Novel Robotic Prostatectomy Technique for Early Urinary Continence (NCT06237114) | Clinical Trial Compass
CompletedNot Applicable
Novel Robotic Prostatectomy Technique for Early Urinary Continence
Canada30 participantsStarted 2024-03-08
Plain-language 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.
Who can participate
Age range
18 Years
Sex
MALE
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
EQ-5D-5L #1.1
Timeframe: Pperioperative baseline
2
EQ-5D-5L #1.2
Timeframe: 4 weeks postoperatively
3
EQ-5D-5L #1.3
Timeframe: 3 months postoperatively
4
EQ-5D-5L #1.4
Timeframe: 6 months postoperatively
5
EPIC-CP #2.1
Timeframe: perioperative baseline
6
Expanded Prostate cancer Index Composite for Clinical Practice (EPIC-CP) #2.2
Timeframe: 4 weeks postoperatively
7
Expanded Prostate cancer Index Composite for Clinical Practice (EPIC-CP) #2.3
Timeframe: 3 months postoperatively
8
Expanded Prostate cancer Index Composite for Clinical Practice (EPIC-CP) #2.4
Trial details
NCT IDNCT06237114
SponsorSir Mortimer B. Davis - Jewish General Hospital