q

Days 1-28: Abiraterone (conventional formulation) 1,000mg orally daily

Days 1-28: Prednisone 5mg orally twice daily.

Repeat cycle every 4 weeks.

Docetaxel + Prednisone (Category 1)23-26,q

Day 1: Docetaxel 75mg/m2 IV over 60 minutes

Days 1-21: Prednisone 5mg orally twice daily.

Repeat cycle every 3 weeks.

Enzalutamide (if not previously received)27-30,q

Days 1-28: Enzalutamide 160mg orally once daily.

Repeat cycle every 4 weeks.

Pembrolizumab (for MSI-H or dMMR disease) (Category 2B)36,37,q

Day 1: Pembrolizumab 200mg IV over 30 minutes.

Repeat cycle every 3 weeks.

Radium-223 for symptomatic bone metastases (Category 1)33,34,q

See NCCN Prostate Cancer Guidelines.1

Sipuleucel-T (if not previously received)38,39,q

See NCCN Prostate Cancer Guidelines.1

No Visceral Metastases and Prior Therapy With Docetaxel

Abiraterone + Methylprednisolone14-20,i-k,q

Days 1-28: Abiraterone (micronized formulation) 500mg orally once daily

Days 1-28: Methylprednisolone 4mg orally twice daily.

Repeat cycle every 4 weeks.

Abiraterone + Prednisone (Category 1)14-20,i-k,q

Days 1-28: Abiraterone (conventional formulation) 1,000mg orally daily

Days 1-28: Prednisone 5mg orally twice daily.

Repeat cycle every 4 weeks.

Cabazitaxel + Prednisone (Category 1)40-42,q,s

Day 1: Cabazitaxel 20mg/m2 IV over 60 minutess

Days 1-21: Prednisone 10mg orally once daily.

Repeat cycle every 3 weeks.

OR

Day 1: Cabazitaxel 25mg/m2 IV over 60 minutess

Days 1-21: Prednisone 10mg orally once daily.

Repeat cycle every 3 weeks.

Docetaxel + Prednisone (rechallenge)23-26,q

Day 1: Docetaxel 75mg/m2 IV over 60 minutes

Days 1-21: Prednisone 5mg orally twice daily.

Repeat cycle every 3 weeks.

Enzalutamide (Category 1)27-30,q

Days 1-28: Enzalutamide 160mg orally once daily.

Repeat cycle every 4 weeks.

Mitoxantrone + Prednisone (if not previously received)24,35,q

Day 1: Mitoxantrone 12mg/m2 IV over 30 minutes.

Days 1-21: Prednisone 5mg orally twice daily.

Repeat cycle every 3 weeks.

Pembrolizumab (for MSI-H or dMMR disease) (Category 2B)36,37,q

Day 1: Pembrolizumab 200mg IV over 30 minutes.

Repeat cycle every 3 weeks.

Sipuleucel-T (if not previously received)38,39,q

See NCCN Prostate Cancer Guidelines.1

Visceral Metastases and Prior Therapy With Enzalutamide or Abiraterone

Abiraterone + Methylprednisolone (if not previously received)14-20,i-k,q

Days 1-28: Abiraterone (micronized formulation) 500mg orally once daily

Days 1-28: Methylprednisolone 4mg orally twice daily.

Repeat cycle every 4 weeks.

Abiraterone + Prednisone (if not previously received)14-20,i-k,q

Days 1-28: Abiraterone (conventional formulation) 1,000mg orally daily

Days 1-28: Prednisone 5mg orally twice daily.

Repeat cycle every 4 weeks.

Cabazitaxel + Prednisone (if not previously received)40-42,q,s

Day 1: Cabazitaxel 20mg/m2 IV over 60 minutess

Days 1-21: Prednisone 10mg orally once daily.

Repeat cycle every 3 weeks.

OR

Day 1: Cabazitaxel 25mg/m2 IV over 60 minutess

Days 1-21: Prednisone 10mg orally once daily.

Repeat cycle every 3 weeks.

Docetaxel + Prednisone (Category 1)23-26,q

Day 1: Docetaxel 75mg/m2 IV over 60 minutes

Days 1-21: Prednisone 5mg orally twice daily.

Repeat cycle every 3 weeks.

Enzalutamide (if not previously received)27-30,q

Days 1-28: Enzalutamide 160mg orally once daily.

Repeat cycle every 4 weeks.

Pembrolizumab (for MSI-H or dMMR disease) (Category 2B)36,37,q

Day 1: Pembrolizumab 200mg IV over 30 minutes.

Repeat cycle every 3 weeks.

Visceral Metastases and Prior Therapy With Docetaxel

Abiraterone + Methyprednisolone14-20,i-k,q

Days 1-28: Abiraterone (micronized formulation) 500mg orally once daily

Days 1-28: Methylprednisolone 4mg orally twice daily.

Repeat cycle every 4 weeks.

Abiraterone + Prednisone (Category 1)14-20,i-k,q

Days 1-28: Abiraterone (conventional formulation) 1,000mg orally daily

Days 1-28: Prednisone 5mg orally twice daily.

Repeat cycle every 4 weeks.

Cabazitazel + Prednisone (Category 1)40-42,q,s

Day 1: Cabazitaxel 20mg/m2 IV over 60 minutess

Days 1-21: Prednisone 10mg orally once daily.

Repeat cycle every 3 weeks.

OR

Day 1: Cabazitaxel 25mg/m2 IV over 60 minutess

Days 1-21: Prednisone 10mg orally once daily.

Repeat cycle every 3 weeks.

Enzalutamide (Category 1)27-30,q

Days 1-28: Enzalutamide 160mg orally once daily.

Repeat cycle every 4 weeks.

Docetaxel + Prednsone (rechallenge)23-26,q

Day 1: Docetaxel 75mg/m2 IV over 60 minutes

Days 1-21: Prednisone 5mg orally twice daily.

Repeat cycle every 3 weeks.

Mitoxantrone + Prednisone24,35,p

Day 1: Mitoxantrone 12mg/m2 IV over 30 minutes

Days 1-21: Prednisone 5mg orally twice daily.

Repeat cycle every 3 weeks.

Pembrolizumab (for MSI-H or dMMR disease) (Category 2B)36,37,q

Day 1: Pembrolizumab 200mg IV over 30 minutes.

Repeat cycle every 3 weeks.

▶Castration Resistant M1 (Adenocarcinoma): Subsequent Treatment1,p

No Visceral Metastases

Abiraterone + Methylprednisolone (if not previously received)14-20,i-k,q

Days 1-28: Abiraterone (micronized formulation) 500mg orally once daily

Days 1-28: Methylprednisolone 4mg orally twice daily.

Repeat cycle every 4 weeks.

Abiraterone + Prednisone (if not previously received) (Category 1)14-20,i-k,q

Days 1-28: Abiraterone (conventional formulation) 1,000mg orally daily

Days 1-28: Prednisone 5mg orally twice daily.

Repeat cycle every 4 weeks.

Cabazitaxel + Prednisone (if not previously received) (Category 1)40-42,q,s

Day 1: Cabazitaxel 20mg/m2 IV over 60 minutess

Days 1-21: Prednisone 10mg orally once daily.

Repeat cycle every 3 weeks.

OR

Day 1: Cabazitaxel 25mg/m2 IV over 60 minutess

Days 1-21: Prednisone 10mg orally once daily.

Repeat cycle every 3 weeks.

Docetaxel + Prednisone (rechallenge)23-26,q

Day 1: Docetaxel 75mg/m2 IV over 60 minutes

Days 1-21: Prednisone 5mg orally twice daily.

Repeat cycle every 3 weeks.

Enzalutamide (if not previously received) (Category 1)27-30,q

Days 1-28: Enzalutamide 160mg orally once daily.

Repeat cycle every 4 weeks.

Mitoxantrone + Prednisone (if not previously received)24,35,q

Day 1: Mitoxantrone 12mg/m2 IV over 30 minutes

Days 1-21: Prednisone 5mg orally twice daily.

Repeat cycle every 3 weeks.

Pembrolizumab for MSI-H or dMMR (if not previously received) (Category 2B)36,37,q

Day 1: Pembrolizumab 200mg IV over 30 minutes.

Repeat cycle every 3 weeks.

