BACKGROUND: Despite standard-of-care androgen-deprivation therapy and an increasing number of treatment options, the mortality rate for prostate cancer remains high. Progress to metastatic castration-resistant prostate cancer (mCRPC) necessitates additional treatments. Abiraterone acetate plus prednisone or prednisolone (AAP) prolongs survival in chemotherapy-naive and docetaxel-experienced patients. OBJECTIVE: To evaluate the real-world safety and efficacy of AAP as first-line and second-line [post-docetaxel only (AAP-PD)] treatment in patients with mCRPC. PATIENTS AND METHODS: The Prostate Cancer Registry (PCR) was a prospective, international, observational study of patients with mCRPC in routine clinical practice. Men aged ≥ 18 years with confirmed mCRPC were included. Baseline characteristics, safety (treatment-emergent adverse events, treatment-emergent severe adverse events), and efficacy [progression-free survival (PFS) and overall survival (OS)] were analyzed. RESULTS: At baseline, patients who received first-line AAP (n = 754) were generally older than patients who received AAP-PD (n = 354); median age was 76 years and 70 years, respectively. However, the rate of visceral metastasis was higher in the AAP-PD cohort than in the AAP cohort (17.7% vs. 9.6%, respectively). Demographics and disease characteristics of patients with baseline cardiovascular disease were similar to those of the overall registry population. Efficacy outcomes were similar for all patients, regardless of the line of AAP therapy. For first-line AAP and AAP-PD, respectively, the median PFS was 8.9 and 5.8 months for all patients and 9.1 and 6.0 months for patients with cardiovascular comorbidities; median OS was 27.1 and 23.4 months for all patients, and 27.4 and 23.1 months for patients with cardiovascular comorbidities. There were no unexpected adverse events in any patient subgroup. CONCLUSIONS: These real-world data complement the findings from randomized controlled trials, indicating that first- and second-line AAP is well tolerated and effective in patients with mCRPC, including those with underlying CV comorbidities. TRIAL REGISTRATION NUMBER: NCT02236637, registered 8 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 Barcelona Spain

Department of Translational Medicine Medical Faculty Lund University Malmö Sweden

Department of Urology Ghent University Hospital Ghent Belgium

Department of Urology Medical University of Vienna Vienna Austria

Department of Urology Skåne University Hospital Malmö Jan Waldenströms gata 5 SE 205 02 Malmö Sweden

EMEA Oncology Janssen Pharmaceutica N 5 Beerse Belgium

Guy's and St Thomas' NHS Foundation Trust and Sarah Cannon Research Institute London UK

Janssen Cilag B 5 Breda The Netherlands

N N Blokhin National Cancer Research Center Moscow Russia

Oncology Division Faculdade de Medicina Hospital de Santa Maria Instituto de Medicina Molecular Universidade de Lisboa 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

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