A Prospective Trial on Nerve Sparing Techniques Performed in Radical Prostatectomy

February 25, 2022 updated by: Weill Medical College of Cornell University
The investigators propose a prospective study to assess recovery of urinary and sexual function by nerve sparing techniques after radical prostatectomy.

Study Overview

Status

Terminated

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

3

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

    • New York
      • New York, New York, United States, 10065
        • Weill Cornell Medicine

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

38 years to 78 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Male

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Retzius sparing
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.
Retzius nerve sparing is a specific approach that avoids disrupting the structures involved in urinary and sexual function.
No Intervention: Conventional (non-Retzius) nerve sparing
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Number of Treatment-Related Adverse Events as Assessed by Common Terminology Criteria for Adverse Events (CTCAE) v5.0
Time Frame: Up to 24 months following surgery
The investigators will obtain patient-reported complications and adverse events captured from patient's medical record.
Up to 24 months following surgery
Change in Patient-reported Health-Related Quality of Life (HRQOL) Scores as Assessed by Expanded Prostate Cancer Index Composite for Clinical Practice (EPIC-CP)
Time Frame: Baseline, 1 month, 6 months, 12 months, and 24 months post-surgery

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.

Baseline, 1 month, 6 months, 12 months, and 24 months post-surgery
Change from Baseline in Prostate Specific Antigen (PSA) value on Laboratory Reports up to 24 Months Following Surgery
Time Frame: Baseline and up to 24 months post-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.
Baseline and up to 24 months post-surgery

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in Baseline in Patient-Reported Penile Shortening as Assessed on Questionnaire
Time Frame: Baseline, 1 month, 6 months, 12 months, and 24 months post-surgery

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.

Baseline, 1 month, 6 months, 12 months, and 24 months post-surgery
Change in Baseline in Patient-Reported Penile Deformity as Assessed on Questionnaire
Time Frame: Baseline, 6 months, 12 months, and 24 months post-surgery

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.

Baseline, 6 months, 12 months, and 24 months post-surgery
Change in Patient-reported Treatment Regret Scores as Assessed by Questionnaire
Time Frame: 12 months, 24 months post-surgery

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.

12 months, 24 months post-surgery

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Investigators

  • Principal Investigator: Jim C Hu, MD MPH, Weill Cornell Medicine, NewYork-Presbyterian

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

June 15, 2021

Primary Completion (Actual)

September 15, 2021

Study Completion (Actual)

September 15, 2021

Study Registration Dates

First Submitted

May 14, 2020

First Submitted That Met QC Criteria

May 14, 2020

First Posted (Actual)

May 19, 2020

Study Record Updates

Last Update Posted (Actual)

March 11, 2022

Last Update Submitted That Met QC Criteria

February 25, 2022

Last Verified

February 1, 2022

More Information

Terms related to this study

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

IPD Plan Description

Individual participant data (IPD) will not be shared with other researchers.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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