Prostate Cancer Treatment Regimens

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 strategi es.

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-d

REGIMEN

DOSING

LHRH Agonistsd

Goserelin2-4

Day 1: Goserelin 3.6mg subcutaneous implant.

Repeat cycle every 4 weeks.

OR

Day 1: Goserelin 10.8mg subcutaneous implant.

Repeat cycle every 3 months.

Leuprolide Acetate3-5

Day 1: Leuprolide Acetate 7.5mg IM or subcutaneous.

Repeat cycle every 4 weeks.

OR

Day 1: Leuprolide Acetate 22.5mg IM or subcutaneous.

Repeat cycle every 3 months.

OR

Day 1: Leuprolide Acetate 30mg IM or subcutaneous.

Repeat cycle every 4 months.

OR

Day 1: Leuprolide Acetate 45mg IM or subcutaneous.

Repeat cycle every 6 months.

Leuprolide Mesylate6,7

Day 1: Leuprolide Mesylate 42mg subcutaneous.

Repeat cycle every 6 months.

Triptorelin4,8

Day 1: Triptorelin 3.75mg IM.

Repeat cycle every 4 weeks.

OR

Day 1: Triptorelin 11.25mg IM.

Repeat cycle every 3 months.

OR

Day 1: Triptorelin 22.5mg IM.

Repeat cycle every 6 months.

First-Generation Antiandrogen

Bicalutamide3,4,9-11

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.

Flutamide3,4,12

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

Repeat cycle every 4 weeks.f

Nilutamide3,4,13

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.

LHRH Antagonists

Degarelix4,14,15

Day 1: Degarelix 120mg subcutaneous injection twice daily.

Administer one 4-week cycle loading dose, followed by maintenance dose of:

Day 1: Degarlix 80mg administered as one subcutaneous injection of 4mL once daily.

Repeat maintenance cycle every 4 weeks.

Relugolix16,17

Day 1 (Cycle 1): Relugolix 360mg orally once daily, followed by:

Days 2-28 (Cycle 1): Relugolix 120mg orally once daily, followed by:

Days 1-28 (Beginning with Cycle 2): Relugolix 120mg orally once daily.

Repeat cycle every 4 week.

▶Other Secondary Hormone Therapy1,a

Second-Generation Antiandrogens

Apalutamide18-21

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

Repeat cycle every 4 weeks.

Darolutamide22-24

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

Repeat cycle every 4 weeks.

Enzalutamide25-29

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

Repeat cycle every 4 weeks.

Androgen Metabolism Inhibitor

Abiraterone (conventional formulation) + Dexamethasone30-32

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

Days 1-28: Dexamethasone 1mg orally once daily.

Repeat cycle every 4 weeks.

Abiraterone (micronized formulation) + Dexamethasone30-32

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

Days 1-28: Dexamethasone 1mg orally once daily.

Repeat cycle every 4 weeks.

Abiraterone (conventional formulation) + Prednisone30,33-36

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

Days 1-28: Prednisone 5mg orally once daily (for regional, clinically localized disease: very high-risk group or castration-sensitive metastatic [M1] disease) OR

Days 1-28: Prednisone 5mg orally twice daily (for castration-resistant metastatic [M1] disease).

Repeat cycle every 4 weeks for 2 years (for regional, clinically localized disease: very high-risk group) OR until disease progression or unacceptable toxicity (for castration-resistant metastatic [M1] disease or castration-sensitive metastatic [M1] disease.

Abiraterone (micronized formulation) + Methylprednisone30,33-36

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

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

Repeat cycle every 4 weeks for 2 years (for regional, clinically localized disease: very high-risk group) OR until disease progression or unacceptable toxicity (for castration-resistant metastatic [M1] disease or castration-sensitive metastatic [M1] disease.

▶Systemic Therapy for Castration-Sensitive Disease (M0)1,a,e

LHRH Agonist alone, LHRH Agonist + First-generation Antiandrogen, or LHRH Antagonist

See above.

▶Systemic Therapy for Castration-Sensitive Disease (M1)1,a,c-e

Preferred Regimens

ADT

See above.

ADT + Abiraterone + Methylprednisolone (Category 1)30,33-36

ADT plus:

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

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

Repeat cycle every 4 weeks.

