Prostatic NeoplasmsNCT01173952
Quality of Life in Men Undergoing Robotic Assisted Laparoscopic Radical Prostatectomy Versus Radical Retropubic Prostatectomy
An observational study of Prostatic Neoplasms and Quality of Life, run by Samsung Medical Center.
Trial summary
This study is prospective evaluation of quality of life in men undergoing robotic assisted laparoscopic radical prostatectomy versus radical retropubic prostatectomy. Read more about this study
- Who is it for?
- Ages 18 years and older, men only
- Conditions the study is for
- Prostatic Neoplasms, Quality of Life
- How many people
- 350 participants
- Where
- No sites listed yet
- Study dates
- Aug 2010to Jan 2014
- 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 18 years and older
- Men only
- No healthy volunteers
- Adult, Older adult
Study population: Patients diagnosed with prostate cancer
Who may be able to join
- Pathologic diagnosis of prostate adenocarcinoma
- Clinical stage: AJCC (VI) stage T1-T2 N0M0
- Primary treatment at Samsung Medical Center for prostate cancer using: radical retropubic prostatectomy, robotic prostatectomy
Who cannot join
- Clinical Stage: T3, T4, nodal or distant metastasis
- All kind of neoadjuvant, concurrent and adjuvant treatment
- poor health forced a patient into dropout
Trial locations and contacts
No sites are listed yet.
About this study
Official title: Prospective Evaluation of Quality of Life in Men Undergoing Robotic Assisted Laparoscopic Radical Prostatectomy Vs. Radical Retropubic Prostatectomy
This study is prospective evaluation of quality of life in men undergoing robotic assisted laparoscopic radical prostatectomy versus radical retropubic prostatectomy.
Read the detailed description
Preoperatively, enrolled patients will complete questionnaires called EPIC that will ask about urinary, sexual, bowel and hormonal function
At 1, 3,6,9 and 12 months after surgery, pateints will complete the questionnaires again.
All will be enrolled at Samsung Medical Center
- Conditions
- Prostatic Neoplasms, Quality of Life
- Medical subject headings
- Prostatic Neoplasms
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Aug 2010 (estimated)
- Study startAug 2010
- Primary completionDec 2013 (estimated)
- Study completionJan 2014 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Prostatic NeoplasmsStudies 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
- Case only
- Time perspective
- Prospective
- Enrolment
- 350 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Samsung Medical Center
- Sponsor type
- University, hospital or other
- Investigators
- Sung Won Lee, M.D.& Ph.D., Study chair, Department of Urology Samsung Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01173952
- Sponsor's protocol ID
- 2010-06-026
- Status last verified
- Jun 2010
- First submitted
- 30 Jul 2010
- Last updated
- 2 Aug 2010
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 2 Aug 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prospective Evaluation of Quality of Life in Men Undergoing Robotic Assisted Laparoscopic Radical Prostatectomy Vs. Radical Retropubic Prostatectomy
- ClinicalTrials.gov ID
- NCT01173952
- Acronym / sponsor ID
- 2010-06-026
- Conditions
- Prostatic Neoplasms, Quality of Life
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 350 participants (estimated)
- Lead sponsor
- Samsung Medical CenterUniversity, hospital or other
- Study start
- Aug 2010
- Primary completion
- Dec 2013 (estimated)
- Study completion
- Jan 2014 (estimated)
- First posted
- 2 Aug 2010 (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.
This study is prospective evaluation of quality of life in men undergoing robotic assisted laparoscopic radical prostatectomy versus radical retropubic prostatectomy.
Detailed description
Preoperatively, enrolled patients will complete questionnaires called EPIC that will ask about urinary, sexual, bowel and hormonal function
At 1, 3,6,9 and 12 months after surgery, pateints will complete the questionnaires again.
All will be enrolled at Samsung Medical Center
Study design
- Observational model
- Case only
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients diagnosed with prostate cancer
Key inclusion criteria (3 listed)
- Pathologic diagnosis of prostate adenocarcinoma
- Clinical stage: AJCC (VI) stage T1-T2 N0M0
- Primary treatment at Samsung Medical Center for prostate cancer using: radical retropubic prostatectomy, robotic prostatectomy
Key exclusion criteria (3 listed)
- Clinical Stage: T3, T4, nodal or distant metastasis
- All kind of neoadjuvant, concurrent and adjuvant treatment
- poor health forced a patient into dropout
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
Not reported in the source record.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Aug 2010.
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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.
Sung Won Lee, M.D.& Ph.D. study chair
Department of Urology Samsung Medical Center
Questions about this trial
What is this clinical trial studying?
An observational study of Prostatic Neoplasms and Quality of Life, run by Samsung Medical Center.
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 3 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: status not confirmed, as of the sponsor's last update on 2 Aug 2010. Status can change between updates, so confirm with the study contact before making plans.
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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Sung Won Lee, M.D.& Ph.D. (82-2-3410-3552, drswlee@skku.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
Where can I read the original study information?
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 2 Aug 2010.