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 @ 3:23 AM
Ignite Modification Date:
2025-12-25 @ 3:23 AM
NCT ID:
NCT00083005
Eligibility Criteria:
DISEASE CHARACTERISTICS:
* Histologically confirmed adenocarcinoma of the prostate
* Metastatic disease
* Androgen-independent disease
* Clinically progressive disease documented by at least 1 of the following parameters:
* Two consecutively rising prostate-specific antigen (PSA) levels taken at least 1 week apart
* PSA ≥ 5.0 ng/mL
* Continued rise in PSA 4 weeks after discontinuation of prior flutamide OR 6 weeks after discontinuation of prior bicalutamide or nilutamide (for patients treated with anti-androgen agents)
* At least 1 new lesion on bone scan
* Progressive measurable disease
* Must have undergone bilateral surgical castration OR continue on a gonadotropin-releasing hormone agonist
* No brain metastases
PATIENT CHARACTERISTICS:
Age
* 18 and over
Performance status
* ECOG 0-2
Life expectancy
* Not specified
Hematopoietic
* Absolute neutrophil count \> 1,500/mm\^3
* Platelet count ≥ 100,000/mm\^3\*
* Hemoglobin ≥ 7.5 g/dL\* NOTE: \*No transfusions within the past 2 weeks
Hepatic
* AST and ALT \< 2.5 times upper limit of normal (ULN)
* Bilirubin \< ULN (≤ 3.0 times ULN for patients with Gilbert's syndrome)
* Alkaline phosphatase ≤ 2.5 times ULN OR
* Fractionated hepatic alkaline phosphatase ≤ 2.5 times ULN
Renal
* Creatinine ≤ 1.5 mg/dL OR
* Creatinine clearance ≥ 40 mL/min
Cardiovascular
* No transient ischemic attacks or cerebrovascular accident within the past 2 years
* No myocardial infarction within the past 6 months
* No uncontrolled congestive heart failure
* No uncontrolled angina pectoris
* No thromboembolic disease
Other
* No peripheral neuropathy ≥ grade 2
* No cognitive impairment that would preclude study participation or giving informed consent
* No other active malignancy within the past 2 years except non-melanoma skin cancer or superficial bladder carcinoma
* Fertile patients must use effective contraception for at least 1 month before, during, and for at least 1 month after study treatment
PRIOR CONCURRENT THERAPY:
Biologic therapy
* No prior thalidomide
Chemotherapy
* No prior docetaxel
* No prior estramustine
* No prior chemotherapy for metastatic prostate cancer
Endocrine therapy
* See Disease Characteristics
Radiotherapy
* Recovered from prior radiotherapy
Surgery
* See Disease Characteristics
* Recovered from prior surgery
Other
* No concurrent antiretroviral therapy for HIV-positive patients
* No concurrent complementary or alternative therapy that would interact with study drugs
* No concurrent herbal or nutritional products or dietary supplements that would interact with study drugs
* No concurrent aprepitant as secondary prophylaxis or antiemetic treatment
Healthy Volunteers:
False
Sex:
MALE
Minimum Age:
18 Years
Study:
NCT00083005
Study Brief:
Protocol Section:
NCT00083005