Radical Prostatectomy in Treating Patients With Locally Advanced Prostate Cancer
Radical Prostatectomy in Treating Patients With Locally Advanced Prostate Cancer
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.
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