PROPENLAP: Multicentric Study Comparing Carcinological and Functional Results of Surgery

• Sponsor: Assistance Publique - Hôpitaux de Paris (Other)
• Overall Status: Unknown status
• CT.gov ID: NCT00502723
• Collaborator: (none)
• Enrollment: 1,440
• Location: 1
• Arms: 2
• Duration (Months): 55
• Patients Per Site Per Month: 26.2

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Cancer of the PROSTATE	Procedure: Radical retropubic prostatectomy; Procedure: Radical laparoscopy prostatectomy	Phase 3

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.

Study Design

• Study Type: Interventional
• Anticipated Enrollment: 1440 participants
• Allocation: Non-Randomized
• Intervention Model: Parallel Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: Prostate Cancer: Multicentric Study Comparing Carcinological and Functional Results of Surgery
• Study Start Date: Dec 1, 2007
• Anticipated Primary Completion Date: Jul 1, 2012
• Anticipated Study Completion Date: Jul 1, 2012

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: 2 Radical laparoscopy prostatectomy	Procedure: Radical laparoscopy prostatectomy; Radical laparoscopy prostatectomy
Experimental: 1 Radical retropubic prostatectomy	Procedure: Radical retropubic prostatectomy; Radical retropubic prostatectomy

Outcome Measures

Primary Outcome Measures

1. laparoscopic way versus open retropubic way among patients requiring a radical prostatectomy for a localised prostate cancer. [during the study]

Secondary Outcome Measures

1. Carcinological (percentage of positive surgical margins, percentage of capsular crossing). [after the surgical]

2. Functional (urinary continence, sexuality, quality of life) [at 2 years]

3. per and post operational morbidity [during the 36 months]

4. economic [duration and cost of hospitalization]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 70 Years
• Sexes Eligible for Study: Male
• Accepts Healthy Volunteers: No

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

Locations

	Site	City	State	Country	Postal Code
1	Groupe Hospitalier Albert Chenevier Henri Mondor	Creteil		France	94000

Sponsors and Collaborators

• Assistance Publique - Hôpitaux de Paris

Investigators

• Principal Investigator: Claude ABBOU, PU-PH, Assistance Publique - Hôpitaux de Paris

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Assistance Publique - Hôpitaux de Paris
• ClinicalTrials.gov Identifier: NCT00502723
• Other Study ID Numbers: K060402
• First Posted: Jul 18, 2007
• Last Update Posted: Jul 30, 2012
• Last Verified: Jan 1, 2008

• Keywords provided by Assistance Publique - Hôpitaux de Paris: Retropubic Prostatectomy; Surgical Procedures; Laparoscopic
• Additional relevant MeSH terms: Prostatic Neoplasms

Study Results

No Results Posted as of Jul 30, 2012