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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 is a Phase 2 study that has completed, run by Case Comprehensive Cancer Center. The registered enrollment target is 54 participants.
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.
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 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT02770391
The ClinicalTrials.gov registry entry for NCT02770391 describes a study currently listed as completed, categorized as Phase 2. The registered enrollment target is 54 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Case Comprehensive Cancer Center, which has 407 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 3 interventions - of which Apalutamide is the first listed.
NCT02770391 reports 0 study locations.
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.
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