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Analysis of clinical characteristics in metastatic hormone-sensitive prostate cancer. A comparative study of patients from cal trials to patients from real life using Big Data

Introduction & Objectives

Androgen deprivation therapy (ADT) has been the standard of care (SOC) for patients with metastatic Hormone Sensitive Prostate Cancer (mHSPC) for decades; recently, emerging therapies associated with ADT have proven to be more effective than ADT alone. However, randomized control trials (RCTs) might underrepresent some patients’ categories. Real Word Data (RWD) may be used to identify relevant outcomes and clinical cohorts with a greater likelihood of benefiting from new therapies. We aim to describe demographics, clinical characteristics, treatment patterns and clinical outcomes of a large multicenter cohort of patients with mHSPC in RWD under the PIONEER project.

Materials & Methods

Data of patients with mHSPC across a distributed network of observational databases were collected. Male patients who developed mHSPC, without orchiectomy or ADT six months before, were enrolled in Cohort 1; while, Cohort 2 was defined as the start of ADT as a subrogated definition of mHSPC disease. Both cohorts were analysed in metachronous and synchronous disease settings.


Overall, 94,261 mHSPC patients were included; among them, 77,123 patients received treatment which means that 28% of mHSPC diagnosed were not under any treatment. More than half of the patients were over 70 years old (54%), older than the average age on the available RCTs. In cohort 2, 2,819 patients were metachronous, and 55,502 patients were synchronous. Most of the patients were treated with ADT only. After a follow-up that endured among 398 and 699 days, 22% of patients in the metachronous setting discontinued the treatment. Regarding the clinical outcomes, time to admission to hospital or emergency department, adverse events and death increase over time; whereas, noticeably events are more common in synchronous disease.

Figure 1: Treatment pattern. In RWD, ADT + ARTA is the most used combination. No triplets in our data. Will change it in the future?


This is the largest study in Europe with RWD in the mHSPC setting. Landscape of prostate cancer treatment is constantly developing, so it is important to understand the behaviour of the disease in real-world setting. Analysing our results, patients in RWD are older, with more comorbidities and 1/3 of them do not undergo a SCO treatment when compared to RCT.