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 @ 6:51 PM
Ignite Modification Date:
2025-12-24 @ 6:51 PM
NCT ID:
NCT00093457
Eligibility Criteria:
DISEASE CHARACTERISTICS:
* Histologically confirmed adenocarcinoma of the prostate
* Metastatic or recurrent disease
* No curative standard therapy exists
* Hormone-refractory disease
* Evidence of prostate-specific antigen (PSA) progression during androgen ablation therapy, including medical or surgical castration
* Documented PSA progression after completion of prior peripheral anti-androgens
* At least a 25% increase (≥ 5 ng/mL) over a reference value PSA with 2 consecutive rising PSAs taken ≥ 1 week apart
* Castrate level of testosterone ≤ 1.7 nmol/L for patients on medical androgen ablation
* Patients receiving luteinizing hormone-releasing hormone agonist therapy must continue this treatment during study participation
* PSA ≥ 10 ng/mL at the time of study entry
* Primary tumor tissue (paraffin embedded) must be available for immunohistochemistry
* Minimal symptomatic disease
* No requirement for morphine or equivalent dose \> 30 mg/day to control pain
* No known brain metastases
PATIENT CHARACTERISTICS:
Age
* 18 and over
Performance status
* ECOG 0-1
Life expectancy
* At least 12 weeks
Hematopoietic
* Absolute granulocyte count ≥ 1,500/mm\^3
* Platelet count ≥ 100,000/mm\^3
* No evidence of bleeding diathesis
Hepatic
* Bilirubin normal
* AST and ALT ≤ 2.5 times upper limit of normal
Renal
* Serum creatinine normal OR
* Creatinine clearance ≥ 60 mL/min
Cardiovascular
* No myocardial infarction within the past 6 months
* No congestive heart failure
* No unstable angina
* No active cardiomyopathy
* No unstable ventricular arrhythmia
* No uncontrolled hypertension
Other
* No serious infection
* No active peptic ulcer disease
* No upper gastrointestinal or other condition that would preclude study compliance with oral medication
* No uncontrolled psychotic disorder
* No history of allergic reaction attributed to compounds of similar chemical or biologic composition to sorafenib or other study agents
* No other serious illness or medical condition that would preclude study participation
* No other malignancy within the past 5 years except adequately treated non-melanoma skin cancer or other curatively treated solid tumor
PRIOR CONCURRENT THERAPY:
Biologic therapy
* Concurrent prophylactic filgrastim (G-CSF), sargramostim (GM-CSF), or other growth factors allowed for the management of adverse events only
Chemotherapy
* No prior chemotherapy
* No other prior cytotoxic chemotherapy
Endocrine therapy
* See Disease Characteristics
* Concurrent steroids allowed provided there has been no increase in steroid requirements within the past 4 weeks AND no increase in dose is planned
Radiotherapy
* At least 4 weeks since prior external-beam radiotherapy except low-dose non-myelosuppressive radiotherapy
* Concurrent low-dose non-myelosuppressive palliative radiotherapy allowed
Surgery
* Not specified
Other
* No prior investigational anticancer agents
* No concurrent therapeutic anticoagulation
* Concurrent prophylactic low-dose warfarin for venous or arterial access devices allowed
* No concurrent combination antiretroviral therapy for HIV-positive patients
* No other concurrent anticancer therapy
* No other concurrent investigational therapy
* No concurrent grapefruit juice
* Concurrent bisphosphonates allowed
Healthy Volunteers:
False
Sex:
MALE
Minimum Age:
18 Years
Maximum Age:
120 Years
Study:
NCT00093457
Study Brief:
Protocol Section:
NCT00093457