ADT + Abiraterone + Prednisone (Category 1)30,33-36

ADT plus:

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

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

Repeat cycle every 4 weeks.

ADT + Apalutamide (Category 1)18-21,f

ADT plus:

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

Repeat cycle every 4 weeks.

ADT + Enzalutamide (Category 1)25-29

ADT plus:

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

Repeat cycle every 4 weeks.

ADT + Docetaxel + Abiraterone (Category 1)30,39,40,f,g

Docetaxel requires premedication.g

ADT plus:

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

Days 1-21: Abiraterone (conventional formulation) 1,000mg orally once daily

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

Repeat every 3 weeks for 6 cycles, followed by:

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

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

Repeat cycle every 4 weeks.

OR

ADT plus:

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

Days 1-21: Abiraterone (micronized formulation) 500mg orally once daily

Days 1-21: Methylprednisolone 4mg twice daily.

Repeat cycle every 3 weeks for 6 cycles, followed by:

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

Days 1-21: Methylprednisolone 4mg twice daily.

Repeat cycle every 4 weeks.

ADT + Docetaxel + Darolutamide (Category 1)22,39,41,f,g

Docetaxel requires premedication.g

ADT plus:

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

Days 1-21: Darolutamide 600mg orally twice daily.

Repeat cycle every 3 weeks for 6 cycles, followed by:

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

Repeat cycle every 4 weeks.

PSADT >10 monthsi

See footnote i

PSADT ≤ 10 monthsi

Preferred Regimens

Apalutamide (Category 1)18-21

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

Repeat cycle every 4 weeks.

Darolutamide (Category 1)22-24

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

Repeat cycle every 4 weeks.

Enzalutamide (Category 1)25-29

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

Repeat cycle every 4 weeks.

Other Recommended Regimensi

See footnote i

▶Systemic Therapy for Castration Resistant M1 Adenocarcinoma

No Prior Docetaxel/No Prior Novel Hormone Therapy

Preferred Regimens

Abiraterone + Methylprednisolone (Category 1)30,33-36

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)30,33-36

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

Days 1-28: Prednisone 5mg orally twice daily Repeat cycle every 4 weeks.

Docetaxel + Prednisone (Category 1)39,42,43,g,h

Docetaxel requires premedication.g

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)25-29

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

Repeat cycle every 4 weeks.

Useful in Certain Circumstancesi

Radium-223 for symptomatic bone metastases (Category 1)44,m

See NCCN Prostate Cancer Guidelines.1

Sipuleucel-T (Category 1)45,n

See NCCN Prostate Cancer Guidelines.1

Other Recommended Regimensi

See footnote i

Prior Docetaxel/No Prior Novel Hormone Therapy

Preferred Regimens

Abiraterone + Methylprednisolone (Category 1)30,33-36

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)30,33-36

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

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

Repeat cycle every 4 weeks.

Cabazitaxel + Prednisone46-49,h,j,k

Carbazitaxel requires premedication.i

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

Days 1-21: Prednisone 10mg orally once daily. Repeat cycle every 3 weeks.

OR

Day 1: Cabazitaxel 25mg/m2 IV over 60 minutes (for healthy men who wish to be more aggressive)

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

Repeat cycle every 3 weeks.

Enzalutamide (Category 1)25-29

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

Repeat cycle every 4 weeks.

Useful in Certain Circumstances

Cabazitaxel/Carboplatin + Prednisone46,50,51,h,j-l

Carbazitaxel requires premedication.i

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

Day 1: Carboplatin AUC 4 IV over 30 minutes

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

Repeat every 3 weeks.

Mitoxantrone + Prednisone (for palliation in symptomatic patients who cannot tolerate other therapies)42,48,52,53,p

Day 1: Mitoxantrone 12mg/m2 IV over 35-15 minutes.

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

Repeat cycle every 3 weeks until disease progression or unacceptable toxicity including reaching a lifetime cumulative anthracycline dose.

Radium-233 for symptomatic bone metastases (Category 1)44,m

See NCCN Prostate Cancer Guidelines.1

Sipuleucel-T45,n

See NCCN Prostate Cancer Guidelines.1

Other Recommended Regimensi

See footnote i

Prior Novel Hormone Therapy/No Prior Docetaxel

Preferred Regimens

Docetaxel + Prednisone (Category 1)39,42,43,g,h

Docetaxel requires premedication.g

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

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

Repeat cycle every 3 weeks.

