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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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 September 22, 2014