radical prostatectomy in treating patients with locally advanced prostate cancer

Conditions: Prostate Cancer

Summary: rationale: radical prostatectomy may be an effective treatment for locally advanced prostate cancer. purpose: phase ii trial to study the effectiveness of radical prostatectomy in treating patients who have locally advanced prostate cancer.

objectives: * determine the success rate of radical prostatectomy in patients with locally advanced adenocarcinoma of the prostate. * determine the serious toxic event rate of this surgery in these patients. * determine the pn status of patients treated with this surgery. * determine the percentage of patients found to have organ-confined tumors (pt2) after undergoing this surgery. * determine the 2-year prostate-specific antigen-free survival rate of patients treated with this surgery. * determine the surgical morbidity rates of patients treated with this surgery. outline: this is a multicenter study. patients undergo limited pelvic lymphadenectomy and then radical retropubic prostatectomy. patients who are found to have pn-positive disease receive further treatment according to the investigator's discretion. patients with pn0 disease are followed every 3 months for 1 year and then every 4 months for 1 year. projected accrual: a total of 32-74 patients will be accrued for this study.

Eligibility criteria:
disease characteristics: * histologically confirmed adenocarcinoma of the prostate * unilateral ct3a, cn0, m0 * well or moderately differentiated tumor * gleason score no greater than 7 (4 plus 3 or 3 plus 4) * total serum prostate-specific antigen no greater than 20 ng/ml (hybritech equivalent) patient characteristics: age: * 70 and under performance status: * who 0-1 life expectancy: * not specified hematopoietic: * wbc greater than 3,000/mm\^3 * platelet count greater than 100,000/mm\^3 * hemoglobin greater than 9 g/dl hepatic: * bilirubin no greater than 1.5 times normal * alt or ast less than 3 times normal * pt and ptt normal renal: * creatinine no greater than 1.5 mg/dl cardiovascular: * no preexisting uncontrolled cardiac disease, signs of cardiac failure, or rhythm disturbances requiring therapy * no myocardial infarction within the past 6 months pulmonary: * no gross abnormalities on chest x-ray other: * no other disease that would preclude surgery * no other prior malignancy except adequately treated basal cell skin cancer * no other concurrent primary malignancy * no psychological, familial, sociological, or geographical condition that would preclude compliance prior concurrent therapy: biologic therapy: * not specified chemotherapy: * not specified endocrine therapy: * no prior hormonal therapy that would affect assessment of clinical t staging, margin positivity, or definitive pt staging radiotherapy: * no prior pelvic radiotherapy that would affect surgical resectability and perioperative morbidity surgery: * no prior surgery in the small pelvis (vascular surgery, mesh graft hernia repair, any surgery for benign prostatic hypertrophy, or transurethral resection of prostate) that would preclude prostatectomy

Keywords: adenocarcinoma of the prostate stage iii prostate cancer