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 @ 2:54 PM
Ignite Modification Date:
2025-12-24 @ 2:54 PM
NCT ID:
NCT00027859
Eligibility Criteria:
DISEASE CHARACTERISTICS:
* Histologically confirmed adenocarcinoma of the prostate that was continuously treated with androgen suppression
* Rising prostate-specific antigen (PSA), defined as PSA \> 5 ng/mL, rising on 2 consecutive measurements at least 4 weeks apart
* Gleason score 7 or higher and/or seminal vesicle involvement at diagnosis
* Patients previously treated with antiandrogen or glucocorticoid therapy must meet the following criteria:
* Must show a continued rise in PSA after stopping antiandrogen (flutamide, bicalutamide, or nilutamide) or glucocorticoid (dexamethasone or prednisone)
* At least 4 weeks continued rise in PSA after flutamide or nilutamide (6 weeks for bicalutamide)
* Testosterone less than 50 ng/dL
* Patients who have not undergone surgical castration must continue primary androgen suppression to maintain castrate levels of testosterone
* No progressive or measurable local or metastatic disease (including bone metastases)
PATIENT CHARACTERISTICS:
Age:
* 18 and over
Performance status:
* ECOG 0-1
Life expectancy:
* Not specified
Hematopoietic:
* Granulocyte count at least 2,000/mm\^3
* Platelet count at least 100,000/mm\^3
Hepatic:
* SGOT no greater than 2 times upper limit of normal
* Bilirubin no greater than 1.5 mg/dL
Renal:
* Creatinine no greater than 1.7 mg/dL
Cardiovascular:
* No American Heart Association class III or IV heart disease
* No uncontrolled congestive heart failure
* No life-threatening cardiac arrhythmias
Other:
* Fertile patients must use effective contraception
* No other prior malignancy unless curatively treated and disease-free for appropriate time period for specific cancer
* No preexisting peripheral neuropathy greater than grade 1
* No known hypersensitivity to polysorbate 80
PRIOR CONCURRENT THERAPY:
Biologic therapy:
* Not specified
Chemotherapy:
* At least 5 years since prior systemic chemotherapy
Endocrine therapy:
* See Disease Characteristics
* At least 4 weeks since prior hydrocortisone
* No prior ketoconazole
Radiotherapy:
* At least 28 days since prior radiotherapy to primary site
* No prior palliative radiotherapy
* No concurrent radiotherapy
Surgery:
* See Disease Characteristics
Other:
* Recovered form prior therapy
* At least 7 days since prior parenteral antibiotics for active infection
* No concurrent digitalis
* No concurrent H\_2 blockers or proton pump inhibitors (arm I only)
* Concurrent bisphosphonates allowed provided they were initiated prior to study therapy
Healthy Volunteers:
False
Sex:
MALE
Minimum Age:
18 Years
Maximum Age:
120 Years
Study:
NCT00027859
Study Brief:
Protocol Section:
NCT00027859