Alternate Title
Basic Trial Information
Objectives
Entry Criteria
Expected Enrollment
Outline
Published Results
Trial Contact Information
Registry Information

Alternate Title

Radical Prostatectomy in Treating Patients With Locally Advanced Prostate Cancer

Basic Trial Information

Phase	Type	Status	Age	Sponsor	Protocol IDs
Phase II	Treatment	Closed	70 and under	Other	EORTC-30001 NCT00027794

Objectives

1. Determine the success rate of radical prostatectomy in patients with locally advanced adenocarcinoma of the prostate.
2. Determine the serious toxic event rate of this surgery in these patients.
3. Determine the pN status of patients treated with this surgery.
4. Determine the percentage of patients found to have organ-confined tumors (pT2) after undergoing this surgery.
5. Determine the 2-year prostate-specific antigen-free survival rate of patients treated with this surgery.
6. Determine the surgical morbidity rates of patients treated with this surgery.

Entry 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)

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

Patient Characteristics:

Age:

• 70 and under

Performance status:

• WHO 0-1

Life expectancy:

• Not specified

Hematopoietic:

• WBC greater than 3,000/mm³
• Platelet count greater than 100,000/mm³
• 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

Expected Enrollment

A total of 32-74 patients will be accrued for this study.

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.

Van Poppel H, Vekemans K, Da Pozzo L, et al.: Radical prostatectomy for locally advanced prostate cancer: results of a feasibility study (EORTC 30001). Eur J Cancer 42 (8): 1062-7, 2006.[PUBMED Abstract]

Trial Contact Information

Trial Lead Organizations

European Organization for Research and Treatment of Cancer

Hein van Poppel, MD, PhD, Study coordinator		Ph: 32-1634-6687 Email: hendrik.vanpoppel@uz.kuleuven.ac.be

Registry Information
Official Title		Radical Prostatectomy for Locally Advanced Prostate Cancer. A Feasibility Study
Trial Start Date		2001-09-05
Registered in ClinicalTrials.gov		NCT00027794
Date Submitted to PDQ		2001-10-16
Information Last Verified		2005-02-23

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