Clinical trial NCT06237114: Novel Robotic Prostatectomy Technique for Early Urinary Continence
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
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Prostate Cancer
Lead sponsor: Sir Mortimer B. Davis - Jewish General Hospital
Sponsor class: OTHER
First posted: 2024-02-01
Enrollment: 30
Sex: MALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Urology clinic at the the hospital

Brief 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.

Eligibility 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

Primary outcomes:
measure: EQ-5D-5L #1.1
timeFrame: Pperioperative baseline
measure: EQ-5D-5L #1.2
timeFrame: 4 weeks postoperatively
measure: EQ-5D-5L #1.3
timeFrame: 3 months postoperatively
measure: EQ-5D-5L #1.4
timeFrame: 6 months postoperatively
measure: EPIC-CP #2.1
timeFrame: perioperative baseline
measure: Expanded Prostate cancer Index Composite for Clinical Practice (EPIC-CP) #2.2
timeFrame: 4 weeks postoperatively
measure: Expanded Prostate cancer Index Composite for Clinical Practice (EPIC-CP) #2.3
timeFrame: 3 months postoperatively
measure: Expanded Prostate cancer Index Composite for Clinical Practice (EPIC-CP) #2.4
timeFrame: 6 months postoperatively
Secondary outcomes:
Other outcomes:
Locations:
city: Montréal
country: Canada
facility: Jewish General Hospital
state: Quebec
Study officials:
References: