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 @ 4:07 AM
Ignite Modification Date:
2025-12-25 @ 4:07 AM
NCT ID:
NCT00946920
Eligibility Criteria:
Inclusion Criteria:
* 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.
* Has a life expectancy of at least one year.
Exclusion Criteria:
* 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.
* Has a heart insufficiency.
* Has a previous history or presence of another malignancy, other than prostate cancer or treated squamous/basal cell carcinoma of the skin, within the last five years.
* Has a clinically significant medical condition (other than prostate cancer) including, but not limited to, renal, haematological, gastrointestinal, endocrine, cardiac, neurological, or psychiatric disease and alcohol or drug abuse or any other condition which may affect the patient's health or the outcome of the trial as judged by the Investigator.
* Has received an investigational drug within the last 28 days before the Screening Visit or longer if considered to possibly influencing the outcome of the current trial.
* Is candidate for curative therapy, i.e. radical prostatectomy or radiotherapy.
Healthy Volunteers:
False
Sex:
MALE
Minimum Age:
18 Years
Study:
NCT00946920
Study Brief:
Protocol Section:
NCT00946920