Prostate Cancer
Conditions
Keywords
adenocarcinoma of the prostate, stage III prostate cancer, stage IV prostate cancer, recurrent prostate cancer
Brief summary
RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Combining hormone therapy with chemotherapy and androgen suppression may kill more tumor cells. It is not yet known which treatment regimen is more effective for prostate cancer. PURPOSE: Randomized phase III trial to compare the effectiveness of chemotherapy plus hormone therapy versus androgen suppression alone as initial therapy in patients with prostate cancer that is metastatic or that cannot be removed surgically.
Detailed description
OBJECTIVES: * Determine the clinical benefit, as measured by time to progression and overall survival, of chemo/hormonal therapy compared to androgen ablation alone, when given as the initial systemic treatment in patients with acinar adenocarcinoma of the prostate that is not amenable to local therapy. * Validate the clinical significance of PSA criteria for progression. OUTLINE: This is a randomized study. Patients are randomized to 1 of 2 treatment arms. * Arm I: Patients are treated with medical or surgical castration followed by an anti-androgen therapy with either flutamide, bicalutamide, or nilutamide. * Arm II: Patients receive chemo/hormonal therapy for 3 eight week courses, followed by total androgen blockade. Each course consists of 6 weeks of cytotoxic therapy with doxorubicin, ketoconazole, vinblastine, and estramustine followed by 2 weeks of rest. These patients are also maintained on hydrocortisone both during treatment and during rest. Patients in arm II have a long-term central venous access device inserted. PROJECTED ACCRUAL: A total of 368 patients will be accrued for this study.
Interventions
DRUGBicalutamide
DRUGDoxorubicin hydrochloride
DRUGEstramustine Phosphate Sodium
DRUGFlutamide
DRUGKetoconazole
DRUGNilutamide
DRUGTherapeutic Hydrocortisone
DRUGVinblastine
PROCEDUREConventional Surgery
Surgical castration
Sponsors
National Cancer Institute (NCI)
M.D. Anderson Cancer Center
Study design
Allocation
RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
MALE
Healthy volunteers
No
Inclusion criteria
DISEASE CHARACTERISTICS: * Histologically proven acinar adenocarcinoma of the prostate * Metastatic or locally advanced disease that either is not appropriately treated with surgery or radiation, or has recurred following previous definitive local therapy * No CNS metastases * No histologic subtypes, such as pure ductal or any component of small cell carcinoma * Elevated PSA (at least 1.0 ng/mL in patients with prior prostatectomy or 4.0 ng/mL in those with prostate in place) PATIENT CHARACTERISTICS: Age: * Not specified Performance status: * Zubrod 0-2 Life expectancy: * At least 3 years Hematopoietic: * Absolute neutrophil count greater than 1,500/mm\^3 * Platelet count greater than 100,000/mm\^3 Hepatic: * Conjugated bilirubin no greater than 0.8 mg/dL or total bilirubin no greater than 1.5 mg/dL * Transaminase no greater than 4 times upper limit of normal Renal: * Creatinine clearance at least 40 mL/min Cardiovascular: * No evidence of bifascicular block on EKG * No evidence of active ischemia on EKG * No prior history of transient ischemic attack * No evidence of congestive heart failure Other: * No active peptic ulcer disease * No regular use of antacid or H2 blockers * No known or predicted achlorhydria * No concurrent use of terfenadine, astemizole, omeprazole, or cisapride * No second malignancy unless curatively treated * No history of deep venous thrombosis * No history of pulmonary embolism * No serious co-morbidity * HIV negative PRIOR CONCURRENT THERAPY: Biologic therapy: * Not specified Chemotherapy: * No prior cytotoxic systemic therapy Endocrine therapy: * Prior androgen deprivation therapy allowed if given for no more than 6 months to downstage primary * No androgen deprivation therapy within 1 year prior to study Radiotherapy: * No prior cytotoxic systemic therapy (including systemic strontium-89 irradiation) * Prior definitive radiotherapy to the prostate and/or one metastatic site allowed * At least 8 weeks since radiotherapy to the pelvis * At least 3 weeks since radiotherapy to a single metastatic site Surgery: * Prior prostatectomy allowed Other: * No concurrent anti-anginal therapy or aggressive anticoagulants
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Time to Progression | From baseline to post treatment (minimally 24+ weeks) |
Countries
United States
Outcome results
None listed