A Phase II study led by The Institute of Cancer Research (ICR) and the Royal Marsden NHS Foundation Trust found that about half the prostate cancer patients given the drug experienced a substantial reduction in levels of prostate specific antigen (PSA) in their blood, the standard measure of prostate cancer activity.
The 47 men enrolled in the trial all had late-stage castration-resistant prostate cancer, which is the second-most common cause of cancer-related death among men in the developed world. Almost all the men exhibited evidence that the cancer had spread to their bones.
They had all already received hormone therapy and docetaxel, the only currently approved chemotherapy drug that has shown benefit among late-stage patients.
“Docetaxel is an important drug but it extends life for an average of just two to three months, so there is a desperate need to improve treatment options for late-stage prostate cancer patients,” Chief Investigator Dr Johann de Bono, from the ICR and The Royal Marsden, says. “In this trial, abiraterone shrank or stabilised men’s cancers for an average of almost six months, which is a very impressive result.”
About three-quarters of men experienced a drop in PSA levels, including a fall of at least 50 per cent for around half of the men on the trial. Three-quarters of men had a drop in the number of circulating tumour cells, another measurement linked to increased survival rates, and many patients noticed the symptoms of cancer had lessened.
Five of the 47 patients are still taking the drug and benefiting from treatment three years after the trial started.
“Side-effects from abiraterone were generally mild and easily treated,” Lead researcher Dr Alison Reid, from the ICR and The Royal Marsden, says. “This is the first time the drug has been tested in prostate cancer patients with such advanced disease, who have already tried all the other effective treatments available to them.”
The UK arm of the trial was held at The Royal Marsden, with infrastructure funding from the Experimental Cancer Medicine Centre (ECMC). In the US, the men were treated at the Memorial Sloan-Kettering Cancer Center and the University of California (San Francisco) Comprehensive Cancer Center.
The results in this study led to the decision to take this drug forward into large-scale clinical trials. A Phase III trial in patients who have already received chemotherapy has finished recruiting. Abiraterone, which is taken once a day as four pills, has also demonstrated encouraging results in Phase II trials in men with advanced prostate cancer who have not received chemotherapy. A Phase III trial in these pre-chemotherapy patients is currently recruiting in 12 countries including the US and UK.
Media Contact: ICR Science Press Officer Jane Bunce or 0207 152 5106 or after hours 077217 47900
Notes to editors:
* Cougar Biotechnology, Inc. (now owned by Johnson & Johnson) was the major funder of the trial, along with Cancer Research UK, the ECMC network which is jointly funded by Cancer Research UK and the Department of Health, the Medical Research Council, the Royal Marsden Hospital Research Fund, the Prostate Cancer Foundation, the National Cancer Research Institute Prostate Cancer Collaborative and the NHS.
- Significant and Sustained Anti-Tumour Activity in Post-Docetaxel, Castration-Resistant Prostate Cancer With the CYP17 Inhibitor Abiraterone Acetate will be published online in the Journal of Clinical Oncology on 16 February 2010
- Selective Inhibition of CYP17 with Abiraterone Acetate is Highly Active in the Treatment of Castration-Resistant Prostate Cancer was published online in the Journal of Clinical Oncology on 26 May 2009
- Phase I Clinical Trial of a Selective Inhibitor of CYP17, Abiraterone Acetate, Confirms That Castration-Resistant Prostate Cancer Commonly Remains Hormone Driven was published online in the Journal of Clinical Oncology on 22 July 2008
Information about eligibility and locations for the Phase III pre-chemotherapy abiraterone trial can be found at www.clinicaltrials.gov or by calling the dedicated abiraterone patient enquiries line at The Royal Marsden on 0800 021 7297. The Phase III trial in men who have already received chemotherapy is closed.
Abiraterone is also in an early clinical trial for women with advanced breast cancer. This Cancer Research UK trial is currently recruiting patients. For information about these and other clinical trials please visit CancerHelp UK (www.cancerhelp.org.uk) or call the Cancer Research UK specialist information nurses on 0808 800 4040. Lines are open Monday to Friday, between 9am and 5pm.
The Institute of Cancer Research (ICR)
- The ICR is Europe’s leading cancer research centre
- The ICR has been ranked the UK’s top academic research centre, based on the results of the Higher Education Funding Council’s Research Assessment Exercise
- The ICR works closely with partner The Royal Marsden NHS Foundation Trust to ensure patients immediately benefit from new research. Together the two organisations form the largest comprehensive cancer centre in Europe
- The ICR has charitable status and relies on voluntary income, spending 95 pence in every pound of total income directly on research
- As a college of the University of London, the ICR also provides postgraduate higher education of international distinction
- Over its 100-year history, the ICR’s achievements include identifying the potential link between smoking and lung cancer which was subsequently confirmed, discovering that DNA damage is the basic cause of cancer and isolating more cancer-related genes than any other organisation in the world.
For more information visit www.icr.ac.uk
The Royal Marsden NHS Foundation Trust
- The Royal Marsden opened its doors in 1851 as the world’s first hospital dedicated to cancer treatment, research and education. The hospital is based in Chelsea, London and Sutton, Surrey
- Today, together with its academic partner, The Institute of Cancer Research, it is the largest and most comprehensive cancer centre in Europe treating over 40,000 patients every year. It is a centre of excellence, and the only NHS Trust to achieve the highest possible ranking in the Healthcare Commission’s Annual Health Check for the third year in a row
- Since 2004, the hospital’s charity, The Royal Marsden Cancer Campaign, has helped raise over £43 million to build theatres, diagnostic centres, and drug development units
- Prince William became President of The Royal Marsden in 2007, following a long royal connection with the hospital
- For more information visit www.royalmarsden.nhs.uk
The Experimental Cancer Medicine Centre (ECMC) network
Cancer Research UK and the Departments of Health in England, Scotland, Wales and Northern Ireland launched a network of 19 Experimental Cancer Medicine Centres (ECMC) across the UK in April 2007, in a £35 million, five-year investment. Each ECMC brings together lab-based experts in cancer biology with cancer doctors to speed up the flow of ideas from the lab bench to the patient’s bedside. Find out more at www.ecmcnetwork.org.uk
Cancer Research UK
- Cancer Research UK is the world’s leading charity dedicated to beating cancer through research
- The charity’s groundbreaking work into the prevention, diagnosis and treatment of cancer has helped save millions of lives. This work is funded entirely by the public.
- Cancer Research UK has been at the heart of the progress that has already seen survival rates double in the last thirty years
- Cancer Research UK supports research into all aspects of cancer through the work of more than 4,800 scientists, doctors and nurses
- Together with its partners and supporters, Cancer Research UK’s vision is to beat cancer
For further information about Cancer Research UK’s work or to find out how to support the charity, please visit www.cancerresearchuk.org