A Prospective Trial on Nerve Sparing Techniques Performed in Radical Prostatectomy

NCT04393831 | Terminated DMC

• 1 other identifier: 1512016820
• Study Type: interventional
• Target: 3
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

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

Outcome Measures

Primary Outcomes (3)

• 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

• 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

• 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 Outcomes (3)

• Change in Baseline in Patient-Reported Penile Shortening as Assessed on Questionnaire

  Baseline, 1 month, 6 months, 12 months, and 24 months post-surgery

• Change in Baseline in Patient-Reported Penile Deformity as Assessed on Questionnaire

  Baseline, 6 months, 12 months, and 24 months post-surgery

• Change in Patient-reported Treatment Regret Scores as Assessed by Questionnaire

  12 months, 24 months post-surgery

Study Arms (2)

Retzius sparing

ACTIVE COMPARATOR

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.

Procedure: Retzius sparing

Conventional (non-Retzius) nerve sparing

NO INTERVENTION

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.

Interventions

Retzius sparing PROCEDURE

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

Retzius sparing

Eligibility Criteria

• Age: 40 Years - 80 Years
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Weill Medical College of Cornell University: lead

Study Sites (1)

Weill Cornell Medicine

New York, New York, 10065, United States

Location

MeSH Terms

Conditions

Prostatic Neoplasms; Urinary Incontinence

Condition Hierarchy (Ancestors)

Genital Neoplasms, Male; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Prostatic Diseases; Male Urogenital Diseases; Urination Disorders; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Lower Urinary Tract Symptoms; Urological Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Jim C Hu, MD MPH

  Weill Cornell Medicine, NewYork-Presbyterian

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Randomized controlled trial comparing Retzius sparing robot-assisted radical prostatectomy versus conventional robot-assisted radical prostatectomy

Study Record Dates

• First Submitted: May 14, 2020
• First Posted: May 19, 2020
• Study Start: June 15, 2021
• Primary Completion: September 15, 2021
• Study Completion: September 15, 2021
• Last Updated: March 11, 2022

Record last verified: 2022-02

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)