Useful in Certain Circumstances

Cabazitaxel/Carboplatin + Prednisone46,50,51,h,j-l

Cabazitaxel requires premedication.i

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

Day 1: Carboplatin AUC 4 IV over 30 minutes

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

Repeat every 3 weeks.

Olaparib for HRR-mutant (Category 1)54,55

Days 1-28: Olaparib 300mg orally twice daily.

Repeat every 4 weeks.

Radium-223 for symptomatic bone metastases (Category 1)44,m

See NCCN Prostate Cancer Guidelines.1

Rucaparib (for BRCA mutation)56,57

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

Repeat cycle every 4 weeks.

Sipuleucel-T45,n

See NCCN Prostate Cancer Guidelines.1

Other Recommended Regimensi

Abiraterone (conventional formulation) + Dexamethasone30-32

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

Days 1-28: Dexamethasone 1mg orally once daily.

Repeat cycle every 4 weeks.

Abiraterone (micronized formulation) + Dexamethasone30-32

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

Days 1-28: Dexamethasone 1mg orally once daily.

Repeat cycle every 4 weeks.

Abiraterone + Methylprednisolone30,33-36

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

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

Repeat cycle every 4 weeks.

Abiraterone + Prednisone30,33-36

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

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

Repeat cycle every 4 weeks.

Enzalutamide25-29

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

Repeat cycle every 4 weeks.

Prior Docetaxel and Prior Novel Hormone Therapy

Preferred Regimens

Cabazitaxel + Prednisone (Category 1 except Category 2B if visceral metastases present)46-49,h,j,k

Cabazitaxel requires premedication.i

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

Days 1-21: Prednisone 10mg orally once daily. Repeat cycle every 3 weeks.

OR

Day 1: Cabazitaxel 25mg/m2 IV over 60 minutes (for healthy men who wish to be more aggressive)

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

Repeat cycle every 3 weeks.

Docetaxel rechallenge (Category 2B if visceral metastases present)39,42,43,g,h

Docetaxel requires premedication.g

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

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

Repeat cycle every 3 weeks.

Useful in Certain Circumstances

Cabazitaxel/Carboplatin + Prednisone (Category 2A; Category 2B if visceral metastases present)46,50,51,h,j-l

Cabazitaxel requires premedication.i

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

Day 1: Carboplatin AUC 4 IV over 30 minutes

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

Repeat every 3 weeks.

Lutetium Lu 177 Vivivotide Tetraxetan (Lu-177-PSMA-617) for PSAM-positive metastases (Category 1)o

See NCCN Prostate Cancer Guidelines.1

Mitoxantrone + Prednisone for palliation in symptomatic patients who cannot tolerate other therapies (Category 2A; Category 2B if visceral metastases present)42,48,52,53,p

Day 1: Mitoxantrone 12mg/m2 IV over 5-15 minutes

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

Repeat cycle every 3 weeks.

Olaparib for HRR-mutant (Category ; Category 2B if visceral metastases present)54,55

Days 1-28: Olaparib 300mg orally twice daily.

Repeat every 4 weeks.

Pembrolizumab for MSI-H, dMMR, or TMB > 10mut/Mb (Category 2A; Category 2B if visceral metastases present)58-62,q

Day 1: Pembrolizumab 200mg IV over 30 minutes.

Repeat cycle every 3 weeks for up to 2 years.

OR

Day 1: Pembrolizumab 400mg IV over 30 minutes.

Repeat cycle every 6 weeks for up to 2 years.

Radium-223 for symptomatic bone metastases (Category 1; Category 2B if visceral metastases present)44,m

See NCCN Prostate Cancer Guidelines.1

Rucaparib for BRCA mutation (Category 2A; Category 2B if visceral metastases present)56,57

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

Repeat cycle every 4 weeks.

Other Recommended Regimensi

Abiraterone + Methylprednisone (Category 2B if visceral metastases present)30,33-36

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 B if visceral metastases present)30,33-36

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

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

Repeat cycle every 4 weeks.

