Last reviewed · How we verify
Abiraterone with Prednisone or Enzalutamide
Abiraterone inhibits CYP17A1 to block androgen synthesis, while enzalutamide antagonizes the androgen receptor, together suppressing testosterone-driven prostate cancer growth; prednisone provides glucocorticoid support to mitigate mineralocorticoid excess from abiraterone.
Abiraterone inhibits CYP17A1 to block androgen synthesis, while enzalutamide antagonizes the androgen receptor, together suppressing testosterone-driven prostate cancer growth; prednisone provides glucocorticoid support to mitigate mineralocorticoid excess from abiraterone. Used for Metastatic castration-resistant prostate cancer (mCRPC), Non-metastatic castration-resistant prostate cancer (nmCRPC).
At a glance
| Generic name | Abiraterone with Prednisone or Enzalutamide |
|---|---|
| Sponsor | Curium US LLC |
| Drug class | CYP17A1 inhibitor (abiraterone) + androgen receptor antagonist (enzalutamide) + glucocorticoid (prednisone) |
| Target | CYP17A1 (abiraterone); androgen receptor (enzalutamide); glucocorticoid receptor (prednisone) |
| Modality | Small molecule |
| Therapeutic area | Oncology |
| Phase | Phase 3 |
Mechanism of action
Abiraterone acetate is a prodrug that inhibits 17α-hydroxylase/17,20-lyase (CYP17A1), a key enzyme in testosterone and DHEA synthesis in the adrenal glands and tumor cells, reducing circulating androgens. Enzalutamide is an androgen receptor antagonist that blocks AR signaling in prostate cancer cells. Prednisone is co-administered with abiraterone to suppress ACTH-driven mineralocorticoid production and manage associated hypertension and hypokalemia. Together, these agents provide dual suppression of androgen production and receptor signaling in castration-resistant prostate cancer.
Approved indications
- Metastatic castration-resistant prostate cancer (mCRPC)
- Non-metastatic castration-resistant prostate cancer (nmCRPC)
Common side effects
- Hypertension
- Hypokalemia
- Fatigue
- Hot flashes
- Diarrhea
- Nausea
- Edema
- Cardiac arrhythmia
- Seizure (enzalutamide)
Key clinical trials
- 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)
- A Study of Tinengotinib (TT-00420) in Combination With Standard Treatments in People With Prostate Cancer (PHASE1, PHASE2)
- Study of Opevesostat (MK-5684) Versus Alternative NHA in mCRPC (MK-5684-003) (PHASE3)
- Study of Sipuleucel-T With or Without Continuing New Hormonal Agents in Metastatic Prostate Cancer (PHASE2)
- A Study of Tazemetostat With Enzalutamide or Abiraterone/Prednisone in Participants With Advanced Prostate Cancer (PHASE1, 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)
- Cognitive Effects of Androgen Receptor Directed Therapies for Advanced Prostate Cancer (PHASE4)
- The Present Study Aims to Compare Patients Who Receive the Investigational Product (177Lu-DOTA-rosopatamab) Plus Standard of Care, in Comparison to Standard of Care Only (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 |
Competitive intelligence
For the full competitive landscape — auto-detected comparators, recent regulatory actions across the set, upcoming PDUFA, patent timeline, sponsor landscape: