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 @ 7:49 PM
Ignite Modification Date:
2025-12-24 @ 7:49 PM
NCT ID:
NCT00096304
Eligibility Criteria:
DISEASE CHARACTERISTICS:
* Histologically confirmed adenocarcinoma of the prostate
* Meets 1 of the following criteria:
* Measurable disease with any prostate-specific antigen (PSA) value
* Unidimensionally measurable lesion ≥ 20 mm by conventional techniques OR ≥ 10 mm by spiral CT scan
* Histologic confirmation required if measurable disease is confined to a solitary lesion
* Non-measurable disease with PSA ≥ 5 ng/mL\*
* The following are considered non-measurable disease:
* Bone lesions
* Pleural or pericardial effusion
* Ascites
* CNS lesions
* Leptomeningeal disease
* Irradiated lesions unless disease progression was documented after prior radiotherapy NOTE: \*Patients with PSA ≥ 5 ng/mL only are not eligible
* Progressive systemic disease despite ≥ 1 prior standard endocrine therapy with orchiectomy, luteinizing hormone-releasing hormone (LHRH) agonist, or diethylstilbestrol, as indicated by 1 of the following criteria:
* Objective evidence of increase \> 20% in the sum of the longest diameters of target lesions from the time of maximal regression OR the appearance of 1 or more new lesions
* One or more new lesions on bone scan secondary to prostate cancer AND PSA ≥ 5 ng/mL
* Elevated PSA (≥ 5 ng/mL) with 2 consecutive increases from baseline (taken ≥ 1 week apart)
* Serum testosterone ≤ 50 ng/dL for patients without bilateral orchiectomy
* Patients who have not had a bilateral orchiectomy should continue therapy with primary testicular androgen suppression (e.g., LHRH analogues)
PATIENT CHARACTERISTICS:
Age
* 18 and over
Performance status
* ECOG 0-2
Life expectancy
* Not specified
Hematopoietic
* Granulocyte count ≥ 1,500/mm\^3
* Platelet count ≥ 100,000/mm\^3
Hepatic
* Meets 1 of the following criteria:
* AST or ALT normal AND alkaline phosphatase ≤ 5 times upper limit of normal (ULN)
* AST or ALT ≤ 1.5 times ULN AND alkaline phosphatase ≤ 2.5 times ULN
* AST or ALT ≤ 5 times ULN AND alkaline phosphatase normal
* Bilirubin normal
Renal
* Creatinine ≤ 1.5 times ULN
Cardiovascular
* No uncontrolled high blood pressure
* No unstable angina
* No symptomatic congestive heart failure
* No myocardial infarction within the past 6 months
* No serious uncontrolled cardiac arrhythmia
* No New York Heart Association class III or IV heart disease
Other
* Fertile patients must use effective contraception during and for at least 3 months after study participation
* No peripheral neuropathy ≥ grade 2
* No prior severe hypersensitivity reaction to docetaxel or other drug formulated with polysorbate 80
PRIOR CONCURRENT THERAPY:
Biologic therapy
* No concurrent filgrastim (G-CSF) or sargramostim (GM-CSF)
Chemotherapy
* No prior chemotherapy, including estramustine or suramin for prostate cancer
* No other concurrent chemotherapy
Endocrine therapy
* See Disease Characteristics
* At least 4 weeks since prior antiandrogen therapy
* No concurrent hormonal therapy except steroids for adrenal insufficiency, hormones for non-disease-related conditions (e.g., insulin for diabetes), or intermittent dexamethasone as an antiemetic
Radiotherapy
* See Disease Characteristics
* At least 4 weeks since prior radiotherapy
* At least 8 weeks since prior strontium chloride Sr 89 or samarium Sm 153 lexidronam pentasodium
* No concurrent palliative radiotherapy
Surgery
* See Disease Characteristics
* At least 4 weeks since prior surgery and recovered
Healthy Volunteers:
False
Sex:
MALE
Minimum Age:
18 Years
Maximum Age:
120 Years
Study:
NCT00096304
Study Brief:
Protocol Section:
NCT00096304