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Abiraterone-associated hepatotoxicity in metastatic hormone-sensitive prostate cancer — MSRA MCQ

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HardProstate CancerAbiraterone-associated hepatotoxicity in metastatic hormone-sensitive prostate cancerMSRA

A 71-year-old man with newly diagnosed high-risk metastatic hormone-sensitive prostate cancer is receiving leuprorelin, abiraterone 1000 mg once daily and prednisolone 5 mg once daily. His cancer has a Gleason score of 4+5 and 5 bone metastases. Eight weeks after starting treatment, routine monitoring shows ALT 312 IU/L (local upper limit of normal [ULN] 40 IU/L), AST 218 IU/L (ULN 40 IU/L), normal bilirubin and normal alkaline phosphatase. His pretreatment liver tests were normal. He is asymptomatic, has no hepatic metastases, drinks minimal alcohol and has started no other medicines or supplements. What is the most appropriate immediate management plan?

Educational content. Not a substitute for clinical judgement or local policy.

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Correct answer: D — Withhold abiraterone immediately, continue prednisolone and leuprorelin, and obtain urgent oncology advice with close liver-test monitoring.

This is abiraterone-associated hepatotoxicity: both ALT and AST exceed 5 times the ULN. The SmPC requires abiraterone to be withheld immediately at this threshold, with close liver-function monitoring. It may be reintroduced only after liver tests have returned to baseline, at a reduced dose of 500 mg once daily; therefore dose reduction is not the immediate action. Permanent discontinuation is required if ALT or AST reaches 20 times the ULN, or if hepatotoxicity recurs after rechallenge at 500 mg daily. Neither applies here. Continuing full-dose abiraterone while awaiting repeat tests disregards the mandatory interruption threshold and risks progression to severe liver injury. Prednisolone should not be stopped abruptly in this setting. The SmPC advises caution and monitoring for adrenocortical insufficiency when prednisone or prednisolone is withdrawn. Leuprorelin should continue because medical castration is maintained during abiraterone treatment in men who have not had orchidectomy. Urgent oncology input is appropriate to coordinate exclusion of alternative causes, monitoring and any subsequent specialist-led rechallenge.

Reference: ZYTIGA 500 mg film-coated tablets - Summary of Product Characteristics (Last updated 06 September 2022) — https://www.medicines.org.uk/emc/product/2381/smpc ZYTIGA 500 mg film-coated tablets - Summary of Product Characteristics (Last updated 06 September 2022) — https://www.medicines.org.uk/emc/product/2381/smpc Abiraterone for treating newly diagnosed high-risk hormone-sensitive metastatic prostate cancer: NICE TA1110 (19 November 2025) — https://www.nice.org.uk/guidance/ta1110/chapter/1-Recommendations