A Prospective Randomized Phase III, Trial Comparing Consolidation Therapy With or Without Strontium-89 Following Induction Chemotherapy in Androgen-Independent Prostate Cancer

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 testosterone must be continued

6. >/= 18 years of age

7. Life expectancy of greater than or equal to 12 weeks

8. Zubrod performance status
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