Back to resultsA Prospective Trial on Nerve Sparing Techniques Performed in Radical Prostatectomy
Primary Purpose
Prostate Cancer, Quality of Life
Status
Terminated
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Retzius sparing
Sponsored by
About this trial
This is an interventional treatment trial for Prostate Cancer focused on measuring prostate cancer, radical prostatectomy, robot-assisted radical prostatectomy, prostatectomy, nerve sparing, Retzius, quality of life, urinary incontinence, sexual function
Eligibility Criteria
Inclusion Criteria:
- clinically localized prostate cancer
- able to read and speak English or Spanish
- no previous history of head injury, dementia or psychiatric illness
- no other concurrent cancer
- estimated life expectancy of 10 years or more
- biopsy proven prostate cancer
Exclusion Criteria:
- evidence of metastases
- Prostate specific antigen (PSA) greater than 30 ng/mL
- previous major pelvic surgery
- diagnosis of another malignancy within the past 5 years, with the exception of non-melanoma skin cancer
Sites / Locations
- Weill Cornell Medicine
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
No Intervention
Arm Label
Retzius sparing
Conventional (non-Retzius) nerve sparing
Arm Description
Using the Retzius technique, the surgeon will remove the prostate in a way that preserves a portion of the nerves and tissue structures that are typically removed during the conventional technique.
A non-Retzius nerve sparing technique will be performed, according to surgeon's preference--nerve sparing during radical prostatectomy is performed with significant variation and there is an absence of universally agreed upon steps or techniques.
Outcomes
Primary Outcome Measures
Number of Treatment-Related Adverse Events as Assessed by Common Terminology Criteria for Adverse Events (CTCAE) v5.0
The investigators will obtain patient-reported complications and adverse events captured from patient's medical record.
Change in Patient-reported Health-Related Quality of Life (HRQOL) Scores as Assessed by Expanded Prostate Cancer Index Composite for Clinical Practice (EPIC-CP)
Patients will fill out the EPIC-CP questionnaire. The EPIC-CP is a 10-item questionnaire assessing five health-related quality of life domains: urinary function, urinary irritation, bowel function, sexual function, and hormonal issues. All questions are about patients' health and symptoms in the last four weeks.
Each domain is scored out of 12 points, with higher scores indicating more complications.
In total, the EPIC-CP score is the final sum of the 5 domains. The EPIC-CP is scored out of 60 points, with higher scores indicating more issues related to overall prostate cancer quality of life.
Change from Baseline in Prostate Specific Antigen (PSA) value on Laboratory Reports up to 24 Months Following Surgery
The investigators will obtain patient's PSA values from their medical record, at baseline and up to 24 months post-surgery. Patient PSA levels are obtained from standard of care blood tests, and PSA values are measured in ng/mL.
Secondary Outcome Measures
Change in Baseline in Patient-Reported Penile Shortening as Assessed on Questionnaire
Patients will fill out a validated, 5-item questionnaire assessing penile shortening, self-esteem, and presence of erections.
Question 1 assesses patients' perceived penile length post-surgery, compared to penile length at 30 years of age. It consists of two possible responses: Yes or No.
Questions 2 and 3 assesses patients' ability to obtain and quality of spontaneous morning erections and sexual activity-related erections. It consists of five possible responses: ranging from "No erections" to "Erections always sufficient".
Question 4 is a visual digital scale assessing patients' present quality of life. It is scored on a scale of 1-7, with higher scores indicating high quality of life.
Question 5 is a visual digital scale assessing patients' present self-esteem. It is scored on a scale of 1-7, with higher scores indicating high self-esteem.
Change in Baseline in Patient-Reported Penile Deformity as Assessed on Questionnaire
Patients will fill out a validated, 3-item questionnaire assessing presence of Peyronie's disease.
Question 1 assesses penile hardening in the flaccid state. Question 2 assesses penile curvature in the erect state. Question 3 assesses pain associated with erection. Each question consists of two possible responses: Yes or No.
Change in Patient-reported Treatment Regret Scores as Assessed by Questionnaire
Patients will fill out a validated, 5-item questionnaire assessing feelings toward treatment regret.
Each item is scored on a 5 point scale ranging from "Strongly Agree" to "Strongly Disagree". Responses are converted to a score ranging from 0-100, with higher scores indicating more regret.
Full Information
NCT ID
NCT04393831
First Posted
May 14, 2020
Last Updated
February 25, 2022
Sponsor
Weill Medical College of Cornell University
1. Study Identification
Unique Protocol Identification Number
NCT04393831
Brief Title
A Prospective Trial on Nerve Sparing Techniques Performed in Radical Prostatectomy
Official Title
A Prospective Trial on Nerve Sparing Techniques Performed in Radical Prostatectomy
Study Type
Interventional
2. Study Status
Record Verification Date
February 2022
Overall Recruitment Status
Terminated
Why Stopped
This study was terminated to facilitate accrual under NCT05155501
Study Start Date
June 15, 2021 (Actual)
Primary Completion Date
September 15, 2021 (Actual)
Study Completion Date
September 15, 2021 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Weill Medical College of Cornell University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
The investigators propose a prospective study to assess recovery of urinary and sexual function by nerve sparing techniques after radical prostatectomy.
Detailed Description
Subjects will be randomized in a 1:1 ratio to Retzius nerve sparing versus non-Retzius nerve sparing to compare cancer outcomes and urinary/sexual outcomes following radical prostatectomy. Using the Retzius technique, the surgeon will remove the prostate in a way that preserves a portion of the nerves and tissue structures that are typically removed during the conventional technique.
