A Phase 2 Study to Evaluate Safety and Efficacy of Abiraterone Acetate in Male Participants With Prostate Cancer

What Was Tested

This registered phase 2 trial tested Leuprolide.

It had two arms (groups): Abiraterone plus leuprolide plus prednisone (experimental) and Leuprolide then abiraterone plus leuprolide plus prednisone (active comparator).

The registry classes the interventions as drug.

More on the Plan

This is an open-label (all people know the identity of the intervention), randomized (the study drug is assigned by chance), and multi-center (conducted in more than one center) study of abiraterone in male participants with prostate cancer.

The duration of study will be approximately 24-32 weeks per participant.

Participants will receive either abiraterone, leuprolide and prednisone for 24 weeks (that is, Group 1) or leuprolide once every 12 weeks up to Week 24 then abiraterone and prednisone from Week 13 to 24 (that is, Group 2).

All the eligible participants will be randomly assigned to 1 of the 2 treatment groups.

Who Took Part

The registry lists 58 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: Histologically or cytologically confirmed adenocarcinoma of the prostate. Serum testosterone \>200 nanogram/deciliter. Participant and urologist must agree that participant is suitable for prostatectomy.

How the Study Was Run

The set-up was 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.

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 2009-11 with completion listed for 2012-02.

It ran at 4 sites in United States (4).

Its stated primary purpose is treatment.

What Was Measured

Researchers chose this as the main measure: Testosterone Concentration in Prostate Tissue (time frame: Week 12). Dihydrotestosterone (DHT) Concentration in Prostate Tissue (time frame: Week 12).

It also tracked 7 secondary outcomes, for example Testosterone and Dihydrotestosterone (DHT) Concentration in Prostate Tissue, Androstenedione and Dehydroepiandrosterone (DHEA) Concentrations in Prostate Tissue, Serum Levels of Androgens, Percentage of Participants With Prostate-specific Antigen (PSA) Response, Percentage of Participants With Pathologic Complete Response (CR) and Number of Participants With Tumor Expression of Androgen Receptor (AR) Regulated Genes at Week 24.

What This Means in Plain Language

Put simply, this is a phase 2, randomized trial of Leuprolide in 58 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.