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

September 5, 2008
October 6, 2008
June 1995
January 2008   (final data collection date for primary outcome measure)
biochemical recurrence of prostate cancer [ Time Frame: upto the final date of study ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT00748514 on ClinicalTrials.gov Archive Site
risk factors for capsular incisions [ Time Frame: at surgery ] [ Designated as safety issue: No ]
Same as current
Not Provided
Not Provided
 
A Capsular Incision and Biochemical Recurrence After Radical Perineal Prostatectomy
Impact of a Capsular Incision on 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.

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.

Observational
Observational Model: Cohort
Time Perspective: Retrospective
Not Provided
Retention:   Samples Without DNA
Description:

prostate gland

Non-Probability Sample

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

Radical Perineal Prostatectomy
Not Provided
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
266
January 2008
January 2008   (final data collection date for primary outcome measure)

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
Male
43 Years to 78 Years
No
Contact information is only displayed when the study is recruiting subjects
Korea, Republic of
 
NCT00748514
SMC IRB 2008-08-012, SMC IRB 2008-08-012
Yes
Choi Han Yong, Samsung Medical Center,Sungkyunkwan University School of Medicine
Samsung Medical Center
Not Provided
Principal Investigator: han yong Choi, professor Department of Urology, Samsung Medical Center, Sungkyunkwan University School of Medicine
Samsung Medical Center
October 2008

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP