{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,10,9]],"date-time":"2026-10-09T15:23:52Z","timestamp":1791559432760,"version":"4.3.4"},"reference-count":31,"publisher":"MDPI AG","issue":"9","license":[{"start":{"date-parts":[[2026,9,2]],"date-time":"2026-09-02T00:00:00Z","timestamp":1788307200000},"content-version":"vor","delay-in-days":0,"URL":"https:\/\/creativecommons.org\/licenses\/by\/4.0\/"}],"content-domain":{"domain":[],"crossmark-restriction":false},"short-container-title":["Curr. Oncol.","Current Oncology"],"abstract":"<jats:p>Therapeutic options for advanced prostate cancer have expanded in recent years, incorporating multiple-system treatment approaches with differing mechanisms of action. However, comparative real-world safety data following drug approval remain limited. As such, the aim of this study is to characterize adverse events and disproportionate safety signals among advanced prostate cancer therapies using the FDA Adverse Event Reporting System (FAERS). A retrospective pharmacovigilance study of FAERS reports evaluated enzalutamide, darolutamide, apalutamide, abiraterone acetate, relugolix, niraparib\/abiraterone, talazoparib, rucaparib, cabazitaxel, sipuleucel-T, and lutetium-177 vipivotide. Adverse events were categorized by System Organ Class and Preferred Terms. Reporting odds ratios (RORs) with 95% confidence intervals identified safety signals. Among 172,440 reports, most involved patients aged 65\u201385 years. Cabazitaxel had the highest proportion of serious reports (86.6%) and deaths (22%), whereas relugolix had the lowest (23.3% and 4.8%). Nervous system disorders predominated with enzalutamide and darolutamide, gastrointestinal disorders with abiraterone, rucaparib, and niraparib\/abiraterone, and hematologic toxicities with cabazitaxel, talazoparib, and lutetium-177 vipivotide. Significant safety signals were identified for abiraterone and cabazitaxel, but not other therapies. The absence of a detected signal should not be interpreted as evidence of safety or equivalence, as reporting volume, detection bias, and statistical power varied across therapies. Overall, the therapies demonstrated distinct toxicity profiles, which may inform treatment selection, toxicity monitoring, and patient counseling.<\/jats:p>","DOI":"10.3390\/curroncol33090530","type":"journal-article","created":{"date-parts":[[2026,9,2]],"date-time":"2026-09-02T07:53:11Z","timestamp":1788335591000},"page":"530","update-policy":"https:\/\/doi.org\/10.3390\/mdpi_crossmark_policy","source":"Crossref","is-referenced-by-count":1,"title":["Comparative Pharmacovigilance Analysis of Safety Signals Among Advanced Prostate Cancer Therapies Using FAERS (FDA Adverse Event Reporting System)"],"prefix":"10.3390","volume":"33","author":[{"ORCID":"https:\/\/orcid.org\/0009-0001-5761-8595","authenticated-orcid":false,"given":"Zaid","family":"Ahmed","sequence":"first","affiliation":[{"name":"Department of Urology, University of California, Irvine School of Medicine, Orange, CA 92868, USA"}],"role":[{"vocabulary":"crossref","role":"author"},{"role":"conceptualization","vocabulary":"credit"},{"role":"methodology","vocabulary":"credit"},{"role":"formal-analysis","vocabulary":"credit"},{"role":"investigation","vocabulary":"credit"},{"role":"data-curation","vocabulary":"credit"},{"role":"writing-original-draft","vocabulary":"credit"},{"role":"visualization","vocabulary":"credit"}]},{"given":"Rashid","family":"Sayyid","sequence":"additional","affiliation":[{"name":"Department of Urology, College of Medicine\u2014Tucson, University of Arizona, Tucson, AZ 85724, USA"}],"role":[{"vocabulary":"crossref","role":"author"},{"role":"writing-original-draft","vocabulary":"credit"},{"role":"writing-review-editing","vocabulary":"credit"},{"role":"validation","vocabulary":"credit"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-5795-461X","authenticated-orcid":false,"given":"Omid","family":"Yazdanpanah","sequence":"additional","affiliation":[{"name":"Division of Hematology and Oncology, Department of Medicine, University of California, Irvine School of Medicine, Orange, CA 