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Abiraterone acetate, Prednisolone
Abiraterone acetate inhibits CYP17A1 to block androgen synthesis, while prednisolone suppresses adrenocorticotropic hormone feedback to further reduce testosterone production in castration-resistant prostate cancer.
Abiraterone acetate inhibits CYP17A1 to block androgen synthesis, while prednisolone suppresses adrenocorticotropic hormone feedback to further reduce testosterone production in castration-resistant prostate cancer. Used for Castration-resistant prostate cancer (metastatic or non-metastatic), Metastatic castration-sensitive prostate cancer (in combination with androgen deprivation therapy).
At a glance
| Generic name | Abiraterone acetate, Prednisolone |
|---|---|
| Sponsor | Cancer Trials Ireland |
| Drug class | CYP17A1 inhibitor (androgen synthesis inhibitor) |
| Target | CYP17A1 (17α-hydroxylase/17,20-lyase) |
| Modality | Small molecule |
| Therapeutic area | Oncology |
| Phase | Phase 2 |
Mechanism of action
Abiraterone acetate is a selective inhibitor of 17α-hydroxylase/17,20-lyase (CYP17A1), an enzyme critical for androgen biosynthesis in the adrenal glands and tumor microenvironment. By blocking this enzyme, it reduces circulating androgens and intratumoral androgen levels. Prednisolone is co-administered as a glucocorticoid to suppress ACTH-driven adrenal androgen production and mitigate mineralocorticoid excess caused by abiraterone, enhancing efficacy and tolerability.
Approved indications
- Castration-resistant prostate cancer (metastatic or non-metastatic)
- Metastatic castration-sensitive prostate cancer (in combination with androgen deprivation therapy)
Common side effects
- Hypertension
- Hypokalemia
- Fluid retention/edema
- Fatigue
- Joint swelling/arthralgia
- Diarrhea
- Urinary tract infection
- Elevated liver enzymes
Key clinical trials
- M9466 Alone or in Combination in Advanced Solid Tumors (DDriver 501) (PHASE1)
- Study on Olaparib Plus Abiraterone as First-line Therapy in Men With Metastatic Castration-resistant Prostate Cancer (China Cohort) (PHASE3)
- A Phase 2 Study to Evaluate the Effects of ASP5541 in Participants With Prostate Cancer (PHASE2)
- RADIANT: A Study of Radium-223 Dichloride (Xofigo) vs Enzalutamide or Abiraterone (ARPIs, Androgen Receptor Pathway Inhibitors) in Patients With Prostate Cancer That Has Spread to the Bones (mCRPC, Metastatic Castration-Resistant Prostate Cancer) (PHASE4)
- Study on Olaparib Plus Abiraterone as First-line Therapy in Men With Metastatic Castration-resistant Prostate Cancer (PHASE3)
- A Study to Compare the Efficacy and Safety of BMS-986365 Versus the Investigator's Choice of Therapy in Participants With Metastatic Castration-resistant Prostate Cancer (PHASE3)
- Capivasertib+Abiraterone as Treatment for Patients With Metastatic Hormone-sensitive Prostate Cancer and PTEN Deficiency (PHASE3)
- Urokinase Plasminogen Activator Receptor in Abiraterone Treated Patients With Castration Resistant Prostate Cancer
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 |
Competitive intelligence
For the full competitive landscape — auto-detected comparators, recent regulatory actions across the set, upcoming PDUFA, patent timeline, sponsor landscape:
- Abiraterone acetate, Prednisolone CI brief — competitive landscape report
- Abiraterone acetate, Prednisolone updates RSS · CI watch RSS
- Cancer Trials Ireland portfolio CI