Randomized Phase III Study of Neo-Adjuvant Docetaxel and Androgen Deprivation Prior to Radical Prostatectomy Versus Immediate Radical Prostatectomy in Patients With High-Risk, Clinically Localized Prostate Cancer

Inclusion Criteria

DISEASE CHARACTERISTICS:

- Histologically confirmed adenocarcinoma of the prostate

- No small cell, neuroendocrine, or transitional cell carcinoma

- Clinically localized, stage T1-3a disease

- No radiographic evidence of metastatic disease*, as demonstrated by all of the
following:

- No pelvic lymph nodes > 1.5 cm by CT scan or MRI of the abdomen and pelvis or
endorectal MRI of the pelvis

- A negative biopsy required for lymph node(s) that measure > 1.5 cm

- If > 1 lymph node is > 1.5 cm, the largest or most accessible node is
biopsied

- Negative bone scan with plain films and/or MRI/CT scan confirmation, if
necessary NOTE: *Positive positron emission tomography scan and Prostascint
scans are not considered proof of metastatic disease

- Serum prostate-specific antigen level ≤ 100 ng/mL within the past 6 weeks

- Patients must have a known Gleason sum based on biopsy or TURP at study entry

- High-risk disease, meeting 1 of the following criteria:

- Probability of biochemical progression-free survival at 5 years after surgery <
60% by Kattan nomogram prediction

- Biopsy Gleason score 8 to 10

- Deemed an appropriate candidate for radical prostatectomy

PATIENT CHARACTERISTICS:

- ECOG performance status 0-2

- Life expectancy > 10 years

- Absolute neutrophil count ≥ 1,500/mm^3

- Platelet count ≥ 150,000/mm^3

- Creatinine ≤ 2.0 mg/dL

- Bilirubin normal (≤ 2.5 times upper limit of normal [ULN] for patients with Gilbert's
disease)

- AST and ALT ≤ 1.5 times ULN

- Fertile patients must use effective contraception during and for ≥ 2 months after
completion of study treatment

- Not at high risk for cardiac complications

- Prior deep venous thrombosis, pulmonary embolism, and/or cerebrovascular
accident allowed

PRIOR CONCURRENT THERAPY:

- No prior treatment for prostate cancer, including surgery, pelvic lymph node
dissection, radiotherapy, or chemotherapy

- Prior transurethral resection of prostate allowed

- Prior androgen-deprivation therapy (e.g., luteinizing hormone-releasing hormone
agonists, antiandrogens, or both) lasting ≤ 4 months allowed

- Concurrent systemic anticoagulation allowed

- No other concurrent systemic therapy, including androgen-deprivation therapy for the
treatment of the prostate cancer

- No concurrent oral antiandrogens

- No concurrent aprepitant

- No other concurrent chemotherapeutic agents except for any of the following:

- Steroids given for adrenal failure

- Hormones administered for nondisease-related conditions (e.g., insulin for
diabetes)

- Intermittent use of dexamethasone as an antiemetic or as pretreatment for
patients receiving docetaxel