A patient at The Christie NHS Foundation Trust in Manchester, who was one of the first people to be recruited to the world’s largest clinical trial for prostate cancer over a decade ago, is still enjoying good health thanks to a new hormone tablet he takes every day.
The culmination of more than a decade of research by scientists and oncologists in Manchester in collaboration with colleagues in London, and the wider UK, has found that adding abiraterone, a new type of hormone therapy, to the standard treatment for locally advanced prostate cancer, where the cancer has a high chance of spreading*, could halve the risk of death from the disease for patients like Jim Thornhill from Sale in Greater Manchester. Following the publication of the findings, this treatment option has now become an international standard of care, widely used in the United States, India and parts of Europe.
In 2011 Jim, 81, a retired engineer, discovered he may have a problem with his prostate because he was unable to pass urine while he was on a cruise with his wife Anne. He went straight to his GP on his return home. A biopsy showed he had stage 4 (the most advanced stage) prostate cancer and it had spread to the lymph nodes and wasn’t curable.
With radiotherapy not possible due to the spread of the disease, and with few options available to him, Jim was offered the opportunity to be part of research in a clinical trial at The Christie. In December 2011, he became one of the first patients to sign up to the STAMPEDE at the National Institute for Health and Care Research (NIHR) Manchester Clinical Research Facility (CRF) at The Christie.
The trial was designed specifically for men with an aggressive form of prostate cancer where the cancer hasn’t yet spread.
At the time of diagnosis Jim’s PSA (the protein produced in the prostate) was dangerously high at 89 (normal levels are between 2.5 and 4.0). After just 6 months on the clinical trial, Jim’s PSA level had dropped dramatically so it was undetectable. For the past 11 years, Jim has been given a hormone injection every 12 weeks and takes abiraterone daily as a tablet along with a steroid.
The urological research team found that only 7% of patients died after receiving the new combination treatment for a period of 2 years, while 15% of patients died from prostate cancer while receiving the currently recommended treatment. The findings of the research concluded that this new drug combination would dramatically improve these patients’ quality of life and could prevent many unnecessary deaths.
Jim Thornhill, who is married to Anne, and has 2 grown-up sons and 4 grandsons said: “I feel very lucky. When I discovered the cancer, it had spread into the lymph nodes and gone beyond normal treatment. The only option was hormone therapy. I was told about the STAMPEDE clinical trial that fortunately had just started and I was willing to give it a go. I’ve enjoyed 11 years of good health thanks to the clinical trial and seen my grandsons grow up.
“I actually like going to The Christie as I’ve known the team for over a decade and we’re like old friends. I think they’re wonderful. They don’t rush you and you feel confident they know what they’re doing. It’s never frightened me to go. Anne and I are looking forward to celebrating our 60th wedding anniversary next March. We’ve always looked at the positives right from day one and have been determined to carry on with our lives.”
The STAMPEDE trial is based at the MRC Clinical Trials Unit at University College London (UCL) and is led by teams at UCL, The Institute of Cancer Research, London, and The Christie in Manchester, and involves over 130 urology/oncology departments across the UK, including the patients that they treat daily. This part of the study followed patients over a 6-year period. The study, which has been running in its broader form since 2005, is funded by Cancer Research UK and the Medical Research Council (MRC) **.
Professor Noel Clarke, urological surgeon and professor of urological oncology at The Christie NHS Foundation Trust in Manchester, said; “Jim’s cancer isn’t curable, but this new treatment combination has extended his life and enabled him to continue to live his life symptom-free. We have very strong evidence that using abiraterone alongside the current standard treatments reduces prostate cancer deaths significantly in men with high-risk disease which has not yet spread beyond the prostate. Use of this combination therapy could improve outcomes for thousands of men every year.”
Professor Noel Clarke, who is the UK’s co-principal investigator for the STAMPEDE study added: “STAMPEDE is the only major high volume prostate intervention trial in the world in this type of prostate cancer and this research is a game changer for men with high-risk disease, that hasn’t spread to other parts of the body. Up to 60% of prostate cancer deaths occur in men who present with this condition and the use of this drug combination would make a major difference to the chance of long-term survival following treatment in this patient population.”
The current standard treatment for this group of patients is a hormone therapy called ADT (androgen deprivation therapy) with radiotherapy to the prostate gland.
Michelle Mitchell, Chief Executive of Cancer Research UK, said: “Our STAMPEDE trial has 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. We hope more people like Jim could soon benefit from this innovative research, by being offered abiraterone before their cancer has spread.”
Around 1 in 8 men get prostate cancer. Up to 52,000 people are diagnosed with prostate cancer every year in the UK, and around 22,000 patients are considered at “high-risk” of their cancer spreading. One third of those diagnosed have the aggressive form of the disease which is ‘localised’ meaning that it hasn’t spread to other parts of the body.
Abiraterone, which is taken in tablet form, is currently being used for patients with advanced prostate cancer which has spread to other parts of the body. It’s also given to people who have stopped responding to standard hormone treatment. It works by stopping the production of testosterone, which helps keep the disease under control, and is always given in combination with the steroid drug, prednisolone.
A total of 1,974 patients were enrolled across two arms of the trial with 988 given the current standard treatment and 986 patients given the standard treatment combined with abiraterone. These patients had nonmetastatic disease with or without spread to lymph nodes (locally advanced disease) and were enrolled at 113 UK and Swiss sites.
Professor Nick James is chief investigator of the STAMPEDE trial and Professor of Prostate and Bladder Cancer Research at The Institute of Cancer Research, London, where abiraterone was discovered.
* Patients with locally advanced prostate where the cancer has broken through the capsule (covering) of the prostate gland. It may have spread into tissue around the prostate; the tubes that carry semen (seminal vesicles); body organs nearby such as the back passage (rectum) or neck of the bladder; or lymph nodes close to the prostate gland.
** Funding was also provided by Janssen and Astellas.