Clinical trial NCT04393831: 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
Overall status: TERMINATED
Phase: NA
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
Lead sponsor: Weill Medical College of Cornell University
Sponsor class: OTHER
First posted: 2020-05-19
Enrollment: 3
Sex: MALE
Minimum age (years): 40
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Randomized controlled trial comparing Retzius sparing robot-assisted radical prostatectomy versus conventional robot-assisted radical prostatectomy
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Number of Treatment-Related Adverse Events as Assessed by Common Terminology Criteria for Adverse Events (CTCAE) v5.0
timeFrame: Up to 24 months following surgery
measure: Change in Patient-reported Health-Related Quality of Life (HRQOL) Scores as Assessed by Expanded Prostate Cancer Index Composite for Clinical Practice (EPIC-CP)
timeFrame: Baseline, 1 month, 6 months, 12 months, and 24 months post-surgery
measure: Change from Baseline in Prostate Specific Antigen (PSA) value on Laboratory Reports up to 24 Months Following Surgery
timeFrame: Baseline and up to 24 months post-surgery
Secondary outcomes:
measure: Change in Baseline in Patient-Reported Penile Shortening as Assessed on Questionnaire
timeFrame: Baseline, 1 month, 6 months, 12 months, and 24 months post-surgery
measure: Change in Baseline in Patient-Reported Penile Deformity as Assessed on Questionnaire
timeFrame: Baseline, 6 months, 12 months, and 24 months post-surgery
measure: Change in Patient-reported Treatment Regret Scores as Assessed by Questionnaire
timeFrame: 12 months, 24 months post-surgery
Other outcomes:
Locations:
city: New York
country: United States
facility: Weill Cornell Medicine
state: New York
Study officials:
affiliation: Weill Cornell Medicine, NewYork-Presbyterian
name: Jim C Hu, MD MPH
role: PRINCIPAL_INVESTIGATOR
References: