A recent study led by researchers at UCL has found that a new combination of drugs may help slow down the progression of an advanced and potentially deadly form of prostate cancer in men with certain genetic mutations.
Published in Nature Medicine, the Phase III AMPLITUDE trial evaluated adding niraparib to abiraterone acetate and prednisone (AAP) could improve patient outcomes. The study comprised men with metastatic castration-sensitive prostate cancer that had spread to other areas of the body. Most specifically, those who were beginning first-line treatment and are carriers of mutations in genes responsible for a crucial DNA repair process called homologous recombination repair (HRR).
Under the guidance of Professor Gerhardt Attard from the UCL Cancer Institute, the randomized trial involved 696 men across 32 countries, with a median age of 68. About half of the participants were treated with the combination of niraparib and AAP, while the other half received AAP with a placebo. It was also estimated that more than half of the participants (55.6%) had mutations in the BRCA1 or BRCA2 genes.
Meanwhile, the trial conducted was termed as “double-blind”, implying that neither patients nor doctors knew which treatment was being administered. The study found that the combination significantly improved radiographic progression-free survival (rPFS), reducing the risk of progression or death by 37% compared to AAP alone in the overall group, and by 48% in patients with BRCA1/2 mutations.
In a statement made by Professor Attard, “These findings are striking because they support widespread genomic testing at diagnosis with the use of a targeted treatment for patients who stand to derive the greatest benefit.”
Although the treatment was generally well tolerated, certain side effects were more prevalent in the group receiving niraparib. Cases of anemia and high blood pressure were significantly more common with niraparib. Also, about 25% of patients in the niraparib group required blood transfusions, likely due to treatment-induced anemia.
The niraparib group also had a higher number of treatment-related deaths (14 vs. 7), though the overall rate of patients stopping treatment remained low. Despite the increased incidence of specific side effects, the drug was described as “generally well tolerated”.
The study’s authors noted that while the results seemed promising, further research is needed to confirm long-term survival benefits and to explore the impact of newer imaging techniques and broader genetic testing.
