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NCT02770391 · ClinicalTrials.gov registry record · Phase 2
Apalutamide and Leuprolide in Intermediate and High-risk Prostate Cancer
A Phase 2 study, sponsored by Case Comprehensive Cancer Center.
- Completed
- Registry status
- Phase 2
- Development phase
- 54
- Enrollment target
NCT02770391: Completed Phase 2 study, sponsored by Case Comprehensive Cancer Center.
NCT02770391 is a Phase 2 study that has completed, run by Case Comprehensive Cancer Center. The registered enrollment target is 54 participants, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (59% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT02770391, a Phase 2 study, has completed, sponsored by Case Comprehensive Cancer Center.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 54 participants
- Enrollment target
Study Summary
This is a research study to test an investigational drug (Not FDA approved), Apalutamide given in combination with Leuprolide acetate (FDA approved) in men diagnosed with high-risk prostate cancer who have already selected to have surgery to remove their prostate gland as part of their treatment plan. The main purpose of this study is to determine how tumors make androgens (male hormones), which makes these tumors more aggressive and resistant to hormonal therapy and how a short period of treatment with Apalutamide and leuprolide acetate prior to surgery can affect the production of these hormones in normal and malignant prostate tissue.
Primary Outcome
To evaluate the differential effect of neo-adjuvant leuprolide and ARN-509 on dihydrotestosterone (DHT) concentration in benign prostate tissue based on HSD3B1 genotype.
Interventions
- DRUG Apalutamide
- DRUG Leuprolide acetate
- PROCEDURE Radical prostatectomy
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 54 participants |
| Start Date | 2016-10-17 |
| Est. Completion | 2020-04-29 |
| Phase | Phase 2 |
What the finished NCT02770391 record still lists
NCT02770391 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 54 participants, a relatively small participant target, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (59% lower).
The record links to 0 conditions, and to 3 interventions - of which Apalutamide is the first listed.
NCT02770391 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT02770391 about?
NCT02770391 is a clinical study titled "Apalutamide and Leuprolide in Intermediate and High-risk Prostate Cancer". This is a research study to test an investigational drug (Not FDA approved), Apalutamide given in combination with Leuprolide acetate (FDA approved) in men diagnosed with high-risk prostate cancer who have already selected to have surgery to remove their prostate gland as part of their treatment pla...
What is the current status of trial NCT02770391?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 54 participants. The study started on 2016-10-17. Estimated completion is 2020-04-29.
What interventions are being tested in trial NCT02770391?
The interventions under investigation include: Apalutamide (DRUG), Leuprolide acetate (DRUG), Radical prostatectomy (PROCEDURE).
Who is sponsoring clinical trial NCT02770391?
This trial is sponsored by Case Comprehensive Cancer Center, which has 407 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT02770391's enrollment target sits among peer trials
54 1160th of 2000 higher than 830 of 2,000 other Phase 2 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 2 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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