Novel Robotic Prostatectomy Technique for Early Urinary Continence

Prostate Cancer Clinical Trial

— TRS-RALP  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06237114
• Other study ID #: 2024-3985
• Status: Recruiting
• Start date: March 8, 2024
• Est. completion date: March 8, 2026

Study information

• Verified date: April 2024
• Source: Sir Mortimer B. Davis - Jewish General Hospital
• Contact: Victor McPherson, MD
• Phone: 514-340-8222
• Email: victor.mcpherson[@]mcgill.ca
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 30
• Est. completion date: March 8, 2026
• Est. primary completion date: March 8, 2025
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Prostate Cancer
• Prostatic Neoplasms

Locations

Country	Name	City	State
Canada	Jewish General Hospital	Montréal	Quebec

Sponsors (1)

Lead Sponsor	Collaborator
Sir Mortimer B. Davis - Jewish General Hospital

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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