A Trial of Degarelix in Patients With Prostate Cancer

What Was Tested

The trial (phase 3) is built around Goserelin and Degarelix.

It had two arms (groups): one (experimental) and Goserelin acetate (active comparator).

The registry classes the interventions as drug.

Who Took Part

The registry lists 859 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: 18 years or older. Has a histological confirmed prostate cancer Gleason graded). Has a screening testosterone above 2.2 ng/mL. Rising prostate-specific antigen (PSA). Has Eastern Cooperative Oncology Group (ECOG) score of ≤ 2.

The full record lists 6 inclusion and 8 exclusion criteria; among the exclusions: current or previous hormone therapy; has received therapy with finasteride and dutasteride within 12 weeks and 25 weeks, respectively, prior to screening; has a history of severe untreated asthma, anaphylactic reactions, or severe urticaria and/or angioedema.

How the Study Was Run

It was run as a randomized, parallel-group and open-label study.

Random assignment meant chance, not the researchers, decided who got Goserelin and who got the comparison, which limits bias.

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

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

It started in 2009-06 with completion listed for 2011-03.

It ran at 126 sites in United States (36), Canada (13), Romania (10), Hungary (9), Russia (9) and Czechia (8).

Its stated primary purpose is treatment.

What Was Measured

Primary outcome: Cumulative Probability of Testosterone at Castrate Level (≤0.5 ng/mL) With Degarelix (time frame: From Day 28 to Day 364). Difference in Cumulative Probability of Testosterone at Castrate Level (≤0.5 ng/mL) Between Degarelix and Goserelin (time frame: Day 3 to Day 364).

It also tracked 4 secondary outcomes, for example Serum Levels of Testosterone Over Time, Percent Change in Serum Levels of Prostate-specific Antigen (PSA) Over Time, Change in Health-related Quality of Life (HRQoL), as Measured by Short Form-36 (SF-36) Score at Month 10 and Month 13 Compared to Baseline and Change in International Prostate Symptom Score (IPSS) Score at Months 1, 4, 7, and 13 Compared to Baseline.

What This Means in Plain Language

Put simply, this is a phase 3, randomized trial of Goserelin and Degarelix in 859 people.

With 859 participants it is a large trial for this field.

The trial is marked completed; results are posted on the registry, and this page does not restate them.

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