This site is intended for US Healthcare Professionals only.

Metastatic castration-sensitive prostate cancer

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

NCCN Guidelines® recommendations
Category
1
  • NHTs that are indicated for mCSPC + ADT*†
  • Chemotherapy + ADT*†
Category
2A
  • External-beam radiation therapy to the primary tumor for low-volume‡ metastases + ADT
  • ADT§
Category
2B
  • A select NHT + 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.

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

Please see NCCN Guidelines for complete information.

*ADT alone or observation are recommended for asymptomatic patients with metastatic disease and a life expectancy ≤ 5 years.1

†ADT options are orchiectomy, LHRH agonist, LHRH agonist plus first-generation anti-androgen, or LHRH antagonist. Certain combinations of ADT with NHT are not recommended.1

‡High-volume disease is differentiated from low-volume disease by visceral metastases and/or ≥ 4 bone metastases, with ≥ 1 metastasis beyond the pelvic vertebral column. Patients with low-volume disease have less certain benefit from early treatment with docetaxel combined with ADT.1

§Intermittent ADT can be considered for men with castration-sensitive prostate cancer, with or without metastases, to reduce toxicity.1

AUA guidelines recommendations

Clinicians should offer

  • NHTs that are indicated for mCSPC + ADT
  • Chemotherapy + ADT
STRONG‖
EVIDENCE LEVEL
GRADE A

Clinicians should not offer

  • First-generation anti-androgens + LHRH agonists, except to block testosterone flare
STRONG‖
EVIDENCE LEVEL
GRADE A

Clinicians may offer

  • Primary radiotherapy to the prostate + ADT in selected patients with low-volume metastatic disease
CONDITIONAL#
EVIDENCE LEVEL
GRADE C

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

A Grade C rating means the AUA’s confidence in the effect estimate is limited. The true effect may be substantially different from 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

¶Defined as androgen pathway directed therapy.2

#Conditional recommendations are nondirective statements used when the evidence indicates that there is no apparent net benefit or harm, when benefits and harms are finely balanced, or when the balance between benefits and risks/burden is unclear.2

ADT, androgen deprivation therapy; AUA, American Urological Association; LHRH, luteinizing hormone-releasing hormone; mCSPC, metastatic castration-sensitive prostate cancer; NCCN, National Comprehensive Cancer Network; NHT, novel hormone therapy.

Pathways to advanced prostate cancer (aPC) diagnosis3

Pathways to advanced prostate cancer diagnoses

mCRPC, metastatic castration-resistant prostate cancer; nmCRPC, nonmetastatic castration-resistant prostate cancer; PSA, prostate-specific antigen.

*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

Patients with mCSPC can be characterized with 1 of the 2 following diagnoses3,5

Experienced biochemical recurrence (ie, PSA progression after definitive therapy* following initial diagnosis)

Have confirmed radiographic metastases

Have not yet received, or who have received and can still respond to, LHRH therapy†

Have confirmed radiographic metastases at the time of initial diagnosis

Have not yet received LHRH therapy†

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

†Or after bilateral orchiectomy.3

The prevalence of patients with mCSPC is estimated to have increased between 2014 and 20206

Total prevalence and incidence of mCSPC in the United States based on SEER data

It is estimated that from 2014 to 2020 the total prevalence had an
18
over
41,000
It is estimated that from 2014 to 2020 the total prevalence had an
18
over
41,000

It is estimated that from 2014 to 2020 the total incidence of men who newly presented with mCSPC had increased 16% to over 13,000

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.

One SEER-based analysis suggests that patients with de novo mCSPC have a compromised survival outlook7

The analysis estimated a lower 5-year relative survival rate for patients with de novo mCSPC vs those with clinically localized prostate cancer7

A retrospective analysis of the SEER database, a collection of cancer incidence and survival data from population-based cancer registries covering approximately 35% of the US population, was conducted between 2011 and 2017.7,8

30.6% of patients

An analysis suggested that most men who are diagnosed with mCSPC may not be treated in accordance with the highest guidelines recommendations9

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
  • 165 physicians reporting on 1514 patients

Patients with mCSPC were identified with the following query:

  • Prostate stage IV, not hormone-refractory, first-line regimen
Patients receiving various treatment categories (%)

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

Ipsos Healthcare US Oncology Monitor (January 2020 to December 2020, 165 physicians reporting on 1514 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. Finianos A, Gupta K, Clark B, Simmens SJ, Aragon-Ching JB. Characterization of differences between prostate cancer patients presenting with de novo versus primary progressive metastatic disease. Clin Genitourin Cancer 2017;16(1):85-9. 6. 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. 7. National Cancer Institute. Prostate: SEER 5-year relative survival rates, 2011-2017. https://seer.cancer.gov/explorer/application.html?site=66&data_type=4&graph_type=5&compareBy=race&chk_race_1=1&chk_race_3=3&chk_race_2=2&series=9&hdn_sex=2&age_range=1&stage=106&advopt_precision=1&advopt_show_ci=on&advopt_display=2. Accessed 07-20-2021. 8. National Cancer Institute. Surveillance, epidemiology, and end results (SEER) (02-2018). https://seer.cancer.gov/about/factsheets/SEER_Overview.pdf. Accessed 01-05-2021. 9. Astellas. XTANDI. Data on File.