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

Condition(s) targeted: Prostate Cancer

Intervention: Enzalutamide (Drug); Leuprolide (Drug); Dutasteride (Drug)

Phase: Phase 2

Status: Completed

Sponsored by: Medivation, Inc.

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

Official title: A Randomized, Open-Label, Phase 2 Study of MDV3100 as a Neoadjuvant Therapy for Patients Undergoing Prostatectomy for Localized Prostate Cancer

Study design: Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Primary outcome: Pathologic Complete Response Rate

Secondary outcome:

Percentage of Patients With Positive Surgical Margins

Percentage of Patients With Extracapsular Extension: Local Review

Percentage of Patients With Extracapsular Extension: Central Review

Percentage of Patients With Positive Seminal Vesicles

Percentage of Patients With Positive Lymph Nodes

Prostate-Specific Antigen (PSA) Nadir

Time to Prostate-Specific Antigen (PSA) Nadir

Percentage of Patients With Reduction in Prostate-Specific Antigen (PSA)

Health-Related Quality of Life (HRQoL): The Expanded Prostate Cancer Index Composite (EPIC) Sexual Domain Summary Score

Health-Related Quality of Life (HRQoL): The Expanded Prostate Cancer Index Composite (EPIC) Sexual Function Subscale Score

Health-Related Quality of Life (HRQoL): The Expanded Prostate Cancer Index Composite (EPIC) Sexual Bother Subscale Score

Health-Related Quality of Life (HRQoL): The Expanded Prostate Cancer Index Composite (EPIC) Hormonal Domain Summary Score

Health-Related Quality of Life (HRQoL): The Expanded Prostate Cancer Index Composite (EPIC) Hormonal Function Subscale Score

Health-Related Quality of Life (HRQoL): The Expanded Prostate Cancer Index Composite (EPIC) Hormonal Bother Subscale Score

Health-Related Quality of Life (HRQoL): The Twelve-Item Short Form Version 2 General Health Domain Score

Health-Related Quality of Life (HRQoL): The Twelve-Item Short Form Version 2 Physical Functioning Domain Score

Health-Related Quality of Life (HRQoL): The Twelve-Item Short Form Version 2 Role-Emotional Domain Score

Health-Related Quality of Life (HRQoL): The Twelve-Item Short Form Version 2 Mental Component Summary

Pharmacodynamic Effects: Tissue Dihydrotestosterone (DHT)

Pharmacodynamic Effects: Tissue Testosterone

Pharmacodynamic Effects: Assessment of Apoptosis

Pharmacodynamic Effects: Assessment of Mitotic Index

Pharmacodynamic Effects: Assessment of Androgen Receptor Signaling

Serum Dihydrotestosterone (DHT): Baseline

Serum Dihydrotestosterone (DHT): 6 Months Postbaseline

Change From Baseline in Serum Dihydrotestosterone (DHT)

Serum Testosterone: Baseline

Serum Testosterone: 6 Months Postbaseline

Change From Baseline in Serum Testosterone

Number of Patients With Adverse Events (AEs) That Led to Dose Interruption, Dose Reduction, and Study Drug Discontinuation

Minimum age: 18 Years. Maximum age: N/A. Gender(s): Male.

Criteria:

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

Vancouver, British Columbia V5Z 1M9, Canada

Boston, Massachusetts 02215, United States

Toronto, Ontario M5G 2M9, Canada

Seattle, Washington 98195, United States

Starting date: March 2012
Last updated: April 21, 2015