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

Primary Purpose

Cancer of the PROSTATE

Status

Unknown status

Phase

Phase 3

Locations

France

Study Type

Interventional

Intervention

Radical retropubic prostatectomy

Radical laparoscopy prostatectomy

About this trial

This is an interventional treatment trial for Cancer of the PROSTATE focused on measuring Retropubic Prostatectomy, Surgical Procedures, Laparoscopic

Eligibility Criteria

18 Years - 70 Years (Adult, Older Adult)MaleDoes not accept healthy volunteers

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.

Sites / Locations

Groupe Hospitalier Albert Chenevier Henri MondorRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

Arm Description

Radical laparoscopy prostatectomy

Radical retropubic prostatectomy

Outcomes

Primary Outcome Measures

laparoscopic way versus open retropubic way among patients requiring a radical prostatectomy for a localised prostate cancer.

Secondary Outcome Measures

Carcinological (percentage of positive surgical margins, percentage of capsular crossing).

Functional (urinary continence, sexuality, quality of life)

per and post operational morbidity

economic

Full Information

NCT ID

NCT00502723

First Posted

July 17, 2007

Last Updated

July 27, 2012

Sponsor

Assistance Publique - Hôpitaux de Paris

1. Study Identification

Unique Protocol Identification Number

NCT00502723

Brief Title

Multicentric Study Comparing Carcinological and Functional Results of Surgery

Acronym

PROPENLAP

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

January 2008

Overall Recruitment Status

Unknown status

Study Start Date

December 2007 (undefined)

Primary Completion Date

July 2012 (Anticipated)

Study Completion Date

July 2012 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Assistance Publique - Hôpitaux de Paris

4. Oversight

Data Monitoring Committee

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Cancer of the PROSTATE

Keywords

Retropubic Prostatectomy, Surgical Procedures, Laparoscopic

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 3

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Non-Randomized

Enrollment

1440 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Arm Type

Active Comparator

Arm Description

Radical laparoscopy prostatectomy

Arm Title

Arm Type

Experimental

Arm Description

Radical retropubic prostatectomy

Intervention Type

Procedure

Intervention Name(s)

Radical retropubic prostatectomy

Intervention Description

Radical retropubic prostatectomy

Intervention Type

Procedure

Intervention Name(s)

Radical laparoscopy prostatectomy

Intervention Description

Radical laparoscopy prostatectomy

Primary Outcome Measure Information:

Title

laparoscopic way versus open retropubic way among patients requiring a radical prostatectomy for a localised prostate cancer.

Time Frame

during the study

Secondary Outcome Measure Information:

Title

Carcinological (percentage of positive surgical margins, percentage of capsular crossing).

Time Frame

after the surgical

Title

Functional (urinary continence, sexuality, quality of life)

Time Frame

at 2 years

Title

per and post operational morbidity

Time Frame

during the 36 months

Title

economic

Time Frame

duration and cost of hospitalization

10. Eligibility

Sex

Male

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

70 Years

Accepts Healthy Volunteers

Eligibility 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.

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Claude ABBOU, PU-PH

Phone

33 (0)1.49.81.25.51

claude.abbou@hmn.aphp.fr

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Claude ABBOU, PU-PH

Organizational Affiliation

Assistance Publique - Hôpitaux de Paris

Official's Role

Principal Investigator

Facility Information:

Facility Name

Groupe Hospitalier Albert Chenevier Henri Mondor

City

Creteil

ZIP/Postal Code

94000

Country

France

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Claude ABBOU, PU-PH

Phone

+33 (0)1.49.81.25.51

claude.abbou@hmn.aphp.fr

12. IPD Sharing Statement

Learn more about this trial

Multicentric Study Comparing Carcinological and Functional Results of Surgery

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