# Abiraterone acetate

Source: https://onco.cc/drugs/abiraterone/  
OnCo record `abiraterone` (Treatment). Data CC BY-NC 4.0, attribute "Data from OnCo (onco.cc)"; commercial use needs a licence.

## TL;DR

Abiraterone is a pill that shuts down testosterone production everywhere, including inside the tumour. Discovered at the Institute of Cancer Research, now generic and used from the first metastatic diagnosis.

## Summary

Abiraterone acetate irreversibly inhibits CYP17A1 (17-alpha-hydroxylase and 17,20-lyase), shutting down androgen synthesis in the adrenal glands and inside the tumour, not just the testes; it is given with prednisone to offset mineralocorticoid excess. Its evidence spans advanced prostate cancer: COU-AA-301 and 302 (mCRPC post- and pre-docetaxel), LATITUDE and STAMPEDE (mHSPC, overall survival benefit; LATITUDE OS 53.3 versus 36.5 months, HR 0.66) and PEACE-1 (triplet with docetaxel). Generic since 2018 to 2019, it is the backbone partner for PARP inhibitors (PROpel, MAGNITUDE), capivasertib (CAPItello-281) and Pluvicto (PSMAddition). Open questions are how to choose between abiraterone and the AR antagonists, and which men need a third drug. Discovered at the Institute of Cancer Research, it is the affordable hormone pill most men with metastatic prostate cancer now start at diagnosis.

## Fields

- Kind: Treatment
- Status: approved
- Last checked: 2026-09-06
- Also known as: Abiraterone
- Brand: Zytiga (generic)
- Modality: Small-molecule CYP17A1 inhibitor
- Mechanism: Irreversible CYP17A1 (17α-hydroxylase/17,20-lyase) inhibition blocks adrenal and intratumoural androgen synthesis.
- Approvals: US 2011: mCRPC after docetaxel; US 2012: mCRPC pre-chemotherapy; US 2018: High-risk mHSPC (LATITUDE)

## Notes

- In England, four NICE appraisals cover abiraterone in prostate cancer and the newest replaced the oldest. TA1110 recommends abiraterone (originator and generics) plus androgen deprivation with prednisolone or prednisone within its marketing authorisation for newly diagnosed high-risk hormone-sensitive metastatic prostate cancer; it is a review of TA721, which did not recommend abiraterone in this indication at all, so TA1110 reverses a refusal rather than lifting a restriction. TA387 recommends abiraterone with prednisone or prednisolone for metastatic hormone-relapsed prostate cancer in men with no or mild symptoms after androgen deprivation has failed and before chemotherapy is indicated. TA259 recommends it after one docetaxel-containing regimen. TA951 recommends olaparib with abiraterone for untreated hormone-relapsed metastatic prostate cancer in adults who cannot have or do not want chemotherapy.

## Sources

- Wikipedia: https://en.wikipedia.org/wiki/Abiraterone_acetate
- FDA label (DailyMed): https://dailymed.nlm.nih.gov/dailymed/search.cfm?query=Abiraterone%20acetate
- NICE TA1110: abiraterone (originator and generics) for newly diagnosed high-risk hormone-sensitive metastatic prostate cancer: https://www.nice.org.uk/guidance/ta1110
- NICE TA387: abiraterone for treating metastatic hormone-relapsed prostate cancer before chemotherapy is indicated: https://www.nice.org.uk/guidance/ta387
- NICE TA259: abiraterone for castration-resistant metastatic prostate cancer previously treated with a docetaxel-containing regimen: https://www.nice.org.uk/guidance/ta259