92868, USA"}],"role":[{"vocabulary":"crossref","role":"author"},{"role":"validation","vocabulary":"credit"},{"role":"writing-original-draft","vocabulary":"credit"},{"role":"writing-review-editing","vocabulary":"credit"}]},{"given":"Ravand","family":"Samaeekia","sequence":"additional","affiliation":[{"name":"Division of Hematology and Oncology, Department of Medicine, University of California, Irvine School of Medicine, Orange, CA 92868, USA"}],"role":[{"vocabulary":"crossref","role":"author"},{"role":"writing-original-draft","vocabulary":"credit"},{"role":"validation","vocabulary":"credit"},{"role":"writing-review-editing","vocabulary":"credit"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-3701-5084","authenticated-orcid":false,"given":"Arash Rezazadeh","family":"Kalebasty","sequence":"additional","affiliation":[{"name":"Division of Hematology and Oncology, Department of Medicine, University of California, Irvine School of Medicine, Orange, CA 92868, USA"}],"role":[{"vocabulary":"crossref","role":"author"},{"role":"validation","vocabulary":"credit"},{"role":"writing-original-draft","vocabulary":"credit"},{"role":"writing-review-editing","vocabulary":"credit"}]},{"ORCID":"https:\/\/orcid.org\/0000-0003-2133-9284","authenticated-orcid":false,"given":"David I.","family":"Lee","sequence":"additional","affiliation":[{"name":"Department of Urology, University of California, Irvine School of Medicine, Orange, CA 92868, USA"}],"role":[{"vocabulary":"crossref","role":"author"},{"role":"validation","vocabulary":"credit"},{"role":"writing-original-draft","vocabulary":"credit"},{"role":"writing-review-editing","vocabulary":"credit"}]},{"given":"Mohammed","family":"Shahait","sequence":"additional","affiliation":[{"name":"Department of Urology, University of California, Irvine School of Medicine, Orange, CA 92868, USA"}],"role":[{"vocabulary":"crossref","role":"author"},{"role":"conceptualization","vocabulary":"credit"},{"role":"formal-analysis","vocabulary":"credit"},{"role":"validation","vocabulary":"credit"},{"role":"investigation","vocabulary":"credit"},{"role":"writing-original-draft","vocabulary":"credit"},{"role":"writing-review-editing","vocabulary":"credit"},{"role":"visualization","vocabulary":"credit"},{"role":"supervision","vocabulary":"credit"},{"role":"project-administration","vocabulary":"credit"}]}],"member":"1968","published-online":{"date-parts":[[2026,9,2]]},"reference":[{"key":"ref_1","first-page":"485","article-title":"Prostate cancer statistics, 2025","volume":"75","author":"Kratzer","year":"2025","journal-title":"CA Cancer J. Clin."},{"key":"ref_2","doi-asserted-by":"crossref","first-page":"1047","DOI":"10.3390\/curroncol31020078","article-title":"Contemporary systemic therapy intensification for prostate cancer: A review for general practitioners in oncology","volume":"31","author":"Batra","year":"2024","journal-title":"Curr. Oncol."},{"key":"ref_3","doi-asserted-by":"crossref","first-page":"2191","DOI":"10.1038\/s44321-025-00282-8","article-title":"New frontiers in prostate cancer treatment from systemic therapy to targeted therapy","volume":"17","author":"Nouruzi","year":"2025","journal-title":"EMBO Mol. Med."},{"key":"ref_4","first-page":"9","article-title":"Overcoming drug resistance in castrate-resistant prostate cancer: Current mechanisms and emerging therapeutic approaches","volume":"8","author":"Khorasanchi","year":"2025","journal-title":"Cancer Drug Resist."},{"key":"ref_5","doi-asserted-by":"crossref","first-page":"607","DOI":"10.1007\/s12672-025-02198-8","article-title":"Advancements and limitations in traditional anti-cancer therapies: A comprehensive review of surgery, chemotherapy, radiation therapy, and hormonal therapy","volume":"16","author":"Zafar","year":"2025","journal-title":"Discov. Oncol."},{"key":"ref_6","doi-asserted-by":"crossref","first-page":"17588359221131525","DOI":"10.1177\/17588359221131525","article-title":"Efficacy and safety of therapies for advanced prostate cancer in Asia: Evidence from a systematic literature review","volume":"14","author":"Saad","year":"2022","journal-title":"Ther. Adv. Med. Oncol."