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Trial record 1 of 1 for:    Prospective, Controlled Study Evaluating Recovery of Potency and Continence Following Robot-Assisted Radical Prostatectomy with and without Cryopreserved Umbilical Cord Allograft
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AMNIOX CORD Study - Radical Prostatectomy With and Without Cryopreserved Umbilical Cord Allograft

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ClinicalTrials.gov Identifier: NCT04263025
Recruitment Status : Recruiting
First Posted : February 10, 2020
Last Update Posted : February 10, 2021
Sponsor:
Information provided by (Responsible Party):
Hackensack Meridian Health

Brief Summary:
This study aims at evaluating if placement of CLARIX® CORD 1K during robotic prostatectomy decreases the time to achieve complete erectile and urinary function after the surgery. As part of the study, the patient will be asked to answer various questions after the surgery regarding sexual and urinary function.

Condition or disease Intervention/treatment Phase
Prostate Cancer Biological: Cryopreserved Umbilical Cord Allograft Procedure: Robot-Assisted Radical Prostatectomy Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 100 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Masking Description: Participant will be Blinded
Primary Purpose: Treatment
Official Title: Prospective, Controlled Study Evaluating Recovery of Potency and Continence Following Robot-Assisted Radical Prostatectomy With and Without Cryopreserved Umbilical Cord Allograft
Actual Study Start Date : January 30, 2020
Estimated Primary Completion Date : April 1, 2022
Estimated Study Completion Date : April 1, 2023

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Prostate Cancer

Arm Intervention/treatment
Experimental: CLARIX CORD 1K
They will receive adjunctive CLARIX® CORD 1K (Amniox Medical, Inc., Miami, FL) during Robot-Assisted Radical Prostatectomy (RARP).
Biological: Cryopreserved Umbilical Cord Allograft
CLARIX® CORD 1K (Amniox Medical, Miami, FL) is an umbilical cord allograft processed using the patented CRYOTEK™ process by TissueTech Inc. to devitalize all living cells but retain the natural structural and biological characteristics relevant to this tissue [43]. CLARIX® CORD 1K (6x3 cm in size) will be cut into two longitudinal pieces (1.5 cm in width) and placed circumferentially around each NVB as a nerve wrap during RARP. CLARIX® CORD 1K has been in market since 2013 in the United States as a "361 human cell and tissue-based product (HCT/P)" and is aseptically processed in compliance with current Good Tissue Practices (cGTP) as outlined in 21 CFR Part 1271.

Procedure: Robot-Assisted Radical Prostatectomy
Robot-Assisted Radical Prostatectomy (RARP) is the most common surgical technique used to treat clinically localized prostate cancer however robot-assisted radical prostatectomy

Active Comparator: Controls
They will undergo RARP without adjunctive CLARIX® CORD 1K.
Procedure: Robot-Assisted Radical Prostatectomy
Robot-Assisted Radical Prostatectomy (RARP) is the most common surgical technique used to treat clinically localized prostate cancer however robot-assisted radical prostatectomy




Primary Outcome Measures :
  1. Erectile function [ Time Frame: At three months post surgery ]
    Erectile function will be evaluated using the International Index of Erectile Function (IIEF)

  2. Erectile function [ Time Frame: At six months post surgery ]
    Erectile function will be evaluated using the International Index of Erectile Function (IIEF)

  3. Erectile function [ Time Frame: At twelve months post surgery ]
    Erectile function will be evaluated using the International Index of Erectile Function (IIEF)


Secondary Outcome Measures :
  1. Return to continence [ Time Frame: At three months post surgery ]
    Continence will be evaluated using the International Consultation of Incontinence Questionnaire - Short Form (ICIQ-SF)

  2. Return to continence [ Time Frame: At six months post surgery ]
    Continence will be evaluated using the International Consultation of Incontinence Questionnaire - Short Form (ICIQ-SF)

  3. Return to continence [ Time Frame: At twelve months post surgery ]
    Continence will be evaluated using the International Consultation of Incontinence Questionnaire - Short Form (ICIQ-SF)

  4. Sexual encounter [ Time Frame: At three months post surgery ]
    Patients will be asked to complete the Sexual Encounter Profile (SEP) Diary to document after each sexual attempt

  5. Sexual encounter [ Time Frame: At six months post surgery ]
    Patients will be asked to complete the Sexual Encounter Profile (SEP) Diary to document after each sexual attempt

  6. Sexual encounter [ Time Frame: At twelve months post surgery ]
    Patients will be asked to complete the Sexual Encounter Profile (SEP) Diary to document after each sexual attempt



Information from the National Library of Medicine

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Ages Eligible for Study:   30 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   Male
Gender Based Eligibility:   Yes
Gender Eligibility Description:   Only male patients will be recruited as we are studying prostate cancer.
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Male aged between 30 and 70 years old
  2. Primary diagnosis of organ confined prostate cancer
  3. Scheduled to undergo bilateral, nerve-sparing RARP
  4. Patient has ICIQ-SF score <6
  5. Patient has no erectile dysfunction (defined as IIEF-6 score ≥ 26)
  6. Patient is willing to return for all visits as defined in the protocol
  7. Patient is willing to follow the instruction of the Investigator
  8. Patient has provided written informed consent

Exclusion Criteria:

  1. Previous history of pelvic radiation
  2. Previous history of simple prostatectomy or transurethral prostate surgery
  3. Previous history of systemic therapy for prostate cancer
  4. Patient has neurogenic bladder
  5. Body weight less than 50 kg (110 pounds) or a body mass index greater than 40 kg/m2
  6. History of open pelvic surgery within 5 years except for hernia repair
  7. Scheduled at the time of screening to undergo chemotherapy, radiation, hormone therapy, or open surgery during the study period.
  8. Any neurologic disorder or psychiatric disorder (e.g., Parkinson's Multiple Sclerosis, etc.) that might confound postsurgical assessments
  9. Received administration of an investigational drug within 30 days prior to study, and/or has planned administration of another investigational product or procedure during participation in this study

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): NCT04263025


Contacts
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Contact: Helaine Koster, BSN 5519963068 Helaine.Koster@hackensackmeridian.org

Locations
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United States, New Jersey
Hackensack University Medical Center Recruiting
Hackensack, New Jersey, United States, 07601
Contact: Helaine Koster, BRN    551-996-3068    Helaine.Koster@hackensackmeridian.org   
Principal Investigator: Michael Stifelman, MD         
New Jersey Center for Prostate Cancer & Urology Recruiting
Maywood, New Jersey, United States, 07607
Contact: Mutahar Ahmed, MD    201-487-8866    Mutahar.Ahmed@hackensackmeridian.org   
Sponsors and Collaborators
Hackensack Meridian Health
Investigators
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Principal Investigator: Michael Stifelman, MD Chair of Urology Department
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Responsible Party: Hackensack Meridian Health
ClinicalTrials.gov Identifier: NCT04263025    
Other Study ID Numbers: Pro2019-0452
First Posted: February 10, 2020    Key Record Dates
Last Update Posted: February 10, 2021
Last Verified: February 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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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 Hackensack Meridian Health:
Prostate cancer
Bilateral, nerve-sparing prostatectomy
Prostatectomy
Additional relevant MeSH terms:
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Prostatic Neoplasms
Genital Neoplasms, Male
Urogenital Neoplasms
Neoplasms by Site
Neoplasms
Prostatic Diseases