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 @ 3:14 PM
Ignite Modification Date:
2025-12-24 @ 3:14 PM
NCT ID:
NCT00118092
Eligibility Criteria:
Inclusion Criteria:
* Histologically confirmed adenocarcinoma of the prostate
* Metastatic disease
* Measurable or evaluable disease
* Prostate-specific antigen (PSA) ≥ 5 ng/mL OR new areas of bony metastases on bone scan are required for patients with no measurable disease
* Objective disease progression OR rising PSA despite receiving androgen deprivation therapy and undergoing antiandrogen withdrawal
* Patients with a rising PSA must have 2 successive elevations (measured ≥ 1 week apart)
* Must be castrate (testosterone \< 50 ng/mL)
* Luteinizing hormone-releasing hormone agonist therapy must be continued during study participation to maintain castrate levels of testosterone
* Must have received ≥ 1 prior chemotherapy regimen for metastatic disease
* No known brain metastases requiring active therapy
* Previously treated asymptomatic brain metastases allowed
* Performance status - ECOG 0-2
* At least 12 weeks
* Absolute neutrophil count ≥ 1,500/mm\^3
* Platelet count ≥ 100,000/mm\^3
* Hemoglobin ≥ 8.0 g/dL
* Bilirubin ≤ 1.5 times upper limit of normal (ULN)
* SGOT and/or SGPT ≤ 2.5 times ULN AND alkaline phosphatase normal
* Alkaline phosphatase ≤ 4 times ULN AND SGOT and/or SGPT normal
* Creatinine clearance ≥ 60 mL/min
* Creatinine normal
* QTc \< 450 msec for male patients
* LVEF \> 40% by MUGA
* EF normal by MUGA if prior anthracycline therapy
* No congenital long QT syndrome
* No left bundle branch block
* Deep venous thrombosis or other clinically significant thromboembolic event within the past 6 months allowed provided patient is clinically stable on anticoagulation therapy
* No history of serious ventricular arrhythmia (i.e., ventricular tachycardia or ventricular fibrillation ≥ 3 beats in a row)
* No myocardial infarction within the past year
* No cerebrovascular accident or transient ischemic attack within the past 6 months
* No New York Heart Association class III or IV congestive heart failure
* No poorly controlled angina
* No uncontrolled dysrhythmia or dysrhythmias requiring medication
* No active ischemic heart disease within the past 12 months
* No other significant cardiac disease
* Pulmonary embolus allowed within the past 6 months provided patient is clinically stable on anticoagulation therapy
* Fertile patients must use effective contraception
* Willing and able to provide blood samples
* No serious allergy (i.e., hypotension, dyspnea, anaphylaxis, or edema) to eggs
* No other concurrent malignancy or history of a curatively treated malignancy with a survival prognosis of \< 5 years
* No known HIV positivity
* No active infection
* No other severe acute or chronic medical or psychiatric condition or laboratory abnormality that would preclude study participation
* At least 4 weeks since prior flutamide (6 weeks for bicalutamide or nilutamide)
* At least 28 days since prior radiotherapy
* No prior radiotherapy field that included the heart (e.g., mantle)
* More than 6 months since prior coronary or peripheral artery bypass grafting
* More than 28 days since prior investigational agents for prostate cancer
* No concurrent agents that interact with cytochrome P450 3A4
* No concurrent warfarin for anticoagulation
* Concurrent low molecular weight heparin injection allowed
* No concurrent medications that would prolong QTc
* No other concurrent antineoplastic agents
* Concurrent zoledronate for bone metastases or hypercalcemia allowed
Healthy Volunteers:
False
Sex:
MALE
Minimum Age:
18 Years
Study:
NCT00118092
Study Brief:
Protocol Section:
NCT00118092