A Study to Evaluate the Safety and Efficacy of Relugolix in Men With Advanced Prostate Cancer

What Was Tested

This registered phase 3 trial tested Leuprolide.

It had two arms (groups): Relugolix (experimental) and Leuprolide Acetate (active comparator).

Relugolix for 48 weeks.

Leuprolide acetate for 48 weeks.

The registry classes the interventions as drug.

More on the Plan

There are 2 analyses for this study, a primary analysis and a final analysis.

Participants were randomized 2:1 to receive relugolix or leuprolide for 48 weeks, followed by a 30-day safety follow-up visit or early termination 30-day safety follow-up.

Final Analysis: The final analysis will occur after additional participants with metastatic disease (approximately 130) have been enrolled and randomized from any sites to the study, and have completed the 48-week treatment period.

A cohort of participants enrolled in China and Taiwan will be analyzed separately once they have completed treatment to support registration in China.

Who Took Part

Enrollment: 1134 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: Has histologically or cytologically confirmed diagnosis of adenocarcinoma of the prostate. Newly diagnosed androgen-sensitive metastatic disease; or. Has a serum testosterone at the Screening visit of ≥ 150 ng/dL (5.2 nanomoles \[nmol\]/liter \[L\]). Has an Eastern Cooperative Oncology Group performance status of 0 or 1 at initial screening and at baseline.

The full record lists 8 inclusion and 7 exclusion criteria; among the exclusions: in the investigator's opinion, is likely to require chemotherapy or surgical therapy for symptomatic disease management within 2 months of initiating androgen deprivation therapy; previous systemic cytotoxic treatment for prostate cancer (for example, taxane-based regimen); metastases to brain per prior clinical evaluation.

How the Study Was Run

The set-up was randomized, parallel-group and open-label.

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

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

Everyone knew when Leuprolide was being given (open label), which is simpler to run but leaves more room for expectations to affect what is reported.

It started in 2017-04-18 with completion listed for 2019-10-25.

It ran at 162 sites in United States (27), Japan (20), China (13), Brazil (12), Slovakia (9) and Canada (8).

Its stated primary purpose is treatment.

What Was Measured

The main thing measured (primary outcome): Sustained Castration Rate (time frame: From Week 5 Day 1 (Day 29) to Week 49 Day 1 (Day 337)).

It also tracked 25 secondary outcomes, for example Castration Rate At Week 1 Day 4, Castration Rate At Week 3 Day 1, Confirmed Prostate-specific Antigen (PSA) Response Rate, Profound Castration Rate At Week 3 Day 1 (Day 15), Follicle-stimulating Hormone (FSH) Level and PSA Response Rate At Week 3 Day 1.

What This Means in Plain Language

Put simply, this is a phase 3, randomized trial of Leuprolide in 1134 people.

With 1134 participants it is a large trial for this field.

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.