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:
2025-12-26 @ 10:19 PM
Ignite Modification Date:
2025-12-26 @ 10:19 PM
NCT ID:
NCT00515112
Eligibility Criteria:
Inclusion Criteria:
* Prostate cancer
* Patient must have received primary definitive local therapy to the prostate (surgery and/or radiotherapy)
* Patient was surgically or pharmacologically castrated at least 6 months prior to starting the study
* Patient must have had a previous trial of anti-androgen therapy
* Patient must have a rising PSA
* No evidence of distant metastatic disease
* ECOG performance status \< 2
* Age \>18 years
* Patients must have normal hepatic function
Exclusion Criteria:
* Patients with a history of any previous cytotoxic therapy or radionuclide therapy (such as rhenium, strontium, or samarium)
* Patients may not be receiving any other investigational agents
* Uncontrolled intercurrent illness including, but not limited to ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, uncontrolled cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements
* Patients receiving renal dialysis
* Patients with significant pulmonary disease who have received chronic or pulse steroid therapy within the last 3 months prior to randomization will be excluded
* Patients who have known hypersensitivity to any of the AndroGel ingredients, including testosterone that is chemically synthesized from soy
Healthy Volunteers:
False
Sex:
MALE
Minimum Age:
18 Years
Study:
NCT00515112
Study Brief:
Protocol Section:
NCT00515112