Department of Urology, Samsung Medical Center, Sungkyunkwan University School of Medicine
Seoul, 135-710, South Korea
Completed
NCT Number: NCT00748514
A Capsular Incision and 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.
Completed
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Notify MeKey information
Conditions
Age range
43 year–78 year
Sex eligibility
Male
Study type
Observational
Primary location
About this study
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.
Who can participate
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
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
Treatment and study plan
Primary outcomes
-
biochemical recurrence of prostate cancer
Time frame: upto the final date of study
Secondary outcomes
-
risk factors for capsular incisions
Time frame: at surgery
Sponsors and collaborators
Lead sponsor
Samsung Medical Center
Other
Registry information
Official study title
Impact of a Capsular Incision on Biochemical Recurrence After Radical Perineal Prostatectomy
Important dates
- Study start
- 1995
- Primary completion
- 2008
- Study completion
- 2008
- First posted
- Sep 8, 2008
- Registry last updated
- Oct 7, 2008
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.