Radical Prostatectomy in Treating Patients With Locally Advanced Prostate Cancer

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00027794
Recruitment Status : Completed
First Posted : January 27, 2003
Last Update Posted : September 24, 2012
Information provided by (Responsible Party):
European Organisation for Research and Treatment of Cancer - EORTC

Brief Summary:

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 or disease Intervention/treatment Phase
Prostate Cancer Procedure: conventional surgery Phase 2

Detailed Description:


  • 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  (Clinical Trial)
Actual Enrollment : 40 participants
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Radical Prostatectomy for Locally Advanced Prostate Cancer. A Feasibility Study
Study Start Date : September 2001
Actual Primary Completion Date : January 2005

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Prostate Cancer
U.S. FDA Resources

Information from the National Library of Medicine

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Ages Eligible for Study:   up to 70 Years   (Child, Adult, Senior)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   No


  • 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)



  • 70 and under

Performance status:

  • WHO 0-1

Life expectancy:

  • Not specified


  • WBC greater than 3,000/mm^3
  • Platelet count greater than 100,000/mm^3
  • Hemoglobin greater than 9 g/dL


  • Bilirubin no greater than 1.5 times normal
  • ALT or AST less than 3 times normal
  • PT and PTT normal


  • Creatinine no greater than 1.5 mg/dL


  • No preexisting uncontrolled cardiac disease, signs of cardiac failure, or rhythm disturbances requiring therapy
  • No myocardial infarction within the past 6 months


  • No gross abnormalities on chest x-ray


  • 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


Biologic therapy:

  • Not specified


  • Not specified

Endocrine therapy:

  • No prior hormonal therapy that would affect assessment of clinical T staging, margin positivity, or definitive pT staging


  • No prior pelvic radiotherapy that would affect surgical resectability and perioperative morbidity


  • 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00027794

Virga Jesse Hospital
Hasselt, Belgium, 3500
U.Z. Gasthuisberg
Leuven, Belgium, B-3000
Istituto Scientifico H. San Raffaele
Milano, Italy, 20132
Ospedale di Circolo e Fondazione Macchi
Varese, Italy, 21100
Martin Faculty Hospital
Martin, Slovakia, 03659
Sponsors and Collaborators
European Organisation for Research and Treatment of Cancer - EORTC
Study Chair: Hein van Poppel, MD, PhD University Hospital, Gasthuisberg

Publications of Results:
Responsible Party: European Organisation for Research and Treatment of Cancer - EORTC Identifier: NCT00027794     History of Changes
Other Study ID Numbers: EORTC-30001
First Posted: January 27, 2003    Key Record Dates
Last Update Posted: September 24, 2012
Last Verified: September 2012

Keywords provided by European Organisation for Research and Treatment of Cancer - EORTC:
adenocarcinoma of the prostate
stage III prostate cancer

Additional relevant MeSH terms:
Prostatic Neoplasms
Genital Neoplasms, Male
Urogenital Neoplasms
Neoplasms by Site
Genital Diseases, Male
Prostatic Diseases