A Capsular Incision and Biochemical Recurrence After Radical Perineal Prostatectomy

Radical Perineal Prostatectomy Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00748514
• Other study ID #: SMC IRB 2008-08-012
• Secondary ID: SMC IRB 2008-08-
• Status: Completed
• Phase: N/A
• First received: September 5, 2008
• Last updated: October 6, 2008
• Start date: June 1995
• Est. completion date: January 2008

Study information

• Verified date: October 2008
• Source: Samsung Medical Center
• Contact: n/a
• Is FDA regulated: No
• Health authority: Korea: Food and Drug Administration
• Study type: Observational

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 266
• Est. completion date: January 2008
• Est. primary completion date: January 2008
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 43 Years to 78 Years

Eligibility

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 Design

Observational Model: Cohort, Time Perspective: Retrospective

Related Conditions & MeSH terms

• Radical Perineal Prostatectomy
• Recurrence

Locations

Country	Name	City	State
Korea, Republic of	Department of Urology, Samsung Medical Center, Sungkyunkwan University School of Medicine	Seoul

Sponsors (1)

Lead Sponsor	Collaborator
Samsung Medical Center

Country where clinical trial is conducted

Korea, Republic of, 

References & Publications (2)

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. Epub 2007 Aug 14. — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	biochemical recurrence of prostate cancer		upto the final date of study	No
Secondary	risk factors for capsular incisions		at surgery	No