Dive Brief:
- Zytiga (abiretone) combined with prednisone significantly reduced PSA levels in men with non-metastatic castration-resistant prostate cancer (CRPC) after six months of treatment in the study.
- Zytiga is currently indicated for the treatment of metastatic castration-resistant prostate cancer.
- The goal is to reduce the risk of progression in men with non-metastatic disease that is also castration resistant.
Dive Insight:
Zytiga was approved in the US in 2011 and the EU in 2012 for the treatment of metastatic CRPC. In these men, Zytiga extends life by approximately five months. It also delays the onset of severe pain and the need for opiates. But is it possible to use Zytiga to prevent men with non-metastatic CRPC from developing progressive disease. Researchers at Janssen/JNJ think that it may delay progression. In a phase II trial, Zytiga significantly reduced prostate-specific antigen (PSA) levels in men with non-metastatic CRPC. That's important because PSA is a strong predictor of disease progression.
As recently as 2011, researchers decried the dearth of treatment options for men with CRPC. They noted that once hormonal therapy (androgen deprivation therapy, ADT) stops working, it can be difficult to prevent disease progression. In their analysis, which was published in the International Journal of Clinical Study, they found that 10% to 20% of men with prostate cancer that initially responds to hormonal treatment will develop CRPC within five years. Among this group, 33% will have bone metastases within two years. Median survival rates for men with CRPC range from 9 to 30 months.
Could Zytiga prevent disease progression in men with non-metastatic CRPC? Janssen is currently recruiting for Phase III trial to evaluate this question further.