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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

No Placebo-Only Group

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.

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.

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

This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline, 3 months, 6 months, 9 months, 12 months post-rarp for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Change in Erectile Function Recovery as Measured by EPIC26 Sexual Domain Score

Secondary study objectives

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 more

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial 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.

Do I qualify?Apply below to find out