A Capsular Incision and Biochemical Recurrence After Radi... | NCT00748514

Studies
A Capsular Incision and Biochemical Recurrence After Radical Perineal Prostatectomy

NCT00748514

Sponsor

Samsung Medical Center

Status

Completed

Last Update Posted

Oct 7, 2008Estimated

Enrollment

266Actual

Phase

Not provided

Conditions

Radical Perineal Prostatectomy

Interventions

Not provided

Countries

South Korea

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

ID	Type	Description	Link
SMC IRB 2008-08-012

Status Module

Record Verification Date

Oct 2008

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jun 1995

Primary Completion Date

Jan 2008Actual

Completion Date

Jan 2008Actual

First Submitted Date

Sep 5, 2008

First Submission Date that Met QC Criteria

Sep 5, 2008

First Posted Date

Sep 8, 2008Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Oct 6, 2008

Last Update Posted Date

Oct 7, 2008Estimated

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

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

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.

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

Retention

Enrollment

266Actual

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
biochemical recurrence of prostate cancer		upto the final date of study

Secondary Outcomes

Measure	Description	Time Frame
risk factors for capsular incisions		at surgery

Other Outcomes

Not provided

Eligibility Module

Eligibility 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

Accepts Healthy Volunteers

Sex

Male

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

43 Years

Maximum Age

78 Years

Standard Ages

AdultOlder Adult

Study Population

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

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
han yong Choi, professor	Department of Urology, Samsung Medical Center, Sungkyunkwan University School of Medicine	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Department of Urology, Samsung Medical Center, Sungkyunkwan University School of Medicine		Seoul		135-710	South Korea

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
17698141	Result	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. doi: 10.1016/j.juro.2007.05.159. Epub 2007 Aug 14.
15201750	Result	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. doi: 10.1097/01.ju.0000132137.02846.ec.