Multicentric Study Comparing Carcinological and Functiona... | NCT00502723

Studies
Multicentric Study Comparing Carcinological and Functional Results of Surgery

NCT00502723

Sponsor

Assistance Publique - Hôpitaux de Paris

Status

Unknown status

Last Update Posted

Jul 30, 2012Estimated

Enrollment

1,440Estimated

Phase

Phase 3

Conditions

Cancer of the PROSTATE

Interventions

Radical retropubic prostatectomy
Radical laparoscopy prostatectomy

Countries

France

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jan 2008

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Dec 2007

Primary Completion Date

Jul 2012Estimated

Completion Date

Jul 2012Estimated

First Submitted Date

Jul 17, 2007

First Submission Date that Met QC Criteria

Jul 17, 2007

First Posted Date

Jul 18, 2007Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jul 27, 2012

Last Update Posted Date

Jul 30, 2012Estimated

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 3

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

1,440Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
2	Active Comparator	Radical laparoscopy prostatectomy	Procedure: Radical laparoscopy prostatectomy
1	Experimental	Radical retropubic prostatectomy	Procedure: Radical retropubic prostatectomy

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Radical retropubic prostatectomy	Procedure	Radical retropubic prostatectomy	1

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
laparoscopic way versus open retropubic way among patients requiring a radical prostatectomy for a localised prostate cancer.		during the study

Secondary Outcomes

Measure	Description	Time Frame
Carcinological (percentage of positive surgical margins, percentage of capsular crossing).		after the surgical
Functional (urinary continence, sexuality, quality of life)		at 2 years

Other Outcomes

Not provided

Eligibility Module

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.

Accepts Healthy Volunteers

Sex

Male

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

70 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Claude ABBOU, PU-PH	Contact	33 (0)1.49.81.25.51		claude.abbou@hmn.aphp.fr

Overall Officials

Name	Affiliation	Role
Claude ABBOU, PU-PH	Assistance Publique - Hôpitaux de Paris	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Groupe Hospitalier Albert Chenevier Henri Mondor	Recruiting	Créteil		94000	France

Condition Browse Module

MeSH Terms

ID	Term
D011471	Prostatic Neoplasms

Ancestor Terms

ID	Term
D005834	Genital Neoplasms, Male
D014565	Urogenital Neoplasms
D009371	Neoplasms by Site
D009369	Neoplasms

Browse Leaves

Not provided

Browse Branches

Not provided