Radium-223 (for symptomatic bone metastases (if not previously received) (Category 1)33,34,q

See NCCN Prostate Cancer Guidelines.1

Visceral Metastases (Category 2B)

Abiraterone + Methylprednisolone (if not previously received)14-20,i-k,q

Days 1-28: Abiraterone (micronized formulation) 500mg orally once daily

Days 1-28: Methylprednisolone 4mg orally twice daily.

Repeat cycle every 4 weeks.

Abiraterone + Prednisone (if not previously received)14-20,i-k,q

Days 1-28: Abiraterone (conventional formulation) 1,000mg orally daily

Days 1-28: Prednisone 5mg orally twice daily.

Repeat cycle every 4 weeks.

Cabazitaxel + Prednisone (if not previously received)40-42,q,s

Day 1: Cabazitaxel 20mg/m2 IV over 60 minutesr

Days 1-21: Prednisone 10mg orally once daily.

Repeat cycle every 3 weeks.

OR

Day 1: Cabazitaxel 25mg/m2 IV over 60 minutesr

Days 1-21: Prednisone 10mg orally once daily.

Repeat cycle every 3 weeks.

Docetaxel + Prednisone (rechallenge)23-26,q

Day 1: Docetaxel 75mg/m2 IV over 60 minutes

Days 1-21: Prednisone 5mg orally twice daily.

Repeat cycle every 3 weeks.

Enzalutamide (if not previously received)27-30,q

Days 1-28: Enzalutamide 160mg orally once daily.

Repeat cycle every 4 weeks.

Mitoxantrone + Prednisone (if not previously received)24,35,q

Day 1: Mitoxantrone 12mg/m2 IV over 30 minutes

Days 1-21: Prednisone 5mg orally twice daily.

Repeat cycle every 3 weeks.

Pembrolizumab (for MSI-H or dMMR disease) (if not previously received)36,37,q

Day 1: Pembrolizumab 200mg IV over 30 minutes.

Repeat cycle every 3 weeks.

▶Castration-Resistant M1: Small Cell Carcinoma/Neuroendocrine Prostate Cancer: First-Line and Subsequent Therapy1,t

Carboplatin + Etoposide43-46

Day 1: Carboplatin AUC 5-6 IV over 30 minutes

Days 1-3: Etoposide 100mg/m2 IV over 60 minutes.

Repeat cycle every 3-4 weeks for 4-6 cycles.

Cisplatin + Etoposide45-48

Day 1: Cisplatin 75-80mg/m2 IV over 60 minutes

Days 1-3: Etoposide 80-100mg/m2 IV over 60 minutes.

Repeat cycle every 3 weeks for 4-6 cycles.

Docetaxel + Carboplatin45,49,50

Day 1: Docetaxel 60-75mg/m2 IV over 60 minutes, followed by:

Day 1: Carboplatin AUC 4-6 IV over 30 minutes.

Repeat cycle every 3 weeks for 4-6 cycles.

a  See Principles of Radiation Therapy in NCCN Prostate Cancer Guidelines.

b  See Principles of Androgen Deprivation Therapy in NCCN Prostate Cancer Guidelines.

c  Not indicated in the setting of bilateral orchiectomy.

d  LHRH agonist or antagonist (medical castration) and bilateral orchiectomy (surgical castration) are equally effective.

e  LHRH agonist alone; LHRH agonist + first-generation antiandrogen; or LHRH antagonist alone. Antiandrogen monotherapy appears to be less effective than medical or surgical castration and is not recommended.

  See NCCN Prostate Cancer Guidelines for duration based on clinical setting.

g  First-generation antiandrogens are used in combination with an LHRH agonist.

h  ADT should not be used as monotherapy (without EBRT) in clinically localized prostate cancer unless there is a contraindication to definitive local therapy such as life expectancy ≤5 years and comorbidities. Under those circumstances, ADT may be an acceptable alternative if the disease is high or very high risk.

 i  Abiraterone should be administered with an LHRH agonist, an LHRH antatagonist, or orchidectomy.

 j  Abiraterone is available in a conventional formulation (250mg and 500mg tablets) and in a micronized formulation (125mg tablets). Use caution when selecting the dosage forms, as the products are not interchangeable. The choice of concurrent steroid depends on the formulation of abiraterone used.

k  Abiraterone should be given with concurrent steroid, either prednisone 5 mg orally twice daily or methylprednisolone 4 mg orally twice daily, depending on the formulation of abiraterone used. Abiraterone with either steroid should not be given following progression on abiraterone with the other steroid.

 l  First-generation antiandrogen must be given for ≥7 days to prevent testosterone flare if metastases are present in weightbearing bone.

