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Radical Prostatectomy in Treating Patients With Locally Advanced Prostate Cancer
This study is ongoing, but not recruiting participants.
Study NCT00027794   Information provided by National Cancer Institute (NCI)
First Received: December 7, 2001   Last Updated: February 6, 2009   History of Changes

December 7, 2001
February 6, 2009
September 2001
 
 
 
Complete list of historical versions of study NCT00027794 on ClinicalTrials.gov Archive Site
 
 
 
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.

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.

Phase II
Interventional
Treatment, Open Label
Prostate Cancer
Procedure: conventional surgery
 
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. Epub 2006 Apr 18.

*   Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
 
Active, not recruiting
 
 
 

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
Male
up to 70 Years
No
Contact information is only displayed when the study is recruiting subjects
Belgium,   Italy,   Slovakia
 
NCT00027794
 
CDR0000069068, EORTC-30001
European Organization for Research and Treatment of Cancer
 
Investigator: Hein van Poppel, MD, PhD U.Z. Gasthuisberg
National Cancer Institute (NCI)
February 2005

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP