Radical Prostatectomy in Treating Patients With Locally Advanced Prostate Cancer

European Organisation for Research and Treatment of Cancer (EORTC)

Status and phase: Completed; Phase 2

Conditions: Prostate Cancer

Treatments: Procedure: conventional surgery

Study type: Interventional

Funder types: NETWORK

Identifiers

NCT00027794

EORTC-30001

Details and patient eligibility

About

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.

Full description

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.

Enrollment: 40 patients

Sex: Male

Ages: Under 70 years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion 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