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 @ 12:39 AM
Ignite Modification Date:
2025-12-25 @ 12:39 AM
NCT ID:
NCT00024167
Eligibility Criteria:
Inclusion Criteria:
1. Rising PSA on at least 2 occasions \>1 week apart (minimum value of 5 ng/ml), accompanied either by bone pain or, if the patient is asymptomatic, by a worsening bone scan with new lesions over a period of \<6 months
2. Patients on antiandrogens should be discontinued from flutamide or nilutamide for at least 4 weeks and bicalutamide for 6 weeks; If progression is documented during this time interval as in inclusion criterion # 1, patients are eligible
3. Osteoblastic metastases on bone scan or CT scan
4. Androgen-independent prostate adenocarcinoma
5. Castrate testosterone level \</= 50 ng/ml; treatment to maintain castrate levels of testosterone must be continued
6. \>/= 18 years of age
7. Life expectancy of greater than or equal to 12 weeks
8. Zubrod performance status \</= 3
9. Patients must have normal organ and marrow function as defined below: Leukocytes greater than 3,000/mcL Absolute neutrophil count greater than 1,500/mcL Platelets greater than 100,000/mcL Total bilirubin less than or equal to 2X institutional upper limit of normal AST(SGOT)/ALT(SGPT) less than or equal to 2X institutional upper limit of normal
10. The patient must have the ability to understand and the willingness to sign a written informed consent document
11. Participating subjects and their female partners agree to the use of adequate contraception (hormonal or barrier method of birth control) prior to study entry and for the duration of study participation
Exclusion Criteria:
1. History of allergic reactions attributed to compounds of similar chemical or biologic composition to the agents used on this trial
2. Prior doxorubicin, or vinblastine in the KAVE arm and prior docetaxel in the prednisone plus docetaxel arm. However, previous treatment using other secondary hormonal agents (aminoglutethimide, diethylstilbesterol, estramustine), steroids (dexamethasone, prednisone, hydrocortisone), angiogenesis inhibitors, gene therapy, or immunotherapy are allowed
3. More than one prior cytotoxic treatment
4. Prior Sr-89 or Sm-153 treatment
5. Patients who have had chemotherapy, immunotherapy, or radiotherapy within 4 weeks (6 weeks for nitrosoureas or mitomycin C) prior to entering the study or those who have not recovered from adverse events due to agents administered more than 4 weeks earlier
6. Previous vagotomy or other conditions (such as pernicious anemia) associated with achlorhydria. Patients with active peptic ulcer disease who still require regular use of H2 blockers (such as cimetidine \[Tagamet\], ranitidine \[Zantac\], famotidine \[Pepcid\], etc), proton pump inhibitors (omeprazole \[Prilosec\]), or antacids (Mylanta, Maalox, Tums, etc) at week 16 of induction chemotherapy (option 1 only) might not be suitable for randomization
7. Predominant visceral metastases in the liver, lungs, or brain
8. Symptomatic lymphadenopathy (scrotal or pedal edema) or significant local invasive disease (hematuria)
9. Small cell carcinoma
10. Recent history of transient ischemic attacks (TIA) or myocardial infarctions (MI) within 12 months, or active angina or claudication sufficient to limit activity
11. Active or likely to become active second malignancy (other than non-melanoma skin cancer)
12. Uncontrolled inter-current illness: including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements
Healthy Volunteers:
False
Sex:
MALE
Minimum Age:
18 Years
Study:
NCT00024167
Study Brief:
Protocol Section:
NCT00024167