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Pelvic Fascia spARing Radical Prostatectomy TrIAL (PARTIAL) (PARTIAL)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04393831
Recruitment Status : Suspended (Temporarily paused due to COVID-19 and will resume based on guidance of public health authorities. This is not a suspension of IRB approval.)
First Posted : May 19, 2020
Last Update Posted : June 4, 2020
Sponsor:
Information provided by (Responsible Party):
Weill Medical College of Cornell University

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

Condition or disease Intervention/treatment Phase
Prostate Cancer Quality of Life Procedure: Retzius sparing Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 112 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: Randomized controlled trial comparing Retzius sparing robot-assisted radical prostatectomy versus conventional robot-assisted radical prostatectomy
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Prospective Trial on Nerve Sparing Techniques Performed in Radical Prostatectomy
Estimated Study Start Date : August 1, 2020
Estimated Primary Completion Date : October 1, 2023
Estimated Study Completion Date : December 1, 2023

Resource links provided by the National Library of Medicine


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.
Procedure: Retzius sparing
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.



Primary Outcome Measures :
  1. 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.

  2. 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.


  3. 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.


Secondary Outcome Measures :
  1. 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.


  2. 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.


  3. 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.




Information from the National Library of Medicine

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Ages Eligible for Study:   30 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04393831


Locations
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United States, New York
Weill Cornell Medicine
New York, New York, United States, 10065
Sponsors and Collaborators
Weill Medical College of Cornell University
Investigators
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Principal Investigator: Jim C Hu, MD MPH Weill Cornell Medicine, NewYork-Presbyterian
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Responsible Party: Weill Medical College of Cornell University
ClinicalTrials.gov Identifier: NCT04393831    
Other Study ID Numbers: 1512016820
First Posted: May 19, 2020    Key Record Dates
Last Update Posted: June 4, 2020
Last Verified: June 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Plan Description: Individual participant data (IPD) will not be shared with other researchers.

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Weill Medical College of Cornell University:
prostate cancer
radical prostatectomy
robot-assisted radical prostatectomy
prostatectomy
nerve sparing
Retzius
quality of life
urinary incontinence
sexual function
Additional relevant MeSH terms:
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Prostatic Neoplasms
Genital Neoplasms, Male
Urogenital Neoplasms
Neoplasms by Site
Neoplasms
Genital Diseases, Male
Prostatic Diseases