Multicentric Study Comparing Carcinological and Functional Results of Surgery (PROPENLAP)

July 27, 2012 updated by: Assistance Publique - Hôpitaux de Paris

Prostate Cancer: Multicentric Study Comparing Carcinological and Functional Results of Surgery

National multicentric prospective open study, comparing two current surgical methods: laparoscopic way versus open retropubic way among patients requiring a radical prostatectomy for a localised prostate cancer.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Detailed Description

The aim of this study is to show that radical prostatectomy by laparoscopic way could obtain carcinological results not lower than theses with radical retropubic surgery.

Study Type

Interventional

Enrollment (Anticipated)

1440

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
      • Creteil, France, 94000
        • Recruiting
        • Groupe Hospitalier Albert Chenevier Henri Mondor
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 70 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Male

Description

Inclusion Criteria:

  • Male, old patient of less than 70 years,
  • having a prostate cancer proven histologically, requiring a radical prostatectomy.
  • Clinical stage T1c and rate of PSA (with 20 ng/ml).
  • Osseous scintiscanning and abdomen-pelvic scanner negative.
  • Patient informed of the study and its participation.
  • Patient affiliated to a social security system.

Exclusion Criteria:

  • Contra-indication with the surgery or the anaesthesia.
  • Antecedent of prostate resection or adenomectomy.
  • Antecedent of inguinal hernia treatment.
  • Antecedent of deep venous thrombosis of the lower limbs or pulmonary embolism
  • Patient privatized of freedom.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: NON_RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
ACTIVE_COMPARATOR: 2
Radical laparoscopy prostatectomy
Procedure: Radical laparoscopy prostatectomy
Radical laparoscopy prostatectomy
EXPERIMENTAL: 1
Radical retropubic prostatectomy
Procedure: Radical retropubic prostatectomy
Radical retropubic prostatectomy

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
laparoscopic way versus open retropubic way among patients requiring a radical prostatectomy for a localised prostate cancer.
Time Frame: during the study
during the study

Secondary Outcome Measures

Outcome Measure
Time Frame
Carcinological (percentage of positive surgical margins, percentage of capsular crossing).
Time Frame: after the surgical
after the surgical
Functional (urinary continence, sexuality, quality of life)
Time Frame: at 2 years
at 2 years
per and post operational morbidity
Time Frame: during the 36 months
during the 36 months
economic
Time Frame: duration and cost of hospitalization
duration and cost of hospitalization

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Assistance Publique - Hôpitaux de Paris

Investigators

  • Principal Investigator: Claude ABBOU, PU-PH, Assistance Publique - Hôpitaux de Paris

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

December 1, 2007

Primary Completion (ANTICIPATED)

July 1, 2012

Study Completion (ANTICIPATED)

July 1, 2012

Study Registration Dates

First Submitted

July 17, 2007

First Submitted That Met QC Criteria

July 17, 2007

First Posted (ESTIMATE)

July 18, 2007

Study Record Updates

Last Update Posted (ESTIMATE)

July 30, 2012

Last Update Submitted That Met QC Criteria

July 27, 2012

Last Verified

January 1, 2008

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • K060402

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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