Enzalutamide (Category 2B if visceral metastases present)25-29

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

Repeat cycle every 4 weeks.

▶Systemic Therapy for Castration Resistant M1 Small Cell Carcinoma/ Neuroendocrine Prostate Cancer1,63,a,r

First Line and Subsequent Treatment Options

Carboplatin/Etoposide50,64-68,k

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

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

Repeat cycle every 3 weeks for 4-6 cycles.

Cabazitaxel/Carboplatin + Prednisone (Category 2B if visceral metastases present)46,50,51,h,j-l

Cabazitaxel requires premedication.i

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

Day 1: Carboplatin AUC 4 IV over 30 minutes

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

Repeat every 3 weeks.

Cisplatin/Etoposide64,66,69-71,s

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/Carboplatin39,50,66,72,73,g

Docetaxel requires premedication.g

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

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

Repeat cycle every 3 weeks for 4-6 cycles.

a.  Abbreviations: ADT – androgen deprivation therapy; CEA – carcinoembryonic antigen; CSF – colony-stimulating factor; dMMR – mismatch recombination repair – deficient;
ECOG – Eastern Cooperative Oncology Group; HRR – homologous recombination repair; LDH – lactate dehydrogenase; LHRH – luteinizing hormone-releasing hormone;
MSI-H – microsatellite instability-high; NEPC – neuroendocrine prostate cancer; PSMA – prostate-specific membrane antigen; RT – radiation therapy; TMB – tumor mutational burden.

b.  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.

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

d.  A first-generation antiandrogen should be given with LHRH agonist ≥7 days to prevent testosterone flare if metastases are present in weight-bearing bone.

e.  The term “castration-sensitive” is used to define patients who have not been treated with ADT and those who are not on ADT at the time of progression. The NCCN Prostate Cancer Panel uses the term “castration-sensitive” even when patients have had neoadjuvant, concurrent, or adjuvant ADT as part of RT provided they have recovered testicular function.

 f.  The panel encourages ADT with Docetaxel and either Darolutamide or Abiraterone for patients with high-volume disease who are fit for chemotherapy.

g.  For Docetaxel: Premedication with Dexamethasone for fluid retention is required. One recommended strategy is:

      i.  Dexamethasone 8mg orally twice daily for three consecutive days starting 1 day prior to Docetaxel administration.

h.  Prednisone is optional on day 1 only when dexamethasone is given as a premedication on the day of chemotherapy.

 i.  Other secondary hormone therapy can also be used including first-generation antiandrogen (Nilutamide, Flutamide, or Bicalutamide), corticosteroids (Hydrocortisone, Prednisone, or Dexamethasone), antiandrogen withdrawal, or Ketoconazole plus Hydrocortisone.

 j.  For Carbazitaxal: Premedication for hypersensitivity is required. H2 antagonist: Famotidine 20mg IV/orally (or equivalent H2 blocker) 30-60 minutes pre-Cabazitaxel AND H2 antagonist: Diphenhydramine 25mg IV/orally 30-60 minutes pre-Cabazitaxel AND Dexamethasone 8mg orally/IV 30 minutes pre-Cabazitaxel.

k.  CSFs may be considered for primary prophylaxis based on the febrile neutropenia (FN) risk of the chemotherapy regimen.

 l.  Carbazitaxel 20mg/m2 plus Carboplatin AUC 4mg/mL per min with growth factor support can be considered for fit patients with aggressive variant prostate cancer (visceral metastases, low PSA and bulky disease, high LDH, high CEA, lytic bone metastases, NEPC histology), or unfavorable genomics (defects in a t least 2 of PTEN, TP53, and RB1). Corn PG, et al. Lancet Oncol. 2019;20:1432-1443.

m. Radium-223 is not recommended for use in combination with Docetaxel or any other systemic therapy except ADT and should not be used in patients with visceral metastases. Concomitant use of Denosumab or Zolendronic acid is recommended.

n.  Sipuleucel-T is recommended only for asymptomatic or minimally symptomatic, no liver metastases, life expectancy >6 mo. and ECOG performance status 0-1. Benefit with Sipuleucel-T has not reported in patients with visceral metastases and is not recommended if visceral metastases are present. Sipuleucel-T also is not recommended for patients with small cell/NEPC.

