Clinical trial · Interventional
Study of Enzalutamide (Formerly MDV3100) as a Neoadjuvant Therapy for Patients Undergoing Prostatectomy for Localized Prostate Cancer
A Randomized, Open-label, Phase 2 Study Of Mdv3100 As A Neoadjuvant Therapy For Patients Undergoing Prostatectomy For Localized Prostate Cancer
NCT01547299CI-TRIAL-00035411completedPhase 2Results postedClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
The purpose of this study is to determine if enzalutamide is an effective therapy in treating localized prostate cancer prior to prostatectomy.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Prostate Cancer | Malignant Prostate Neoplasm | CURATED_EXACT | 0.92 |
Interventions
Interventions (3)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Dutasteride | Drug | — | UNRESOLVED |
| Enzalutamide | Drug | Enzalutamide | ALIAS |
| Leuprolide | Drug | Leuprolide | ALIAS |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Enzalutamide alone
- description
- Enzalutamide 160 mg, orally, once daily
- interventionNames
- Drug: Enzalutamide
- type
- EXPERIMENTAL
- label
- Enzalutamide & Leuprolide & Dutasteride
- description
- Enzalutamide 160 mg, orally, once daily and leuprolide 22.5 mg, intramuscular injection, every 3 months, and dutasteride, 0.5 mg, orally, once daily
- interventionNames
- Drug: Enzalutamide
- Drug: Leuprolide
- Drug: Dutasteride
Primary outcomes (1)
- measure
- Pathologic Complete Response Rate
Eligibility
Eligibility (as posted)
- Sex
- Male
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Willing to provide informed consent * 18 years of age or older * Histologically confirmed adenocarcinoma of the prostate * Must be a candidate for radical prostatectomy and considered surgically resectable Exclusion Criteria: * Stage T4 prostate cancer by clinical or radiologic evaluation * Treatment with an investigational agent within 4 weeks prior to randomization * Received therapy for other neoplastic disorders within 5 years * Hypogonadism or severe androgen deficiency
References
Publications (0)
Data not yet available
No reference posted for this study.