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

The recruitment status of this study is unknown because the information has not been verified recently.

Verified January 2008 by Assistance Publique - Hôpitaux de Paris.
Recruitment status was Recruiting

Sponsor:

Information provided by (Responsible Party):

Assistance Publique - Hôpitaux de Paris

ClinicalTrials.gov Identifier:

NCT00502723

First received: July 17, 2007

Last updated: July 27, 2012

Last verified: January 2008

History of Changes

Tracking Information

First Received Date ^ICMJE

July 17, 2007

Last Updated Date

July 27, 2012

Start Date ^ICMJE

December 2007

Estimated Primary Completion Date

July 2012 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

laparoscopic way versus open retropubic way among patients requiring a radical prostatectomy for a localised prostate cancer. [ Time Frame: during the study ] [ Designated as safety issue: No ]

Original Primary Outcome Measures ^ICMJE

the percentage of absence of biological relapse [ Time Frame: at 3 years in each arm ]

Change History

Complete list of historical versions of study NCT00502723 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

Carcinological (percentage of positive surgical margins, percentage of capsular crossing). [ Time Frame: after the surgical ] [ Designated as safety issue: No ]
Functional (urinary continence, sexuality, quality of life) [ Time Frame: at 2 years ] [ Designated as safety issue: No ]
per and post operational morbidity [ Time Frame: during the 36 months ] [ Designated as safety issue: No ]
economic [ Time Frame: duration and cost of hospitalization ] [ Designated as safety issue: No ]

Original Secondary Outcome Measures ^ICMJE

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

Current Other Outcome Measures ^ICMJE

Not Provided

Original Other Outcome Measures ^ICMJE

Not Provided

Descriptive Information

Brief Title ^ICMJE

Multicentric Study Comparing Carcinological and Functional Results of Surgery

Official Title ^ICMJE

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

Brief Summary

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

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 ^ICMJE

Interventional

Study Phase

Phase 3

Study Design ^ICMJE

Allocation: Non-Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment

Condition ^ICMJE

Cancer of the PROSTATE

Intervention ^ICMJE

Procedure: Radical retropubic prostatectomy
Radical retropubic prostatectomy

Other Name: Radical retropubic prostatectomy
Procedure: Radical laparoscopy prostatectomy
Radical laparoscopy prostatectomy

Other Name: Radical laparoscopy prostatectomy

Study Arm (s)

Active Comparator: 2
Radical laparoscopy prostatectomy

Intervention: Procedure: Radical laparoscopy prostatectomy
Experimental: 1
Radical retropubic prostatectomy

Intervention: Procedure: Radical retropubic prostatectomy

Publications *

Not Provided

* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Recruiting

Estimated Enrollment ^ICMJE

1440

Estimated Completion Date

July 2012

Estimated Primary Completion Date

July 2012 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

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.

Gender

Male

Ages

18 Years to 70 Years

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact: Claude ABBOU, PU-PH

33 (0)1.49.81.25.51

claude.abbou@hmn.aphp.fr

Location Countries ^ICMJE

France

Administrative Information

NCT Number ^ICMJE

NCT00502723

Other Study ID Numbers ^ICMJE

K060402

Has Data Monitoring Committee

Responsible Party

Assistance Publique - Hôpitaux de Paris

Study Sponsor ^ICMJE

Assistance Publique - Hôpitaux de Paris

Collaborators ^ICMJE

Not Provided

Investigators ^ICMJE

Principal Investigator:

Claude ABBOU, PU-PH

Assistance Publique - Hôpitaux de Paris

Information Provided By

Assistance Publique - Hôpitaux de Paris

Verification Date

January 2008

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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