Prostate Cancer
Conditions
Brief summary
One month degarelix/comparator treatment for prostate cancer in Chinese population
Interventions
DRUGDegarelix
DRUGGoserelin
Sponsors
Ferring Pharmaceuticals
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
MALE
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Chinese male over 18 years * Adenocarcinoma of the prostate * Relevant disease status based on lab values and as judged by the physician * Life expectancy of at least a year
Exclusion criteria
* Previous hormonal treatment for prostate cancer * Considered to be candidate for curative therapy * Risk or history of any serious or significant health condition * Has received an investigational drug within the last 28 days and no previous treatment with degarelix
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Cumulative probability of testosterone at castrate level (≤0.5 ng/mL) | Day 28 to Day 364 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Percentage change in prostate-specific antigen (PSA) | from baseline to Day 28 | — |
| Changes in testosterone and PSA levels | Day 0 to 364 | — |
| Significant changes in laboratory values | Day 0 to Day 364 | — |
| Proportion of patients with testosterone levels ≤0.5 ng/mL | at Day 3 | — |
| Significant changes in body weight | Day 0 to Day 364 | — |
| Frequency and severity of adverse events | Day 0 to Day 364 | — |
| Cumulative probability of no PSA failure | Day 0 to Day 364 | PSA failure defined as two consecutive (at least two weeks apart) increase of 50 percentage and at least 5ng/mL increase compared to nadir |
| Significant changes in vital signs | Day 0 to Day 364 | — |
Countries
China
Outcome results
None listed