Multicentric Study Comparing Carcinological and Functional Results of Surgery
PROPENLAP
Prostate Cancer: Multicentric Study Comparing Carcinological and Functional Results of Surgery
1 other identifier
interventional
1,440
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_3
Started Dec 2007
Longer than P75 for phase_3
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
July 17, 2007
CompletedFirst Posted
Study publicly available on registry
July 18, 2007
CompletedStudy Start
First participant enrolled
December 1, 2007
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 1, 2012
CompletedStudy Completion
Last participant's last visit for all outcomes
July 1, 2012
CompletedJuly 30, 2012
January 1, 2008
4.6 years
July 17, 2007
July 27, 2012
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
laparoscopic way versus open retropubic way among patients requiring a radical prostatectomy for a localised prostate cancer.
during the study
Secondary Outcomes (4)
Carcinological (percentage of positive surgical margins, percentage of capsular crossing).
after the surgical
Functional (urinary continence, sexuality, quality of life)
at 2 years
per and post operational morbidity
during the 36 months
economic
duration and cost of hospitalization
Study Arms (2)
2
ACTIVE COMPARATORRadical laparoscopy prostatectomy
1
EXPERIMENTALRadical retropubic prostatectomy
Interventions
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Groupe Hospitalier Albert Chenevier Henri Mondor
Créteil, 94000, France
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Claude ABBOU, PU-PH
Assistance Publique - Hôpitaux de Paris
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- NON RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
July 17, 2007
First Posted
July 18, 2007
Study Start
December 1, 2007
Primary Completion
July 1, 2012
Study Completion
July 1, 2012
Last Updated
July 30, 2012
Record last verified: 2008-01