Multicentric Study Comparing Carcinological and Functional Results of Surgery

NCT ID: NCT00502723

Last Updated: 2012-07-30

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE3

Total Enrollment

1440 participants

Study Classification

INTERVENTIONAL

Study Start Date

2007-12-31

Study Completion Date

2012-07-31

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Cancer of the PROSTATE

Keywords

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Retropubic Prostatectomy Surgical Procedures Laparoscopic

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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2

Radical laparoscopy prostatectomy

Group Type ACTIVE_COMPARATOR

Radical laparoscopy prostatectomy

Intervention Type PROCEDURE

Radical laparoscopy prostatectomy

1

Radical retropubic prostatectomy

Group Type EXPERIMENTAL

Radical retropubic prostatectomy

Intervention Type PROCEDURE

Radical retropubic prostatectomy

Interventions

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Radical retropubic prostatectomy

Radical retropubic prostatectomy

Intervention Type PROCEDURE

Radical laparoscopy prostatectomy

Radical laparoscopy prostatectomy

Intervention Type PROCEDURE

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

70 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

No

Sponsors

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Assistance Publique - Hôpitaux de Paris

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Claude ABBOU, PU-PH

Role: PRINCIPAL_INVESTIGATOR

Assistance Publique - Hôpitaux de Paris

Locations

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Groupe Hospitalier Albert Chenevier Henri Mondor

Créteil, , France

Site Status RECRUITING

Countries

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France

Central Contacts

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Claude ABBOU, PU-PH

Role: CONTACT

Phone: 33 (0)1.49.81.25.51

Email: [email protected]

Facility Contacts

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Claude ABBOU, PU-PH

Role: primary

Other Identifiers

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K060402

Identifier Type: -

Identifier Source: org_study_id