ACTIVE_NOT_RECRUITING

Human Amnion Membrane Allograft and Early Return of Erectile Function After Radical Prostatectomy

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

The purpose of this research study is to evaluate if placing a dehydrated human amnion chorion membrane (dHACM) over the nerves after removal of the prostate during surgery (radical prostatectomy) will allow an earlier recovery of erectile function and urinary control after surgery.

Official Title

Phase 2 Randomized Trial: Human Amnion Membrane Allograft and Early Return of Erectile Function After Radical Prostatectomy (HAMMER)

Quick Facts

Study Start:2023-08-24
Study Completion:2028-08-31
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:ACTIVE_NOT_RECRUITING

Study ID

NCT05842057

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:40 Years to 80 Years
Sexes Eligible for Study:MALE
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. 1. Men aged 40 to 80 years with localized prostate cancer who are undergoing bilateral nerve-sparing RARP at the University of Miami (UM).
  1. 1. Men requiring any use of pads for urinary leakage.
  2. 2. Men requiring the use of any non-oral erectile aids for erectile dysfunction (ED)
  3. 3. Men with baseline EPIC26 scores \< 60.
  4. 4. Previous treatment for prostate cancer.
  5. 5. Previous history of pelvic radiation.
  6. 6. Patients with impaired decision-making capacity.

Contacts and Locations

Principal Investigator

Sanoj Punnen, MD, MAS
PRINCIPAL_INVESTIGATOR
University of Miami

Study Locations (Sites)

University of Miami
Miami, Florida, 33136
United States

Collaborators and Investigators

Sponsor: University of Miami

  • Sanoj Punnen, MD, MAS, PRINCIPAL_INVESTIGATOR, University of Miami

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 Date2023-08-24
Study Completion Date2028-08-31

Study Record Updates

Study Start Date2023-08-24
Study Completion Date2028-08-31

Terms related to this study

Keywords Provided by Researchers

  • Prostatectomy
  • Allograft Membrane

Additional Relevant MeSH Terms

  • Prostate Cancer
  • Erectile Dysfunction Following Radical Prostatectomy