Chemotherapy With or Without Strontium-89 in Treating Patients With Prostate Cancer
Prostate Cancer

About this trial
This is an interventional treatment trial for Prostate Cancer focused on measuring adenocarcinoma of the prostate, stage IV prostate cancer, recurrent prostate cancer, Strontium-89, Induction Chemotherapy, Androgen-Independent Prostate Cancer
Eligibility Criteria
Inclusion Criteria: 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 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 Osteoblastic metastases on bone scan or CT scan Androgen-independent prostate adenocarcinoma Castrate testosterone level </= 50 ng/ml; treatment to maintain castrate levels of testosterone must be continued >/= 18 years of age Life expectancy of greater than or equal to 12 weeks Zubrod performance status </= 3 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 The patient must have the ability to understand and the willingness to sign a written informed consent document 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: History of allergic reactions attributed to compounds of similar chemical or biologic composition to the agents used on this trial 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 More than one prior cytotoxic treatment Prior Sr-89 or Sm-153 treatment 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 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 Predominant visceral metastases in the liver, lungs, or brain Symptomatic lymphadenopathy (scrotal or pedal edema) or significant local invasive disease (hematuria) Small cell carcinoma Recent history of transient ischemic attacks (TIA) or myocardial infarctions (MI) within 12 months, or active angina or claudication sufficient to limit activity Active or likely to become active second malignancy (other than non-melanoma skin cancer) 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
Sites / Locations
- Northeast Georgia Medical Center
- Curtis and Elizabeth Anderson Cancer Institute at Memorial Health University Medical Center
- Veterans Affairs Medical Center - Hines
- Swedish-American Regional Cancer Center
- Hematology Oncology Associates of the Quad Cities
- Genesis Regional Cancer Center at Genesis Medical Center
- Siouxland Hematology-Oncology Associates, LLP
- Mercy Medical Center - Sioux City
- St. Luke's Regional Medical Center
- University of Mississippi Cancer Clinic
- CCOP - Montana Cancer Consortium
- Hematology-Oncology Centers of the Northern Rockies - Billings
- Northern Rockies Radiation Oncology Center
- St. Vincent Healthcare Cancer Care Services
- Billings Clinic - Downtown
- Bozeman Deaconess Cancer Center
- St. James Healthcare Cancer Care
- Big Sky Oncology
- Great Falls Clinic - Main Facility
- Sletten Cancer Institute at Benefis Healthcare
- St. Peter's Hospital
- Glacier Oncology, PLLC
- Kalispell Medical Oncology at KRMC
- Kalispell Regional Medical Center
- Community Medical Center
- Guardian Oncology and Center for Wellness
- Montana Cancer Specialists at Montana Cancer Center
- Montana Cancer Center at St. Patrick Hospital and Health Sciences Center
- Good Samaritan Cancer Center at Good Samaritan Hospital
- Kinston Medical Specialists
- Summa Center for Cancer Care at Akron City Hospital
- Barberton Citizens Hospital
- Cancer Care Center, Incorporated
- Cancer Treatment Center
- McLeod Regional Medical Center
- CCOP - Greenville
- Medical City Dallas Hospital
- University of Texas MD Anderson Cancer Center
- Welch Cancer Center at Sheridan Memorial Hospital
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm 4
Experimental
Experimental
Experimental
Experimental
Induction regimen A
Induction regimen B
Consolidation arm I
Consolidation arm II
Doxorubicin IV over 24 hours day 1; Oral ketoconazole 3 x daily on days 1-7 of weeks 1, 3, and 5; Vinblastine IV over 30 minutes Day 1, oral Estramustine 3 x daily on Days 1-7 of weeks 2, 4, and 6.
Oral Prednisone 2 x daily on days 1-21 (days 1-14 of course 5 only) and Docetaxel IV over 1 hour Day 1.
Doxorubicin IV over 24 hours once weekly for 6 weeks + Strontium-89 IV once at beginning of chemotherapy.
Doxorubicin as in Consolidation arm I.