Combination Chemotherapy Followed by Surgery in Treating Patients With Localized Prostate Cancer
Prostate Cancer

About this trial
This is an interventional treatment trial for Prostate Cancer focused on measuring adenocarcinoma of the prostate, stage II prostate cancer, stage III prostate cancer
Eligibility Criteria
DISEASE CHARACTERISTICS: Histologically confirmed adenocarcinoma of the prostate High-risk, as defined by 1 of the following: Stage T2b (palpable bilateral involvement) or surgically resectable T3 PSA 15 ng/mL or greater Gleason grade greater than 4+3 (4+3, 4+4, or 5+any, but not 3+4) At least a 50% chance of prostate cancer recurrence within 5 years Planned prostatectomy as primary therapy No evidence of bone metastases by bone scan No evidence of lymph nodes greater than 2 cm on pelvic computed tomography (CT) scan (scan required only if PSA greater than 40 ng/mL) PATIENT CHARACTERISTICS: Age: 18 and over Performance status: Eastern Cooperative Oncology Group(ECOG) 0-2 Life expectancy: At least 10 years Hematopoietic: White Blood Cell(WBC) at least 3,000/mm^3 Neutrophil count at least 1,500/mm^3 Platelet count at least 100,000/mm^3 Hepatic: Conjugated bilirubin no greater than upper limit of normal (ULN) Alkaline phosphatase no greater than 4 times ULN Alanine transaminase(ALT) no greater than 2 times ULN (1.5 times ULN if alkaline phosphatase greater than 2.5 times ULN) Renal: Not specified Cardiovascular: Ejection fraction greater than 50% by Multiple Gated Acquisition(MUGA)scan Other: No other malignancy within the past 5 years except nonmelanoma skin cancer No significant active medical illness that would preclude study therapy No peripheral neuropathy grade 2 or greater No hypersensitivity to drugs formulated with polysorbate-80 No significant contraindications to corticosteroids PRIOR CONCURRENT THERAPY: Biologic therapy: Not specified Chemotherapy: No prior cytotoxic chemotherapy No other concurrent cytotoxic chemotherapy Endocrine therapy: No prior or concurrent conventional hormonal therapy Radiotherapy: No prior or concurrent radiotherapy (external beam or brachytherapy) Surgery: See Disease Characteristics Other: No prior or concurrent cryotherapy
Sites / Locations
- OHSU Knight Cancer Institute
- Portland VA Medical Center
Arms of the Study
Arm 1
Experimental
Docetaxel, Mitoxantrone, Conventional Surgery
Drug: Docetaxel-35 mg/m2 i.v. over 15 - 30 minutes will be administered immediately after the mitoxantrone on the same schedule. Drug: Mitoxantrone-Initial dose will be 2 mg/m2 weekly for 3 of every 4 weeks. The dose will then be escalated as described in the dose escalation section up to a maximum dose of 6 mg/m2 weekly for 3 of every 4 weeks. Procedure/Surgery: Conventional Surgery- Prostatectomy will be scheduled 2-4 weeks after the last dose of chemotherapy