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 @ 6:36 PM
Ignite Modification Date:
2025-12-24 @ 6:36 PM
NCT ID:
NCT00201357
Eligibility Criteria:
Inclusion Criteria:
* 18 years of age or older.
* Histologically or cytologically confirmed adenocarcinoma of prostate that is metastatic, hormone-refractory (confirmed by testing serum testosterone), and clinically progressive following at least one prior hormonal regimen.
* Patients must have documented progression of disease on anti-androgen withdrawal, if the patient have documented progression on previous anti-androgen therapy.
* Measurable (patient with measurable bi-dimensional disease) or evaluable disease (defined as the presence of a nonmeasurable abnormality on CT or on physical examination coupled with a PSA ³ 30).
* Karnofsky performance status ³ 60%.6. Adequate bone marrow functions: Granulocyte count 1,000/mm3, Platelets 75,000/mm3, haemoglobin 8 g/dl.
* Adequate renal and liver functions: Creatinine \< 1.5 mg/dl, Bilirubin \< 2 mg/dl, ALT/AST less than 2.5 times the upper limit of the reference range for the institute.
* Patients with chemical or clinical hypothyroidism should have their thyroid replacement prior to starting study.
* Patients must have recovered from the effect of recent surgery (at least 4 weeks apart), radiotherapy (at least 4 weeks apart).
* Patients have ability to complete Quality of Life (QoL) questionnaires.
* Patients must sign informed consent.
Exclusion Criteria:
* Patients with advanced second primary malignancy.
* Patients with brain metastases.
* Patients with hypersensitivity to thalidomide.
* History of myocardial infarction within past 6 months, uncontrolled congestive heart failure or angina pectoris.
* Patients with orthostatic hypotension before therapy.
* Patients with NCI CTC grade 3 or greater peripheral neuropathy of any cause that is clinically detectable.
* Patients with active infection, including positive serology for HIV.
* Patients who have received chemotherapy before for treatment of metastases of prostate cancer, or received other investigational agents or corticosteroids within 4 weeks prior to enrollment of study.
Healthy Volunteers:
False
Sex:
MALE
Minimum Age:
18 Years
Study:
NCT00201357
Study Brief:
Protocol Section:
NCT00201357