A real-world evidence (RWE) focused study of a prostate cancer population, including those who had a poor prognosis or were difficult-to-treat patients, usually excluded from clinical trials, is part of data presented at this year’s American Society of Clinical Oncology Genitourinary Cancers Symposium.

The data shows radiographic progression-free survival (rPFS) of 16.5 months (95% CI, 13.5–20.0) and treatment duration of 11.6 months (95% CI, 10.2–12.8) in men treated with abiraterone acetate plus prednisone (AAP), in the real-world, outside the clinical trial setting.

Prostate cancer is the most commonly diagnosed cancer in men, with over 400,000 new cases diagnosed in Europe each year.

Latest prostate cancer figures show that there are currently three million men living with the disease in Europe.

The study assessed men being treated for asymptomatic and mildly symptomatic metastatic castration-resistant prostate cancer (mCRPC), following androgen deprivation therapy (ADT).

Patients in the pivotal COU–AA–302 trial reached a median duration of treatment of 13.8 months (IQR, 8.3–27.4) and a median rPFS of 16.5 months (95% CI, 13.8–16.8).

Results were similar across both settings, despite almost 10% of patients in the RWE study having visceral metastases (metastases to internal organs i.e. the liver and/or lungs) and/or an Eastern Cooperative Oncology Group (ECOG) performance status of 2-3 (those unable to carry out work, but still capable or partially capable of self-care).1 These patients were not included in the COU-AA-302 study.4

Further to this, additional findings from The Prostate Cancer Registry, Europe’s first and largest prospective RWE study in mCRPC are being presented at ASCO GU.

“Real-world evidence research is key in patient-focused clinical practice, as it helps physicians to better address patient needs. It complements data obtained from clinical trials to provide greater understanding of treatment outcomes, disease management and impact on quality of life in broad patient populations, including those with comorbidities,” said Dr Martin Boegemann, Department of Urology, Muenster University Medical Center, Muenster, Germany. 

"It is helpful to see new data for treatment outcomes in real world patients confirm those seen in a clinical trial setting. These new findings add to the growing bank of real-world evidence available across Europe, which is becoming more and more important in helping us choose the best treatments to transform patient outcomes."

Source: ASCO GU