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 @ 9:11 PM
Ignite Modification Date:
2025-12-24 @ 9:11 PM
NCT ID:
NCT00715104
Eligibility Criteria:
Inclusion Criteria:
* Adenocarcinoma of the prostate.
* Subject is scheduled for RP as the initial therapy for localized prostate cancer.
* Subject is ≥ 18 years of age.
* Subject has an Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.
* Subject has adequate hematologic, renal, and liver function.
Exclusion Criteria:
* Subject has any evidence of metastasis.
* Subject received hormones, including luteinizing hormone-releasing hormone agonists, antiandrogens, or 5 α-reductase inhibitors at any time prior to study screening.
* Subject has received prior radiation therapy or chemotherapy for prostate cancer.
* Subject has received systemic steroid therapy within 14 days.
* Subject has a history of stage III or greater cancer, excluding prostate cancer.
* Subjects with a history of basal or squamous cell skin cancers are allowed, provided that the subject was adequately treated and is disease-free at the time of study screening.
* Subjects with a history of stage I or II cancer must have been adequately treated and been disease-free for ≥ 3 years prior to study screening.
Healthy Volunteers:
False
Sex:
MALE
Minimum Age:
18 Years
Study:
NCT00715104
Study Brief:
Protocol Section:
NCT00715104