The investigators will assess recovery of urinary and sexual function of patients through questionnaires at 1 week, 1 month, 6 months, 12 months, and 24 months after surgery.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Prostate Cancer, Quality of Life
Keywords
prostate cancer, radical prostatectomy, robot-assisted radical prostatectomy, prostatectomy, nerve sparing, Retzius, quality of life, urinary incontinence, sexual function
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Randomized controlled trial comparing Retzius sparing robot-assisted radical prostatectomy versus conventional robot-assisted radical prostatectomy
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
3 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Retzius sparing
Arm Type
Active Comparator
Arm Description
Using the Retzius technique, the surgeon will remove the prostate in a way that preserves a portion of the nerves and tissue structures that are typically removed during the conventional technique.
Arm Title
Conventional (non-Retzius) nerve sparing
Arm Type
No Intervention
Arm Description
A non-Retzius nerve sparing technique will be performed, according to surgeon's preference--nerve sparing during radical prostatectomy is performed with significant variation and there is an absence of universally agreed upon steps or techniques.
Intervention Type
Procedure
Intervention Name(s)
Retzius sparing
Intervention Description
Retzius nerve sparing is a specific approach that avoids disrupting the structures involved in urinary and sexual function.
Primary Outcome Measure Information:
Title
Number of Treatment-Related Adverse Events as Assessed by Common Terminology Criteria for Adverse Events (CTCAE) v5.0
Description
The investigators will obtain patient-reported complications and adverse events captured from patient's medical record.
Time Frame
Up to 24 months following surgery
Title
Change in Patient-reported Health-Related Quality of Life (HRQOL) Scores as Assessed by Expanded Prostate Cancer Index Composite for Clinical Practice (EPIC-CP)
Description
Patients will fill out the EPIC-CP questionnaire. The EPIC-CP is a 10-item questionnaire assessing five health-related quality of life domains: urinary function, urinary irritation, bowel function, sexual function, and hormonal issues. All questions are about patients' health and symptoms in the last four weeks.
Each domain is scored out of 12 points, with higher scores indicating more complications.
In total, the EPIC-CP score is the final sum of the 5 domains. The EPIC-CP is scored out of 60 points, with higher scores indicating more issues related to overall prostate cancer quality of life.
Time Frame
Baseline, 1 month, 6 months, 12 months, and 24 months post-surgery
Title
Change from Baseline in Prostate Specific Antigen (PSA) value on Laboratory Reports up to 24 Months Following Surgery
Description
The investigators will obtain patient's PSA values from their medical record, at baseline and up to 24 months post-surgery. Patient PSA levels are obtained from standard of care blood tests, and PSA values are measured in ng/mL.
Time Frame
Baseline and up to 24 months post-surgery
Secondary Outcome Measure Information:
Title
Change in Baseline in Patient-Reported Penile Shortening as Assessed on Questionnaire
Description
Patients will fill out a validated, 5-item questionnaire assessing penile shortening, self-esteem, and presence of erections.
Question 1 assesses patients' perceived penile length post-surgery, compared to penile length at 30 years of age. It consists of two possible responses: Yes or No.
Questions 2 and 3 assesses patients' ability to obtain and quality of spontaneous morning erections and sexual activity-related erections. It consists of five possible responses: ranging from "No erections" to "Erections always sufficient".
Question 4 is a visual digital scale assessing patients' present quality of life. It is scored on a scale of 1-7, with higher scores indicating high quality of life.
Question 5 is a visual digital scale assessing patients' present self-esteem. It is scored on a scale of 1-7, with higher scores indicating high self-esteem.
Time Frame
Baseline, 1 month, 6 months, 12 months, and 24 months post-surgery
Title
Change in Baseline in Patient-Reported Penile Deformity as Assessed on Questionnaire
Description
Patients will fill out a validated, 3-item questionnaire assessing presence of Peyronie's disease.
Question 1 assesses penile hardening in the flaccid state. Question 2 assesses penile curvature in the erect state. Question 3 assesses pain associated with erection. Each question consists of two possible responses: Yes or No.
Time Frame
Baseline, 6 months, 12 months, and 24 months post-surgery
Title
Change in Patient-reported Treatment Regret Scores as Assessed by Questionnaire
Description
Patients will fill out a validated, 5-item questionnaire assessing feelings toward treatment regret.
Each item is scored on a 5 point scale ranging from "Strongly Agree" to "Strongly Disagree". Responses are converted to a score ranging from 0-100, with higher scores indicating more regret.
Time Frame
12 months, 24 months post-surgery
10. Eligibility
Sex
Male
Minimum Age & Unit of Time
40 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
clinically localized prostate cancer
able to read and speak English or Spanish
no previous history of head injury, dementia or psychiatric illness
no other concurrent cancer
estimated life expectancy of 10 years or more
biopsy proven prostate cancer
Exclusion Criteria:
evidence of metastases
Prostate specific antigen (PSA) greater than 30 ng/mL
previous major pelvic surgery
diagnosis of another malignancy within the past 5 years, with the exception of non-melanoma skin cancer
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jim C Hu, MD MPH
Organizational Affiliation
Weill Cornell Medicine, NewYork-Presbyterian
Official's Role
Principal Investigator
Facility Information:
Facility Name
Weill Cornell Medicine
City
New York
State/Province
New York
ZIP/Postal Code
10065
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
No
IPD Sharing Plan Description
Individual participant data (IPD) will not be shared with other researchers.
Learn more about this trial
A Prospective Trial on Nerve Sparing Techniques Performed in Radical Prostatectomy
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