Safety and Efficacy of TAK-385 for Patients With Localized Prostate Cancer

What Was Tested

This registered phase 2 trial tested Degarelix.

It had two arms (groups): TAK-385 (experimental) and Degarelix (active comparator).

The registry classes the interventions as drug.

More on the Plan

The drug being tested in this study is called TAK-385.

This study will see if TAK-385 \[an oral gonadotropin-releasing hormone (GnRH) antagonist\] brings testosterone levels down sufficiently, with the convenience and comfort of taking a pill.

It will look at the time it takes to restore testosterone levels after radiation therapy as well.

One hundred participants will be assigned by chance (like flipping a coin) to a treatment group: 60 to TAK-385, and 40 to degarelix.

Who Took Part

Enrollment: 103 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: Is male, 18 years of age or older. T2b-T2c disease, or. Gleason score 7, or. Prostate-specific antigen (PSA) 10-20 nanogram per milliliter (ng/mL). Is scheduled for EBRT to begin greater than or equal to (\>=) 12 weeks after the Baseline visit.

How the Study Was Run

It was run as a randomized, parallel-group and open-label study.

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

The Degarelix group and the comparison group ran side by side rather than switching.

Being open-label, the Degarelix study did not mask who received what.

It started in 2014-06 with completion listed for 2015-12.

It ran at 25 sites in United States (19) and United Kingdom (6).

Its stated primary purpose is treatment.

What Was Measured

It also tracked 22 secondary outcomes, for example Number of Participants With Treatment-emergent Adverse Events (TEAEs) Related to Vital Signs, Number of Participants With TEAEs Related to Physical Findings, Number of Participants With TEAEs Related to 12-lead Electrocardiogram (ECG) Findings, Number of Participants With TEAEs Categorized Into Investigations Related to Chemistry, Hematology or Urinalysis, Number of Participants Reporting One or More TEAEs and Serious Adverse Events (SAEs) and Average Percent Change in Prostate Size.

What This Means in Plain Language

Put simply, this is a phase 2, randomized trial of Degarelix in 103 people.

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

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