Efficacy and safety of leuprorelin acetate 6-month depot in prostate cancer patients: a Phase III, randomized, open-label, parallel-group, comparative study in Japan

What Was Tested

The paper reports a study of Leuprolide, published as a randomized controlled trial.

Leuprorelin acetate (TAP-144-SR) is commonly used worldwide in prostate cancer patients.

Who Took Part

The abstract describes 81 subjects taking part.

By PubMed's age tags, the people studied were middle-aged adults, older adults and people over 80, men only.

How the Study Was Run

The researchers set it up as a randomized, open-label and parallel-group study.

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.

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.

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

This was a 48-week Phase III, open-label, parallel-group comparative study.

The primary endpoint was the rate of serum testosterone suppression to the castrate level (≤100 ng/dl).

What Was Measured

The subject headings attached to it are Antineoplastic Agents, Hormonal, Biomarkers, Tumor, Japan, Leuprolide, Prostate-Specific Antigen, Prostatic Neoplasms and Testosterone.

The authors tagged it with the keywords leuprorelin, luteinizing hormone-releasing hormone and prostate cancer.

What This Means in Plain Language

The paper is a randomized, open-label and parallel-group study of Leuprolide in 81 subjects.

Results are reported in around 8 sentences of the abstract; we leave them to the paper itself rather than summarise them.

The publication is from 2015 (Japanese journal of clinical oncology), a journal based in England.

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