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

Assistance Publique - Hôpitaux de Paris

Status and phase: Unknown; Phase 3

Conditions: Cancer of the PROSTATE

Treatments: Procedure: Radical retropubic prostatectomy; Procedure: Radical laparoscopy prostatectomy

Study type: Interventional

Funder types: Other

Identifiers

NCT00502723

K060402

Details and patient eligibility

About

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.

Full 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.

Enrollment: 1,440 estimated patients

Sex: Male

Ages: 18 to 70 years old

Volunteers: No 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.

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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1,440 participants in 2 patient groups

2

Active Comparator group

Description:

Radical laparoscopy prostatectomy

Treatment:

Procedure: Radical laparoscopy prostatectomy

1

Experimental group

Description:

Radical retropubic prostatectomy

Treatment:

Procedure: Radical retropubic prostatectomy