A Prospective Trial on Nerve Sparing Techniques Performed in Radical Prostatectomy

Prostate Cancer Clinical Trial

Official title:

A Prospective Trial on Nerve Sparing Techniques Performed in Radical Prostatectomy

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT04393831
• Other study ID #: 1512016820
• Status: Terminated
• Phase: N/A
• Start date: June 15, 2021
• Est. completion date: September 15, 2021

Study information

• Verified date: February 2022
• Source: Weill Medical College of Cornell University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The investigators propose a prospective study to assess recovery of urinary and sexual function by nerve sparing techniques after radical prostatectomy.

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 3
• Est. completion date: September 15, 2021
• Est. primary completion date: September 15, 2021
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 40 Years to 80 Years

Eligibility

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

Related Conditions & MeSH terms

• Prostate Cancer
• Prostatic Neoplasms
• Quality of Life

Intervention

Procedure:
• Retzius sparing
Retzius nerve sparing is a specific approach that avoids disrupting the structures involved in urinary and sexual function.

Locations

Country	Name	City	State
United States	Weill Cornell Medicine	New York	New York

Sponsors (1)

Lead Sponsor	Collaborator
Weill Medical College of Cornell University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	Up to 24 months following surgery
Primary	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.	Baseline, 1 month, 6 months, 12 months, and 24 months post-surgery
Primary	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.	Baseline and up to 24 months post-surgery
Secondary	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.	Baseline, 1 month, 6 months, 12 months, and 24 months post-surgery
Secondary	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.	Baseline, 6 months, 12 months, and 24 months post-surgery
Secondary	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.	12 months, 24 months post-surgery