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  » Latest Medical News  »  New Drug Benefits Late-Stage Prostate Cancer Patients
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The prostate cancer drug abiraterone shows encouraging results in men who have exhausted standard treatment options, according to clinical trial results published online in the Journal of Clinical Oncology.

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.

Abiraterone was discovered at the ICR in the Cancer Research UK Centre for Cancer Therapeutics and has been licensed from BTG International Ltd to Cougar Biotechnology Inc, who funded the trial*.

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.


* 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

Abiraterone is also in an early clinical trial for women with advanced breast cancer. This Cancer Research UK trial is currently recruiting