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Clinical Trials/NCT00027794
NCT00027794
Completed
Phase 2

Radical Prostatectomy for Locally Advanced Prostate Cancer. A Feasibility Study

European Organisation for Research and Treatment of Cancer - EORTC5 sites in 3 countries40 target enrollmentStarted: September 2001Last updated:
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ConditionsProstate Cancer

Overview

Phase
Phase 2
Status
Completed
Enrollment
40
Locations
5
OverviewStudy DesignEligibility CriteriaInvestigatorsSitesRecords & IdentifiersSimilar Trials

Overview

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.

Study Design

Study Type
Interventional
Primary Purpose
Treatment
Masking
None

Eligibility Criteria

Ages
— to 70 Years (Child, Adult, Older Adult)
Sex
Male
Accepts Healthy Volunteers
No

Inclusion Criteria

  • Not provided

Exclusion Criteria

  • Not provided

Investigators

Sponsor Class
Network
Responsible Party
Sponsor

Study Sites (5)

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