A Capsular Incision and Biochemical Recurrence After Radical Perineal Prostatectomy - Full Text View

Sponsored by:	Samsung Medical Center
Information provided by:	Samsung Medical Center
ClinicalTrials.gov Identifier:	NCT00748514

Purpose

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

Condition
Radical Perineal Prostatectomy

U.S. FDA Resources

Study Type:	Observational
Study Design:	Cohort, Retrospective
Official Title:	Impact of a Capsular Incision on Biochemical Recurrence After Radical Perineal Prostatectomy

Further study details as provided by Samsung Medical Center:

Primary Outcome Measures:

biochemical recurrence of prostate cancer [ Time Frame: upto the final date of study ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

risk factors for capsular incisions [ Time Frame: at surgery ] [ Designated as safety issue: No ]

Biospecimen Retention: Samples Without DNA

Biospecimen Description:

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)

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.

Eligibility

Ages Eligible for Study:	43 Years to 78 Years
Genders Eligible for Study:	Male
Accepts Healthy Volunteers:	No
Sampling Method:	Non-Probability Sample

Study Population

the prostate cancer patients treated with radical perineal prostatectomy at single tertiary institution

Criteria

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

Please refer to this study by its ClinicalTrials.gov identifier: NCT00748514

Locations

Korea, Republic of
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

More Information

Publications of Results:

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.

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.

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

Keywords provided by Samsung Medical Center:

capsular incision
biochemical recurrence
radical perineal prostatectomy

Study placed in the following topic categories:

Recurrence

Additional relevant MeSH terms:

Disease Attributes
Pathologic Processes

ClinicalTrials.gov processed this record on January 14, 2009