Apalutamide should be administered with an LHRH agonist, an LHRH antagonist, or orchidectomy.

n  Docetaxel should be administered with an LHRH agonist, and LHRH agonist + first-generation antiandrogen, or an LHRH antagonist, or orchidectomy.

o  Enzalutamide should be administered with an LHRH agonist, and LHRH antagonist, or orchidectomy.

p  Other secondary hormone therapies for second-line treatment for M0 or M1 castrate-resistant adenocarcinoma include ketoconazole, ketoconazole + hydrocortisone, first-generation antiandrogen, corticosteroids (hydrocortisone, prednisone, or dexamethasone), diethylstilbestrol or other estrogens, and androgen withdrawal. Ketoconazole with or without hydrocortisone should not be used if disease has progressed on abiraterone with the other steroid.

q  Castrate levels of testosterone (<50 ng/dL) should be maintained by continuing LHRH agonist or antagonist while additional therapies are applied.

  Darolutamide should be administered with an LHRH agonist, an LHRH antagonist, or orchidectomy.

s  Cabazitaxel 25mg/m2 with concurrent steroid may be considered for healthy men who wish more aggressive treatment. Growth factor support may be needed with either dose.

 t  See NCCN Small-cell Lung Cancer Guidelines.

References

  1. Referenced with permission from NCCN Clinical Practice Guidelines in Oncology™ Prostate Cancer. V4.2019. Available at: https://www.nccn.org/professionals/physician_gls/pdf/prostate.pdf. Accessed September 19, 2019.

  2. Goserelin (Zoladex) [package insert]. Lake Forest, IL; TerSera Therapeutics LLC: 2019.

  3. Schellhammer PF, Sharifi R, Block NL, et al. Clinical benefits of bicalutamide compared with flutamide in combined androgen blockade for patients with advanced prostatic carcinoma: final report of a double-blind, randomized, multicenter trial. Casodex Combination Study Group. Urology. 1997;50:330-336.

  4. Basch E, Loblaw DA, Oliver TK, et al. Systemic therapy in men with metastatic castration-resistant prostate cancer: American Society of Clinical Oncology and Cancer Care Ontario clinical practice guideline. J Clin Oncol. 2014;32:3436-3448.

  5. Histrelin (Supprelin LA) [package insert]. Malvern, PA: Endo Pharmaceuticals Solutions, Inc.; 2017.

  6. Schlegel PN, Histrelin Study Group. Efficacy and safety of histrelin subdermal implant in patients with advanced prostate cancer. J Urol. 2006;175:1353-1358.

  7. Leuprolide (Lupron Depot) [package insert]. North Chicago, IL: AbbVie Inc.; 2018.

  8. Triptorelin (Triptodur) [package insert]. Atlanta, GA: Arbor Pharmaceuticals, LLC; 2018.

  9. Bicalutamide (Casodex) [package insert]. Wilmington, DE: AstraZeneca Pharmaceuticals; 2015.

10. McLeod DG, Iversen P, See WA, et al. Bicalutamide 150 mg plus standard care vs standard care alone for early prostate cancer. BJU Int. 2006;97:247-254.

11. Nilutamide (Nilandron) [package insert]. Bridgewater, NJ: sanofi-aventis U.S LLC; 2006.

12. Degarelix (Firmagon) [package insert]. Parsippany, NJ; Ferring Pharmaceuticals, INc.; 2017.

13. Crawford ED, Tombal B, Miller K, et al. A phase III extension trial with a 1-arm crossover from leuprolide to degarelix: comparison of gonadotropin-releasing hormone agonist and antagonist effect on prostate cancer. J Urol. 2011;186:889-897.

14. Abiraterone (Zytiga) [package insert]. Horsham, PA: Janssen Biotech, Inc.; 2019.

15. James ND, de Bono JS, Spears MR, et al. Abiraterone for prostate cancer not previously treated with hormone therapy. N Engl J Med. 2017;377:338-351.

