Radical Prostatectomy in Treating Patients With Locally Advanced Prostate Cancer

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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Radical Prostatectomy for Locally Advanced Prostate Cancer. A Feasibility Study

Conditions
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Prostate Cancer

Intervention / Treatment
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* Procedure: conventional surgery


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Maximum Age: 70 Years

Sexes Eligible for Study
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Male

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Masking: None (Open Label)


Arms and Interventions

| Intervention/Treatment |
| --- |
|Procedure: conventional surgery|nan|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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adenocarcinoma of the prostate, stage III prostate cancer