## Connected records

- cancers: [Localised prostate cancer, high and very high risk](https://onco.cc/cancers/prostate-high-risk/), [Metastatic castration-resistant prostate cancer](https://onco.cc/cancers/prostate-mcrpc/), [Metastatic hormone-sensitive prostate cancer](https://onco.cc/cancers/prostate-mhspc/), [Prostate cancer](https://onco.cc/cancers/prostate/)
- technologies: [Adaptive therapy (evolution-based dosing)](https://onco.cc/technologies/adaptive-therapy-dynamics/), [Androgen deprivation & AR pathway inhibitors](https://onco.cc/technologies/androgen-deprivation/)
- targets: [5-alpha-reductase type 2 (SRD5A2)](https://onco.cc/targets/srd5a2/), [Androgen receptor](https://onco.cc/targets/androgen-receptor/), [CYP17A1 (17-alpha-hydroxylase/17,20-lyase)](https://onco.cc/targets/cyp17a1/)
- companies: [Dr. Reddy's Laboratories](https://onco.cc/companies/dr-reddys/), [Johnson & Johnson](https://onco.cc/companies/johnson-johnson/), [Sun Pharmaceutical Industries](https://onco.cc/companies/sun-pharma/)
- institutions: [Centre hospitalier de l'Université de Montréal (CHUM)](https://onco.cc/institutions/chum/), [Prostate Cancer Foundation](https://onco.cc/institutions/pcf/), [The Institute of Cancer Research](https://onco.cc/institutions/icr-london/), [The Royal Marsden](https://onco.cc/institutions/royal-marsden/)
- pathways: [Androgen receptor signalling](https://onco.cc/pathways/ar-signaling/), [Chemical carcinogenesis - receptor activation](https://onco.cc/pathways/chemical-carcinogenesis-receptor-activation/), [Prostate cancer (KEGG map)](https://onco.cc/pathways/prostate-cancer-signalling/)
- terms: [Androgen receptor pathway inhibitor (ARPI)](https://onco.cc/terms/arpi/), [Bipolar androgen therapy (BAT)](https://onco.cc/terms/bipolar-androgen-therapy/), [Disease volume (CHAARTED high-volume versus low-volume) and LATITUDE risk](https://onco.cc/terms/disease-volume-chaarted/), [Hatch-Waxman Act 1984](https://onco.cc/terms/hatch-waxman/), [mCRPC and mHSPC (castration-resistant vs hormone-sensitive prostate cancer)](https://onco.cc/terms/mcrpc-mhspc/), [Prostate cancer drugs in England: what NICE recommends, and what it refuses](https://onco.cc/terms/prostate-uk-drug-approvals/)
- trials: [A Clinical Study of QLC5508 and/or QLH12016 in Combination With Other Anti-tumor Therapies in Subjects With Advanced Prostate Cancer](https://onco.cc/trials/nct07198633/), [A Comparative Dose-finding Study of RS-113 in Patients With Metastatic Castration-resistant Prostate Cancer](https://onco.cc/trials/nct07553988/), [A Multicenter, Randomized, Double-Blind, Placebo-Controlled Phase III Study of Fuzuloparib Combined With Abiraterone Acetate and Prednisone (AA-P) Ver](https://onco.cc/trials/nct04691804/), [A Phase 2 Study to Evaluate the Effects of ASP5541 in Participants With Prostate Cancer](https://onco.cc/trials/nct07005154/), [A Phase Ib/II Open-label Study of AMO959 With Lutetium (177Lu) Vipivotide Tetraxetan (AAA617) in Combination With ARPI in Adult Participants With PSMA](https://onco.cc/trials/nct07226986/), [A Study for Subjects With Prostate Cancer Who Previously Participated in an Enzalutamide Clinical Study](https://onco.cc/trials/nct02960022/), [A Study of Abiraterone Acetate Plus Prednisone With or Without Abemaciclib (LY2835219) in Participants With Prostate Cancer](https://onco.cc/trials/nct03706365/), [A Study of ARV-766 Given by Mouth in Men With Metastatic Prostate Cancer](https://onco.cc/trials/nct05067140/), [A Study of Niraparib Combination Therapies for the Treatment of Metastatic Castration-Resistant Prostate Cancer](https://onco.cc/trials/nct03431350/), [A Study of