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Laparoscopic Radical Prostatectomy: A Registry and Database

18 Years
Not Enrolling
Prostate Cancer

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Trial Information

Laparoscopic Radical Prostatectomy: A Registry and Database

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.

Inclusion Criteria

Inclusion criteria:

- 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)

Exclusion criteria:

- Major abdominal surgery precluding a safe laparoscopic approach

- Bleeding diathesis or anticoagulation

- Medical disease (such as cardiovascular or pulmonary diseases) precluding general

- Transplanted kidney in the pelvis

- Radiation therapy to pelvis

- Morbid obesity

Type of Study:


Study Design:

Observational Model: Cohort, Time Perspective: Prospective

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.

Outcome Time Frame:

One year

Safety Issue:


Principal Investigator

Larry Munch, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Methodist Urology, LLC


United States: Institutional Review Board

Study ID:




Start Date:

June 2003

Completion Date:

April 2009

Related Keywords:

  • Prostate Cancer
  • Prostate Cancer
  • Prostatic Neoplasms



Methodist HospitalIndianapolis, Indiana  46202