Novel Robotic Prostatectomy Technique for Early Urinary Continence (TRS-RALP)

Phase II Clinical Trial to Evaluate the Early Return of Urinary Continence Utilizing a Novel Hybrid Transvesical Adapted Retzius Sparing Robotic Assisted Radical Prostatectomy Technique

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.

Study Overview

• Status: Recruiting
• Conditions: Prostate Cancer

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.

• Study Type: Observational
• Enrollment (Estimated): 30

Contacts and Locations

• Study Contact: Name: Victor McPherson, MD; Phone Number: 24904 514-340-8222; Email: victor.mcpherson@mcgill.ca

Study Locations

• Canada
  • Quebec
    • Montréal, Quebec, Canada, H3T 1E2
      • Recruiting
      • Jewish General Hospital
      • Contact: Oleg Loutochin; Phone Number: 21627 514-340-8222; Email: oloutochin@jgh.mcgill.ca
      • Contact: Victor McPherson, MD; Phone Number: 24904 514-340-8222; Email: victor.mcpherson@gmail.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Probability Sample

Study Population

Urology clinic at the the hospital

Description

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

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
EQ-5D-5L #1.1	The EuroQol - 5 Dimension - 5 Level is a questionnaire that provides a descriptive profile for health status. The questionnaire is comprised of 5 dimension questions; mobility, self care, usual activities, pain/discomfort, anxiety/depression. For each dimension, the patient is asked to check off a level associated; no problems, slight problems, moderate problems, severe problems, extreme problems. Each result is a 1-digit number expressing the level of that dimension. The final result is a 5 digit number describing the patient's health state. The digits range from 1 (best health - best possible outcome) to 5 (worst health - worst possible outcome). The final question asks the patient to check their current health status. This ranges from 100 (best health you can imagine - best outcome) to 0 (worst health you can imagine - worst outcome).	Pperioperative baseline
EQ-5D-5L #1.2	The EuroQol - 5 Dimension - 5 Level is a questionnaire that provides a descriptive profile for health status. The questionnaire is comprised of 5 dimension questions; mobility, self care, usual activities, pain/discomfort, anxiety/depression. For each dimension, the patient is asked to check off a level associated; no problems, slight problems, moderate problems, severe problems, extreme problems. Each result is a 1-digit number expressing the level of that dimension. The final result is a 5 digit number describing the patient's health state. The digits range from 1 (best health - best possible outcome) to 5 (worst health - worst possible outcome). The final question asks the patient to check their current health status. This ranges from 100 (best health you can imagine - best outcome) to 0 (worst health you can imagine - worst outcome).	4 weeks postoperatively
EQ-5D-5L #1.3	The EuroQol - 5 Dimension - 5 Level is a questionnaire that provides a descriptive profile for health status. The questionnaire is comprised of 5 dimension questions; mobility, self care, usual activities, pain/discomfort, anxiety/depression. For each dimension, the patient is asked to check off a level associated; no problems, slight problems, moderate problems, severe problems, extreme problems. Each result is a 1-digit number expressing the level of that dimension. The final result is a 5 digit number describing the patient's health state. The digits range from 1 (best health - best possible outcome) to 5 (worst health - worst possible outcome). The final question asks the patient to check their current health status. This ranges from 100 (best health you can imagine - best outcome) to 0 (worst health you can imagine - worst outcome).	3 months postoperatively
EQ-5D-5L #1.4	The EuroQol - 5 Dimension - 5 Level is a questionnaire that provides a descriptive profile for health status. The questionnaire is comprised of 5 dimension questions; mobility, self care, usual activities, pain/discomfort, anxiety/depression. For each dimension, the patient is asked to check off a level associated; no problems, slight problems, moderate problems, severe problems, extreme problems. Each result is a 1-digit number expressing the level of that dimension. The final result is a 5 digit number describing the patient's health state. The digits range from 1 (best health - best possible outcome) to 5 (worst health - worst possible outcome). The final question asks the patient to check their current health status. This ranges from 100 (best health you can imagine - best outcome) to 0 (worst health you can imagine - worst outcome).	6 months postoperatively
EPIC-CP #2.1	The Expanded Prostate cancer Index Composite for Clinical Practice is a questionnaire to measure urinary, bowel,sexual and hormonal function of the patient's prostate cancer quality of life. The questionnaire is scored by the sum of the following scores: Urinary Incontinence symptom score, Urinary Irritation/Obstructive symptom score, Bowel Symptom score, Vitality/Hormonal symptom score and the overall prostate cancer quality of life score. The range of the score varies from 0 (best possible outcome) to 60 (worst possible outcome).	perioperative baseline
Expanded Prostate cancer Index Composite for Clinical Practice (EPIC-CP) #2.2	The Expanded Prostate cancer Index Composite for Clinical Practice is a questionnaire to measure urinary, bowel,sexual and hormonal function of the patient's prostate cancer quality of life. The questionnaire is scored by the sum of the following scores: Urinary Incontinence symptom score, Urinary Irritation/Obstructive symptom score, Bowel Symptom score, Vitality/Hormonal symptom score and the overall prostate cancer quality of life score. The range of the score varies from 0 (best possible outcome) to 60 (worst possible outcome).	4 weeks postoperatively
Expanded Prostate cancer Index Composite for Clinical Practice (EPIC-CP) #2.3	The Expanded Prostate cancer Index Composite for Clinical Practice is a questionnaire to measure urinary, bowel,sexual and hormonal function of the patient's prostate cancer quality of life. The questionnaire is scored by the sum of the following scores: Urinary Incontinence symptom score, Urinary Irritation/Obstructive symptom score, Bowel Symptom score, Vitality/Hormonal symptom score and the overall prostate cancer quality of life score. The range of the score varies from 0 (best possible outcome) to 60 (worst possible outcome).	3 months postoperatively
Expanded Prostate cancer Index Composite for Clinical Practice (EPIC-CP) #2.4	The Expanded Prostate cancer Index Composite for Clinical Practice is a questionnaire to measure urinary, bowel,sexual and hormonal function of the patient's prostate cancer quality of life. The questionnaire is scored by the sum of the following scores: Urinary Incontinence symptom score, Urinary Irritation/Obstructive symptom score, Bowel Symptom score, Vitality/Hormonal symptom score and the overall prostate cancer quality of life score. The range of the score varies from 0 (best possible outcome) to 60 (worst possible outcome).	6 months postoperatively

Collaborators and Investigators

• Sponsor: Sir Mortimer B. Davis - Jewish General Hospital

Study record dates

Study Major Dates

• Study Start (Actual): March 8, 2024
• Primary Completion (Estimated): March 8, 2025
• Study Completion (Estimated): March 8, 2026

Study Registration Dates

• First Submitted: January 24, 2024
• First Submitted That Met QC Criteria: January 24, 2024
• First Posted (Actual): February 1, 2024

Study Record Updates

• Last Update Posted (Actual): April 23, 2024
• Last Update Submitted That Met QC Criteria: April 21, 2024
• Last Verified: April 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Neoplasms; Urogenital Neoplasms; Neoplasms by Site; Genital Neoplasms, Male; Prostatic Diseases; Urogenital Diseases; Male Urogenital Diseases; Genital Diseases, Male; Genital Diseases; Prostatic Neoplasms
• Other Study ID Numbers: 2024-3985

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No