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

July 17, 2007
July 27, 2012
December 2007
July 2012   (final data collection date for primary outcome measure)
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 ]
the percentage of absence of biological relapse [ Time Frame: at 3 years in each arm ]
Complete list of historical versions of study NCT00502723 on ClinicalTrials.gov Archive Site
  • 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 ]
  • 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 ]
Not Provided
Not Provided
 
Multicentric Study Comparing Carcinological and Functional Results of Surgery
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.

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.

Interventional
Phase 3
Allocation: Non-Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Cancer of the PROSTATE
  • Procedure: Radical retropubic prostatectomy
    Radical retropubic prostatectomy
    Other Name: Radical retropubic prostatectomy
  • Procedure: Radical laparoscopy prostatectomy
    Radical laparoscopy prostatectomy
    Other Name: Radical laparoscopy prostatectomy
  • Active Comparator: 2
    Radical laparoscopy prostatectomy
    Intervention: Procedure: Radical laparoscopy prostatectomy
  • Experimental: 1
    Radical retropubic prostatectomy
    Intervention: Procedure: Radical retropubic prostatectomy
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
1440
July 2012
July 2012   (final data collection date for primary outcome measure)

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.
Male
18 Years to 70 Years
No
Contact: Claude ABBOU, PU-PH 33 (0)1.49.81.25.51 claude.abbou@hmn.aphp.fr
France
 
NCT00502723
K060402
No
Assistance Publique - Hôpitaux de Paris
Assistance Publique - Hôpitaux de Paris
Not Provided
Principal Investigator: Claude ABBOU, PU-PH Assistance Publique - Hôpitaux de Paris
Assistance Publique - Hôpitaux de Paris
January 2008

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