NCT01927627

Enzalutamide in Patients With High-risk Prostate Cancer

A Phase 2 Study of Enzalutamide in Patients With High-risk Prostate Cancer Who Have Undergone Local Definitive Therapy With Radical Prostatectomy

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 42 (actual)
• Sponsor: Case Comprehensive Cancer Center · Academic / Other
• Sex: Male
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

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.

Conditions

• Adenocarcinoma of the Prostate

Interventions

Type	Name	Description
DRUG	enzalutamide	oral therapy with enzalutamide at 160mg (4 capsules) orally once daily (QD).

Timeline

• Start date: 2013-11-11
• Primary completion: 2017-03-29
• Completion: 2017-04-26
• First posted: 2013-08-22
• Last updated: 2019-03-20
• Results posted: 2019-03-12

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study