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 @ 4:12 AM
Ignite Modification Date:
2025-12-25 @ 4:12 AM
NCT ID:
NCT00244920
Eligibility Criteria:
DISEASE CHARACTERISTICS:
* Histologically confirmed adenocarcinoma of the prostate
* Locally advanced disease
* No metastatic disease
* High-risk characteristics, meeting ≥ 1 of the following criteria:
* Large, hard tumor on digital exam
* Aggressive-appearing cancer cells on biopsy
* Prostate-specific antigen \> 10 ng/mL
PATIENT CHARACTERISTICS:
Performance status
* 0-1
Life expectancy
* Not specified
Hematopoietic
* WBC \> 1,500/mm\^3
* Platelet count \> 100,000/mm\^3
* Hemoglobin \> 11.0 g/dL
Hepatic
* Bilirubin \< 2 times upper limit of normal (ULN)
* SGOT and SGPT \< 2 times ULN
* PT and PTT normal
Renal
* Creatinine \< 1.8 g/dL
Cardiovascular
* No history of ventricular arrhythmia or dysfunction
* No congestive heart failure
* No symptomatic coronary artery disease
* No prior myocardial infarction
* No history of thromboembolic disease (e.g., deep vein thrombosis or stroke) within the past 12 months
* No other significant cardiovascular disease
Pulmonary
* No pulmonary embolism within the past 12 months
* No exercise-limiting respiratory disease
Other
* Fertile patients must use effective barrier method contraception
* No sexual intercourse for 6 weeks after surgery
* No uncontrolled diabetes
* No serious acute infection
* No other malignancy except nonmelanoma skin cancer
PRIOR CONCURRENT THERAPY:
Biologic therapy
* No prior squalamine lactate
Chemotherapy
* No prior chemotherapy for prostate cancer
* No concurrent anticancer chemotherapy
Endocrine therapy
* No concurrent systemic corticosteroids
Radiotherapy
* No prior radiotherapy for prostate cancer
* No concurrent radiotherapy
Surgery
* No prior surgery for prostate cancer
* No other concurrent surgery
Other
* At least 6 weeks since prior and no concurrent use of over-the-counter or herbal drugs that have estrogenic activity
* No participation in another investigational study within the past 3 months
* No concurrent participation in another investigational study
Healthy Volunteers:
False
Sex:
MALE
Minimum Age:
18 Years
Study:
NCT00244920
Study Brief:
Protocol Section:
NCT00244920