Niraparib in Combination With Abiraterone Acetate and Prednisone Versus Abiraterone Acetate and Prednisone for the Treatment of Participants With Deleterious Germline or Somatic Homologous Recombination Repair (HRR) Gene-MutatedProstatic Neoplasms (mCSPC)](https://onco.cc/trials/nct04497844/), [A Study of SHR3680, HS-20093 and SHR2554 in Subjects With Prostate Cancer](https://onco.cc/trials/nct07230106/), [A Study of Xaluritamig Plus Abiraterone Versus Investigator's Choice in Participants With Chemotherapy-naïve Metastatic Castration-resistant Prostate ](https://onco.cc/trials/nct07213674/), [A Study That Provides Long-term Safety Follow-up and Examines Long-term Exposure to Abiraterone Acetate](https://onco.cc/trials/nct01517802/), [A Study to Test Inavolisib Treatment in Participants With Metastatic Castration-Resistant Prostate Cancer](https://onco.cc/trials/nct07287150/), [Abiraterone, Enzalutamide, or Apalutamide in Castrate-sensitive Prostate Cancer.](https://onco.cc/trials/nct05422911/), [An Efficacy and Safety Study of Apalutamide (JNJ-56021927) in Combination With Abiraterone Acetate and Prednisone Versus Abiraterone Acetate and Prednisone in Participants With Chemotherapy-naive Metastatic Castration-resistant Prostate Cancer (mCRPC)](https://onco.cc/trials/nct02257736/), [An Open-label Study of JSB462 (Luxdegalutamide) in Combination With Abiraterone in Adult Male Patients With Metastatic Hormone-sensitive Prostate Canc](https://onco.cc/trials/nct06991556/), [AZD2265 Compared With Standard of Care in PSMA-positive Metastatic Castration-resistant Prostate Cancer (VECTRA-01)](https://onco.cc/trials/nct07611110/), [CAPItello-281](https://onco.cc/trials/capitello-281/), [CARD](https://onco.cc/trials/card/), [Conventional Androgen Deprivation Therapy (ADT) With or Without Abiraterone Acetate + Prednisone and Apalutamide Following a Detectable PSA After Radiation and ADT](https://onco.cc/trials/nct03777982/), [COU-AA-301](https://onco.cc/trials/cou-aa-301/), [COU-AA-302](https://onco.cc/trials/cou-aa-302/), [ERA 223](https://onco.cc/trials/era-223/), [LATITUDE](https://onco.cc/trials/latitude/), [Long-Term Extension Study for Participants Previously Enrolled in an Exelixis-Sponsored Study](https://onco.cc/trials/nct07620574/), [MAGNITUDE](https://onco.cc/trials/magnitude/), [PEACE-1](https://onco.cc/trials/peace-1/), [Pharmacogenomics IND Commercial SNP Clinical Study - Abiraterone and Single Nucleotide Polymorphisms](https://onco.cc/trials/nct03348670/), [PROpel](https://onco.cc/trials/propel/), [STAMPEDE](https://onco.cc/trials/stampede/), [Standard Systemic Therapy With or Without Definitive Treatment in Treating Participants With Metastatic Prostate Cancer](https://onco.cc/trials/nct03678025/), [Study of AZD5305 When Given in Combination With New Hormonal Agents in Patients With Metastatic Prostate Cancer](https://onco.cc/trials/nct05367440/), [Study of Cabozantinib in Combination With Atezolizumab Versus Second NHT in Subjects With mCRPC](https://onco.cc/trials/nct04446117/), [Study of Pembrolizumab (MK-3475) Combination Therapies in Metastatic Castration-Resistant Prostate Cancer (MK-3475-365/KEYNOTE-365)](https://onco.cc/trials/nct02861573/), [Study on Olaparib Plus Abiraterone as First-line Therapy in Men With Metastatic Castration-resistant Prostate Cancer (China Cohort)](https://onco.cc/trials/nct05171816/), [The Study of 177Lu-TLX591 Plus SOC Versus SOC Alone in Patients With mCRPC (ProstACT Global)](https://onco.cc/trials/nct06520345/), [TulmiSTAR-02: A Phase I/II Open-label Study of Tulmimetostat in Combination With Darolutamide vs. Darolutamide, and Tulmimetostat With Abiraterone in ](https://onco.cc/trials/nct07190300/)
