Multicentric Study Comparing Carcinological and Functional Results of Surgery

• Register: ClinicalTrials.gov
• Last refreshed on: 19 February 2015
• Main ID: NCT00502723
• Date of registration: 17/07/2007
• Prospective Registration: Yes
• Primary sponsor: Assistance Publique - Hôpitaux de Paris
• Public title: Multicentric Study Comparing Carcinological and Functional Results of Surgery PROPENLAP
• Scientific title: Prostate Cancer: Multicentric Study Comparing Carcinological and Functional Results of Surgery
• Date of first enrolment: December 2007
• Target sample size: 1440
• Recruitment status: Recruiting
• URL: http://clinicaltrials.gov/show/NCT00502723
• Study type: Interventional
• Study design: Allocation: Non-Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
• Phase: Phase 3

Countries of recruitment

France

Contacts

• Name: Claude ABBOU, PU-PH

• Name: Claude ABBOU, PU-PH

• Name: Claude ABBOU, PU-PH
• Affiliation: Assistance Publique - Hôpitaux de Paris

Key inclusion & exclusion 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.



Age minimum: 18 Years
Age maximum: 70 Years
Gender: Male

Health Condition(s) or Problem(s) studied

Cancer of the PROSTATE

Intervention(s)

Procedure: Radical retropubic prostatectomy

Procedure: Radical laparoscopy prostatectomy

Primary Outcome(s)

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

Secondary Outcome(s)

per and post operational morbidity [Time Frame: during the 36 months]

economic [Time Frame: duration and cost of hospitalization]

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

Functional (urinary continence, sexuality, quality of life) [Time Frame: at 2 years]

Secondary ID(s)

K060402

Source(s) of Monetary Support

Please refer to primary and secondary sponsors