Multicentric Study Comparing Carcinological and Functional Results of Surgery

Cancer of the PROSTATE Clinical Trial

— PROPENLAP  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT00502723
• Other study ID #: K060402
• Status: Recruiting
• Phase: Phase 3
• First received: July 17, 2007
• Last updated: July 27, 2012
• Start date: December 2007
• Est. completion date: July 2012

Study information

• Verified date: January 2008
• Source: Assistance Publique - Hôpitaux de Paris
• Contact: Claude ABBOU, PU-PH
• Phone: 33 (0)1.49.81.25.51
• Email: claude.abbou[@]hmn.aphp.fr
• Is FDA regulated: No
• Health authority: France: Ministry of Health
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 1440
• Est. completion date: July 2012
• Est. primary completion date: July 2012
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 18 Years to 70 Years

Eligibility

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.

Study Design

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

Related Conditions & MeSH terms

• Cancer of the PROSTATE
• Prostatic Neoplasms

Intervention

Procedure:
• Radical retropubic prostatectomy
Radical retropubic prostatectomy
• Radical laparoscopy prostatectomy
Radical laparoscopy prostatectomy

Locations

Country	Name	City	State
France	Groupe Hospitalier Albert Chenevier Henri Mondor	Creteil

Sponsors (1)

Lead Sponsor	Collaborator
Assistance Publique - Hôpitaux de Paris

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	laparoscopic way versus open retropubic way among patients requiring a radical prostatectomy for a localised prostate cancer.		during the study	No
Secondary	Carcinological (percentage of positive surgical margins, percentage of capsular crossing).		after the surgical	No
Secondary	Functional (urinary continence, sexuality, quality of life)		at 2 years	No
Secondary	per and post operational morbidity		during the 36 months	No
Secondary	economic		duration and cost of hospitalization	No