16. Fizazi K, Tran N, Fein L, et al. Abiraterone plus prednisone in metastatic, castration-­sensitive prostate cancer. N Engl J Med. 2017;377:352-360.

17. Ryan CJ, Smith MR, de Bono JS, et al. Abiraterone in metastatic prostate cancer without previous chemotherapy. N Engl J Med. 2013;368:138-148.

18. Fizazi K, Scher HI, Molina A, 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;13:983-992.

19. Szmulewitz RZ, Peer CJ, Ibraheem A, et al. Prospective international randomized phase II study of low-dose abiraterone with food versus standard dose abiraterone In castration-resistant prostate cancer. J Clin Oncol. 2018;36:1389-1395.

20. Stein CA, Levin R, Given R, 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.

21. Apalutamide (Erleada) [package insert]. Horsham, PA: Janssen Pharmaceutical Co.; 2019.

22. Smith MR, Saad F, Chowdhury S, et al. Apalutamide treatment and metastasis-free survival in prostate cancer. N Engl J Med. 2018;378:1408-1418.

23. Sweeney CJ, Chen YH, Carducci M, et al. Chemohormonal therapy in metastatic hormone-sensitive prostate cancer. N Engl J Med. 2015;373:737-746.

24. Tannock IF, de Wit R, Berry WR, et al. Docetaxel plus prednisone or mitoxantrone plus prednisone for advanced prostate cancer. N Engl J Med. 2004;351:1502-1512.

25. Berthold DR, Pond GR, Soban F, et al. Docetaxel plus prednisone or mitoxantrone plus prednisone for advanced prostate cancer: updated survival in the TAX 327 study. J Clin Oncol. 2008;26:242-245.

26. James ND, Sydes MR, Clarke NW, 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. 2016;387:1163-1177.

27. Enzalutamide (Xtandi) [package insert]. Northbrook, IL: Astellas Pharmaceuticals U.S. Inc.; 2018.

28. Scher HI, Fizazi K, Saad F, et al. Increased survival with enzalutamide in prostate cancer after chemotherapy. N Engl J Med. 2012;367:1187-1197.

29. Beer TM, Armstrong AJ, Rathkopf DE, et al. Enzalutamide in metastatic prostate cancer before chemotherapy. N Engl J Med. 2014;371:424-433.

30. Hussain M, Fizazi K, Saad F, et al. Enzalutamide in men with nonmetastatic, castration-resistant prostate cancer. N Engl J Med. 2018;378:2465-2474.

31. Darolutamide (Nubeqa) [package insert]. Whippany, NJ: Bayer Healthcare Pharmaceuticals, Inc.; 2019.

32. Fizazi K, Shore N, Tammela TL, et al. Darolutamide in nonmetastatic, castration-resistant prostate cancer. N Engl J Med. 2019;380:1235-1246.

33. Radium-223 (Xifigo) [package insert]. Whippany, NJ; Bayer Healthcare Pharmaceuticals, Inc.;2018.

34. Parker C, Nilsson S, Heinrich D, et al. Alpha emitter radium-223 and survival in metastatic prostate cancer. N Engl J Med. 2013;369:213-223.

35. Petrylak DP, Tangen CM, Hussain MH, et al. Docetaxel and estramustine compared with mitoxantrone and prednisone for advanced refractory prostate cancer. N Engl J Med. 2004;351:1513-1520.

36. Pembrolizumab (Keytruda) [package insert]. Whitehouse Station, NJ: Merck & Co., Inc.; 2019.

37. Le DT, Uram JN, Wang H, et al. PD-1 blockade in tumors with mismatch-repair deficiency. N Engl J Med. 2015;372:2509-2520.

38. Sipuleucel-T (Provenge) [package insert]. Seattle, WA; Dendreon Corp.: 2017.

39. Kantoff PW, Higano CS, Shore ND, et al. Sipuleucel-T immunotherapy for castration-resistant prostate cancer. N Engl J Med. 2010;363:411-422

40. Cabazitaxel (Jevtana) [package insert]. Bridgewater, NJ: sanofi-aventis U.S. LLC; 2018.

41. Eisenberger M, Hardy-Bessard AC, Kim CS, et al. Phase III study comparing a reduced dose of cabazitaxel (20 mg/m2) and the currently approved dose (25 mg/m2) in postdocetaxel patients with metastatic castration-resistant prostate cancer-PROSELICA. J Clin Oncol. 2017;35:3198-3206.

