Urology, Uro-oncology and Sexology Update

7 5 alone. Notably, the risk of developing castration resistance was signicantly reduced ® in patients starting with ERLEADA + ADT compared to ADT alone (adjusted hazard ratio 5 [aHR] 0.36, 95% CI 0.19-0.67; p=0.0016). Moreover, overall survival was longer in ® patients treated with ERLEADA + ADT compared to those receiving enzalutamide + ADT (aHR 0.48, 95% CI 0.23-0.99; p<0.05) or abiraterone acetate/prednisone + ADT (aHR 5 0.43, 95% CI 0.21-0.90; p<0.05). The OASIS study highlights the importance of ® starting treatment with ERLEADA + ADT in patients with mHSPC to maximise clinical 5 outcomes. ROME study insights Complementing the OASIS study, the ROME study provided additional RWE supporting the ® 6 use of ERLEADA over enzalutamide. This study focused on survival outcomes among men with mHSPC who initiated treatment with either ® 6 ERLEADA or enzalutamide. The ROME study utilised data from the Flatiron Metastatic Prostate Cancer Core Registry over a period of 6 10 years. The study reported that by 24 months post-initiation, a signicantly higher proportion ® of patients treated with ERLEADA survived compared to those treated with enzalutamide 6 (85.4% vs. 73.9%; p=0.030). This survival benet ® highlights ERLEADA 's efcacy in a real-world setting, supporting its use as a rst choice ARPI 6,7 in mHSPC. Conclusion The convergence of clinical trial data and ® real-world evidence underscores ERLEADA 's 3,5,6 efcacy in treating mHSPC. The TITAN trial, alongside real-world studies like OASIS and ® ROME, has established ERLEADA as a valuable addition to the treatment strategy for 3,5,6,7 mHSPC. With its demonstrated ability to extend survival, delay disease progression, and ® offer a manageable safety prole, ERLEADA stands out as a valuable tool in the oncologist's 3 armamentarium. References: 1. Hoy SM. Apalutamide: A Review in Metastatic Castration-Sensitive Prostate Cancer. Drugs 2020;80:1579-1585. DOI: https://doi.org/10.1007/s40265-020-01401-0. 2. ERLEADA® professional information, March 2023. 3. Chi KN, Agarwal N, Bjartell A, et al. Apalutamide for Metastatic, Castration-Sensitive Prostate Cancer. N Engl J Med 2019;381:13-24. DOI: 10.1056/NEJMoa1903307. 4. Dang A. Real-World Evidence: A Primer. Pharm Med 2023;37:25-36. DOI: https://doi.org/10.1007/s40290022-00456-6. 5. Maughan BL, Mundle S, Nematian-Samani M, et al. Survival Outcomes of APA as a Starting Treatment: Impact in Real-World Patients with mHSPC (OASIS). J Clin Oncol 2024;42(4 Suppl):65. DOI: https://doi.org/10.1200/JCO.2024.42.4_suppl.65. 6. Bilen MA, Du S, Khifeh I, et al. Real-world survival of men with metastatic castration-sensitive prostate cancer (mHSPC) initiated on apalutamide (APA) or enzalutamide (ENZ) in an oncology database: ROME Study. J Clin Oncol 2024;42(4 Suppl):57. DOI: https://doi.org/10.1200/JCO.2024.42.4_suppl.57. 7. Boukovala M, Spetsieris N, Efstathiou E. An evaluation of apalutamide for the treatment of prostate cancer, Exp Opin Pharmacother 2020;21(13):15371546, DOI: 10.1080/14656566.2020.1770726. ® S4 ERLEADA 60 mg lm-coated tablets. Each lm-coated tablet contains 60 mg of apalutamide. Reg. No.: 53/21.12/0453. For full prescribing information refer to the ® approved ERLEADA Professional Information (March 2023). Further information available on request from Market Authorisation Holder. JANSSEN PHARMACEUTICA (PTY) LTD (Reg. No. 1980/011122/07), 2 Medical Street, Halfway House, Midrand 1685. www.janssen.com. Medical Info Line: 0860 11 11 17. CP-475684 UROLOGY, URO-ONCOLOGY AND SEXOLOGY UPDATE

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