Combination therapy was associated with significantly higher rates of metastasis-free survival compared with androgen-deprivation therapy (ADT) alone, according to the study in The Lancet .

Abiraterone with prednisone is currently recommended by NICE in some cases of metastatic prostate cancer. However, questions have remained over its benefits and impact on survival in earlier-stage disease.

Treatment Option to be Reviewed by NHS England

Using abiraterone (Zytiga, Janssen) for patients with locally advanced prostate cancer, where the cancer has a high chance of spreading, will now be considered by NHS England, based on the research led by University College London and the Institute for Cancer Research (ICRS).

Researchers on the STAMPEDE trial analysed data from two randomised controlled phase 3 trials involving 1974 patients in the UK and Switzerland with a median age of 68 years.

In the first trial, 459 participants were randomly allocated to receive combination therapy with abiraterone and prednisolone in addition to androgen-deprivation therapy (ADT), and 455 to a control group receiving androgen-deprivation therapy (ADT) alone.

In the second trial, 527 received the combination therapy plus enzalutamide, while 533 were allocated to a control group.

After a median follow up of 6 years, results showed that adding abiraterone alone, or with enzalutamide, to standard prostate cancer treatment improved survival and decreased the chance of cancer spreading.

Metastasis-free survival was 82% (95% CI 79 to 85) in the combination-therapy cohort compared with 69% (95% CI 66 to 72) in the control group.

There was no evidence of a difference in metastasis-free survival when enzalutamide and abiraterone acetate were administered at the same time compared with abiraterone alone.

‘Convincing Evidence’

Prof Gert Attard, from the UCL Cancer Institute, who co-led the investigation, said: “This is the first time we’ve seen a treatment for this kind of prostate cancer that can do more than extend life.

“We’re seeing clear and convincing evidence that some people who would have died of prostate cancer, the third leading cause of cancer death in the UK, will no longer die from it.”

Nick James, professor of prostate and bladder cancer research at the ICRS, and chief investigator of the STAMPEDE trial, said: “The next step is for NICE to consider and implement our findings, so that men can benefit from abiraterone before their cancer has spread, drastically improving their quality of life and preventing many unnecessary deaths.”

The study was funded by Cancer Research UK, the Medical Research Council, the Swiss Group for Clinical Cancer Research, Janssen, and Astellas.

Michelle Mitchell, chief executive of Cancer Research UK, said: “These results are the latest in a long line of practice-changing findings from our STAMPEDE trial. It’s recruited over 10,000 patients and has led to 29 changes in clinical practice across the world, directly influencing the treatment of people with prostate cancer.

“It’s great to see that yet more people with prostate cancer could soon see benefit from this innovative research.”