Please note that this summary only contains information from the full scientific abstract: View ESMO Scientific Abstract

Response to enzalutamide plus hormone therapy in men with metastatic hormone-sensitive prostate cancer, based on the cancer’s characteristics

Date of summary: September 2019

Study number: NCT02677896

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Study start date: March 2016

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Estimated study end date: December 2023

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The full title of this abstract is: ARCHES – the role of androgen deprivation therapy (ADT) with enzalutamide (ENZA) or placebo (PBO) in metastatic hormone-sensitive prostate cancer (mHSPC): Post hoc analyses of high and low disease volume and risk groups

This study drug is not approved to treat the condition under study that is discussed in this summary.

 

Researchers must look at the results of many types of studies to understand whether a study drug works, how it works, and whether it is safe to prescribe to patients.

This summary reports the results of only one study. The results of this study might be different from the results of other studies that the researchers look at.

 

More information can be found in the scientific abstract of this study, which you can access here:
View ESMO Scientific Abstract

What did this study look at?

  • Prostate cancer is one of the most common cancers in men.
    • If the cancer spreads outside of the prostate, it is called metastatic.
  • The growth of prostate cancer cells depends on male sex hormones. These are called androgens.
    • Treatment for prostate cancer involves lowering the amount of androgens in the body through surgery or drugs, which is called androgen-deprivation therapy.
    • Lowering the amount of androgens in the body with the help of drugs is also known as medical castration.
  • In some men, treatment resulting in lower androgen levels will slow down the growth of the cancer cells.
    • This type of cancer is known as hormone-sensitive prostate cancer (HSPC for short).
  • Enzalutamide (ENZA for short) is not approved for the treatment of HSPC.
  • In the ARCHES study, researchers wanted to find out whether ENZA + androgen-deprivation therapy is effective in men with metastatic HSPC (known as mHSPC).
  • This summary shows the results in dfferent groups of men, based on certain characteristics of their cancer:
    • How much the cancer had spread – known as tumor volume.
    • How much the cancer had spread, plus how likely it is to grow and spread further based on the characteristics of the cancer, including how it looks under the microscope – known as tumor risk. Knowing the way the tumor looks under the microscope may help to assess if the cancer is likely to get worse.
  • This summary shows results from these groups of men.

Who took part in this study?

* A placebo does not contain any active ingredients. The placebo and study drug(s) look alike.

  • Researchers divided the men into 2 groups based on tumor volume.
    • Men had high-volume tumors if the prostate cancer had spread:
      – to other internal organs, or
      – to the bone in 4 or more locations, with one or more of these locations being outside of the pelvis.
  • Researchers also divided the men into 2 groups based on tumor risk.
    • Men had high-risk tumors if they had 2 or more of the following:
      – Cancer that had spread to the bone in 3 or more different locations
      – Cancer that had spread to other internal organs
      – Cancer cells that are more likely to grow and spread.

What were the results of the study?

  • The researchers monitored the men for around 14 months.
  • Compared with placebo + androgen-deprivation therapy, ENZA + androgen-deprivation therapy increased the time before the cancer got worse or caused death across all the groups of men.
  • Overall, men who received ENZA + androgen-deprivation therapy and men who received placebo + androgen-deprivation therapy had a similar risk of medical problems.

More results from this study can be found here:
View ESMO Scientific Abstract

What were the main conclusions reported by the researchers?

  • In this study, men who received ENZA + androgen-deprivation therapy had a lower risk of their prostate cancer worsening or dying compared with men who received placebo + androgen-deprivation therapy. The researchers saw this benefit regardless of the men’s tumor volume or tumor risk.
  • Compared with placebo + androgen-deprivation therapy, ENZA + androgen-deprivation therapy increased the time before the cancer got worse or caused death across all groups of men studied here.
  • The medical problems experienced by men with mHSPC receiving ENZA were similar to those seen in other studies of ENZA.

Who sponsored this study?

Astellas Pharma Inc
1 Astellas Way, Northbrook, IL 60062-6111
Phone (United States): +1 800-888-7704

 

Medivation LLC, a Pfizer company
235 East 42nd Street NY, NY 10017
Phone (United States): +1 212-733-2323

Pfizer would like to thank all of the men who took part in this study.

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