Study of Robot-assisted Radical Prostatectomy Performed on Outpatient in Patients With Localized Prostate Cancer

NCT04319146 | Active Not Recruiting

• 1 other identifier: 19-AOIP-03
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

Brief Summary

The promoter propose a pilot study evaluating the feasability of robot-assisted radical prostatectomy on outpatient in patients with localized prostate cancer. This study will enrole a total of 20 patients over one center, followed for 1 month. The total study duration will be 15 months, including statistical analysis and publication.

Conditions

Prostate Cancer

Outcome Measures

Primary Outcomes (1)

• Absence of conventional hospitalization after robot-assisted radical prostatectomy

  24 hours following the intervention

Secondary Outcomes (7)

• Outpatient failure defined by a Chung score of less than 9 who cannot be discharged or admitted to a conventional hospitalization.

  24 hours following the intervention

• Mesure of the operation duration will be estimated in minutes and will be recorded with a stopwatch in the operating room

  The day of surgery

• The complication rate is determined by the number of patients who had one or more complications in the first month following the operation. Complications will be graded according to the Clavien Dindo classification.

  within the month after surgery

• The consultation rate in a doctor's office is set by the number of patients who consulted a general practitioner in the first month after the operation, declared by the patient during the control visite (at 1 month)

  one month after surgery

• •Any form of admission for urological reasons judged by the investigator in relation to robot-assisted radical prostatectomy within one month after the operation is considered as early unscheduled re-hospitalisation.

  one month after surgery

Study Arms (1)

robot-assisted radical prostatectomy

OTHER

patient with a prostate cancer will be operated with a robot-assisted method. They will be supported on an outpatient basis

Procedure: robot-assisted radical prostatectomy

Interventions

robot-assisted radical prostatectomy PROCEDURE

robot-assisted radical prostatectomy as first-line treatment

robot-assisted radical prostatectomy

Eligibility Criteria

• Age: 18 Years+
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Men
• Older than 18 years old, if\> 70 years old, then patient having had a favorable onco-geriatric consultation (Balducci 2 and life expectancy\> 10 years)
• Patient with localized prostate cancer applying for radical prostatectomy treatment
• Patient accepting outpatient surgery
• Radical prostatectomy performed as first-line treatment
• BMI \<35
• ASA score \<3
• Accompanying person available (taxi authorized) to ensure return home
• Have quick access to a telephone line
• Patient who signed their informed consent
• Patient covered by social security or other health insurance

You may not qualify if:

• History of major abdominal surgery
• History of pelvic radiotherapy
• History of major urogenital malformation
• Sleep apnea syndrome
• Taking the following drugs within 48 hours (Plavix®, anti-vitamin K / curative LMWH)
• Contraindication to ambulatory medical care
• Inability to understand and sign the informed consent and to complete the self-questionnaires
• Vulnerable people

Sponsors & Collaborators

• Centre Hospitalier Universitaire de Nice: lead

Study Sites (1)

CHU de NICE Pasteur 2

Nice, CHU de Nice, 06000, France

Location

MeSH Terms

Conditions

Prostatic Neoplasms

Condition Hierarchy (Ancestors)

Genital Neoplasms, Male; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Prostatic Diseases; Male Urogenital Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Open label, monocentric study

Study Record Dates

• First Submitted: March 17, 2020
• First Posted: March 24, 2020
• Study Start: January 25, 2022
• Primary Completion: December 1, 2025
• Study Completion: December 1, 2025
• Last Updated: December 4, 2025

Record last verified: 2025-11

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)