Giving abiraterone at early stages helps people with advanced prostate cancer to live longer

03 May 2023

It has previously been shown that adding the drug abiraterone to the standard hormone therapy just after diagnosis improves survival of people with prostate cancer that has spread to other parts of the body. New findings from the STAMPEDE trial have confirmed that use of abiraterone remains the best option without the addition of enzalutamide. These results from the STAMPEDE trial were published in Lancet Oncology yesterday.  

Abiraterone and enzalutamide are two different types of hormone therapy that were originally developed to treat people with metastatic prostate cancer (cancer that has spread outside the prostate) that has stopped responding to standard hormone therapy. 

This part of the STAMPEDE trial investigated if using abiraterone alone or in combination with enzalutamide, earlier, while standard hormone therapy is still working, improves how long patients live and delay the disease getting worse.  

To address this question, two different comparisons were carried out:

  1. the abiraterone comparison, which tested if adding abiraterone to the standard hormone therapy was better than the standard therapy alone.
  2. the abiraterone and enzalutamide comparison, which tested if adding both drugs to standard hormone therapy was better than the standard hormone therapy alone. In some cases, they also received docetaxel chemotherapy.

The results from these comparisons were divided into two groups. The first group included people whose cancer had not yet spread elsewhere but was at high risk of spreading. The second group included people whose cancer had already spread beyond the prostate.  

In 2021 we published the findings from the first group, which showed that abiraterone reduced their risk of death or the cancer from spreading, leading to NHS Scotland to approve the use of abiraterone in these group of patients. 

In this paper, we report the analysis from the second group which included 1,974 people with metastatic prostate cancer. They were randomly allocated to one of the two comparisons: 

  • 1,003 of them received either abiraterone and standard hormone therapy (abiraterone group), or standard hormone therapy alone (control group).
  • 916 of them received either abiraterone, enzalutamide, and standard hormone therapy (abiraterone and enzalutamide group), or standard hormone therapy alone (control group).

Results from both comparisons confirmed that using abiraterone (with or without enzalutamide), improves survival and helps preventing the cancer from coming back. After six years, the proportion of people still alive was 53% in the abiraterone group and 50% in the abiraterone and enzalutamide group, compared to 35% of patients still alive in the control groups from both comparisons.  

However, there were no extra benefits when adding enzalutamide on top of abiraterone and those who received both drugs were more likely to experience severe side effects than those in the abiraterone or control groups. These findings were similar to the results we published in 2021 for people whose cancer has not spread. 

These results provide clear evidence that adding abiraterone to the current standard hormone therapy benefits people with prostate cancer both at early stages of the disease and once the cancer has already spread. They also demonstrate that adding enzalutamide on top of abiraterone is not justified as it does not improve survival further and brings additional side effects and costs.

These STAMPEDE comparisons took place across 117 hospitals in the UK and Switzerland. The STAMPEDE trial is funded by Cancer Research UK, the Medical Research Council, Prostate Cancer UK, Astellas, Clovis Oncology, Janssen, Novartis, Pfizer, and Sanofi-Aventis.  

 

 Further information: