BACKGROUND: Metastatic prostate cancer has a 30% 5-year survival rate despite recent therapeutic advances. There is a need to improve the clinical understanding and treatment of this disease, particularly in the real-world setting and among patients who are under-represented in clinical trials. OBJECTIVE: We aimed to evaluate the characteristics and clinical outcomes of patients who received their first treatment for metastatic castration-resistant prostate cancer (mCRPC) in routine clinical practice, independent of treatment used, including subgroups with baseline cardiac disease, diabetes mellitus, or visceral metastases. PATIENTS AND METHODS: Prospective, noninterventional analysis of patient record data in the multicenter Prostate Cancer Registry (PCR) of men with mCRPC. The data were collected in 16 countries with the aim of recruiting more than 3000 patients between 2013 and 2016. The study end date was 9 July 2018. Data evaluated included baseline characteristics, treatment exposure, and efficacy outcomes [overall survival (OS) and time to progression (TTP)] of patients treated with abiraterone acetate plus prednisone or prednisolone (collectively, "abiraterone"), enzalutamide, or docetaxel. Descriptive outcomes are reported from the overall patient population and subgroups of patients with baseline cardiovascular disease, diabetes mellitus, or visceral metastases. The treatment effects for time to progression were compared for the overall patient population. RESULTS: The study enrollment period lasted 2.5 years, and each patient was followed for a maximum of 3 years. A total of 1874 patients in the PCR had not received previous mCRPC treatment at baseline, although they had received androgen-deprivation therapy. Prevalent co-morbidities included cardiovascular disease in 65.4% and diabetes mellitus in 17.4% of patients. Baseline characteristics suggested that patients with more advanced disease received docetaxel treatment. In the overall patient population, the median time to progression with abiraterone, enzalutamide, and docetaxel as first-line mCRPC therapy was 9.6, 10.3, and 7.6 months, respectively, and median OS was 27.1, 27.1, and 27.9 months, respectively. Outcomes in the subgroups of patients with cardiovascular disease or diabetes mellitus were similar to those of the whole population in the analysis. As expected, patients with visceral metastases had shorter TTP and OS than patients in the overall population. CONCLUSIONS: This analysis shows, for the first time, the effectiveness in parallel of first-line abiraterone, enzalutamide, and docetaxel in mCRPC, including in patients with co-morbidities such as cardiovascular disease or diabetes mellitus or in patients with visceral metastases. These real-world findings from the PCR provide meaningful information to help manage mCRPC, particularly in patients under-represented in clinical studies. TRIAL REGISTRATION: ClinicalTrials.gov identifier NCT02236637; registered September 2014.

Centre d'Oncologie de Gentilly Nancy France

Clinic of Oncology Polish Mother's Memorial Hospital Research Institute Lodz Poland

Department of Medical Oncology Hospital de la Santa Creu i Sant Pau Autonomous University of Barcelona 08025 Barcelona Spain

Department of Urology Ghent University Hospital C Heymanslaan 10 9000 Ghent Belgium

Department of Urology Medical University of Vienna Vienna Austria

Department of Urology Skåne University Hospital Malmö Malmö Sweden

EMEA Oncology Janssen Pharmaceutica N 5 Beerse Belgium

Guy's and St Thomas' NHS Foundation Trust and Sarah Cannon Research Institute Westminster Bridge Rd Lambeth London SE1 7EH UK

Janssen Cilag B 5 Breda the Netherlands

N N Blokhin National Cancer Research Center Moscow Russia

Oncology Division Hospital de Santa Maria Instituto de Medicina Molecular Faculdade de Medicina Universidade de Lisboa 1649 035 Lisbon Portugal

Parexel International Czech Republic s r o on behalf of Janssen Pharmaceutica N 5 Beerse Belgium

Royal Preston Hospital Preston UK

Studienpraxis Urologie Nürtingen Germany

Urologie Team Ulm Ulm Germany

Urology Department and Kidney Transplant Unit Translational Research Group of Urology GITUR IBSAL Salamanca University Hospital Salamanca Spain

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Real-world Treatment Sequencing in Patients with Metastatic Castration-resistant Prostate Cancer: Results from the Prospective, International, Observational Prostate Cancer Registry

Real-World Safety and Efficacy Outcomes with Abiraterone Acetate Plus Prednisone or Prednisolone as the First- or Second-Line Treatment for Metastatic Castration-Resistant Prostate Cancer: Data from the Prostate Cancer Registry

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ClinicalTrials.gov
NCT02236637