Radical Prostatectomy in Treating Patients With Locally Advanced Prostate Cancer

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
European Organisation for Research and Treatment of Cancer - EORTC
ClinicalTrials.gov Identifier:
NCT00027794
First received: December 7, 2001
Last updated: September 20, 2012
Last verified: September 2012
  Purpose

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 Intervention Phase
Prostate Cancer
Procedure: conventional surgery
Phase 2

Study Type: Interventional
Study Design: Masking: Open Label
Primary Purpose: Treatment
Official Title: Radical Prostatectomy for Locally Advanced Prostate Cancer. A Feasibility Study

Resource links provided by NLM:


Further study details as provided by European Organisation for Research and Treatment of Cancer - EORTC:

Enrollment: 40
Study Start Date: September 2001
Primary Completion Date: January 2005 (Final data collection date for primary outcome measure)
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.

  Eligibility

Ages Eligible for Study:   up to 70 Years
Genders Eligible for Study:   Male
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00027794

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

Additional Information:
Publications:
Responsible Party: European Organisation for Research and Treatment of Cancer - EORTC
ClinicalTrials.gov Identifier: NCT00027794     History of Changes
Other Study ID Numbers: EORTC-30001, EORTC-30001
Study First Received: December 7, 2001
Last Updated: September 20, 2012
Health Authority: United States: Federal Government

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
Neoplasms
Genital Diseases, Male
Prostatic Diseases

ClinicalTrials.gov processed this record on August 28, 2014