- key papers: [Abiraterone in metastatic prostate cancer without previous chemotherapy](https://onco.cc/key-papers/paper-abiraterone-acetate-prostate-n-engl-j-med-2013/), [AR-V7 and resistance to enzalutamide and abiraterone in prostate cancer](https://onco.cc/key-papers/paper-antonarakis-ar-v7-resistance-nejm-2014/), [Circulating tumour DNA genomics correlate with resistance to abiraterone and enzalutamide in prostate cancer](https://onco.cc/key-papers/paper-annala-ctdna-resistance-abiraterone-enzalutamide-cancer-discov-2018/), [IPATential150: ipatasertib plus abiraterone and prednisolone in metastatic castration-resistant prostate cancer](https://onco.cc/key-papers/paper-ipatential150-ipatasertib-abiraterone-pten-lancet-2021/), [Phase 1 trial of abiraterone acetate confirms that castration-resistant prostate cancer commonly remains hormone driven](https://onco.cc/key-papers/paper-attard-abiraterone-phase-1-cyp17-jco-2008/), [PTEN protein loss and clinical outcome from castration-resistant prostate cancer treated with abiraterone acetate](https://onco.cc/key-papers/paper-ferraldeschi-pten-protein-loss-abiraterone-eur-urol-2015/), [STAMPEDE: abiraterone with or without enzalutamide added to androgen deprivation for high-risk non-metastatic prostate cancer](https://onco.cc/key-papers/paper-stampede-abiraterone-high-risk-attard-lancet-2022/), [TRANSFORMER: bipolar androgen therapy versus enzalutamide in asymptomatic metastatic castration-resistant prostate cancer](https://onco.cc/key-papers/paper-denmeade-transformer-bipolar-androgen-therapy-jco-2021/), [TRITON3: rucaparib or physician's choice in metastatic castration-resistant prostate cancer](https://onco.cc/key-papers/paper-fizazi-triton3-rucaparib-nejm-2023/)
- ideas: [Prescribe a quarter dose of abiraterone with breakfast](https://onco.cc/ideas/idea-cost-low-dose-abiraterone-food/), [Randomise the order of treatment, not only the drugs: a strategy platform for metastatic prostate cancer](https://onco.cc/ideas/idea-prostate-randomise-the-sequence-not-only-the-drugs/), [Take high-dose testosterone to phase 3, with progression-free survival through the second line as the primary endpoint](https://onco.cc/ideas/idea-prostate-bipolar-androgen-therapy-phase-3-on-pfs2/), [Transparent cost-plus pricing for every oral oncology generic](https://onco.cc/ideas/idea-cost-transparent-generic-pricing/), [Watch for the cancer changing cell type before the biopsy says neuroendocrine, and act on it](https://onco.cc/ideas/idea-prostate-plasticity-surveillance-before-it-is-neuroendocrine/)
- people: [Howard I. Scher](https://onco.cc/people/howard-scher/), [Johann de Bono](https://onco.cc/people/johann-de-bono/), [Karim Fizazi](https://onco.cc/people/karim-fizazi/), [Kim N. Chi](https://onco.cc/people/kim-chi/), [Michael Milken](https://onco.cc/people/michael-milken/), [Nicholas James](https://onco.cc/people/nicholas-james/), [Paul Workman](https://onco.cc/people/paul-workman/), [Robert A. Gatenby](https://onco.cc/people/robert-gatenby/)
- collections: [Prostate Cancer Foundation (PCF)](https://onco.cc/collections/prostate-cancer-foundation/)
- drugs: [Prednisone](https://onco.cc/drugs/prednisone/)
- biomarkers: [AR-V7 splice variant](https://onco.cc/biomarkers/ar-v7-splice-variant/), [PTEN alteration (sequencing) and PTEN loss (IHC)](https://onco.cc/biomarkers/pten-alteration/)
- roadmaps: [Hormonal therapy roadmap: removing the ovaries → tamoxifen → oral degraders switched by a blood test](https://onco.cc/roadmaps/hormonal-therapy-roadmap/)

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