Ignite Creation Date:
2025-12-25 @ 5:09 AM
Ignite Modification Date:
2026-03-05 @ 12:14 AM
Study NCT ID:
NCT01927627
Status:
COMPLETED
Last Update Posted:
2019-03-20
First Post:
2013-08-19
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Enzalutamide in Patients With High-risk Prostate Cancer
Sponsor:
Case Comprehensive Cancer Center
Organization:
Study Overview
Official Title:
A Phase 2 Study of Enzalutamide in Patients With High-risk Prostate Cancer Who Have Undergone Local Definitive Therapy With Radical Prostatectomy
Status:
COMPLETED
Status Verified Date:
2019-03
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The purpose of this study is to see how long it takes for prostate cancer to come back in patients who have had surgery to remove their prostate gland (radical prostatectomy), while being treated with enzalutamide (formerly known as MDV3100).
Enzalutamide is known as an androgen-receptor signaling inhibitor, which means that it blocks activity of the male hormone, testosterone. Most prostate cancers are dependent on testosterone for growth. In this study, patients will take enzalutamide after surgery to see if it keeps their cancer from coming back.
Enzalutamide is known as an androgen-receptor signaling inhibitor, which means that it blocks activity of the male hormone, testosterone. Most prostate cancers are dependent on testosterone for growth. In this study, patients will take enzalutamide after surgery to see if it keeps their cancer from coming back.
Detailed Description:
This is a pilot phase II study evaluating the clinical activity and safety of Enzalutamide (formerly known as MDV3100) a novel androgen receptor (AR) inhibitor in men with high-risk prostate cancer who have undergone local definitive therapy with radical prostatectomy.
Primary Objectives:
-To evaluate the clinical efficacy of enzalutamide in patients with high-risk prostate cancer with regards to: Time to disease progression defined by biochemical recurrence (BCR)
Secondary Objectives:
-To further evaluate the safety of enzalutamide in patients with high-risk prostate cancer
Patients will receive daily oral therapy with enzalutamide at 160mg (4 capsules) orally once daily (QD). Patients will continue on study until progressive disease, drug intolerability, consent withdrawal or completion of study at 24 months.
Primary Objectives:
-To evaluate the clinical efficacy of enzalutamide in patients with high-risk prostate cancer with regards to: Time to disease progression defined by biochemical recurrence (BCR)
Secondary Objectives:
-To further evaluate the safety of enzalutamide in patients with high-risk prostate cancer
Patients will receive daily oral therapy with enzalutamide at 160mg (4 capsules) orally once daily (QD). Patients will continue on study until progressive disease, drug intolerability, consent withdrawal or completion of study at 24 months.
Study Oversight
Has Oversight DMC:
True
Is a FDA Regulated Drug?:
True
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
False
Is an FDA AA801 Violation?:
Secondary ID Infos
| Secondary ID | Type | Domain | Link | View |
|---|---|---|---|---|
| NCI-2013-01661 | OTHER | NCI/CTRP | View |