At a glance
ClinicalIndex Comparison Record- ✓Histologically or cytologically confirmed adenocarcinoma of the prostate without neuroendocrine differentiation, signet cell, or small cell features
- ✓Prior definitive treatment by radical prostatectomy or radiotherapy (including brachytherapy) with curative intent
- ✓PSA doubling time ≤9 months
- ✓Screening PSA ≥1 ng/mL (after prostatectomy ± radiotherapy) or ≥2 ng/mL above nadir (radiotherapy only)
- ✕Evidence of distant metastatic disease on imaging
- ✕Prior hormonal therapy, with limited exceptions: neoadjuvant/adjuvant therapy ≤36 months duration and ≥9 months before randomization, or single dose/short course (≤6 months) given ≥9 months before randomization
- ✕Prior cytotoxic chemotherapy, aminoglutethimide, ketoconazole, abiraterone acetate, or enzalutamide
- ✕Prior systemic biologic therapy including immunotherapy for prostate cancer
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
A Phase 3, Randomized, Efficacy and Safety Study of Enzalutamide Plus Leuprolide, Enzalutamide Monotherapy, and Placebo Plus Leuprolide in Men With High-Risk Nonmetastatic Prostate Cancer Progressing After Definitive Therapy
In Brief
A Phase 3 clinical trial evaluating Enzalutamide, Placebo (No longer applicable in Open Label study period), and 1 other intervention for Hormone Sensitive Prostate Cancer and 2 related conditions. Active but no longer recruiting, targeting 1,068 participants across 255 sites in 17 countries.
Detailed Summary
The purpose of this study is to assess enzalutamide plus leuprolide in patients with high-risk nonmetastatic prostate cancer progressing after radical prostatectomy or radiotherapy or both. The randomized / blinded portion of the study is now completed following primary endpoint analyses. The study remains ongoing in open label format.
Study Details
Timeline
Interventions
Sugar pill to mimic enzalutamide