A real-world registry of patients with metastatic castration-resistant prostate cancer (mCRPC): REMPRO study.

Abstract

TPS286 Background: Rapidly expanding treatment armamentarium for mCRPC calls for an appropriate patient and treatment selection, and sequencing with existing agents. Data describing mCRPC management are fragmented across Africa, Asia Pacific, Latin America, and the Middle East with marked cross-country differences in treatment practices and patient outcomes. To address these gaps, we have established an mCRPC registry (REMPRO) that aims to describe the real-life treatment patterns and their associated survival outcomes in patients with mCRPC in non-US and non-European region. The results of this study may serve as baseline data for the policy makers in devising access programs for novel therapies in this region. Methods: REMPRO is an ongoing multinational, multicenter, retrospective, non-interventional real-world cohort study in adults diagnosed with histologically or radiologically confirmed mCRPC between 01 January 2016 and 31 December 2018 who have progressed on androgen deprivation therapy alone and received at least one line of treatment in routine clinical care, with at least 12 months of available records. After obtaining informed consent, clinical information from medical records (from index date [mCRPC diagnosis] to end of follow-up [until death, last record entry or date of data extraction]) is captured into electronic system. Data collection includes demographics, clinico-pathological characteristics, disease status, treatments received, outcomes, laboratory results, comorbidities, and healthcare resource utilization. Primary outcome analysis will describe real-world treatment patterns (monotherapy or as combinations) for overall cohort, each country, and in pre-defined subgroups like castration sensitivity, ECOG performance, AJCC staging, Gleason grade and/or score, site of metastases, and genetic alterations ( BRCA1/BRCA2 and/or HRRm). Secondary outcome analysis will include overall and real-world progression-free survival associated with different treatment regimens using Kaplan–Meier method. Of the planned sample size of 991 patients, a total of 760 patients with mCRPC have been enrolled until 26 August 2022 from 34 oncology centers across 8 countries (Colombia: 51, Egypt: 83, India: 200, Peru: 32, Saudi Arabia: 16, South Korea: 300, Turkey: 53, UAE: 25). Analysis of the dataset for primary and secondary endpoints have not been performed. Clinical trial information: NCT04801186 .