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Human Amnion Membrane Allograft for Prostate Cancer Recovery (HAMMER Trial)
Phase 2
Recruiting
Led By Sanoj Punnen, MD, MAS
Research Sponsored by University of Miami
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up baseline, 3 months, 6 months, 9 months, 12 months post-rarp
Awards & highlights
Summary
This trial looks at if a membrane can help men recover from prostate surgery faster by improving erectile function and urinary control.
Who is the study for?
This trial is for men aged 40 to 80 with localized prostate cancer, planning to have nerve-sparing robotic surgery at the University of Miami. It's not suitable for those who don't meet these specific age, health condition, and treatment location criteria.Check my eligibility
What is being tested?
The study is testing if a special placental tissue membrane (BioDFence G3) can help men recover faster from erectile dysfunction and urinary issues after their prostates are removed using robot-assisted surgery.See study design
What are the potential side effects?
Potential side effects may include reactions at the surgical site where the membrane is placed, such as infection or inflammation. However, detailed side effects will be monitored throughout the trial.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ baseline, 3 months, 6 months, 9 months, 12 months post-rarp
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline, 3 months, 6 months, 9 months, 12 months post-rarp
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Change in Erectile Function Recovery as Measured by EPIC26 Sexual Domain Score
Secondary outcome measures
Change in Biochemical Failure
Change in Erectile Function Recovery as Measured by SHIM Score
Change in Proportion of Men with Mild ED or Better as Defined by EPIC26 Sexual Domain Score
+5 moreTrial Design
2Treatment groups
Experimental Treatment
Group I: Membrane Arm: dHACM GroupExperimental Treatment2 Interventions
Participants will undergo standard of care robot-assisted radical prostatectomy (RARP) surgery and the dehydrated Human Amnion Chorion Membrane (dHACM) membrane placed after removal of the prostate. Participants will be in the group for approximately 12 months.
Group II: Control Arm: No dHACM GroupExperimental Treatment1 Intervention
Participants will undergo standard of care RARP surgery but will have no dehydrated Human Amnion Chorion Membrane (dHACM) placed after removal of the prostate. Participants will be in the group for approximately 12 months.
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Who is running the clinical trial?
University of MiamiLead Sponsor
918 Previous Clinical Trials
412,389 Total Patients Enrolled
17 Trials studying Prostate Cancer
3,681 Patients Enrolled for Prostate Cancer
Integra LifeSciences CorporationIndustry Sponsor
85 Previous Clinical Trials
9,589 Total Patients Enrolled
1 Trials studying Prostate Cancer
Sanoj Punnen, MD, MASPrincipal InvestigatorUniversity of Miami
2 Previous Clinical Trials
507 Total Patients Enrolled
2 Trials studying Prostate Cancer
507 Patients Enrolled for Prostate Cancer
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Eligibility Criteria:
This trial includes the following eligibility criteria:- I have had radiation therapy to my pelvic area before.I use pads due to urinary leakage.My EPIC26 score is below 60.I have received treatment for prostate cancer before.I use non-oral aids for erectile dysfunction.I am unable to make my own medical decisions.I am a man aged 40-80 with localized prostate cancer planning a specific surgery at UM.
Research Study Groups:
This trial has the following groups:- Group 1: Membrane Arm: dHACM Group
- Group 2: Control Arm: No dHACM Group
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
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