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A Capsular Incision and Biochemical Recurrence After Radical Perineal Prostatectomy

Sponsor
Samsung Medical Center (Other)
Overall Status
Completed
CT.gov ID
NCT00748514
Collaborator
(none)
266
Enrollment
1
Location
151
Duration (Months)
1.8
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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

Condition or Disease Intervention/Treatment Phase

    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 Design

    Study Type:
    Observational
    Actual Enrollment :
    266 participants
    Observational Model:
    Cohort
    Time Perspective:
    Retrospective
    Official Title:
    Impact of a Capsular Incision on Biochemical Recurrence After Radical Perineal Prostatectomy
    Study Start Date :
    Jun 1, 1995
    Actual Primary Completion Date :
    Jan 1, 2008
    Actual Study Completion Date :
    Jan 1, 2008

    Outcome Measures

    Primary Outcome Measures

    1. biochemical recurrence of prostate cancer [upto the final date of study]

    Secondary Outcome Measures

    1. risk factors for capsular incisions [at surgery]

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    43 Years to 78 Years
    Sexes Eligible for Study:
    Male
    Accepts Healthy Volunteers:
    No
    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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Department of Urology, Samsung Medical Center, Sungkyunkwan University School of Medicine Seoul Korea, Republic of 135-710

    Sponsors and Collaborators

    • Samsung Medical Center

    Investigators

    • Principal Investigator: han yong Choi, professor, Department of Urology, Samsung Medical Center, Sungkyunkwan University School of Medicine

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    , ,
    ClinicalTrials.gov Identifier:
    NCT00748514
    Other Study ID Numbers:
    • SMC IRB 2008-08-012
    • SMC IRB 2008-08-012
    First Posted:
    Sep 8, 2008
    Last Update Posted:
    Oct 7, 2008
    Last Verified:
    Oct 1, 2008
    Keywords provided by , ,
    capsular incision
    biochemical recurrence
    radical perineal prostatectomy
    Additional relevant MeSH terms:
    Recurrence

    Study Results

    No Results Posted as of Oct 7, 2008