Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-25 @ 2:51 AM
Ignite Modification Date:
2025-12-25 @ 2:51 AM
NCT ID:
NCT00728533
Eligibility Criteria:
Inclusion Criteria:
* Patients, aged 18 years or older, with a histologically proven prostate cancer of all stages in whom endocrine treatment is indicated.
* Screening testosterone level above the lower limit of normal range, globally defined as \> 2.2 ng/mL.
* Screening PSA level of =2 ng/mL. ECOG score of =2.
* Life expectancy of at least one year.
CRITERIA FOR EVALUATION:
Primary endpoint:
* Probability of testosterone at castrate level (=0.5 ng/mL) from Day 28 through Day 364.
Secondary endpoints:
* Probability of testosterone at castrate level (=0.5 ng/mL) from Day 56 through Day 364.
* Serum levels of testosterone, LH, FSH, and PSA over time.
* Time to PSA failure - defined as two consecutive increases of 50%, and at least 5 ng/mL, compared to nadir.
* Plasma levels of degarelix over time.
* Frequency and severity of adverse events.
* Clinically significant changes in laboratory safety parameters.
* Clinically significant changes in physical examinations, ECGs, vital signs, and body weight.
Healthy Volunteers:
False
Sex:
MALE
Minimum Age:
18 Years
Study:
NCT00728533
Study Brief:
Protocol Section:
NCT00728533