An investigational drug aimed at treating patients with advanced prostate cancer was found to be so successful at extending survival times during a Phase III trial that it was unblinded, meaning that those on a placebo were offered the option of receiving abiraterone acetate, researchers from the Institute of Cancer Research and the Royal Marsden NHS Foundation Trust announced at the European Society for Medical Oncology Congress in Milan, Italy.
The scientists, from the Institute of Cancer Research, which discovered (abiraterone acetate), say the drug is aimed at patients with aggressive prostate cancer, which is currently the cause of over 10,000 male premature deaths in the UK annually.
Head researcher, Dr. Johann de Bono said that the trial results may alter the way clinicians treat patients with advanced prostate cancer who had already been treated with other available therapies, including docetaxel-based chemotherapy.
Dr de Bono said:
This is extremely exciting because men with this aggressive type of prostate cancer currently have very few treatment options and a poor prognosis. Around one man in the UK dies every hour from this disease, so the news that abiraterone acetate may extend survival with manageable side-effects will be incredibly important to men with prostate cancer and their families.
The clinical trial involved 1,195 men with advanced prostate cancer. They had all received other available therapies, including chemotherapy (docetaxel-based). 797 of them received abiraterone acetate + prednisone (a steroid), while 398 received prednisone + a placebo.
Those on the abiraterone acetate plus the steroid prednisone group had an overall survival of 14.8 months, versus 10.9 months in the placebo group.
The patients in the abiraterone acetate plus the steroid prednisone group were also found to have a considerably great chance of experiencing a reduction in the PSA (prostate specific antigen) levels, which are generally good indicators of cancer activity and severity. Imaging scans showed that those in the abiraterone acetate plus the steroid prednisone group had longer periods without tumor growth, compared to the other group, as well as significantly longer periods before PSA levels started going up again.
The majority of patients on abiraterone acetate did not (generally) experience some of the adverse events (undesirable side effects) linked to chemotherapy. The abiraterone acetate group had more minerlocorticoid-related side effects compared to those in the placebo group – however, clinicians said they were usually “amenable to medical management.”
In a communiqué, the Institute of Cancer Research (ICR) informs that:
Abiraterone acetate is an investigational compound discovered by Professor Mike Jarman and his colleagues in what is now the Cancer Research UK Cancer Therapeutics Unit at the ICR, and is licensed from BTG International LTD to Janssen Pharmaceutical Companies.
The male hormone testosterone encourages and accelerates the growth of prostate cancer. In advanced prostate cancer the tumor can produce its own supply. Abiraterone acetate can stop an enzyme which is involved in the production of testosterone from working.
The clinical trial’s Independent Data Monitoring Committee felt that the study should be unblinded so that those on a placebo could opt to receive abiraterone acetate. The Institute of Cancer Research Chief Executive Professor Peter Rigby said:
We are very proud that a drug discovered at The Institute of Cancer Research may give men with advanced prostate cancer a new treatment option for managing their condition and improving survival.
According to the Institute of Cancer Research, lung cancer is no longer the most common cancer in men in the UK, it is now prostate cancer. Over 35,000 men are diagnosed with prostate cancer annually in the UK, and one patient dies each hour of the disease. When the cancer has spread outside the prostate region it is considered advanced.
Source: Institute of Cancer Research
Written by Christian Nordqvist