This article was taken from: http://www.telegraph.co.uk/science/2018/02/09/two-years-extra-life-men-worst-prostate-cancer-offers-hope-10000/
By Henry Bodkin
A major international clinical trial proved that a new drug, Apalutamide, more than doubles progression-free survival for patients not responding to the standard therapy.
Published in the New England Journal of Medicine, the study offers hope to patients who currently have no options once androgen-deprivation therapy (ADT) fails.
Scientists at Massachusetts General Hospital and the University of California enrolled more than 1,200 patients across 23 countries onto the trial.
All had non-metastatic prostate cancer that had stopped responding to ADT but elevated prostate-specific antigen levels indicating they were at a high risk of the cancer spreading.
The patients either received a daily dose of Apalutamide or a placebo.
Prostate tumours are worsened by testosterone, but the new drug blocks the receptor which allows this to happen.
The participants on the drug enjoyed an average of 40.5 months’ progression-free survival before their tumours metastasised, the study reported.
By contrast, those give the placebo had an average of 16.2 months.
Taking apalutamide also reduced other signs of disease progression, including symptoms such as bone pain and death from other causes.
“This trial’s results suggest that the availability of apalutamide should offer men with nonmetastatic, castration-resistant prostate cancer a treatment that can delay or prevent the development of metastases and other complications associated with disease progression,” said Dr Eric Small, from the University of California.
ADT, either through surgical removal of the testicles or the use of drugs that suppress testosterone production, is standard treatment for men with metastatic prostate cancer and is also used for nonmetastatic cancer.
However, the therapy eventually stops working for almost all patients, leading to what is called castration-resistant disease.
“At this time, there are no approved treatments for men in that situation, so we need to wait until their disease progresses to add the standard therapies that have been approved for metastatic disease.”
The study follows the announcement last year that the drug abiraterone, when added to standard hormone therapy, could double life expectancy in patients with the most advanced form the disease and effectively cure it in many less critical patients.
The drug was declared safe by the European Medicines Agency last November, however patients in England will have to wait until autumn this year before health chiefs decide whether to provide it on the NHS.
In such patients whose cancer has not yet spread, a rapid rise in prostate-specific antigen (PSA) levels warns of the near-term development of metastases, the major cause of complications and death from prostate cancer.
“Our study found that apalutamide treatment markedly improved metastasis-free survival and other clinical outcomes in men with castration-resistant prostate cancers and no detectable metastases,” said Dr Matthew Smith, who also contributed to the research.
“At this time, there are no approved treatments for men in that situation, so we need to wait until their disease progresses to add the standard therapies that have been approved for metastatic disease.”
The study follows the announcement last year that the drug abiraterone, when added to standard hormone therapy, could double life expectancy in patients with the most advanced form the disease and effectively cure it in many less critical patients.
The drug was declared safe by the European Medicines Agency last November, however patients in England will have to wait until autumn this year before health chiefs decide whether to provide it on the NHS.