A Prospective Trial on Nerve Sparing Techniques Performed in Radical Prostatectomy

NCT ID: NCT04393831

Last Updated: 2022-03-11

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

NA

Total Enrollment

3 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-06-15

Study Completion Date

2021-09-15

Brief Summary

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

Detailed Description

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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.

Conditions

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Prostate Cancer Quality of Life

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Randomized controlled trial comparing Retzius sparing robot-assisted radical prostatectomy versus conventional robot-assisted radical prostatectomy
Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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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.

Group Type ACTIVE_COMPARATOR

Retzius sparing

Intervention Type PROCEDURE

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

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.

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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Retzius sparing

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

Intervention Type PROCEDURE

Eligibility Criteria

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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
Minimum Eligible Age

40 Years

Maximum Eligible Age

80 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

No

Sponsors

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Weill Medical College of Cornell University

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Jim C Hu, MD MPH

Role: PRINCIPAL_INVESTIGATOR

Weill Cornell Medicine, NewYork-Presbyterian

Locations

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Weill Cornell Medicine

New York, New York, United States

Site Status

Countries

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United States

Other Identifiers

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1512016820

Identifier Type: -

Identifier Source: org_study_id

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