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
  Purpose

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.


Condition Intervention Phase
Cancer of the PROSTATE
Procedure: Radical retropubic prostatectomy
Procedure: Radical laparoscopy prostatectomy
Phase 3

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Prostate Cancer: Multicentric Study Comparing Carcinological and Functional Results of Surgery

Resource links provided by NLM:


Further study details as provided by Assistance Publique - Hôpitaux de Paris:

Primary Outcome Measures:
  • 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 ]

Secondary Outcome Measures:
  • 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 ]

Estimated Enrollment: 1440
Study Start Date: December 2007
Estimated Study Completion Date: July 2012
Estimated Primary Completion Date: July 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: 2
Radical laparoscopy prostatectomy
Procedure: Radical laparoscopy prostatectomy
Radical laparoscopy prostatectomy
Other Name: Radical laparoscopy prostatectomy
Experimental: 1
Radical retropubic prostatectomy
Procedure: Radical retropubic prostatectomy
Radical retropubic prostatectomy
Other Name: Radical retropubic prostatectomy

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.

  Eligibility

Ages Eligible for Study:   18 Years to 70 Years
Genders Eligible for Study:   Male
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00502723

Contacts
Contact: Claude ABBOU, PU-PH 33 (0)1.49.81.25.51 claude.abbou@hmn.aphp.fr

Locations
France
Groupe Hospitalier Albert Chenevier Henri Mondor Recruiting
Creteil, France, 94000
Contact: Claude ABBOU, PU-PH    +33 (0)1.49.81.25.51    claude.abbou@hmn.aphp.fr   
Sponsors and Collaborators
Assistance Publique - Hôpitaux de Paris
Investigators
Principal Investigator: Claude ABBOU, PU-PH Assistance Publique - Hôpitaux de Paris
  More Information

No publications provided

Responsible Party: Assistance Publique - Hôpitaux de Paris
ClinicalTrials.gov Identifier: NCT00502723     History of Changes
Other Study ID Numbers: K060402
Study First Received: July 17, 2007
Last Updated: July 27, 2012
Health Authority: France: Ministry of Health

Keywords provided by Assistance Publique - Hôpitaux de Paris:
Retropubic Prostatectomy
Surgical Procedures
Laparoscopic

Additional relevant MeSH terms:
Prostatic Neoplasms
Genital Diseases, Male
Genital Neoplasms, Male
Neoplasms
Neoplasms by Site
Prostatic Diseases
Urogenital Neoplasms

ClinicalTrials.gov processed this record on October 23, 2014