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:
2025-12-24 @ 2:14 PM
Ignite Modification Date:
2025-12-24 @ 2:14 PM
NCT ID:
NCT00769795
Eligibility Criteria:
Inclusion Criteria:
* Men 18 years or older with clinically localized prostate cancer who have chosen surgery (prostatectomy) and are at high risk of cancer relapse due to clinical stage, Gleason Score, PSA level, or a combination of the three.
* Good health and laboratory values within reasonable limits
Exclusion Criteria:
* Patients with prostate cancer that has spread outside the prostate.
* Patients who have low testosterone
* Patients who have received hormonal therapies or drugs which affect hormone metabolism
* Patients with serious medical conditions such as diabetes, other cancers, stroke, cardiovascular disease.
* Patients who are receiving other investigational therapy or chemotherapy.
* Patients who are unwilling to use contraceptives during and for a short time after the study
* Inability to give informed consent for any reason
Healthy Volunteers:
False
Sex:
MALE
Minimum Age:
18 Years
Study:
NCT00769795
Study Brief:
Protocol Section:
NCT00769795