A Capsular Incision and Biochemical Recurrence After Radical Perineal Prostatectomy

October 6, 2008 updated by: Samsung Medical Center

Impact of a Capsular Incision on Biochemical Recurrence After Radical Perineal Prostatectomy

To evaluate the impact of capsular incisions on biochemical recurrence (BCR) and the potential risk factors of capsular incisions.

Study Overview

Status

Completed

Conditions

Detailed Description

The pathological classification of the prostate following radical prostatectomy provides important prognostic information; an accurate pathology report is the cornerstone to cancer treatment and follow-up. In addition to the preoperative serum PSA, Gleason score on pathology specimens, seminal vesicle invasion and lymph node status, and a positive surgical margin with extraprostatic extension (EPE) are significant predictors of clinical and biochemical recurrence. However, the prognostic implication of a capsular incision, a tumor extending to the inked margins without a histologically documented EPE, remains to be defined.

Study Type

Observational

Enrollment (Actual)

266

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Korea, Republic of
      • Seoul, Korea, Republic of, 135-710
        • Department of Urology, Samsung Medical Center, Sungkyunkwan University School of Medicine

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

43 years to 78 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Male

Sampling Method

Non-Probability Sample

Study Population

the prostate cancer patients treated with radical perineal prostatectomy at single tertiary institution

Description

Inclusion Criteria:

  • pathologically proven prostate cancer
  • follow-up for at least 6 months

Exclusion Criteria:

  • insufficient biopsy data
  • seminal vesicle invasion or lymph node involvement on pathology
  • neoadjuvant or adjuvant therapy

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
biochemical recurrence of prostate cancer
Time Frame: upto the final date of study
upto the final date of study

Secondary Outcome Measures

Outcome Measure
Time Frame
risk factors for capsular incisions
Time Frame: at surgery
at surgery

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Samsung Medical Center

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

June 1, 1995

Primary Completion (ACTUAL)

January 1, 2008

Study Completion (ACTUAL)

January 1, 2008

Study Registration Dates

First Submitted

September 5, 2008

First Submitted That Met QC Criteria

September 5, 2008

First Posted (ESTIMATE)

September 8, 2008

Study Record Updates

Last Update Posted (ESTIMATE)

October 7, 2008

Last Update Submitted That Met QC Criteria

October 6, 2008

Last Verified

October 1, 2008

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • SMC IRB 2008-08-012

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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