A new international study led by researchers at University College London (UCL) has found that a new drug combination could help slow down a dangerous type of prostate cancer in men who carry certain gene mutations.
The results come from a major clinical trial called the Phase III AMPLITUDE trial, which was published in the journal Nature Medicine.
The study tested whether adding a drug called niraparib to the current standard treatment—abiraterone acetate and prednisone (known together as AAP)—could help men with advanced prostate cancer. These men had cancers that had already spread to other parts of the body and also had mutations in a group of genes responsible for fixing damaged DNA.
These genes, known as homologous recombination repair (HRR) genes, include BRCA1, BRCA2, CHEK2, and PALB2. About one in four men with this kind of prostate cancer have changes in these genes, which can make the cancer grow faster and become harder to treat.
The trial involved 696 men from 32 countries. Their average age was 68. Half of them were given the new drug combination (niraparib plus AAP), and the other half got the standard treatment with a placebo. Importantly, over half of the participants had mutations in either BRCA1 or BRCA2 genes.
After following the patients for just over two and a half years, researchers found that adding niraparib helped in important ways. It reduced the chance of the cancer getting worse by 37% overall, and by 48% in men with BRCA1 or BRCA2 mutations.
Patients who took niraparib also had fewer worsening symptoms. Only 16% of them saw symptoms get worse, compared to 34% in the group who did not take niraparib.
While there was a trend toward longer survival in the niraparib group, more time is needed to confirm whether this treatment actually helps men live longer.
Professor Gerhardt Attard, who led the study, said that while current treatments work well for many men, those with HRR gene mutations often have cancers that return quickly and act more aggressively. He believes that this new combination could give these patients more time before the cancer comes back and could potentially extend their lives.
Professor Attard also stressed the importance of genetic testing at the time of diagnosis. By identifying which patients have these specific gene changes, doctors can offer targeted treatments like niraparib to those who are most likely to benefit.
However, the new treatment does come with some risks. Men who took niraparib experienced more side effects than those who did not.
These included anemia (low red blood cell count), high blood pressure, and a greater need for blood transfusions. There were also more treatment-related deaths in the niraparib group (14 versus 7), though few patients had to stop treatment because of side effects.
The researchers say that although the findings are very hopeful, more studies are needed to fully understand the long-term effects and to explore how new imaging tools and genetic tests might help further.
Each year, around 1.5 million men worldwide are diagnosed with prostate cancer. In the UK alone, it is the most common cancer among men, with over 56,000 new cases annually. Sadly, around 12,000 men die from the disease in the UK every year.
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The study is published in Nature Medicine.
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