42. de Bono JS, Oudard S, Ozguroglu M, et al. Prednisone plus cabazitaxel or mitoxantrone for metastatic castration-resistant prostate cancer progressing after docetaxel treatment: a randomised open-label trial. Lancet. 2010;376:1147-1154.

43. Skarlos DV, Samantas E, Briassoulis E, et al. Randomized comparison of early versus late hyperfractionated thoracic irradiation concurrently with chemotherapy in limited disease small-cell lung cancer: a randomized phase II study of the Hellenic Cooperative Oncology Group (HeCOG). Ann Oncol. 2001;12:1231-1238.

44. Okamoto H, Watanabe K, Nishiwaki Y, et al. Phase II study of area under the plasma-concentration-versus-time curve-based carboplatin plus standard-dose intravenous etoposide in elderly patients with small-cell lung cancer. J Clin Oncol. 1999;17:3540-3345.

45. Brennan SM, Gregory DL, Stillie A, et al. Should extrapulmonary small cell cancer be managed like small cell lung cancer? Cancer. 2010;116:888-895.

46. NCCN Clinical Practice Guidelines in Oncology. Small Cell Lung Cancer. V2.2019. Available at: https://www.nccn.org/professionals/physician_gls/pdf/sclc.pdf. Accessed September 19, 2019.

47. Ihde DC, Mulshine JL, Kramer BS, et al. Prospective randomized comparison of high-dose and standard-dose etoposide and cisplatin chemotherapy in patients with extensive-stage small-cell lung cancer. J Clin Oncol. 1994;12:2022-2034.

48. Sundstrøm S, Bremnes RM, Kaasa S, et al. Cisplatin and etoposide regimen is superior to cyclophosphamide, epirubicin, and vincristine regimen in small-cell lung cancer: results from a randomized phase III trial with 5 years’ follow-up. J Clin Oncol. 2002;20:4665-4672.

49. Nakabayashi M, Sartor O, Jacobus S, et al. Response to docetaxel/carboplatin-based chemotherapy as first- and second-line therapy in patients with metastatic hormone-refractory prostate cancer. BJU Int. 2008;101:308-312.

50. Bouman-Wammes EW, van den Berg HP, de Munck L, et al. A randomised phase II trial of docetaxel versus docetaxel plus carboplatin in patients with castration-resistant prostate cancer who have progressed after response to prior docetaxel chemotherapy: The RECARDO trial. Eur J Cancer. 2018;90:1-9.

(Revised 10/2019) © 2019 by Haymarket Media, Inc.

Genitourinary Cancer Drug Monographs

Bladder, Kidney, And Other Urologic Cancers

AFINITOR AVASTIN CABOMETYX
Cisplatin COSMEGEN DEPO-PROVERA
Doxorubicin HCl Doxorubicin HCl Solution INLYTA
LENVIMA NEXAVAR OPDIVO
PROLEUKIN SUTENT TECENTRIQ
Thiotepa TICE BCG TORISEL
VALSTAR VINCASAR PFS VOTRIENT

Prostate And Other Male Cancers

Bleomycin CASODEX Cisplatin
COSMEGEN DELESTROGEN ELIGARD
EMCYT ESTRACE ETOPOPHOS
FIRMAGON Flutamide IFEX
JEVTANA Leuprolide acetate LUPRON DEPOT 7.5mg
LUPRON DEPOT-3 MONTH 22.5mg LUPRON DEPOT-4 MONTH 30mg LUPRON DEPOT-6 MONTH 45mg
MENEST Mitoxantrone HCl NILANDRON
PREMARIN PROVENGE TAXOTERE
TOPOSAR TRELSTAR VANTAS
Vinblastine for injection Vinblastine injection XOFIGO
XTANDI ZOLADEX ZOLADEX 3-MONTH 10.8mg
ZYTIGA
Data provided by eMPR.com

This article originally appeared on Cancer Therapy Advisor