},{"key":"ref_7","doi-asserted-by":"crossref","first-page":"836","DOI":"10.1002\/pros.22965","article-title":"Safety of enzalutamide in patients with metastatic castration-resistant prostate cancer previously treated with docetaxel: Expanded access in North America","volume":"75","author":"Joshua","year":"2015","journal-title":"Prostate"},{"key":"ref_8","doi-asserted-by":"crossref","first-page":"20601","DOI":"10.1038\/s41598-022-23726-4","article-title":"A real-world pharmacovigilance study of FDA Adverse Event Reporting System (FAERS) events for niraparib","volume":"12","author":"Guo","year":"2022","journal-title":"Sci. Rep."},{"key":"ref_9","doi-asserted-by":"crossref","unstructured":"Yaghi, S., Siegler, J.E., and Nguyen, T.N. (2023). Pitfalls of randomized controlled trials in stroke: How can we do better?. Stroke Vasc. Interv. Neurol., 3.","DOI":"10.1161\/SVIN.123.000807"},{"key":"ref_10","doi-asserted-by":"crossref","first-page":"1147","DOI":"10.1016\/S0140-6736(10)61389-X","article-title":"Prednisone plus cabazitaxel or mitoxantrone for metastatic castration-resistant prostate cancer progressing after docetaxel treatment: A randomised open-label trial","volume":"376","author":"Oudard","year":"2010","journal-title":"Lancet"},{"key":"ref_11","doi-asserted-by":"crossref","unstructured":"Peng, Y., Dong, S., Yang, Z., Song, Y., Ding, J., Hou, D., Wang, L., Zhang, Z., Li, N., and Wang, H. (2021). Identification of docetaxel-related biomarkers for prostate cancer. Andrologia, 53.","DOI":"10.1111\/and.14079"},{"key":"ref_12","doi-asserted-by":"crossref","first-page":"538.e7","DOI":"10.1016\/j.urolonc.2022.09.011","article-title":"Efficacy of cabazitaxel in fourth or later line of therapy in metastatic castration-resistant prostate cancer: Multi-institutional real-world experience in Germany","volume":"40","author":"Wenzel","year":"2022","journal-title":"Urol. Oncol."},{"key":"ref_13","doi-asserted-by":"crossref","first-page":"1187","DOI":"10.1056\/NEJMoa1207506","article-title":"Increased survival with enzalutamide in prostate cancer after chemotherapy","volume":"367","author":"Scher","year":"2012","journal-title":"N. Engl. J. Med."},{"key":"ref_14","doi-asserted-by":"crossref","first-page":"424","DOI":"10.1056\/NEJMoa1405095","article-title":"Enzalutamide in metastatic prostate cancer before chemotherapy","volume":"371","author":"Beer","year":"2014","journal-title":"N. Engl. J. Med."},{"key":"ref_15","doi-asserted-by":"crossref","first-page":"1235","DOI":"10.1056\/NEJMoa1815671","article-title":"Darolutamide in nonmetastatic, castration-resistant prostate cancer","volume":"380","author":"Fizazi","year":"2019","journal-title":"N. Engl. J. Med."},{"key":"ref_16","doi-asserted-by":"crossref","first-page":"403","DOI":"10.1007\/s11523-023-00959-5","article-title":"Comparison of cerebral blood flow in regions relevant to cognition after enzalutamide, darolutamide, and placebo in healthy volunteers: A randomized crossover trial","volume":"18","author":"Williams","year":"2023","journal-title":"Target. Oncol."},{"key":"ref_17","doi-asserted-by":"crossref","first-page":"352","DOI":"10.1056\/NEJMoa1704174","article-title":"Abiraterone plus prednisone in metastatic, castration-sensitive prostate cancer","volume":"377","author":"Fizazi","year":"2017","journal-title":"N. Engl. J. Med."},{"key":"ref_18","doi-asserted-by":"crossref","first-page":"138","DOI":"10.1056\/NEJMoa1209096","article-title":"Abiraterone in metastatic prostate cancer without previous chemotherapy","volume":"368","author":"Ryan","year":"2013","journal-title":"N. Engl. J. Med."},{"key":"ref_19","doi-asserted-by":"crossref","first-page":"3339","DOI":"10.1200\/JCO.22.01649","article-title":"Niraparib and abiraterone acetate for metastatic castration-resistant prostate cancer","volume":"41","author":"Chi","year":"2023","journal-title":"J. Clin. Oncol."},{"key":"ref_20","doi-asserted-by":"crossref","first-page":"1157","DOI":"10.1093\/jjco\/hyz108","article-title":"Safety and efficacy of cabazitaxel in 660 patients with metastatic castration-resistant prostate cancer in real-world settings: Results of a Japanese post-marketing surveillance study","volume":"49","author":"Suzuki","year":"2019","journal-title":"Jpn. J. Clin. Oncol."