Radical Prostatectomy in Treating Patients With Locally Advanced Prostate Cancer

Prostate Cancer Clinical Trial

Official title:

Radical Prostatectomy for Locally Advanced Prostate Cancer. A Feasibility Study

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00027794
• Other study ID #: EORTC-30001
• Secondary ID: EORTC-30001
• Status: Completed
• Phase: Phase 2
• First received: December 7, 2001
• Last updated: September 20, 2012
• Start date: September 2001

Study information

• Verified date: September 2012
• Source: European Organisation for Research and Treatment of Cancer - EORTC
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Federal Government
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 40
• Est. primary completion date: January 2005
• Accepts healthy volunteers: No
• Gender: Male
• Age group: N/A to 70 Years

Eligibility

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 Design

Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Prostate Cancer
• Prostatic Neoplasms

Intervention

Procedure:
• conventional surgery

Locations

Country	Name	City	State
Belgium	Virga Jesse Hospital	Hasselt
Belgium	U.Z. Gasthuisberg	Leuven
Italy	Istituto Scientifico H. San Raffaele	Milano
Italy	Ospedale di Circolo e Fondazione Macchi	Varese
Slovakia	Martin Faculty Hospital	Martin

Sponsors (1)

Lead Sponsor	Collaborator
European Organisation for Research and Treatment of Cancer - EORTC

Countries where clinical trial is conducted

Belgium,  Italy,  Slovakia, 

References & Publications (1)

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. — View Citation