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Sponsored by: |
Samsung Medical Center |
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Information provided by: | Samsung Medical Center |
ClinicalTrials.gov Identifier: | NCT00748514 |
To evaluate the impact of capsular incisions on biochemical recurrence (BCR) and the potential risk factors of capsular incisions.
Condition |
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Radical Perineal Prostatectomy |
Study Type: | Observational |
Study Design: | Cohort, Retrospective |
Official Title: | Impact of a Capsular Incision on Biochemical Recurrence After Radical Perineal Prostatectomy |
prostate gland
Enrollment: | 266 |
Study Start Date: | June 1995 |
Study Completion Date: | January 2008 |
Primary Completion Date: | January 2008 (Final data collection date for primary outcome measure) |
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.
Ages Eligible for Study: | 43 Years to 78 Years |
Genders Eligible for Study: | Male |
Accepts Healthy Volunteers: | No |
Sampling Method: | Non-Probability Sample |
the prostate cancer patients treated with radical perineal prostatectomy at single tertiary institution
Inclusion Criteria:
Exclusion Criteria:
Korea, Republic of | |
Department of Urology, Samsung Medical Center, Sungkyunkwan University School of Medicine | |
Seoul, Korea, Republic of, 135-710 |
Principal Investigator: | han yong Choi, professor | Department of Urology, Samsung Medical Center, Sungkyunkwan University School of Medicine |
Responsible Party: | Samsung Medical Center,Sungkyunkwan University School of Medicine ( Choi Han Yong ) |
Study ID Numbers: | SMC IRB 2008-08-012, SMC IRB 2008-08-012 |
Study First Received: | September 5, 2008 |
Last Updated: | October 6, 2008 |
ClinicalTrials.gov Identifier: | NCT00748514 |
Health Authority: | Korea: Food and Drug Administration |
capsular incision biochemical recurrence radical perineal prostatectomy |
Recurrence |
Disease Attributes Pathologic Processes |