A Phase 2 Study to Evaluate the Safety and Efficacy of TAK-385, Together With a Leuprorelin Observational Cohort, in Participants With Prostate Cancer

What Was Tested

This registered phase 2 trial tested Leuprolide.

It had three arms (groups): one (experimental), one (experimental) and one (active comparator).

The registry classes the interventions as drug.

More on the Plan

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

Relugolix is being tested to treat people who have prostate cancer.

This study will look at achieving and maintaining testosterone suppression (\<50 ng/dL).

The study enrolled 136 patients.

Who Took Part

Enrollment: 136 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: Male participant 18 years or older. Histologically or cytologically confirmed diagnosis of prostate adenocarcinoma. Appropriate serum testosterone and serum PSA concentration at screening as specified in the protocol. A body mass index (BMI) ≥ 18.0 at screening and/or baseline. Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1 at screening and/or baseline.

The full record lists 9 inclusion and 19 exclusion criteria; among the exclusions: visceral metastases (liver or lung); features of the participant's medical condition that may make adt unnecessary or not indicated; scheduled for additional surgical or (salvage) radiation therapy within 6 months after baseline evaluations.

How the Study Was Run

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

The participants were allocated by chance, so the Leuprolide group and the comparison group should start out alike.

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

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

It started in 2014-03-26 with completion listed for 2016-01-01.

It ran at 23 sites in United States (19) and Canada (4).

Its stated primary purpose is treatment.

What Was Measured

It also tracked 16 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 Examination, Number of Participants With TEAEs Related to 12-lead Electrocardiogram (ECG) Findings, Number of Participants With TEAES Related to Clinical Laboratory Test Results, Number of Participants Reporting One or More Treatment Emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs) and Prostate-Specific Antigen Nadir.

What This Means in Plain Language

Put simply, this is a phase 2, randomized trial of Leuprolide in 136 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.