Neoadjuvant Hormones + Docetaxel in Node-Positive Prostate Cancer

Inclusion Criteria

• Patients with adenocarcinoma of the prostate that in the opinion of the surgeon could be resectable after response to systemic therapy. Ductal carcinoma variant is included.
• All patients must be regarded as acceptable anesthetic risk for radical prostatectomy and confirm their intention to undergo radical prostatectomy at the end of the neoadjuvant therapy.
• Zubrod performance status 2 or better.
• All patients must have thorough tumor staging and meet one of the following criteria: a) Either lymph node biopsy or lymph node dissection demonstrating presence of lymph node metastasis. b) Pelvic or retroperitoneal lymphadenopathy >/= 2.0 cm visualized on CT scan (biopsy is not required if >/= 2.0 cm and in typical distribution) c) Primary tumor Gleason score >/= 8 and serum PSA concentration >/= 25 ng/ml, indicating high risk of occult lymph node metastases.
• (# 4 cont'd) d) Primary tumor stage T3 and Gleason score >/= 7, indicating high risk of occult lymph node metastases. e) Primary tumor stage T4 indicating high risk of occult lymph node metastases.
• Prior hormonal therapy up to 6 months is permitted. No concurrent ketoconazole is permitted.
• Patients must have adequate bone marrow function defined as an absolute peripheral granulocyte count of > 1,500/mm^3 and platelet count of > 100,000/mm^3; adequate hepatic function defined with a total bilirubin of 40 cc/min (measured or calculated).
• Patients must sign an informed consent indicating that they are aware of the investigational nature of this study, in keeping with the policies of the institution.
• All patients must be evaluated in the Department of Urology and Department of Genitourinary Medical Oncology prior to signing informed consent.

Exclusion Criteria

• Patients with small cell or sarcomatoid histology.
• Patients with clinical or radiological evidence of bone or other extranodal metastasis (M1b or M1c).
• Prior chemotherapy.
• Patients with severe or uncontrolled intercurrent infection.
• Patients with New York Heart Association (NYHA) Class III/IV congestive heart failure, unstable angina or history of myocardial infarction within the last 6 months.
• Contraindications to corticosteroids.
• Uncontrolled severe hypertension, persistently uncontrolled diabetes mellitus, oxygen-dependent lung disease, chronic liver disease or HIV infection.
• Second malignancies (excluding non-melanoma skin cancer) unless disease-free for 3 years.
• Overt psychosis, mental disability or otherwise incompetent to give informed consent.