A Capsular Incision and Biochemical Recurrence After Radical Perineal Prostatectomy

This study has been completed.
Sponsor:
Information provided by:
Samsung Medical Center
ClinicalTrials.gov Identifier:
NCT00748514
First received: September 5, 2008
Last updated: October 6, 2008
Last verified: October 2008
  Purpose

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


Condition
Radical Perineal Prostatectomy

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: 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

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:
Responsible Party: Choi Han Yong, Samsung Medical Center,Sungkyunkwan University School of Medicine
ClinicalTrials.gov Identifier: NCT00748514     History of Changes
Other Study ID Numbers: SMC IRB 2008-08-012, SMC IRB 2008-08-012
Study First Received: September 5, 2008
Last Updated: October 6, 2008
Health Authority: Korea: Food and Drug Administration

Keywords provided by Samsung Medical Center:
capsular incision
biochemical recurrence
radical perineal prostatectomy

Additional relevant MeSH terms:
Recurrence
Disease Attributes
Pathologic Processes

ClinicalTrials.gov processed this record on April 23, 2014