Radical Prostatectomy in Treating Patients With Locally Advanced Prostate Cancer

Radical Prostatectomy for Locally Advanced Prostate Cancer. A Feasibility Study

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.

Study Overview

• Status: Completed
• Conditions: Prostate Cancer
• Intervention / Treatment: Procedure: conventional surgery

Detailed 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.

• Study Type: Interventional
• Enrollment (Actual): 40
• Phase: Phase 2

Contacts and Locations

Study Locations

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

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: No older than 70 years (Child, Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Male

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Masking: None (Open Label)

Collaborators and Investigators

• Sponsor: European Organisation for Research and Treatment of Cancer - EORTC

Publications and helpful links

General Publications

• Van Poppel H, Vekemans K, Da Pozzo L, Bono A, Kliment J, Montironi R, Debois M, Collette L. Radical prostatectomy for locally advanced prostate cancer: results of a feasibility study (EORTC 30001). Eur J Cancer. 2006 May;42(8):1062-7. doi: 10.1016/j.ejca.2005.11.030. Epub 2006 Apr 18.

Study record dates

Study Major Dates

• Study Start: September 1, 2001
• Primary Completion (Actual): January 1, 2005

Study Registration Dates

• First Submitted: December 7, 2001
• First Submitted That Met QC Criteria: January 26, 2003
• First Posted (Estimate): January 27, 2003

Study Record Updates

• Last Update Posted (Estimate): September 24, 2012
• Last Update Submitted That Met QC Criteria: September 20, 2012
• Last Verified: September 1, 2012

More Information

Terms related to this study

• Keywords: stage III prostate cancer; adenocarcinoma of the prostate
• Additional Relevant MeSH Terms: Neoplasms; Urogenital Neoplasms; Neoplasms by Site; Genital Neoplasms, Male; Prostatic Diseases; Prostatic Neoplasms
• Other Study ID Numbers: EORTC-30001