Study of Enzalutamide (Formerly MDV3100) as a Neoadjuvant Therapy for Patients Undergoing Prostatectomy for Localized Prostate Cancer

Pfizer

Status and phase: Completed; Phase 2

Conditions: Prostate Cancer

Treatments: Drug: Leuprolide; Drug: Dutasteride; Drug: Enzalutamide

Study type: Interventional

Funder types: Industry

Identifiers

NCT01547299

MDV3100-07

C3431019 (Other Identifier)

Details and patient eligibility

About

The purpose of this study is to determine if enzalutamide is an effective therapy in treating localized prostate cancer prior to prostatectomy.

Enrollment: 52 patients

Sex: Male

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Willing to provide informed consent
• 18 years of age or older
• Histologically confirmed adenocarcinoma of the prostate
• Must be a candidate for radical prostatectomy and considered surgically resectable

Exclusion criteria

• Stage T4 prostate cancer by clinical or radiologic evaluation
• Treatment with an investigational agent within 4 weeks prior to randomization
• Received therapy for other neoplastic disorders within 5 years
• Hypogonadism or severe androgen deficiency

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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52 participants in 2 patient groups

Enzalutamide alone

Experimental group

Description:

Enzalutamide 160 mg, orally, once daily

Treatment:

Drug: Enzalutamide

Enzalutamide & Leuprolide & Dutasteride

Experimental group

Description:

Enzalutamide 160 mg, orally, once daily and leuprolide 22.5 mg, intramuscular injection, every 3 months, and dutasteride, 0.5 mg, orally, once daily

Treatment:

Drug: Enzalutamide

Drug: Dutasteride

Drug: Leuprolide