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.

Condition	Treatment or Intervention	Phase
adenocarcinoma of the prostate stage III prostate cancer	Procedure: conventional surgery  Procedure: surgery	Phase II

Further Study Details: 

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.

Ages Eligible for Study:  up to  70 Years,  Genders Eligible for Study:  Both

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

Belgium
      U.Z. Gasthuisberg, Leuven,  B-3000,  Belgium
      Virga Jesse Hospital, Hasselt,  3500,  Belgium
Italy
      Istituto Scientifico H. San Raffaele, Milano,  20132,  Italy
      Ospedale di Circolo e Fondazione Macchi, Varese,  21100,  Italy
Slovakia
      Martin Faculty Hospital, Martin,  03659,  Slovakia

Study chairs or principal investigators

Hein van Poppel, MD, PhD,  U.Z. Gasthuisberg   

Study ID Numbers:  CDR0000069068; EORTC-30001; NCT00027794
Record last reviewed:  February 2005
Last Updated:  February 9, 2005
Record first received:  December 7, 2001
ClinicalTrials.gov Identifier:  NCT00027794
Health Authority: United States: Federal Government
ClinicalTrials.gov processed this record on 2005-04-08