Study to Find Maintenance Dose for Periodic Administration of ASP3550

What Was Tested

This registered phase 2 trial tested Degarelix.

It had two arms (groups): one (experimental) and one (experimental).

The registry classes the interventions as drug.

More on the Plan

ASP3550 is administered periodically to patients with prostate cancer.

Who Took Part

155 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: Histologically proven prostate cancer (adenocarcinoma) of all stages. A patient in whom endocrine treatment is indicated. Patients with rising serum PSA after having prostatectomy or radiotherapy performed with curative intention. Serum testosterone level above 2.2 ng/mL. An ECOG (Eastern Co-operative Oncology Group) P.S. (Performance Status) score of 0 to 2. Serum PSA level above 2 ng/mL.

The full record lists 5 inclusion and 7 exclusion criteria; among the exclusions: previous or present endocrine treatment for prostate cancer; A candidate for curative therapy, i.e., radical prostatectomy or radiotherapy within 12 months; concurrent or a history of severe liver disease.

How the Study Was Run

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

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

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

Nothing was hidden in this open-label Degarelix study: the participants and staff both knew the treatment.

It started in 2010-10-12 with completion listed for 2012-04-24.

It ran at 8 sites in Japan (8).

Its stated primary purpose is treatment.

What Was Measured

Researchers chose this as the main measure: Change in proportion of patients with serum testosterone ≤0.5 ng/mL over time (time frame: Baseline and for one year).

It also tracked 6 secondary outcomes, for example Changes in serum level of testosterone over time, Changes in serum level of Luteinizing Hormone (LH) over time, Changes in serum level of Follicle Stimulating Hormone (FSH) over time, Changes in serum level of Prostate Specific Antigen (PSA) over time, Time to the recurrence of serum PSA and Safety evaluated by the incidence of Adverse Events (AEs), physical exam and results of lab tests.

What This Means in Plain Language

Put simply, this is a phase 2, randomized trial of Degarelix in 155 people.

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

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