Epidemiology, Comorbidities and Associated Treatments, Therapeutic Management, and Clinical Outcomes in Patients with Prostate Cancer in Spain (SRealProstate): A Real-World Cohort Study

Background/Objectives: Prostate cancer (PC) is the most prevalent cancer in men in Spain. Clinical management depends on the stage/tumor response to therapy/therapy availability. Given the limited national data, we analyzed real-world prevalence and management patterns. Methods: This was an observational, retrospective study using electronic medical records from public primary care centers/hospitals in Spain (BIG-PAC® database), between 1 June 2014, and 31 December 2021. Adult PC-diagnosed patients were classified into localized PC with no compromised lymph nodes and no metastasis (N0/M0), locally advanced PC with compromised lymph nodes, no metastasis (N1/M0), metastatic hormone-sensitive PC (mHSPC), non-metastatic castration-resistant PC (nmCRPC), and metastatic castration-resistant PC (mCRPC, categorized by treatment line). Progression across stages was recorded. All analyses were descriptive and exploratory. Results: A total of 19,224 patients met the inclusion criteria. The five-year PC prevalence was 590 cases/100,000 males; localized PC was the most prevalent form of cancer (PC[N0/M0]: 473/100,000; PC[N1/M0]: 78/100,000), followed by mCRPC (16/100,000), mHSPC (14/100,000), and nmCRPC (8/100,000). We further analyzed 5583 patients with progression. Surgery was performed in 61.7% PC (N1/M0), while radiotherapy was used in 24.3%. Taxanes were used in 52.4% of the mHSPC patients. First prescription options for mCRPC L1 and L2 were androgen receptor pathway inhibitors (55.9% and 49.7%); 44.9% of mCRPC L3 and 83.3% of L4+ (≥4 treatment lines) patients used taxanes. Analgesics were common in mHSPC, nmCRPC, and mCRPC patients. Few mHSPC patients died without progression (11.6%); 90.2% and 56.2% of the mCRPC patients received first- and second-line treatments, respectively. During follow-up, 2436 patients died. Cardiovascular comorbidities increased with stage. Conclusions: PC management in Spain varies substantially by disease stage. Advanced disease was associated with higher comorbidity burden and reduced survival in mHSPC and mCRPC patients, despite multiple available treatments.