Docetaxel, Androgen Ablation, and External-Beam Radiation Therapy in Patients With High-Risk Localized Prostate Cancer

Inclusion Criteria:

Histologically confirmed adenocarcinoma of the prostate with any of following clinical features:

A) T3 or T4 B) T1-2 + Gleason Score 8-10 C) T1-2 + Gleason Score 7 + Prostate Specific Antigen (PSA) >10 ng/mL D) T1-2 + Any Gleason Score + PSA >20 ng/mL

No evidence of metastatic disease on chest x-ray, bone scan or CT scan of abdomen/pelvis.
Age > 18
The Eastern Cooperative Oncology Group (ECOG) Performance Status 0-1
Peripheral neuropathy: must be < grade 1
Hematologic parameters A) Absolute neutrophil count > 1,500/mm3 B) Hemoglobin > 8.0 g/dL C) Platelet count > 100,000/mm3.
Hepatic parameters / Renal function A) Total Bilirubin must be ≤ 1.2 mg/dL B) Transaminases (AST and ALT) must be < 1.5 x upper limit of normal (ULN) C) Alkaline phosphatase must be < 2.5 x ULN D) Creatinine < 1.5 x ULN ( < 2.1 mg/dL)
No prior pelvic or prostate radiation or chemotherapy for prostate cancer. Androgen ablation therapy with one of the luteinizing hormone-releasing hormone (LH-RH) agonists prior to enrollment is acceptable as long as protocol treatment with radiotherapy and chemotherapy is started within 3 months of the initiation of androgen ablation.
Patient must be willing to consent to using effective contraception while on treatment and for at least 3 months thereafter.

Exclusion Criteria:

Documented metastases on staging studies
Life expectancy <10 years secondary to co-morbid illness
Myocardial infarction or significant change in anginal pattern within one year prior to study entry or current congestive heart failure (New York Heart Association Class 2 or higher)
Patients with a history of severe hypersensitivity reaction to docetaxel or other drugs formulated with polysorbate 80
History of invasive malignancy within the last five years prior to study entry except for carcinoma in situ or nonmelanoma skin cancer.
Psychiatric conditions which would prevent compliance with treatment or adequate informed consent.
Patients receiving another investigational agent during chemo- and radiotherapy
Uncontrolled intercurrent illness or other conditions that limit compliance with protocol treatment