Radical Prostatectomy in Treating Patients With Locally Advanced Prostate Cancer
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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 |
| Enrollment: | 40 |
| Study Start Date: | September 2001 |
| Primary Completion Date: | January 2005 (Final data collection date for primary outcome measure) |
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 |
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| 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 | |
| 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 May 22, 2013