Treatment Guidelines

National Comprehensive Cancer Network® (NCCN®)1

Metastatic (M1) Castration-Naive Prostate Cancer

The NCCN Clinical Practice Guidelines in Oncology (NCCN Guidelines®) include apalutamide (ERLEADA®) with androgen deprivation* as a Category 1 treatment option for patients with metastatic (M1) castration-naive prostate cancer.

Non-Metastatic (M0) Castration-Resistant Prostate Cancer

The NCCN Clinical Practice Guidelines in Oncology (NCCN Guidelines®) include apalutamide (ERLEADA®) with continued androgen deprivation* as a Category 1 treatment option for patients with non-metastatic (M0) CRPC and a PSA doubling time ≤10 months.

*Orchiectomy, LHRH agonist, or LHRH antagonist.

The term “castration-naive” is used to define patients who are not on ADT at the time of progression. The NCCN Prostate Cancer Panel uses the term “castration-naive” even when patients have had neoadjuvant, concurrent, or adjuvant ADT as part of radiation therapy provided they have recovered testicular function.

Definition of non-metastatic (M0): Conventional imaging studies negative for distant metastases.

Category 1:

Based upon high-level evidence, there is uniform NCCN consensus that the intervention is appropriate.

Other terms used to describe the M1 castration-naive prostate cancer patient population include metastatic castration-sensitive prostate cancer (mCSPC) and metastatic hormone-sensitive prostate cancer (mHSPC).2,3

American Urological Association (AUA)4

According to the AUA Guidelines for CRPC, apalutamide (ERLEADA®) with continued androgen deprivation is one of the options clinicians should offer to patients with non-metastatic CRPC at high risk for developing metastatic disease (Standard; Evidence Level Grade A).

AUA nomenclature§:

Standard: Directive statement that an action should (benefits outweigh risks/burdens) or should not (risks/burdens outweigh benefits) be taken based on Grade A or B evidence.

Evidence Level Grade A: The quality of the evidence is high.

§The AUA rates the quality of evidence as high, moderate, or low (A, B, or C).

CRPC = castration-resistant prostate cancer; LHRH = luteinizing hormone-releasing hormone; PSA = prostate-specific antigen.

References

1. Referenced with permission from the NCCN Clinical Practice Guidelines in Oncology (NCCN Guidelines®) for Prostate Cancer V.4.2019. © National Comprehensive Cancer Network, Inc. 2019. All rights reserved. Accessed September 24, 2019. To view the most recent and complete version of the NCCN Guidelines®, go online to NCCN.org. 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.

2. Hahn AW, Higano CS, Taplin ME, Ryan CJ, Agarwal N. Metastatic castration-sensitive prostate cancer: optimizing patient selection and treatment. Am Soc Clin Oncol Educ Book. 2018;38:363-371.

3. Kyriakopoulos CE, Chen YH, Carducci MA, et al. Chemohormonal therapy in metastatic hormone-sensitive prostate cancer: long-term survival analysis of the randomized phase III E3805 CHAARTED trial. J Clin Oncol. 2018;36(11):1080-1087.

4. Cookson MS, Roth BJ, Dahm P, et al. Castration-resistant prostate cancer: AUA Guideline. American Urological Association website: https://www.auanet.org/guidelines/prostate-cancer-castration-resistant-guideline-(2013-amended-2018). Amended 2018. Accessed September 24, 2019.