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Castration-resistant prostate cancer

For the treatment of nmCRPC
Guidelines include NHTs + ADT at their highest level of recommendation1,2

NCCN Guidelines® recommendations
Category
1
  • NHTs that are indicated for nmCRPC in patients with PSADT ≤ 10 months + ADT
Category
2A
  • Other secondary hormone therapy* in patients with PSADT ≤ 10 months + ADT
  • Observation† or other secondary hormone therapy* in patients with PSADT > 10 months + ADT

A Category 1 recommendation is based on high-level evidence and indicates uniform NCCN consensus that the intervention is appropriate.

A Category 2A recommendation is based on lower-level evidence and indicates uniform NCCN consensus that the intervention is appropriate.

Please see NCCN Guidelines for complete information.

*Ketoconazole, ketoconazole plus hydrocortisone, first-generation anti-androgen, corticosteroids, estrogens including diethylstilbestrol, or anti-androgen withdrawal.1

†Observation involves monitoring the course of disease with the expectation to deliver palliative therapy for the development of symptoms or a change in exam or PSA that suggests symptoms are imminent.1

AUA guidelines recommendations

Clinicians should offer

  • NHTs that are indicated for nmCRPC + ADT to patients at high risk for developing metastatic disease (with PSADT of ≤ 10 months)
STRONG‡
EVIDENCE LEVEL
GRADE A

A Grade A rating means the AUA is very confident that the true effect lies close to that of the estimate of the effect.

Please see AUA Guidelines for complete information.

‡Strong recommendations are directive statements 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.2

ADT, androgen deprivation therapy; AUA, American Urological Association; NCCN, National Comprehensive Cancer Network; NHT, novel hormone therapy; nmCRPC, nonmetastatic castration-resistant prostate cancer; PSA, prostate-specific antigen; PSADT, prostate-specific antigen doubling time.

Pathways to advanced prostate cancer (aPC) diagnosis3

Pathways to advanced prostate cancer diagnoses

LHRH, luteinizing hormone-releasing hormone; mCRPC, metastatic castration-resistant prostate cancer; mCSPC, metastatic castration-sensitive prostate cancer.

*PSA progression.3

†Definitive therapy is defined as a radical prostatectomy or radiotherapy with curative intent.3

‡Or prior bilateral orchiectomy.2

§Castration-resistant prostate cancer is defined as progression on ADT (LHRH therapy or prior bilateral orchiectomy).4

Defining CRPC5

Rising
PSA*

Castrate levels
of testosterone
(≤ 50 ng/dL)

With or without
metastatic
disease

Castration-resistant prostate cancer is defined as disease progression on androgen deprivation therapy (LHRH therapy or prior bilateral orchiectomy).4

CRPC, castration-resistant prostate cancer.

*PSA level of ≥ 2 ng/mL with at least 2 consecutive rises despite castrate testosterone levels ≤ 50 ng/dL.6

The prevalence of patients with nmCRPC and mCRPC is estimated to have increased between 2014 and 20207

Total prevalence of nmCRPC in the United States based on SEER data

It is estimated that from 2014 to 2020 the total prevalence had a
 9
over
112,000
It is estimated that from 2014 to 2020 the total prevalence had a
 9
over
112,000

Total prevalence of mCRPC in the United States based on SEER data

It is estimated that from 2014 to 2020 the total prevalence had an
11
over
76,000
It is estimated that from 2014 to 2020 the total prevalence had an
11
over
76,000

Based on a forward-looking model that used the SEER Program age-specific prostate cancer incidence rate data from 2008 to estimate prostate cancer incidence for each year from 2009 to 2020. To validate the model, the final results were compared with published estimates of prostate cancer incidence and prevalence in the United States for 2009 and 2020. The model estimates for the year 2020 are based on existing/current (2009) disease incidence, diagnosis, and treatment patterns, and reflect demographic changes in the US population over time (eg, the impact of the baby boomer population).3

SEER, Surveillance, Epidemiology, and End Results.

An analysis showed that 1 in 5 men with CRPC were treated with LHRH therapy alone8

Context for analysis:

US, physician-based, syndicated, patient record-tracking analysis capturing usage of anti-cancer and supportive care agents in prostate cancer

  • Data collected online between January 2020 and December 2020
  • 211 physicians reporting on 1080 patients

Patients with CRPC were identified with the following query:

  • Prostate, hormone-refractory, first-line regimen
Patients receiving various treatment categories (%)

*Excludes regimens containing an androgen synthesis inhibitor or an androgen receptor inhibitor.

Ipsos Healthcare US Oncology Monitor (January 2020 to December 2020, 211 physicians reporting on 1080 patients, all data collected online) © Ipsos 2021, all rights reserved.

Data for this analysis were purchased by Astellas from Ipsos Healthcare US Oncology Monitoring.

Review Treatment Guidelines

References: 1. Referenced with permission from the NCCN Clinical Practice Guidelines in Oncology (NCCN Guidelines®) for Prostate Cancer V.2.2021. © National Comprehensive Cancer Network, Inc. 2021. All rights reserved. Accessed 03-10-2021. To view the most recent and complete version of the guideline, 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. American Urological Association. Advanced prostate cancer: AUA/ASTRO/SUO guideline (08-2020). http://www.auanet.org/guidelines/advanced-prostate-cancer. Accessed 08-06-2021. 3. Scher HI, Solo K, Valant J, Todd MB, Mehra M. Prevalence of prostate cancer clinical states and mortality in the United States: estimates using a dynamic progression model. PLoS One 2015;10(10):e0139440. 4. Eisenberger MA, Saad F. Introduction—castration resistant prostate cancer: a rapidly expanding clinical state and a model for new therapeutic opportunities. In: Saad F, Eisenberger MA, eds. Management of Castration Resistant Prostate Cancer. 1st ed. New York, NY: Springer, 2014:3-8. 5. Beer TM, Armstrong AJ, Rathkopf DE, et al. Enzalutamide in metastatic prostate cancer before chemotherapy. N Engl J Med 2014;371(5):424-33. 6. Protocol for: Beer TM, Armstrong AJ, Rathkopf DE, et al. Enzalutamide in metastatic prostate cancer before chemotherapy. N Engl J Med 2014;371(5):424-33. 7. Supplement to: Scher HI, Solo K, Valant J, Todd MB, Mehra M. Prevalence of prostate cancer clinical states and mortality in the United States: estimates using a dynamic progression model. PLoS One 2015;10(10):e0139440. 8. Astellas. XTANDI. Data on File.