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Spots Global Cancer Trial Database for Radical Prostatectomy in Treating Patients With Locally Advanced Prostate Cancer

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We do not endorse or review these studies in any way.

Trial Identification

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 ID: NCT00027794

Conditions

Prostate Cancer

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.

Eligibility

Minimum Age:

Eligible Ages: CHILD, ADULT, OLDER_ADULT

Sex: MALE

Healthy Volunteers: No

Locations

Virga Jesse Hospital, Hasselt, , Belgium

U.Z. Gasthuisberg, Leuven, , Belgium

Istituto Scientifico H. San Raffaele, Milano, , Italy

Ospedale di Circolo e Fondazione Macchi, Varese, , Italy

Martin Faculty Hospital, Martin, , Slovakia

Contact Details

Name: Hein van Poppel, MD, PhD

Affiliation: University Hospital, Gasthuisberg

Role: STUDY_CHAIR

Useful links and downloads for this trial

Clinicaltrials.gov

Google Search Results

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