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Abiraterone acetate and prednisone
Abiraterone acetate inhibits CYP17A1 to block androgen synthesis, while prednisone suppresses ACTH-driven compensatory steroid production in castration-resistant prostate cancer.
Abiraterone acetate inhibits CYP17A1 to block androgen synthesis, while prednisone suppresses ACTH-driven compensatory steroid production in castration-resistant prostate cancer. Used for Metastatic castration-resistant prostate cancer, High-risk castration-sensitive prostate cancer (in combination with androgen deprivation therapy).
At a glance
| Generic name | Abiraterone acetate and prednisone |
|---|---|
| Sponsor | Janssen Research & Development, LLC |
| Drug class | CYP17A1 inhibitor (androgen synthesis inhibitor) |
| Target | CYP17A1 (17α-hydroxylase/17,20-lyase) |
| Modality | Small molecule |
| Therapeutic area | Oncology |
| Phase | Phase 3 |
Mechanism of action
Abiraterone acetate is a selective inhibitor of 17α-hydroxylase/17,20-lyase (CYP17A1), a key enzyme in androgen biosynthesis that blocks testosterone production in the testes, adrenal glands, and tumor microenvironment. Prednisone is co-administered as a glucocorticoid to suppress adrenocorticotropic hormone (ACTH) feedback and prevent mineralocorticoid excess caused by shunting of steroid precursors. Together, they achieve more complete androgen deprivation in men with castration-resistant prostate cancer.
Approved indications
- Metastatic castration-resistant prostate cancer
- High-risk castration-sensitive prostate cancer (in combination with androgen deprivation therapy)
Common side effects
- Hypertension
- Hypokalemia
- Fluid retention/edema
- Fatigue
- Hot flashes
- Diarrhea
- Nausea
- Elevated liver enzymes
- Cardiac arrhythmias
Key clinical trials
- A Single-Arm Phase II Study of Neoadjuvant Intensified Androgen Deprivation (Leuprolide and Abiraterone Acetate) in Combination With AKT Inhibition (Capivasertib) for High-Risk Localized Prostate Cancer With PTEN Loss (PHASE2)
- Multi-arm Multi-modality Therapy for Very High Risk Localized and Low Volume Metastatic Prostatic Adenocarcinoma (PHASE2)
- A Study of Niraparib Combination Therapies for the Treatment of Metastatic Castration-Resistant Prostate Cancer (PHASE2)
- A Study of Opevesostat (MK-5684) Versus Alternative Next-generation Hormonal Agent (NHA) in Metastatic Castration-resistant Prostate Cancer (mCRPC) Post One NHA (MK-5684-004) (PHASE3)
- M9466 Alone or in Combination in Advanced Solid Tumors (DDriver 501) (PHASE1)
- Study of Opevesostat (MK-5684) Versus Alternative NHA in mCRPC (MK-5684-003) (PHASE3)
- 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-Mutated Metastatic Castration-Sensitive Prostate Cancer (mCSPC) (PHASE3)
- 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) (PHASE3)
Primary sources
Every claim on this page is sourced from regulatory or scientific primary sources. See our editorial policy for full methodology.
| Source | Used for |
|---|---|
| ClinicalTrials.gov | Trial enrolment, design, endpoints, results |
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