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 Preferred treatment option for patients with metastatic (M1) castration-naive prostate cancer.†
Non-Metastatic (M0) Castration-Resistant Prostate Cancer
The NCCN Guidelines® include apalutamide (ERLEADA®) with continued androgen deprivation* as a Category 1 Preferred 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.
Based upon high-level evidence, there is uniform NCCN consensus that the intervention is appropriate.
Interventions that are based on superior efficacy, safety, and evidence, and, when appropriate, affordability.
- Metastatic castration-naive prostate cancer (mCNPC)
- Metastatic hormone-sensitive prostate cancer (mHSPC)
American Urological Association (AUA)/American Society for Radiation Oncology (ASTRO)/Society of Urologic Oncology (SUO)5
Metastatic Hormone-Sensitive Prostate Cancer (mHSPC)
The AUA/ASTRO/SUO Guideline states that apalutamide (ERLEADA®) with continued ADT is a treatment option that clinicians should offer to patients with mHSPC [Strong Recommendation; Evidence Level: Grade A].
Non-Metastatic Castration-Resistant Prostate Cancer (nmCRPC)
The AUA/ASTRO/SUO Guideline states that apalutamide (ERLEADA®) with continued ADT is a treatment option that clinicians should offer to patients with nmCRPC at high risk for developing metastatic disease (PSADT ≤10 months) [Strong Recommendation; Evidence Level: Grade A].
AUA/ASTRO/SUO nomenclature for statement type and evidence strength:
Strong Recommendation: Directive statement that an action should (benefits outweigh risks/burdens) or should not (risks/burdens outweigh benefits) be undertaken because net benefit or net harm is substantial.
Evidence Level: Grade A: Applies to most patients in most circumstances and future research is unlikely to change confidence.
ADT = androgen deprivation therapy; CRPC = castration-resistant prostate cancer; LHRH = luteinizing hormone-releasing hormone; PSA = prostate-specific antigen; PSADT = prostate-specific antigen doubling time.
1. Referenced with permission from the NCCN Clinical Practice Guidelines in Oncology (NCCN Guidelines®) for Prostate Cancer V.2.2020. © National Comprehensive Cancer Network, Inc. 2020. All rights reserved. Accessed August 14, 2020. 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. Chi KN, Protheroe A, Rodriguez-Antolin A, et al. Patient-reported outcomes following abiraterone acetate plus prednisone added to androgen deprivation therapy in patients with newly diagnosed metastatic castration-naive prostate cancer (LATITUDE): an international, randomised phase 3 trial. Lancet Oncol. 2018;19(2):194-206.
4. 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.
5. Lowrance W, Breau R, Chou R, et al. Advanced prostate cancer: AUA/ASTRO/SUO Guideline. Accessed August 14, 2020. https://www.auanet.org/guidelines/advanced-prostate-cancer