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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.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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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.

United States1 site
  • Methodist Hospital

    Indianapolis, Indiana, 46202

Other trials in United States

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 groups in NCT00169676
Study groupRoleWhat they receive
cohortRegistry and Database
Receives: Other: observation

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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.

  1. First posted15 Sep 2005 (estimated)
  2. Study startJun 2003
  3. Primary completionApr 2016
  4. Study completionApr 2016

Resources

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)
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

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.

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