RECRUITING

AMNIOX CORD Study - Radical Prostatectomy With and Without Cryopreserved Umbilical Cord Allograft

Conditions

Prostate Cancer Bilateral, nerve-sparing prostatectomy Prostatectomy

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

Prospective, Controlled Study Evaluating Recovery of Potency and Continence Following Robot-Assisted Radical Prostatectomy With and Without Cryopreserved Umbilical Cord Allograft

Quick Facts

Study Start:2020-01-30

Study Completion:2025-10-01

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:RECRUITING

Study ID

NCT04263025

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:30 Years to 70 Years

Sexes Eligible for Study:MALE

Accepts Healthy Volunteers:No

Standard Ages:ADULT, OLDER_ADULT

Inclusion Criteria	Exclusion 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	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 10. Previous history of anaphylaxis or hypersensitivity to liposomal amphotericin- B

Inclusion Criteria

Exclusion 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

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
10. Previous history of anaphylaxis or hypersensitivity to liposomal amphotericin- B

Contacts and Locations

Study Contact

Sharon Seidman, RN

CONTACT

5519963749

Sharon.Seidman@hmhn.org

Principal Investigator

Michael Stifelman, MD

PRINCIPAL_INVESTIGATOR

Chair of Urology Department

Study Locations (Sites)

Hackensack University Medical Center

Hackensack, New Jersey, 07601

United States

Collaborators and Investigators

Sponsor: Hackensack Meridian Health

Michael Stifelman, MD, PRINCIPAL_INVESTIGATOR, Chair of Urology Department

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2020-01-30

Study Completion Date2025-10-01

Study Record Updates

Study Start Date2020-01-30

Study Completion Date2025-10-01

Terms related to this study

Keywords Provided by Researchers

Prostate cancer
Bilateral, nerve-sparing prostatectomy
Prostatectomy

Additional Relevant MeSH Terms

Prostate Cancer