o.  Lu-177-PSMA-617 is a treatment option for patients with ≥1 PSMA-positive lesion and/or metastatic disease that is predominantly PSMA-positive and with no dominant PSMA-negative metastatic lesions who have been treated previously with androgen receptor-directed therapy and a taxane-based chemotherapy. The panel believes that both Ga-68 PSMA-11 or F-18 pifluflolastat PSMA imaging can be used to determine eligibility. Sartor et al. N Engl J Med. 2021;385:1091-1102.

p.  Mitoxantrone is an anthracycline. Cumulative anthracycline dosage should be monitored.

q.  Early- and late-onset immune-related adverse events affecting multiple organ systems can occur in patients receiving immune checkpoint inhibitors. Patients with neurologic or life- threatening autoimmune disorders as well as receiving high levels of immunosuppression for their underlying disease should be approached with caution when considering immunotherapy. All patients will require extensive resources including ongoing intensive monitoring and supportive care.

 r.  For additional options, see NCCN Guidelines for Small Cell Lung Cancer.

 s.  Hydration is required with supplemental electrolytes pre- and post-administration of Cisplatin.

References

  1. Referenced with permission from NCCN Clinical Practice Guidelines in OncologyTM Prostate Cancer. V1.2023. Available at: https://www.nccn.org/professionals/physician_gls/pdf/prostate.pdf. Accessed December 3, 2022.

  2. Goserelin (Zoladex) [package insert]. Deerfield, IL; TerSera Therapeutics LLC: December 2020. https://dailymed.nlm.nih.gov/dailymed/fda/fdaDrugXsl.cfm?setid=294b168b-6e5f-4db9-bf70-d599271458b3. Accessed December 4, 2022.

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  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. doi: 10.1200/JCO.2013.54.8404.

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  7. Shore N, Mincik I, DeGuenther M, et al. A phase 3, open-label, multicenter study of a 6-month pre-mixed depot formulation of leuprolide mesylate in advanced prostate cancer patients. World J Urol. 2020;38(1):111-119. doi: 10.1007/s00345-019-02741-7.

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  9. Bicalutamide (Casodex) [package insert]. Baudette, MN: ANI Pharmaceuticals, Inc. August 2019. https://dailymed.nlm.nih.gov/dailymed/fda/fdaDrugXsl.cfm?setid=5bd7e54e-8497-4bc4-8964-151943db0626. Accessed December 4, 2022.

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. doi: 10.1111/j.1464-410X.2005.06051.x.

11. Shipley WU, Seiferheld W, Lukka HR, et al. Radiation with or without antiandrogen therapy in recurrent prostate cancer. N Engl J Med. 2017;376(5):417-428. doi: 10.1056/NEJMoa1607529.

12. Flutamide [package insert]. Miami, FL: Cipla USA Inc.; May 2017. Flutamide Capsules USP, 125 mg (nih.gov). Accessed December 4, 2022.

13. Nilutamide [package insert] Baudette, MN: ANI Pharmaceuticals, Inc.; July 2017. Nilutamide Tablets Rx only (nih.gov). Accessed December 4, 2022.

14. Degarelix (Firmagon) [package insert]. Parsippany, NJ; Ferring Pharmaceuticals, INC.; February 2020. https://dailymed.nlm.nih.gov/dailymed/fda/fdaDrugXsl.cfm?setid=ab11dd8a-0fd9-4013-89ab-e114557c7e4b. Accessed December 4, 2022.

15. 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. doi: 10.1016/j.juro.2011.04.083. Epub 2011 Jul 23.

16. Relugolix (Orgovyx) [package insert]. Brisbane, CA; Myovant Sciences, Inc.; September 2022. https://www.myovant.com/wp-content/uploads/2022/10/NDA-214621-USPIandPI.pdf. Accessed December 4, 2022.

17. Shore ND, Saad F, Cookson MS, et al. Oral relugolix for androgen-deprivation therapy in advanced prostate cancer. N Engl J Med. 2020;382(23):2187-2196.

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(Revised 1/2023; NCCN Bladder Cancer Guidelines v1.2023) © 2023 by Haymarket Media, Inc.