Radical Prostatectomy in Treating Patients With Locally Advanced Prostate Cancer
- Conditions
- Prostate Cancer
- Registration Number
- NCT00027794
- 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- Male
- Target Recruitment
- 40
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (5)
Virga Jesse Hospital
🇧🇪Hasselt, Belgium
U.Z. Gasthuisberg
🇧🇪Leuven, Belgium
Martin Faculty Hospital
🇸🇰Martin, Slovakia
Istituto Scientifico H. San Raffaele
🇮🇹Milano, Italy
Ospedale di Circolo e Fondazione Macchi
🇮🇹Varese, Italy