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

What Was Tested

The trial (phase 2) is built around Leuprolide.

It had two arms (groups): Enzalutamide alone (experimental) and Enzalutamide & Leuprolide & Dutasteride (experimental).

The registry classes the interventions as drug.

Who Took Part

Enrollment: 52 actual participants took part.

It was open to men only aged from 18 years with no upper age limit.

Healthy volunteers were not accepted; participants needed the condition being studied.

Examples of who could join: 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.

The full record lists 4 inclusion and 4 exclusion criteria; among the exclusions: 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.

How the Study Was Run

Design: randomized, parallel-group and open-label.

Because people in this Leuprolide study were split into groups at random, differences between the groups are less likely to reflect who happened to join each one.

Groups ran in parallel: each of the participants stayed in one arm throughout.

Nothing was hidden in this open-label Leuprolide study: the participants and staff both knew the treatment.

It started in 2012-03-31 with completion listed for 2013-11-30.

It ran at 4 sites in United States (2) and Canada (2).

Its stated primary purpose is treatment.

What Was Measured

The main thing measured (primary outcome): Pathologic Complete Response Rate (time frame: Day 180).

It also tracked 30 secondary outcomes, for example Percentage of Participants With Positive Surgical Margins, Percentage of Participants With Extracapsular Extension: Local Review, Percentage of Participants With Extracapsular Extension: Central Review, Percentage of Participants With Positive Seminal Vesicles, Percentage of Participants With Positive Lymph Nodes and Prostate-Specific Antigen (PSA) Nadir.

What This Means in Plain Language

Put simply, this is a phase 2, randomized trial of Leuprolide in 52 people.

The trial is marked completed; results are posted on the registry, and this page does not restate them.

More context: the Leuprolide compound page, all human trials.