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 @ 10:17 PM
Ignite Modification Date:
2025-12-24 @ 10:17 PM
NCT ID:
NCT01117935
Eligibility Criteria:
Inclusion Criteria:
* Patients with biopsy-proven adenocarcinoma of the prostate are eligible for protocol enrollment when the following criteria are met; patients must have low, intermediate or high-risk adenocarcinoma of the prostate, as defined by the National Comprehensive Cancer Network (NCCN) criteria
* A diagnostic CT scan of the abdomen and pelvis will be obtained to rule out regional disease (maximum of 60 days prior to registration) for high-risk patients only
* A bone scan showing no evidence of metastatic disease is also required for patients whose prostate-specific antigen (PSA) is greater than 20 ng/ml, Gleason's sum is greater than 7, or T-stage is greater than T2b
* Alkaline phosphatase within 1.5 x upper limit of normal (ULN) is required for all patients beginning hormone therapy
* AST within 1.5 x ULN is required for all patients beginning hormone therapy
* Bilirubin within 1.5 x ULN is required for all patients beginning hormone therapy
* Karnofsky Performance score \>= 80
* Prior to registration, patients having received no more than three months treatment with anti-androgen, luteinizing hormone-releasing hormone (LHRH) agonist, or a combination of the two remain eligible for protocol treatment; the qualifying PSA for these patients will be the value recorded prior to the initiation of the hormone therapy
Exclusion Criteria:
* Patients with history of inflammatory bowel disease, or who require steroid or cytotoxic therapy for collagen vascular disease
* Patients with a history of cancer other than skin cancer within five years of the initiation of protocol treatment
* Patients with a history of pelvic irradiation for any reason
Healthy Volunteers:
False
Sex:
MALE
Minimum Age:
18 Years
Study:
NCT01117935
Study Brief:
Protocol Section:
NCT01117935