Project title

ePAD – capturing real world data about prostate cancer treatments and outcomes

Investigators

Dr Ben Tran (Principal Investigator)

Dr Arsha Anton (Sub-Investigator)

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Prostate cancer is the most common non-cutaneous cancer in Australian men, with more than 24,000 new cases identified each year and the incidence predicted to increase further due to the ageing population. It’s also the third leading cause of cancer death among men, so identifying the most effective treatment regime is a critical focus for clinicians.

Capturing treatment and outcome data to support clinical decision making

Over the past 10 to 15 years prostate cancer treatments have evolved with the introduction of new agents that are successfully improving patient outcomes. The challenge for clinicians is to sift through all the available information to make the right treatment decisions for their patients, and this is where the ePAD study assists.

ePAD (Electronic Prostate cancer Australian Database) was developed in 2016 to support clinicians by collecting real world information about patients with advanced prostate cancer.

Patients are enrolled prospectively by their clinicians when they have been diagnosed with advanced prostate cancer, and data about their subsequent treatments, responses and outcomes is tracked. The data includes information from multiple sources including medical oncologists, urologists, radiation oncologists and hospital admissions.

Real world information to cut through complexity

This enables researchers to follow the patient journey and investigate choices and durations of treatments, how patients are tolerating treatments, and how the cancer responds to the treatments – all in a real-world context.

Patients are enrolled from both public and private settings across jurisdictions around Australia including both metropolitan and regional areas. Recently, ePAD has expanded into Asia, and the ePAD team is keen to expand further to gain greater understanding of treatment patterns and outcomes within our region.

The enrolment of patients from a wide range of clinical settings makes it possible for researchers to review the outcomes from groups that are often under-represented in studies done in more formal research settings, such as patients from culturally and linguistically diverse (CALD) backgrounds, older people, or people living in regional and remote areas.

The program evaluates the impact of age, cardiovascular co-morbidity and performance status on treatment recommendations, as well as interactions with other treatments where co-morbidities exist. It maps survival outcomes and investigates the role of novel hormonal therapies in changing tumour biology.

The purpose of ePAD is to complement the data coming from clinical trials relating to prostate cancer and help clinicians investigate important research questions that may influence real-world patient management.

Dr Arsha Anton

ePAD database updated to accommodate new treatment data

Treatments for prostate cancer have changed since ePAD was established in 2016. Prostate cancer has two broad disease phases, the ‘hormone sensitive’ state when the cancer  would respond to hormone-deprivation therapies, followed by a ‘castration-resistant’ state, when those therapies are no longer effective and addition therapies are required. ePAD was originally designed to capture data and evaluate different treatments within this castration-resistant state.

Now, thanks to new studies, clinicians are finding that if patients are treated earlier with some of these newer drugs, in the hormone sensitive setting, outcomes are more favourable. Several of these treatments are now accessible in Australia and therefore ePAD has recently been updated to enable capture of this new treatment information from participating sites.

The plethora of new treatments means that these data collected and analysed by the ePAD project will provide valuable information about treatment outcomes for different types of patients that will help guide clinicians in treating current and future patients.

The ePAD database has also been updated to accommodate data from the molecular testing of tumours. This inclusion results from the recent understanding that genetic changes can occur within tumours, which can impact the behaviour of the tumour. Studies have shown that this information can be used to target these genetic changes with specific treatments, so the ePAD team are now tracking molecular testing patterns, results and the efficacy of the new treatments.

How BioGrid supports the ePAD program

BioGrid’s extensive experience building registries was an important part of the ePAD program’s decision to use BioGrid’s services. However, BioGrid also helped with management, contracts with industry (specifically by initially bringing together three partners with different needs), database development and roll out of ePAD to participating sites.

With the evolution of the scope of the ePAD program to include new prostate cancer treatments, the BioGrid team has also worked on expanding the database to include the required new fields and rolling out the updated collection application to participating sites. The BioGrid team have also managed the recent expansion of the ePAD project to Asian sites.  

BioGrid has helped with management, contracts with industry (specifically by initially bringing together three partners with different needs), database development and roll out to sites.

A/Prof Tran

ANZCTR information ID: ACTRN12616000585426