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Radical Prostatectomy in Treating Patients With Locally Advanced Prostate Cancer

Primary Purpose

Prostate Cancer

Status
Completed
Phase
Phase 2
Locations
International
Study Type
Interventional
Intervention
conventional surgery
Sponsored by
European Organisation for Research and Treatment of Cancer - EORTC
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Prostate Cancer focused on measuring adenocarcinoma of the prostate, stage III prostate cancer

Eligibility Criteria

undefined - 70 Years (Child, Adult, Older Adult)MaleDoes not accept healthy volunteers

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

Sites / Locations

  • Virga Jesse Hospital
  • U.Z. Gasthuisberg
  • Istituto Scientifico H. San Raffaele
  • Ospedale di Circolo e Fondazione Macchi
  • Martin Faculty Hospital

Outcomes

Primary Outcome Measures

Secondary Outcome Measures

Full Information

First Posted
December 7, 2001
Last Updated
September 20, 2012
Sponsor
European Organisation for Research and Treatment of Cancer - EORTC
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1. Study Identification

Unique Protocol Identification Number
NCT00027794
Brief Title
Radical Prostatectomy in Treating Patients With Locally Advanced Prostate Cancer
Official Title
Radical Prostatectomy for Locally Advanced Prostate Cancer. A Feasibility Study
Study Type
Interventional

2. Study Status

Record Verification Date
September 2012
Overall Recruitment Status
Completed
Study Start Date
September 2001 (undefined)
Primary Completion Date
January 2005 (Actual)
Study Completion Date
undefined (undefined)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
European Organisation for Research and Treatment of Cancer - EORTC

4. Oversight

5. Study Description

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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Prostate Cancer
Keywords
adenocarcinoma of the prostate, stage III prostate cancer

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Masking
None (Open Label)
Enrollment
40 (Actual)

8. Arms, Groups, and Interventions

Intervention Type
Procedure
Intervention Name(s)
conventional surgery

10. Eligibility

Sex
Male
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Hein van Poppel, MD, PhD
Organizational Affiliation
University Hospital, Gasthuisberg
Official's Role
Study Chair
Facility Information:
Facility Name
Virga Jesse Hospital
City
Hasselt
ZIP/Postal Code
3500
Country
Belgium
Facility Name
U.Z. Gasthuisberg
City
Leuven
ZIP/Postal Code
B-3000
Country
Belgium
Facility Name
Istituto Scientifico H. San Raffaele
City
Milano
ZIP/Postal Code
20132
Country
Italy
Facility Name
Ospedale di Circolo e Fondazione Macchi
City
Varese
ZIP/Postal Code
21100
Country
Italy
Facility Name
Martin Faculty Hospital
City
Martin
ZIP/Postal Code
03659
Country
Slovakia

12. IPD Sharing Statement

Citations:
PubMed Identifier
16624554
Citation
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. doi: 10.1016/j.ejca.2005.11.030. Epub 2006 Apr 18.
Results Reference
result

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Radical Prostatectomy in Treating Patients With Locally Advanced Prostate Cancer

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