The efficacy and safety of degarelix: a 12-month, comparative, randomized, open-label, parallel-group phase III study in patients with prostate cancer

What Was Tested

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

Who Took Part

The study group was 610 patients.

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

In all, 610 patients with adenocarcinoma of the prostate (any stage; median age 72 years; median testosterone 3.93 ng/mL, median prostate-specific antigen, PSA, level 19.0 ng/mL) were randomized and received study treatment.

Androgen-deprivation therapy was indicated (neoadjuvant hormonal treatment was excluded) according to the investigator's assessment.

How the Study Was Run

In design terms this was a randomized 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.

Therapy was maintained for the 12-month study.

Both the intent-to-treat (ITT) and per protocol populations were analysed.

What Was Measured

The subject headings attached to it are Adenocarcinoma, Antineoplastic Agents, Hormonal, Gonadotropin-Releasing Hormone, Leuprolide, Oligopeptides, Prostate-Specific Antigen and Prostatic Neoplasms.

What This Means in Plain Language

The paper is a randomized study of Leuprolide and Degarelix in 610 patients.

With several hundred people or more, it is a fairly large study for this kind of research.

Results are reported in around 14 sentences of the abstract; we leave them to the paper itself rather than summarise them.

The publication is from 2008 (BJU international), a journal based in England.

More context: the Leuprolide compound page and the Degarelix compound page.