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 @ 1:39 AM
Ignite Modification Date:
2025-12-25 @ 1:39 AM
NCT ID:
NCT00499694
Eligibility Criteria:
DISEASE CHARACTERISTICS:
* Histologically confirmed adenocarcinoma of the prostate, meeting the following criteria:
* Metastatic disease
* Objective progression or rising prostate-specific antigen (PSA) despite androgen-deprivation therapy and antiandrogen withdrawal
* Patients with rising PSA must demonstrate a rising trend with 2 successive elevations at a minimum interval of 1 week
* Minimum PSA of 5 ng/mL or new areas of bony metastases on bone scan required if no measurable disease
* No minimum PSA for measurable disease
* Must have received ≤ 1 prior docetaxel-based chemotherapy for metastatic disease
* No known CNS disease or brain metastases
* Testosterone \< 0.5 ng/mL (castrate level)
* Concurrent luteinizing-hormone releasing-hormone agonist allowed to maintain castrate level
PATIENT CHARACTERISTICS:
* Zubrod performance status 0-1
* Life expectancy ≥ 12 weeks
* Absolute neutrophil count ≥ 1,500/mm³
* Platelet count ≥ 100,000/mm³
* Hemoglobin ≥ 8.0 g/dL
* Bilirubin normal
* Creatinine ≤ 2 mg/dL OR creatinine clearance ≥ 50 mL/min
* Urine protein:creatinine ratio ≤ 1.0 OR proteinuria ≤ 2+ by urine dipstick OR ≤ 1 g protein/24-hour urine collection
* Fertile patients must use effective contraception during and for ≥ 6 months after completion of study treatment
* No significant traumatic injury within the past 28 days
* Adequately controlled hypertension (defined as systolic blood pressure \[BP\] ≤ 150 mm Hg and/or diastolic BP ≤ 100 mm Hg on antihypertensive medications)
* No history of hypertensive crisis or hypertensive encephalopathy
* No New York Heart Association class II-IV congestive heart failure
* No myocardial infarction or unstable angina within the past 6 months
* No stroke or transient ischemic attack within the past 6 months
* No significant vascular disease (e.g., aortic aneurysm, aortic dissection)
* No symptomatic peripheral vascular disease
* No evidence of bleeding diathesis or coagulopathy
* No prior malignancy except adequately treated skin cancer or any other cancer in complete remission for ≥ 2 years
* Able to swallow and retain capsules
* No abdominal fistula, gastrointestinal perforation, or intra-abdominal abscess within the past 6 months
* No serious nonhealing wound, ulcer, or bone fracture
* No known hypersensitivity to any component of bevacizumab
* No history of allergic reactions attributed to compounds of similar chemical or biological composition to bevacizumab
* No uncontrolled intercurrent illness, including, but not limited to, any of the following:
* Ongoing or active infection
* Symptomatic congestive heart failure
* Unstable angina pectoris
* Cardiac arrhythmia
* No psychiatric illness or social situation that would preclude compliance with study requirements
* No HIV positivity
* No immune deficiency
PRIOR CONCURRENT THERAPY:
* See Disease Characteristics
* More than 4 weeks since prior flutamide
* More than 6 weeks since prior bicalutamide or nilutamide
* At least 4 weeks since prior radiotherapy
* At least 2 weeks since prior minor surgery
* More than 7 days since prior core biopsy or minor surgery (excluding placement of a vascular access device)
* More than 28 days since prior major surgery or open biopsy (8 weeks if high-risk procedure such as liver resection, thoracotomy, or neurosurgery)
* Concurrent low-dose aspirin (≤ 325 mg/day) allowed
* Concurrent anticoagulants allowed if patient has been on therapy ≥ 4 weeks and has no acute thromboembolic activity
* No concurrent major surgery
* No concurrent aprepitant
* No concurrent immunosuppressive therapy
* No concurrent combination anti-retroviral therapy for HIV-positive patients
* No other concurrent antitumor therapy (including radiotherapy)
* No other concurrent investigational agents
Healthy Volunteers:
False
Sex:
MALE
Minimum Age:
18 Years
Maximum Age:
120 Years
Study:
NCT00499694
Study Brief:
Protocol Section:
NCT00499694