Prostate CancerNCT00169676
Registry and Database Lap Prostatectomy
An observational study of Prostate Cancer, run by Indiana Kidney Stone Institute at 1 site in United States.
Trial summary
Recently, many centers have begun offering laparoscopic radical prostatectomy (LRP) as a minimally invasive therapy for localized prostate cancer.1-6 LRP may offer the advantages of improved neurovascular bundle sparing, a more precise urethrovesical anastomosis, shorter hospitalization, and decreased convalescence. Read more about this study
- Who is it for?
- Ages 18 years and older, men only
- Conditions the study is for
- Prostate Cancer
- What is being tested?
- observation
- How many people
- 9 participants
- Where
- 1 siteUnited States
- Study dates
- Jun 2003to Apr 2016
- 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 of Methodist Urology that are scheduled to undergo a laser procedure for prostate removal
Who may be able to join
- Patient of Methodist Urology in Indianapolis, IN
- Ability to give informed consent
- Biopsy proven diagnosis of prostate cancer without local extension or metastatic disease (Clinical T2 or less in the TNM classification)
Who cannot join
- Major abdominal surgery precluding a safe laparoscopic approach
- Bleeding diathesis or anticoagulation
- Medical disease (such as cardiovascular or pulmonary diseases) precluding general anesthesia/laparoscopy
- Transplanted kidney in the pelvis
- Radiation therapy to pelvis
- Morbid obesity
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Laparoscopic Radical Prostatectomy: A Registry and Database
Recently, many centers have begun offering laparoscopic radical prostatectomy (LRP) as a minimally invasive therapy for localized prostate cancer.1-6 LRP may offer the advantages of improved neurovascular bundle sparing, a more precise urethrovesical anastomosis, shorter hospitalization, and decreased convalescence.
Our group at Methodist Urology, LLC has extensive experience in laparoscopy and in treating prostate cancer and are planning to offer LRP. We intend to maintain a registry and database to document the outcomes with LRP.
Read the detailed description
Prostate cancer is the second leading cause of cancer death in men today. An estimated 220,900 new cases will be diagnosed in 2003 according to the American Cancer Society.7 Prostate cancer will account for one-third of the new cancer diagnoses in men in 2003. Prostate specific antigen (PSA), a sensitive screening method for prostate cancer, has helped diagnose prostate cancer at earlier stages. Stamey et al. found that the diagnosis of prostate cancer in patients with T1c disease (no abnormalities on digital rectal examination but elevated PSA) increased from10% in 1988 to 73% in 1996 and the increase in organ confined cancers increased from 40% to 75% over the same time period.8
Current surgical options for organ confined prostate cancer include open radical retropubic prostatectomy, open radical perineal prostatectomy, radioactive seed implantation, and radiation therapy. Open radical retropubic prostatectomy was pioneered in 1947 by Millin but what was slow to gain widespread acceptance secondary to associated morbidity.9-13 Refinement of the retropubic approach by Walsh has greatly improved outcomes, making it the most common surgical approach for radical prostatectomy.14, 15
As with other procedures, interest in the laparoscopic approach for radical prostatectomy developed in hopes of minimizing patient morbidity. In 1992, Schuessler et al performed the first LRP but the technical difficulties of the procedure at that time prohibited the widespread application of this technique.16 In 1998, Guillonneau et al introduced the Mountsouris technique in which a transperitoneal approach was used to perform the LRP.17, 18 Other groups have used this approach and even adapted this technique to perform extraperitoneal approaches to LRP.1, 2, 4, 5, 19, 20 Many centers are currently offering LRP as primary therapy for organ confined prostate cancer.
All curative surgical therapies for prostate cancer, whether performed in an open or laparoscopic manner, can result in impotence and/or incontinence. Incontinence can be treated with simple measures, such as muscle strengthening exercises, or if more bothersome, can be treated with surgical therapy. Impotence can be treated with medications or, if needed, surgery.
