A Study to Compare the Effect of ASP3550 With Goserelin in Patients With Prostate Cancer

What Was Tested

In this phase 3 trial, researchers set out to test Goserelin and Degarelix.

It had two arms (groups): ASP3550 PART 1 and PART 2 (experimental) and Goserelin (active comparator).

Part 1 for 1 year treatment and Part 2 for an extended period of treatment.

Part 1 for 1 year treatment.

The registry classes the interventions as drug.

More on the Plan

This study consists of two parts.

Who Took Part

Enrollment: 234 actual participants took part.

It was open to men only aged from 20 years with no upper age limit.

Healthy volunteers were not accepted; participants needed the condition being studied.

Examples of who could join: Male patient with histologically confirmed prostate cancer (adenocarcinoma). Has a serum testosterone level above 2.2 ng/mL at screening. Has an Eastern Cooperative Oncology Group (ECOG) Performance Status (PS) score of 0 to 2 at screening. Has a serum PSA ≥ 2 ng/mL at screening. Has a life expectancy of at least 12 months.

The full record lists 6 inclusion and 7 exclusion criteria; among the exclusions: is a candidate for curative therapy, i.e., radical prostatectomy or radiotherapy within 12 months; has concurrent or a history of poorly controlled severe asthma, anaphylactic reactions, severe urticaria or angioedema; has hypersensitivity towards mannitol.

How the Study Was Run

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

Because people in this Goserelin study were split into groups at random, differences between the groups are less likely to reflect who happened to join each one.

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

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

It started in 2013-08-13 with completion listed for 2015-06-05.

It ran at 8 sites in Japan (8).

Its stated primary purpose is treatment.

What Was Measured

Researchers chose this as the main measure: Cumulative castration rate of treatment in terms of serum testosterone level (time frame: Up to one year of the treatment).

It also tracked 4 secondary outcomes, for example Proportion of castrated subjects in terms of serum testosterone level, Proportion of castrated subjects in terms of serum testosterone level, Changes in serum levels of prostate-specific antigen (PSA) over time and Safety assessed by the incidence of adverse events.

What This Means in Plain Language

Put simply, this is a phase 3, randomized trial of Goserelin and Degarelix in 234 people.

The trial is marked completed; no results are posted to the registry yet, so nothing here describes outcomes.

More context: the Goserelin compound page and the Degarelix compound page, all human trials.