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Completed

NCT Number: NCT06237114

Novel Robotic Prostatectomy Technique for Early Urinary Continence

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.

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Key information

Conditions

Prostate Cancer Genital Diseases Genital Diseases, Male Genital Neoplasms, Male Male Urogenital Diseases Neoplasms Neoplasms by Site Prostatic Diseases Prostatic Neoplasms Urogenital Diseases Urogenital Neoplasms

Age range

18 year and older

Sex eligibility

Male

Study type

Observational

Primary location

Jewish General Hospital

Montreal, Quebec, H3T 1E2, Canada

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  1. EQ-5D-5L #1.1

    Time frame: Pperioperative baseline

    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).

  2. EQ-5D-5L #1.2

    Time frame: 4 weeks postoperatively

    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. EQ-5D-5L #1.3

    Time frame: 3 months postoperatively

    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. EQ-5D-5L #1.4

    Time frame: 6 months postoperatively

    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).

  5. EPIC-CP #2.1

    Time frame: perioperative baseline

    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. Expanded Prostate cancer Index Composite for Clinical Practice (EPIC-CP) #2.2

    Time frame: 4 weeks postoperatively

    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).

  7. Expanded Prostate cancer Index Composite for Clinical Practice (EPIC-CP) #2.3

    Time frame: 3 months postoperatively

    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).

  8. Expanded Prostate cancer Index Composite for Clinical Practice (EPIC-CP) #2.4

    Time frame: 6 months postoperatively

    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).

Sponsors and collaborators

Lead sponsor

Sir Mortimer B. Davis - Jewish General Hospital

Other

Registry information

Official study 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

Acronym: TRS-RALP

Important dates

Study start
2024
Primary completion
2025
Study completion
2025
First posted
Feb 1, 2024
Registry last updated
Apr 18, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

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This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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