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NCT02677896 · ClinicalTrials.gov registry record · Phase 3
A Study of Enzalutamide Plus Androgen Deprivation Therapy (ADT) Versus Placebo Plus ADT in Patients With Metastatic Hormone Sensitive Prostate Cancer (mHSPC)
A Phase 3 study, sponsored by Astellas Pharma Global Development.
- Completed
- Registry status
- Phase 3
- Development phase
- 1,150
- Enrollment target
NCT02677896: Completed Phase 3 study, sponsored by Astellas Pharma Global Development.
NCT02677896 is a Phase 3 study that has completed, run by Astellas Pharma Global Development. The registered enrollment target is 1,150 participants, above the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (49% higher). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT02677896, a Phase 3 study, has completed, sponsored by Astellas Pharma Global Development.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 1,150 participants
- Enrollment target
Study Summary
The purpose of this study was to evaluate the efficacy of enzalutamide plus androgen deprivation therapy (ADT) as measured by radiographic progression-free survival (rPFS) based on central review. The study also evaluated the safety of enzalutamide plus ADT in mHSPC.
Primary Outcome
rPFS was calculated as the time from the date of randomization to the first objective evidence of radiographic progression disease (rPD) at any time or death up to 24 weeks after study drug discontinuation without documented radiographic progression, whichever occurred first. rPD was defined as progressive disease by Response Evaluation Criteria in Solid Tumors version 1.1 for soft tissue disease or by appearance of 2 or more new lesions on bone scan compared to baseline or week 13 according to
Interventions
- DRUG Placebo
- DRUG Enzalutamide
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 1,150 participants |
| Start Date | 2016-03-09 |
| Est. Completion | 2024-07-31 |
| Phase | Phase 3 |
What the finished NCT02677896 record still lists
NCT02677896 is an interventional study that assigns participants to a tested intervention. Its 1,150 participants enrollment target places it among the larger protocols in the corpus, above the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (49% higher).
The record links to 0 conditions, and to 2 interventions - of which Placebo is the first listed.
NCT02677896 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT02677896 about?
NCT02677896 is a clinical study titled "A Study of Enzalutamide Plus Androgen Deprivation Therapy (ADT) Versus Placebo Plus ADT in Patients With Metastatic Hormone Sensitive Prostate Cancer (mHSPC)". The purpose of this study was to evaluate the efficacy of enzalutamide plus androgen deprivation therapy (ADT) as measured by radiographic progression-free survival (rPFS) based on central review. The study also evaluated the safety of enzalutamide plus ADT in mHSPC.
What is the current status of trial NCT02677896?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 1,150 participants. The study started on 2016-03-09. Estimated completion is 2024-07-31.
What interventions are being tested in trial NCT02677896?
The interventions under investigation include: Placebo (DRUG), Enzalutamide (DRUG).
Who is sponsoring clinical trial NCT02677896?
This trial is sponsored by Astellas Pharma Global Development, which has 168 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT02677896's enrollment target sits among peer trials
1,150 238th of 2000 higher than 1,759 of 2,000 other Phase 3 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 3 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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