Prostate Cancer SurgeryNCT00695773
Laparoscopic Vs. Open Prostatectomy Outcomes
An observational study of Prostate Cancer Surgery, run by Lahey Clinic at 1 site in United States.
Trial summary
This study is aimed at discovering the differences in outcomes, regarding quality of life issues(continence, impotence) of patients who have had either laparoscopic or open surgical technique for prostate cancer. Read more about this study
- Who is it for?
- Any age, men only
- Conditions the study is for
- Prostate Cancer Surgery
- How many people
- 158 participants
- Where
- 1 siteUnited States
- Study dates
- Feb 2006to Nov 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 Any age
- Men only
- No healthy volunteers
- Child, Adult, Older adult
Study population: A Lahey Clinic IRB approved database and current clinic population of patients having a laparascopic or open prostatectomy
Who may be able to join
- Subjects who have undergone a prostatectomy
Who cannot join
- none
Trial locations and contacts
1 site in 1 country.
About this study
This study is aimed at discovering the differences in outcomes, regarding quality of life issues(continence, impotence) of patients who have had either laparoscopic or open surgical technique for prostate cancer.
Read the detailed description
This study is a post surgical, data collection effort in order to gather definitive, Quality of Life(continence, impotence) information regarding the outcomes of patients who have undergone either Laparoscopic vs. Prostatectomy surgeries for Prostate Cancer. As part of the study, 200 subject's medical records will be retrospectively reviewed and 100 current subjects will be prospectively contacted. The information collected may benefit patients who undergo a prostatectomy
- Conditions
- Prostate Cancer Surgery
- Keywords
- Prostate Cancer Surgery, Laparoscopic surgery for Prostate Cancer, Prostatectomy, Urologic Surgical Procedures
What is being measured
The primary outcome is the main question the study is designed to answer.
The post-surgical questionnaire information collected will be used to determine any benefits to future patients who are to undergo a prostatectomy
Measured: Post Surgical
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Jun 2008 (estimated)
- Study startFeb 2006
- Primary completionNov 2008
- Study completionNov 2008
Why it stopped: Insufficient findings for data analysis
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Prostate Cancer SurgeryStudies of the same condition, open and under way.
- 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
- Enrolment
- 158 participants (actual)
Sponsor and investigators
- Lead sponsor
- Lahey Clinic
- Sponsor type
- University, hospital or other
- Investigators
- John A. Libertino, M.D., Principal investigator, Lahey Clinic, Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00695773
- Sponsor's protocol ID
- 2006-014
- Status last verified
- Nov 2008
- First submitted
- 10 Jun 2008
- Last updated
- 1 Dec 2008
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Dec 2008. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Laparoscopic Vs. Open Prostatectomy Outcomes
- ClinicalTrials.gov ID
- NCT00695773
- Acronym / sponsor ID
- 2006-014
- Conditions
- Prostate Cancer Surgery
- Keywords
- Prostate Cancer Surgery, Laparoscopic surgery for Prostate Cancer, Prostatectomy, Urologic Surgical Procedures
- Study type
- Observational
- Recruitment status
- TerminatedReason stopped: Insufficient findings for data analysis
- Enrolment
- 158 participants (actual)
- Lead sponsor
- Lahey ClinicUniversity, hospital or other
- Study start
- Feb 2006
- Primary completion
- Nov 2008 (actual)
- Study completion
- Nov 2008 (actual)
- First posted
- 12 Jun 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.
This study is aimed at discovering the differences in outcomes, regarding quality of life issues(continence, impotence) of patients who have had either laparoscopic or open surgical technique for prostate cancer.
Detailed description
This study is a post surgical, data collection effort in order to gather definitive, Quality of Life(continence, impotence) information regarding the outcomes of patients who have undergone either Laparoscopic vs. Prostatectomy surgeries for Prostate Cancer. As part of the study, 200 subject's medical records will be retrospectively reviewed and 100 current subjects will be prospectively contacted. The information collected may benefit patients who undergo a prostatectomy
Study design
- Observational model
- Case only
Who may qualify
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- A Lahey Clinic IRB approved database and current clinic population of patients having a laparascopic or open prostatectomy
Key inclusion criteria (1 listed)
- Subjects who have undergone a prostatectomy
Key exclusion criteria (1 listed)
- none
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
The post-surgical questionnaire information collected will be used to determine any benefits to future patients who are to undergo a prostatectomy
Time frame: Post Surgical
Results and safety
The study was stopped early (reason given: Insufficient findings for data analysis). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Dec 2008.
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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.
John A. Libertino, M.D. principal investigator
Lahey Clinic, Inc.
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 Prostate Cancer Surgery, run by Lahey Clinic at 1 site in United States.
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 1 inclusion and 1 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: stopped early, as of the sponsor's last update on 1 Dec 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 United States. 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 was stopped early (reason given: Insufficient findings for data analysis). Results are not available in the source record.
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?
The post-surgical questionnaire information collected will be used to determine any benefits to future patients who are to undergo a prostatectomy (time frame: Post Surgical). It is what the study was designed to measure, not a finding.
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 1 Dec 2008; AzTrials last refreshed its copy on 27 Oct 2026.