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A Capsular Incision and Biochemical Recurrence After Radical Perineal Prostatectomy

NCT ID: NCT00748514

Last Updated: 2008-10-07

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

266 participants

Study Classification

OBSERVATIONAL

Study Start Date

1995-06-30

Study Completion Date

2008-01-31

Brief Summary

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

Detailed Description

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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.

Conditions

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Radical Perineal Prostatectomy

Keywords

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capsular incision biochemical recurrence radical perineal prostatectomy

Study Design

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Observational Model Type

COHORT

Study Time Perspective

RETROSPECTIVE

Eligibility Criteria

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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
Minimum Eligible Age

43 Years

Maximum Eligible Age

78 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

No

Sponsors

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Samsung Medical Center

OTHER

Sponsor Role lead

Responsible Party

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Samsung Medical Center,Sungkyunkwan University School of Medicine

Principal Investigators

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han yong Choi, professor

Role: PRINCIPAL_INVESTIGATOR

Department of Urology, Samsung Medical Center, Sungkyunkwan University School of Medicine

Locations

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Department of Urology, Samsung Medical Center, Sungkyunkwan University School of Medicine

Seoul, , South Korea

Site Status

Countries

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South Korea

References

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Chuang AY, Nielsen ME, Hernandez DJ, Walsh PC, Epstein JI. The significance of positive surgical margin in areas of capsular incision in otherwise organ confined disease at radical prostatectomy. J Urol. 2007 Oct;178(4 Pt 1):1306-10. doi: 10.1016/j.juro.2007.05.159. Epub 2007 Aug 14.

Reference Type RESULT
PMID: 17698141 (View on PubMed)

Shuford MD, Cookson MS, Chang SS, Shintani AK, Tsiatis A, Smith JA Jr, Shappell SB. Adverse prognostic significance of capsular incision with radical retropubic prostatectomy. J Urol. 2004 Jul;172(1):119-23. doi: 10.1097/01.ju.0000132137.02846.ec.

Reference Type RESULT
PMID: 15201750 (View on PubMed)

Other Identifiers

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SMC IRB 2008-08-012

Identifier Type: -

Identifier Source: secondary_id

SMC IRB 2008-08-012

Identifier Type: -

Identifier Source: org_study_id