Upfront docetaxel for men with non-metastatic prostate cancer

01 Aug 2022

Adding the chemotherapy drug docetaxel to standard treatment helps patients with prostate cancer to live for longer without their disease coming back or getting worse but does not improve survival overall. These results from the STAMPEDE trial were published, open access, in the Journal of the National Cancer Institute (JNCI) Cancer Spectrum last week.

These findings from the “docetaxel comparison” are a long-term follow-up study from STAMPEDE focused on patients with non-metastatic disease. In these patients, their prostate cancer had not already spread to other parts of the body before they joined the study.

In 2015, the STAMPEDE trial team published the first results from the “docetaxel comparison” in STAMPEDE, which included a larger group of patients, some with metastatic and some with non-metastatic disease. By then, the study revealed that adding docetaxel to the standard treatment improved survival of patients with metastatic disease. However, there was not enough evidence to be sure whether docetaxel benefits those patients with non-metastatic disease.

Therefore, follow-up continued in the long-term and findings were presented separately for metastatic and non-metastatic patients.

In 2019, we published the long-term results for those patients with metastatic disease when they joined the trial. That paper confirmed docetaxel improved survival in that setting.

This new paper in 2022 addresses whether patients with non-metastatic disease could benefit from adding docetaxel to standard treatment.

690 patients were randomly allocated between two groups:

  • standard treatment
  • standard treatment + docetaxel

In both groups, the standard treatment was hormone therapy with or without radiotherapy to the prostate. The doctor and patient decided before joining the trial whether radiotherapy would be part of the treatment for the patient. The study took place in the UK and Switzerland. Consenting participants were followed-up for at least 5 years after being assigned to one of the two groups.

These new findings are consistent with the previous results presented in 2015. Adding docetaxel to the standard treatment did not improve the survival of patients with non-metastatic prostate cancer.

However, docetaxel chemotherapy did reduce the number of patients whose disease went on to spread to other parts of the body. The study showed that adding docetaxel improved the proportion of patients whose disease had not come back or got worse within five years, from 52% in the standard treatment to 63% if they were in the docetaxel group.

A similar proportion of patients on each group reported unwanted side-effects in the long-term.



Previous results from STAMPEDE in 2014 confirmed findings from the MRC PR07 trials and SPCG7 trial that adding radiotherapy to the standard treatment helped patients with prostate cancer to live longer. The new findings show that if these non-metastatic patients are going to receive prostate radiotherapy, there is no need to include docetaxel.

The STAMPEDE trial was funded by Cancer Research UK (CRUK), the Medical Research Council (MRC), and the Swiss Group for Cancer Clinical Research (SAKK), with further support from industry collaborators including Janssen, Astellas, Prostate Cancer UK, Clovis Oncology, Novartis, Pfizer, and Sanofi-Aventis. 

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