The relative risk of having positive surgical margins in patients undergoing open radical retropubic prostatectomy compared to laparoscopic radical prostatectomy is not known. Preliminary publications regarding laparoscopic radical prostatectomy report rates of positive surgical margins (13-25%) that are similar to open radical prostatectomy (11-46%).2, 5, 6, 19, 21-28 However, long-term follow-up is not available for patients undergoing laparoscopic radical prostatectomy, so the impact of positive margins on long-term survival is not known.
- Conditions
- Prostate Cancer
- Being tested
- observation
- Keywords
- Prostate Cancer
- Medical subject headings
- Prostatic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
observationOther
registry and database for surgery outcomes
| Study group | Role | What they receive |
|---|---|---|
| cohort | Registry and Database Receives: Other: observation |
What is being measured
The primary outcome is the main question the study is designed to answer.
To create a registry and database for the treatment of localized prostate cancer with LRP. To record long term outcomes for patients undergoing Laparoscopic Radical Prostatectomy.
Measured: One year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Sep 2005 (estimated)
- Study startJun 2003
- Primary completionApr 2016
- Study completionApr 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Prostate CancerStudies 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 9 participants (actual)
Sponsor and investigators
- Lead sponsor
- Indiana Kidney Stone Institute
- Sponsor type
- University, hospital or other
- Investigators
- Larry Munch, MD, Principal investigator, Methodist Urology, LLC
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00169676
- Sponsor's protocol ID
- 03-040
- Status last verified
- Sep 2008
- First submitted
- 9 Sep 2005
- Last updated
- 29 Jun 2016
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Jun 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Laparoscopic Radical Prostatectomy: A Registry and Database
- ClinicalTrials.gov ID
- NCT00169676
- Acronym / sponsor ID
- 03-040
- Conditions
- Prostate Cancer
- Keywords
- Prostate Cancer
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 9 participants (actual)
- Lead sponsor
- Indiana Kidney Stone InstituteUniversity, hospital or other
- Study start
- Jun 2003
- Primary completion
- Apr 2016 (actual)
- Study completion
- Apr 2016 (actual)
- First posted
- 15 Sep 2005 (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.
Recently, many centers have begun offering laparoscopic radical prostatectomy (LRP) as a minimally invasive therapy for localized prostate cancer.1-6 LRP may offer the advantages of improved neurovascular bundle sparing, a more precise urethrovesical anastomosis, shorter hospitalization, and decreased convalescence.
Our group at Methodist Urology, LLC has extensive experience in laparoscopy and in treating prostate cancer and are planning to offer LRP. We intend to maintain a registry and database to document the outcomes with LRP.
Detailed description
Prostate cancer is the second leading cause of cancer death in men today. An estimated 220,900 new cases will be diagnosed in 2003 according to the American Cancer Society.7 Prostate cancer will account for one-third of the new cancer diagnoses in men in 2003. Prostate specific antigen (PSA), a sensitive screening method for prostate cancer, has helped diagnose prostate cancer at earlier stages. Stamey et al. found that the diagnosis of prostate cancer in patients with T1c disease (no abnormalities on digital rectal examination but elevated PSA) increased from10% in 1988 to 73% in 1996 and the increase in organ confined cancers increased from 40% to 75% over the same time period.8
Current surgical options for organ confined prostate cancer include open radical retropubic prostatectomy, open radical perineal prostatectomy, radioactive seed implantation, and radiation therapy. Open radical retropubic prostatectomy was pioneered in 1947 by Millin but what was slow to gain widespread acceptance secondary to associated morbidity.9-13 Refinement of the retropubic approach by Walsh has greatly improved outcomes, making it the most common surgical approach for radical prostatectomy.14, 15
As with other procedures, interest in the laparoscopic approach for radical prostatectomy developed in hopes of minimizing patient morbidity. In 1992, Schuessler et al performed the first LRP but the technical difficulties of the procedure at that time prohibited the widespread application of this technique.16 In 1998, Guillonneau et al introduced the Mountsouris technique in which a transperitoneal approach was used to perform the LRP.17, 18 Other groups have used this approach and even adapted this technique to perform extraperitoneal approaches to LRP.1, 2, 4, 5, 19, 20 Many centers are currently offering LRP as primary therapy for organ confined prostate cancer.
All curative surgical therapies for prostate cancer, whether performed in an open or laparoscopic manner, can result in impotence and/or incontinence. Incontinence can be treated with simple measures, such as muscle strengthening exercises, or if more bothersome, can be treated with surgical therapy. Impotence can be treated with medications or, if needed, surgery.
The relative risk of having positive surgical margins in patients undergoing open radical retropubic prostatectomy compared to laparoscopic radical prostatectomy is not known. Preliminary publications regarding laparoscopic radical prostatectomy report rates of positive surgical margins (13-25%) that are similar to open radical prostatectomy (11-46%).2, 5, 6, 19, 21-28 However, long-term follow-up is not available for patients undergoing laparoscopic radical prostatectomy, so the impact of positive margins on long-term survival is not known.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| cohort | – | Other: observationRegistry and Database |
Who may qualify
- Ages
- 18 years and older
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients of Methodist Urology that are scheduled to undergo a laser procedure for prostate removal
Key inclusion criteria (3 listed)
- Patient of Methodist Urology in Indianapolis, IN
- Ability to give informed consent
- Biopsy proven diagnosis of prostate cancer without local extension or metastatic disease (Clinical T2 or less in the TNM classification)
Key exclusion criteria (6 listed)
- Major abdominal surgery precluding a safe laparoscopic approach
- Bleeding diathesis or anticoagulation
- Medical disease (such as cardiovascular or pulmonary diseases) precluding general anesthesia/laparoscopy
- Transplanted kidney in the pelvis
- Radiation therapy to pelvis
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| observationregistry and database for surgery outcomes | Other | cohort |
Primary outcome
To create a registry and database for the treatment of localized prostate cancer with LRP. To record long term outcomes for patients undergoing Laparoscopic Radical Prostatectomy.
Time frame: One year
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 29 Jun 2016.
Related trials for Prostate Cancer
RecruitingPhase 1/2
Study of HLD-0915 (JNJ-101556143) in Patients With Metastatic Prostate Cancer
Metastatic Prostate Cancer
RecruitingPhase 1
A Study of JNJ-98768111 in Participants With Advanced Prostate Cancer
Prostatic Neoplasms
RecruitingPhase 3
A Study of Pasritamig With Docetaxel Versus Docetaxel in Participants With Metastatic Castration-Resistant Prostate Cancer
Prostatic Neoplasms, Castration-Resistant
RecruitingPhase 2
Testing the Safety and Effectiveness of Radiation-based Treatment (Lutetium Lu 177 Dotatate) for Metastatic Prostate Cancer That Has Neuroendocrine Cells
Metastatic Prostate Adenocarcinoma With Neuroendocrine Differentiation, Metastatic Prostate Neuroendocrine Carcinoma
RecruitingPhase 3
Testing Different Dosing Schedules of the Anti-cancer Drug, Lutetium 177Lu PSMA RLT and Its Effect on Patients With Advanced Prostate Cancer, RECIPROCAL Trial
Metastatic Castration-Resistant Prostate Carcinoma, Metastatic Prostate Adenocarcinoma
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.
Larry Munch, MD principal investigator
Methodist Urology, LLC
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, run by Indiana Kidney Stone Institute 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 3 inclusion and 6 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 29 Jun 2016. 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 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?
To create a registry and database for the treatment of localized prostate cancer with LRP. To record long term outcomes for patients undergoing Laparoscopic Radical Prostatectomy. (time frame: One year). 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 29 Jun 2016; AzTrials last refreshed its copy on 3 Nov 2026.