Study on Surgery With or Without Docetaxel and Hormone Therapy for Treating High-Risk Localized Prostate Cancer

Histologic documentation - Histologic documentation of prostatic adenocarcinoma.

Patients with small cell, neuroendocrine, or transitional cell carcinomas are not eligible.

All eligible patients must have a known Gleason sum based on biopsy or TURP at the time of registration.

Clinically localized disease - Patients must have clinical stage T1-T3a and no radiographic evidence of metastatic disease as demonstrated by:

• EITHER CT or MRI of the abdomen and pelvis, OR endorectal MRI of the pelvis that demonstrate no nodes > 1.5 cm. If one or more pelvic lymph node(s) measures > 1.5 cm, a negative biopsy is required. If more than one lymph node is > 1.5 cm, the largest or most accessible node should be biopsied.

AND

• Negative bone scan (with plain films and/or MRI and/or CT scan confirmation, if necessary). Positive PET and Prostascint scans are not considered proof of metastatic disease.

Determination of high-risk status: Patients must have either:

• A Kattan nomogram predicted probability of being free from biochemical progression at 5 years after surgery of < 60%.

OR

• Prostate biopsy Gleason sum ≥ 8 (NOTE: The Kattan nomogram probability must be calculated for all patients, including those eligible based on Gleason sum ≥ 8 only.)

Prior treatment - No prior treatment for prostate cancer including prior surgery (excluding TURP), pelvic lymph node dissection, radiation therapy, or chemotherapy.

Patients may have received up to 4 months of androgen deprivation therapy (LHRH agonists, antiandrogens, or both) prior to being enrolled on the study.

Appropriate surgical candidates - Patients must be appropriate candidates for radical prostatectomy with an estimated life expectancy > 10 years as determined by a urologist. Evidence of underlying cardiac disease should be evaluated prior to enrollment to ensure that patients are not at high risk of cardiac complications.

Clotting history - Patients with a history of deep venous thrombosis, pulmonary embolism, and/or cerebrovascular accident or currently requiring systemic anticoagulation are eligible provided they are determined to be candidates for radical prostatectomy.

ECOG performance status: 0-2

Age: ≥ 18 years of age

Required Initial Laboratory Values:

• ANC ≥ 1500/μL
• Platelet count ≥ 150,000/μL
• Creatinine ≤ 2.0 mg/dL
• Pre-registration serum PSA level ≤ 100 ng/mL
• Bilirubin ≤ 1.5XULN (2.5XULN in patients with Gilbert's disease)
• AST/ALT ≤1.5XULN