Real-World Treatment Patterns and Clinical Outcomes Among Patients with Metastatic Castration-resistant Prostate Cancer (mCRPC): An Emerging Market Medical Record Review Study

Prostate cancer is the second most common cancer worldwide and the fifth leading cause of cancer-related mortality among men. In 2020, there were 1.4 million new cases of prostate cancer worldwide, accounting for 7.3% of all cancer cases; and 0.4 million deaths, accounting for 3.8% of all cancer-related deaths. Incidence rates (per 100,000 people) vary globally, with the highest rates being reported in Northern Europe (83.4) and Western Europe (77.6), whilst the lowest rates are reported in South Central Asia (6.3), South-East Asia (13.5), and Northern Africa (16.6). Specifically, the incidence rates (per 100,000 people) in Emerging Market (EM) (eg: India: 5.0-9.1, Taiwan: 17.2-52.9, Turkey: 42.5, Saudi Arabia: 7.0, United Arab Emirates [UAE]:13.4, Egypt: 13.9, Argentina: 42.0) were lower than developed countries.

Mortality rates due to prostate cancer, since mid-1990s, have decreased in most high-income countries, including those in North America, Oceania, and Northern and Western Europe. However, during the same period, increased mortality rates have been observed in Central and Eastern Europe, Asia, and Africa. Around 4%-15% of prostate cancer cases are already metastatic at diagnosis; and approximately 10%-50% of prostate cancer cases progress into mCRPC within 3 years of diagnosis. The long-term prognosis for mCRPC is poor, with an OS since development of castration resistance ranging from 13 to 33 months, which varies depending on individual and disease characteristics, as well as treatment.

Data on mCRPC epidemiology, disease burden, and treatment landscape is scarce across EM compared with the US and other developed markets. The lack of this data is an important barrier to formulating treatment strategies and guidelines. To bridge this gap, it is planned to capture real-world data to yield an enhanced picture of patient characteristics and treatment patterns; these data can uncover areas where current clinical needs are not being met and offer insights into how innovative therapies can enhance patient outcomes. This study therefore seeks to describe demographic and clinical characteristics, treatment patterns, clinical outcomes, and healthcare resource use (HCRU) where applicable among patients with mCRPC in EM.

By means of study we would hereby like to notify your Directorate about conduct of non-interventional study- ‘Real-World Treatment Patterns and Clinical Outcomes Among Patients with Metastatic Castration-resistant Prostate Cancer (mCRPC): An Emerging Market Medical Record Review Study’. Protocol Number C3441067, Version 1.0 Dated 15 December 2023.’