Results published today in The Lancet Oncology show that adding the drug celecoxib to standard hormone therapy does not improve outcomes for men with prostate cancer.
These results are from the STAMPEDE trial
, which is testing several promising new approaches to see if they can prevent the re-growth of prostate cancer tumours. A pre-planned intermediate analysis showed that the addition of celecoxib to hormone therapy did not result in enough benefit to justify continuing to recruit further patients to the comparison. Recruitment of patients to the celecoxib arms of the trial was halted and treatment with the drug was also stopped. Researchers will continue to follow up patients who received celecoxib, to monitor the long-term effects and whether any benefit does emerge. Further information about these results is available in a short briefing paper
While these results are disappointing, the design of the trial means that it focuses its efforts on other more promising new drugs. STAMPEDE uses an innovative “multi-arm multi-stage” (or “MAMS”) design. This allows it to compare several different treatment approaches to a single control group. Treatments that are not active enough can be stopped early, while recruitment continues throughout to more promising arms. Furthermore, investigators can investigate other new treatments as the trial goes on. The trial recently added a new arm, testing abiraterone. Abiraterone can help patients whose prostate cancer has stopped responding to standard hormone therapy. STAMPEDE will look at whether it can also benefit men whose tumours are responding to hormone therapy.
The STAMPEDE trial started in 2005, and currently has nearly 3,000 patients taking part. It is taking place in more than 100 hospitals, mainly in the UK. MRC CTU runs STAMPEDE, and Cancer Research UK funds it, along with Janssen, Novartis, Sanofi-Aventis and Pfizer. The trial registration number is NCT00268476.