},{"key":"ref_21","doi-asserted-by":"crossref","first-page":"470","DOI":"10.1111\/bju.15542","article-title":"Safety and survival of docetaxel and cabazitaxel in metastatic castration-resistant prostate cancer","volume":"129","author":"Kreis","year":"2022","journal-title":"BJU Int."},{"key":"ref_22","doi-asserted-by":"crossref","first-page":"210","DOI":"10.1186\/s13643-025-02958-1","article-title":"Comparative efficacy and safety of cabazitaxel versus other taxanes: A systematic review and meta-analysis","volume":"14","author":"Abdu","year":"2025","journal-title":"Syst. Rev."},{"key":"ref_23","doi-asserted-by":"crossref","first-page":"65","DOI":"10.1007\/s10555-025-10283-1","article-title":"Hematological toxicity of PARP inhibitors in solid tumors: A systematic review and safety meta-analysis","volume":"44","author":"Maiorano","year":"2025","journal-title":"Cancer Metastasis Rev."},{"key":"ref_24","doi-asserted-by":"crossref","first-page":"3365","DOI":"10.1002\/cam4.5062","article-title":"Hematological toxicities in PARP inhibitors: A real-world study using the FDA Adverse Event Reporting System (FAERS) database","volume":"12","author":"Shu","year":"2023","journal-title":"Cancer Med."},{"key":"ref_25","doi-asserted-by":"crossref","first-page":"12595","DOI":"10.1038\/s41598-024-63600-z","article-title":"Safety assessments and clinical features of PARP inhibitors from real-world data of Japanese patients with ovarian cancer","volume":"14","author":"Uekusa","year":"2024","journal-title":"Sci. Rep."},{"key":"ref_26","doi-asserted-by":"crossref","unstructured":"Liu, J., Liu, X., Zeng, H., Tong, Y., Chen, Z., and Dong, Z. (2025). Severe cutaneous adverse reactions associated with second-generation androgen receptor antagonists in prostate cancer patients. PLoS ONE, 20.","DOI":"10.1371\/journal.pone.0325448"},{"key":"ref_27","doi-asserted-by":"crossref","first-page":"1010","DOI":"10.1097\/JU.0000000000002425","article-title":"Dermatologic adverse events in prostate cancer patients treated with the androgen receptor inhibitor apalutamide","volume":"207","author":"Pan","year":"2022","journal-title":"J. Urol."},{"key":"ref_28","doi-asserted-by":"crossref","first-page":"1408","DOI":"10.1056\/NEJMoa1715546","article-title":"Apalutamide treatment and metastasis-free survival in prostate cancer","volume":"378","author":"Smith","year":"2018","journal-title":"N. Engl. J. Med."},{"key":"ref_29","doi-asserted-by":"crossref","first-page":"2187","DOI":"10.1056\/NEJMoa2004325","article-title":"Oral relugolix for androgen-deprivation therapy in advanced prostate cancer","volume":"382","author":"Shore","year":"2020","journal-title":"N. Engl. J. Med."},{"key":"ref_30","doi-asserted-by":"crossref","first-page":"459","DOI":"10.1001\/jamacardio.2025.5586","article-title":"Coronary plaque progression after androgen deprivation therapy in men with prostate cancer: A randomized clinical trial","volume":"11","author":"Patel","year":"2026","journal-title":"JAMA Cardiol."},{"key":"ref_31","doi-asserted-by":"crossref","unstructured":"Peng, Y., Song, Y., and Wang, H. (2022). Systematic elucidation of the aneuploidy landscape and identification of aneuploidy driver genes in prostate cancer. Front. Cell Dev. Biol., 9.","DOI":"10.3389\/fcell.2021.723466"}],"container-title":["Current Oncology"],"original-title":[],"language":"en","link":[{"URL":"https:\/\/www.mdpi.com\/1718-7729\/33\/9\/530\/pdf","content-type":"unspecified","content-version":"vor","intended-application":"similarity-checking"}],"deposited":{"date-parts":[[2026,9,2]],"date-time":"2026-09-02T08:25:43Z","timestamp":1788337543000},"score":1,"resource":{"primary":{"URL":"https:\/\/www.mdpi.com\/1718-7729\/33\/9\/530"}},"subtitle":[],"short-title":[],"issued":{"date-parts":[[2026,9,2]]},"references-count":31,"journal-issue":{"issue":"9","published-online":{"date-parts":[[2026,9]]}},"alternative-id":["curroncol33090530"],"URL":"https:\/\/doi.org\/10.3390\/curroncol33090530","relation":{},"ISSN":["1718-7729"],"issn-type":[{"value":"1718-7729","type":"electronic"}],"subject":[],"published":{"date-parts":[[2026,9,2]]}}}