Heterogeneity of treatment effects in androgen receptor pathway inhibitors for metastatic hormone-sensitive prostate cancer

Prostate cancer is the second most common cancer in men worldwide, affecting more than 1.4 million people each year. In some cases, the cancer spreads beyond the prostate but still responds to treatments that lower male hormones, such as testosterone. This stage is called metastatic hormone-sensitive prostate cancer (mHSPC).

One of the main treatment options for mHSPC is a group of medicines called androgen receptor pathway inhibitors (ARPIs). These medicines block signals from male hormones that help cancer cells grow. While ARPIs have been shown to improve survival for many patients, we do not yet know whether they work equally well for all individuals, or if some patients benefit more than others.

We will carry out this research because understanding who benefits most from ARPIs can help doctors choose treatments that are better tailored to each patient. This could improve outcomes, reduce unnecessary side effects, and make better use of healthcare resources.

To do this, we will perform a type of study called an individual participant data (IPD) meta-analysis. This means we will gather and re-analyze detailed, anonymized information from people who took part in previous randomized controlled trials (RCTs) of ARPI treatments for mHSPC.

Our analysis will focus on whether the effect of ARPIs changes depending on patient characteristics such as age, overall health, or results from medical tests. Our analysis will use a method that helps us predict how the benefits of treatment vary for patients at different risk levels for poor outcomes. This approach will allow us to see if there are patterns in who responds best to ARPIs.

By the end of this study, we hope to give doctors and patients clearer guidance on which individuals are most likely to benefit from ARPI treatment. This will support more personalized cancer care and could help improve survival and quality of life for men living with mHSPC.