Phase 3 Clinical Trial Confirms Abiraterone Acetate Effectiveness in Metastatic Prostate Cancer
The newest results coming from a phase 3 clinical trial show that the drug marketed as Zytiga (abiraterone acetate) has beneficial effects on the survival rate of patients with metastatic prostate cancer. The study was published in the journal Lancet Oncology and the clinical trial behind the study had investigated patients with castration-resistant prostate cancer.
The action mechanism of the drug involves the blocking of an enzyme that has a role in the production of testosterone. This hormone is responsible for the proliferation of cancerous cells, thus through its action, the drug can reduce or even stop the growth of the prostate tumor.
This is the first phase 3 clinical trial that is able to show that abiraterone increases the survival rate of prostate cancer patients. The trial involved almost 1200 patients from 13 different countries. Participants were divided into two groups. The first group received abiraterone and prednisone whilst the second group received placebo and prednisone.
Prior to being selected to take part in this trial, all patients underwent at least one round of chemotherapy with Docetaxel. This chemotherapy round showed little to no effect in the stopping of cancer progression. The research team observed that the group that received abiraterone acetate had an average survival time of almost 16 months, compared to a survival time of 11 months in the placebo group.
Patients that had metastatic prostate cancer have a survival time of less than two years, even after undergoing chemotherapy. Therefore, the increased survival time that is obtained through the use of abiraterone acetate is considered to be a real improvement for patients that continue to experience the growth of the tumor after the treatment with Docetaxel is stopped. Furthermore, the clinical trial has revealed that abiraterone acetate has a good safety profile. All the adverse side effects caused by the use of abiraterone were reversible.
“Our work confirms that abiraterone acetate can be used as an effective and safe treatment for castration-resistant metastatic prostate cancer patients whose disease continues to progress after docetaxel treatment”, said Dr Karim Fizazi from the Gustave Roussy Institute, in France. Dr Fizazi is one of the lead authors of the study. The director of the Urologic Medical Oncology from the University of Alabama, USA, Dr Guru Sonpavde, said that this study represents a major advancement in the treatment of metastatic prostate cancer and castration-resistant prostate cancer. Dr Sonpavde added that further clinical trials are needed in order to improve the survival time of prostate cancer patients.