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Placebo plus enzalutamide
Enzalutamide is an androgen receptor inhibitor that blocks the binding and nuclear translocation of androgens, thereby suppressing androgen-driven prostate cancer cell growth.
Enzalutamide is an androgen receptor inhibitor that blocks the binding and nuclear translocation of androgens, thereby suppressing androgen-driven prostate cancer cell growth. Used for Castration-resistant prostate cancer (CRPC), Metastatic castration-sensitive prostate cancer (mCSPC).
At a glance
| Generic name | Placebo plus enzalutamide |
|---|---|
| Also known as | Monotherapy arm |
| Sponsor | Pfizer |
| Drug class | Androgen receptor antagonist |
| Target | Androgen receptor (AR) |
| Modality | Small molecule |
| Therapeutic area | Oncology |
| Phase | Phase 3 |
Mechanism of action
Enzalutamide competitively inhibits androgen receptor (AR) signaling by preventing ligand binding and blocking AR nuclear accumulation and DNA binding. This mechanism is particularly effective in castration-resistant prostate cancer (CRPC) where AR remains active despite androgen deprivation therapy. The addition of placebo in this trial design serves as a control arm to assess enzalutamide's efficacy in a Phase 3 study.
Approved indications
- Castration-resistant prostate cancer (CRPC)
- Metastatic castration-sensitive prostate cancer (mCSPC)
Common side effects
- Fatigue
- Hot flashes
- Diarrhea
- Musculoskeletal pain
- Headache
- Hypertension
- Seizures
Key clinical trials
- A Study to Learn How PF-06821497 (Mevrometostat) Works in Men With Metastatic Castration-resistant Prostate Cancer. (PHASE3)
- Efficacy and Safety of Pembrolizumab (MK-3475) Plus Enzalutamide Plus Androgen Deprivation Therapy (ADT) Versus Placebo Plus Enzalutamide Plus ADT in Participants With Metastatic Hormone-Sensitive Prostate Cancer (mHSPC) (MK-3475-991/KEYNOTE-991) (PHASE3)
- Talazoparib + Enzalutamide vs. Enzalutamide Monotherapy in mCRPC (PHASE3)
- Study of Talazoparib With Enzalutamide in Men With DDR Gene Mutated mCSPC (PHASE3)
- This Study Will Explore Whether a Combination of the Investigational Drug Mevrometostat (PF-06821497) and Enzalutamide Will Work Better Than Taking Enzalutamide Alone in Participants With mCSPC Who Are ARPI naïve. (PHASE3)
- A Study of Enzalutamide Plus the Glucocorticoid Receptor Antagonist Relacorilant Versus Placebo for Patients With High-risk Localized Prostate Cancer (PHASE2)
- Contributions to Hypertension With Androgen Deprivation Therapy (PHASE4)
- An Efficacy and Safety Study of Enzalutamide Plus Androgen Deprivation Therapy (ADT) Versus Placebo Plus ADT in Chinese Patients With Metastatic Hormone Sensitive Prostate Cancer (mHSPC) (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:
- Placebo plus enzalutamide CI brief — competitive landscape report
- Placebo plus enzalutamide updates RSS · CI watch RSS
- Pfizer portfolio CI