Radical Perineal ProstatectomyNCT00748514
A Capsular Incision and Biochemical Recurrence After Radical Perineal Prostatectomy
An observational study of Radical Perineal Prostatectomy, run by Samsung Medical Center at 1 site in South Korea.
Trial summary
To evaluate the impact of capsular incisions on biochemical recurrence (BCR) and the potential risk factors of capsular incisions. Read more about this study
- Who is it for?
- Ages 43 to 78 years, men only
- Conditions the study is for
- Radical Perineal Prostatectomy
- How many people
- 266 participants
- Where
- 1 siteSouth Korea
- Study dates
- Jun 1995to Jan 2008
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 43 to 78 years
- Men only
- No healthy volunteers
- Adult, Older adult
Study population: the prostate cancer patients treated with radical perineal prostatectomy at single tertiary institution
Who may be able to join
- pathologically proven prostate cancer
- follow-up for at least 6 months
Who cannot join
- insufficient biopsy data
- seminal vesicle invasion or lymph node involvement on pathology
- neoadjuvant or adjuvant therapy
Trial locations and contacts
1 site in 1 country.
South Korea1 site
Department of Urology, Samsung Medical Center, Sungkyunkwan University School of Medicine
Seoul, 135-710
About this study
Official title: 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.
Read the 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.
- Conditions
- Radical Perineal Prostatectomy
- Keywords
- capsular incision, biochemical recurrence, radical perineal prostatectomy
What is being measured
The primary outcome is the main question the study is designed to answer.
biochemical recurrence of prostate cancer
Measured: upto the final date of study
Secondary outcomes (1)
risk factors for capsular incisions
Measured: at surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Sep 2008 (estimated)
- Study startJun 1995
- Primary completionJan 2008
- Study completionJan 2008
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Radical Perineal ProstatectomyStudies of the same condition, open and under way.
- More trials run by Samsung Medical CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 266 participants (actual)
Sponsor and investigators
- Lead sponsor
- Samsung Medical Center
- Sponsor type
- University, hospital or other
- Investigators
- han yong Choi, professor, Principal investigator, Department of Urology, Samsung Medical Center, Sungkyunkwan University School of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00748514
- Sponsor's protocol ID
- SMC IRB 2008-08-012
- Other IDs
- SMC IRB 2008-08-012
- Status last verified
- Oct 2008
- First submitted
- 5 Sep 2008
- Last updated
- 7 Oct 2008
- Results posted
- No
- Data monitoring committee
- Yes
Publications
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.
PubMed 17698141Shuford 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.
PubMed 15201750
Study at a glance
From the registry record, last updated by the sponsor on 7 Oct 2008. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact of a Capsular Incision on Biochemical Recurrence After Radical Perineal Prostatectomy
- ClinicalTrials.gov ID
- NCT00748514
- Acronym / sponsor ID
- SMC IRB 2008-08-012
- Conditions
- Radical Perineal Prostatectomy
- Keywords
- capsular incision, biochemical recurrence, radical perineal prostatectomy
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 266 participants (actual)
- Lead sponsor
- Samsung Medical CenterUniversity, hospital or other
- Study start
- Jun 1995
- Primary completion
- Jan 2008 (actual)
- Study completion
- Jan 2008 (actual)
- First posted
- 8 Sep 2008 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
Who may qualify
- Ages
- 43 to 78 years
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- the prostate cancer patients treated with radical perineal prostatectomy at single tertiary institution
Key inclusion criteria (2 listed)
- pathologically proven prostate cancer
- follow-up for at least 6 months
Key exclusion criteria (3 listed)
- insufficient biopsy data
- seminal vesicle invasion or lymph node involvement on pathology
- neoadjuvant or adjuvant therapy
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
biochemical recurrence of prostate cancer
Time frame: upto the final date of study
1 secondary outcome
risk factors for capsular incisions
Time frame: at surgery
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Oct 2008.
- Results publication: PubMed 17698141Chuang 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.
- Results publication: PubMed 15201750Shuford 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.
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
han yong Choi, professor principal investigator
Department of Urology, Samsung Medical Center, Sungkyunkwan University School of Medicine
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Radical Perineal Prostatectomy, run by Samsung Medical Center at 1 site in South Korea.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 7 Oct 2008. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
biochemical recurrence of prostate cancer (time frame: upto the final date of study). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00748514, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Oct 2008.