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Trial Title:
Novel Robotic Prostatectomy Technique for Early Urinary Continence
NCT ID:
NCT06237114
Condition:
Prostate Cancer
Conditions: Official terms:
Prostatic Neoplasms
Study type:
Observational
Overall status:
Recruiting
Study design:
Time perspective:
Prospective
Summary:
The goal of this a single arm prospective study is to evaluating the 3-month return of
urinary continence outcomes of patients undergoing the transvesical retzius sparing
robotic radical prostatectomy (TRS-RALP) for standard of care surgical prostate removal
for treatment of prostate cancer.
The main question it aims: To have patients respond to questionnaires to collect
exploratory data on patient's quality of life (QoL; EuroQol-5 Dimension 5-Level
[EQ-5D-5L] and prostate cancer related urinary, bowel, and sexual function questionnaires
(Expanded Prostate cancer Index Composite for Clinical Practice (EPIC-CP), at their
standard of care perioperative visits at baseline and at 4 weeks, 3- and 6-months post
operatively.
Detailed description:
Patients undergoing robotic prostatectomy will have their surgery performed utilizing
TRS-RALP technique, which is a novel combination of two previously described techniques.
This technique is a recent alteration to our standard of care method of prostate removal,
and comprises two halves of two previously validated techniques performed in succession.
No new safety signals are anticipated, and the technique has been in use since May 2023.
The purpose of this technique change is to improve the rate of return urinary continence,
which early institutional experience supports. This trial protocol has been generated to
formally evaluate this continence return improvement inside a statistical framework for
prospective verification in our entire patient cohort.
Criteria for eligibility:
Study pop:
Urology clinic at the the hospital
Sampling method:
Probability Sample
Criteria:
Inclusion Criteria:
- Patients undergoing standard of care robotic radical prostatectomy for localized
prostate cancer
Exclusion Criteria:
- Patients with previous pelvic surgery
- Patients with previous pelvic radiotherapy
- Patient with previous focal therapy for prostate cancer
- Patients aged < 18 years at diagnosis
- Legally incapable patients
- Patients who are unable to receive information about the study in a language they
understand
- Patients who are unable to complete questionnaires and have no companion to help
complete them
- Patients undergoing a concomitant cancer surgery
Gender:
Male
Gender based:
Yes
Gender description:
Prostate cancer
Minimum age:
18 Years
Maximum age:
N/A
Healthy volunteers:
No
Locations:
Facility:
Name:
Jewish General Hospital
Address:
City:
Montréal
Zip:
H3T 1E2
Country:
Canada
Status:
Recruiting
Contact:
Last name:
Victor McPherson, MD
Phone:
514-340-8222
Phone ext:
24904
Email:
victor.mcpherson@gmail.com
Contact backup:
Last name:
Oleg Loutochin
Phone:
514-340-8222
Phone ext:
21627
Email:
oloutochin@jgh.mcgill.ca
Start date:
March 8, 2024
Completion date:
March 8, 2026
Lead sponsor:
Agency:
Sir Mortimer B. Davis - Jewish General Hospital
Agency class:
Other
Source:
Sir Mortimer B. Davis - Jewish General Hospital
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT06237114
