NCT02784314

Brief Summary

In this observational cost efficacy study, the investigator compare the Laparoscopic Radical Prostatectomy (LRP) versus Robotic-Assisted Laparoscopic Prostatectomy (RALP). Every cost of care that include hospitalization related or post operative medical consumption are obtained and recorded up to 5 years follow up. Functional results (continence, potency, quality of life) are obtained through standardised questionnaires. Carcinologic results are estimated by Prostate Specific Antigen (PSA) relapse and salvage treatments. Economic evaluation will be made to estimate direct costs of the four postoperative year along with the incremental cost-effectiveness ratio (ICER) per successful surgical treatment (preserved urinary continence and erectile function and PSA \< 0.2).

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
25

participants targeted

Target at below P25 for not_applicable prostate-cancer

Timeline
Completed

Started May 2010

Longer than P75 for not_applicable prostate-cancer

Geographic Reach
1 country

3 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 1, 2010

Completed
3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2013

Completed
3.1 years until next milestone

First Submitted

Initial submission to the registry

May 20, 2016

Completed
7 days until next milestone

First Posted

Study publicly available on registry

May 27, 2016

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2016

Completed
Last Updated

June 5, 2017

Status Verified

June 1, 2017

Enrollment Period

3 years

First QC Date

May 20, 2016

Last Update Submit

June 2, 2017

Conditions

Prostate Cancer

Keywords

Clinically localized prostate cancerRobotic-assisted prostatectomyLaparoscopic prostatectomyErectile function ;Cost efficacy study

Outcome Measures

Primary Outcomes (1)

  • Erectile function

    Proportion of patients with recovery of erectile function between T0 (before surgery) and 12 months after surgery. Recovery is defined as a maximum decrease of 5 points score of the International Index of Erectile Function (IIEF) between pre and postoperative evaluations.

    12 months after surgery

Secondary Outcomes (6)

  • Surgical margins

    During surgery

  • Prostate Specific Antigen (PSA)

    Before surgery (T0), 6 months (M6), 12 months (M12), 24 months (M24) and 60 months (M60) after surgery

  • Continence

    Before surgery (T0), 6 months (M6), 9 months (M9),12 months (M12), 24 months (M24) and 60 months (M60) after surgery

  • Tolerance

    Perioperative period, 6 months (M6), 12 months (M12) and 24 months (M24) afer surgery

  • Quality of life

    Before surgery (T0), 6 months (M6), 9 months (M9),12 months (M12) and 24 months (M24) after surgery

  • +1 more secondary outcomes

Study Arms (2)

Robotic-Assisted Radical Prostatectomy

EXPERIMENTAL

Robotic-Assisted Radical Prostatectomy using da Vinci Surgical System

Procedure: Robotic-Assisted Radical Prostatectomy

Laparoscopic Radical Prostatectomy

ACTIVE COMPARATOR

Standard laparoscopic Radical Prostatectomy

Procedure: Laparoscopic Radical Prostatectomy

Interventions

Robotic-Assisted Radical ProstatectomyPROCEDURE
Robotic-Assisted Radical Prostatectomy
Laparoscopic Radical ProstatectomyPROCEDURE
Laparoscopic Radical Prostatectomy

Eligibility Criteria

Age40 Years - 70 Years
Sexmale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Localized prostate cancer
  • Gleason grade ≤ 3 + 4
  • PSA \< 15 ng / mL
  • Stage ≤ T2b
  • Eligible to receive laparoscopic radical prostatectomy
  • Candidate bilateral or unilateral erectile preservation

You may not qualify if:

  • Patient at high risk of postoperative progression (PSA\> 15 ng / mL; grade 5 predominant, clinical or radiological stage T3
  • Presenting erectile dysfunction (IIEF \< 22)
  • Past history of urinary incontinence (\> grade 1 WHO)
  • Body mass index \> 30

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (3)

Service d'Urologie - Clinique St Augustin

Bordeaux, 33074, France

Location

Service d'Urologie et Chirurgie de la Transplantation - Hôpital Edouard Herriot -Hospices Civils de Lyon

Lyon, 69437, France

Location

Service d'Urologie - Institut Mutualiste Montsouris

Paris, 75014, France

Location

MeSH Terms

Conditions

Prostatic Neoplasms

Condition Hierarchy (Ancestors)

Genital Neoplasms, MaleUrogenital NeoplasmsNeoplasms by SiteNeoplasmsGenital Diseases, MaleGenital DiseasesUrogenital DiseasesProstatic DiseasesMale Urogenital Diseases

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 20, 2016

First Posted

May 27, 2016

Study Start

May 1, 2010

Primary Completion

May 1, 2013

Study Completion

August 1, 2016

Last Updated

June 5, 2017

Record last verified: 2017-06

Locations

FR(3)