Prostate Cancer Real World Evidence Registry (PROCARE): Recurrent and Metastatic Prostate Cancer.

TPS274 Background: Prostate cancer remains the most common malignancy among men and the fifth leading cause of cancer-related mortality globally. Over the past 15 years, advances in imaging techniques and therapeutic options have significantly transformed the management of recurrent, advanced, and metastatic prostate cancer. However, treatment efficacy and toxicity are highly influenced by prior therapy sequences, highlighting the need for a deeper understanding of the optimal treatment sequence. The prospective real-world evidence registry, PROCARE, addresses this gap by documenting treatment patterns, imaging exams, oncologic outcomes, and safety profiles in routine clinical practice. Methods: This study focuses on four distinct patient cohorts: biochemical recurrence after local treatment with curative intent (e.g. radical prostatectomy, radiotherapy of the prostate or combination thereof), non-metastatic castration-resistant prostate cancer (nmCRPC), metastatic hormone-sensitive prostate cancer (mHSPC), and metastatic castration-resistant prostate cancer (mCRPC). PROCARE is a comprehensive long-term follow-up registry designed to document treatment patterns and outcomes in patients receiving systemic treatment. The study aims to enroll 5,000 patients across 50 sites in Germany. Recruitment is being conducted independently for each cohort, beginning with the mHSPC and mCRPC cohorts. First patient in was in January 2024. Patients will remain in the registry from the time of enrollment until death, withdrawal of consent, or study cohort closure. Throughout the study, additional blood samples will be collected at baseline and with each treatment change, respectively, and at first routine follow-up visit thereafter for exploratory research purposes, such as assessing circulating tumor DNA and RNA, as well as genome-wide single nucleotide polymorphisms (SNPs). This approach will enable a deeper understanding of treatment distribution, sequencing, efficacy, and safety in the real-world setting, contributing valuable insights into the evolving therapeutic landscape. Furthermore, analyses from liquid biopsies might provide important insights potentially guiding future therapeutic strategies for recurrent and metastatic prostate cancer. Clinical trial information: DRKS00033411 .