Human Amnion Membrane Allograft for Prostate Cancer Recovery

(HAMMER Trial)

Overseen By Elena M Cortizas

Age: 18+

Sex: Male

Trial Phase: Phase 2

Sponsor: University of Miami

Disqualifiers: Urinary leakage, Erectile aids, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Prior Safety Data This treatment has passed at least one previous human trial

Approved in 1 Jurisdiction This treatment is already approved in other countries

Compensation: Varies

Number of Visits: 3

Duration: Surgery and immediate recovery

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests whether a special tissue, dHACM (including BioDFence G3 Placental Tissue Membrane), can aid recovery after prostate surgery. The goal is to determine if placing this tissue over nerves during surgery improves erectile function and urinary control more quickly. Men with localized prostate cancer planning to undergo prostate surgery might be suitable candidates. Participants will either receive the tissue or not, allowing researchers to compare results over about a year. As a Phase 2 trial, this research focuses on measuring the treatment's effectiveness in an initial, smaller group.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.

What prior data suggests that the BioDFence G3 Placental Tissue Membrane is safe for prostate cancer recovery?

Research has shown that human amnion membrane allografts, such as the BioDFence G3 Placental Tissue Membrane, are generally safe. These membranes have aided recovery after prostate surgery without major safety concerns. Reports indicate that the treatment is well-tolerated, with no serious side effects commonly associated with its use. This treatment employs a special three-layer tissue to promote healing. While further research continues, current evidence supports its safety for potential participants. ^{1 2 3 4 5}

Why do researchers think this study treatment might be promising for prostate cancer recovery?

Researchers are excited about using the BioDFence G3 Placental Tissue Membrane for prostate cancer recovery because it introduces a new approach to post-surgery healing. Unlike traditional treatments, which primarily focus on surgical removal and follow-up therapies, this treatment employs a dehydrated Human Amnion Chorion Membrane (dHACM) to promote healing after prostate removal. The membrane is rich in growth factors and anti-inflammatory properties, potentially speeding up recovery and reducing complications. This innovative use of placental tissue could enhance recovery outcomes and offer a significant advancement over existing recovery methods.

What evidence suggests that the BioDFence G3 Placental Tissue Membrane is effective for prostate cancer recovery?

Research has shown that the BioDFence G3 Placental Tissue Membrane, a special type of tissue from the placenta, may help nerves heal faster after prostate surgery. In this trial, participants in the Membrane Arm will receive this membrane during their surgery. Some studies have found that this membrane can improve the return of erectile function and urinary control post-surgery. Acting as a protective layer, it may help tissues heal better and faster. Early findings suggest that patients using this membrane might experience better recovery outcomes compared to those in the Control Arm, who will not receive the membrane. This treatment remains under study, but initial results are promising for recovery after prostate surgery. ^{1 3 4 6 7}

Who Is on the Research Team?

Sanoj Punnen

Principal Investigator

University of Miami

Are You a Good Fit for This Trial?

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.

Inclusion Criteria

I am a man aged 40-80 with localized prostate cancer planning a specific surgery at UM.

Exclusion Criteria

I have had radiation therapy to my pelvic area before.

I use pads due to urinary leakage.

My EPIC26 score is below 60.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants undergo standard of care robot-assisted radical prostatectomy (RARP) surgery with or without the placement of dehydrated Human Amnion Chorion Membrane (dHACM)

Surgery and immediate recovery

Follow-up

Participants are monitored for recovery of erectile function and urinary control, as well as other health outcomes

12 months

Regular follow-up visits at 3, 6, 9, and 12 months post-RARP

What Are the Treatments Tested in This Trial?

Interventions

• BioDFence G3 Placental Tissue Membrane

Trial Overview 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.

How Is the Trial Designed?

Group I: Membrane Arm: dHACM Group Experimental Treatment 2 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 Group Experimental Treatment 1 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.

Who Is Running the Clinical Trial?

University of Miami

Lead Sponsor

Trials

976

Recruited

423,000+

Integra LifeSciences Corporation

Industry Sponsor

Trials

110

Recruited

11,300+

Mojdeh Poul

Integra LifeSciences Corporation

Chief Executive Officer

Bachelor’s and Master’s degrees in Mechanical Engineering from the University of Louisville, MBA from the University of North Carolina at Chapel Hill

Dr. Lisa Egbuonu-Davis

Integra LifeSciences Corporation

Chief Medical Officer since 2023

MD from Harvard Medical School

Published Research Related to This Trial

The study found that using dehydrated human amnion/chorion membrane (dHACM) allografts after partial tumor resection led to significantly faster tumor growth in prostate and bladder cancer models, indicating a potential risk for rapid local recurrence in patients with positive surgical margins.

In both cancer types studied, the presence of dHACM was associated with larger tumor volumes compared to controls without the membrane, suggesting that dHACM may not be beneficial and could potentially exacerbate cancer progression.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The potential risk of tumor progression after use of dehydrated human amnion/chorion membrane allograft in a positive margin resection model. Alvim, RG., Hughes, C., Somma, A., et al.[2022]

In a pilot study of 28 patients undergoing redo-hypospadias repair, the use of human amniotic membrane allograft significantly reduced the occurrence of urethrocutaneous fistulas, with only two cases reported in the first two weeks post-surgery.

The amniotic membrane graft was found to be a safe, low-cost, and effective option for covering suture lines in urethroplasty, with no serious complications like penile torsion or meatal stenosis observed during a follow-up period averaging 13.3 months.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Use of human amniotic membrane repair of anterior urethral defect: First clinical report. Razzaghi, M., Rahavian, A., Fallah Karkan, M., et al.[2021]

The use of dehydrated human amnion/chorion membrane (dHACM) allograft during robotic-assisted radical prostatectomy (RARP) significantly accelerates the return to erectile potency, with a mean time to potency of 2.37 months compared to 3.94 months in the control group.

Patients receiving the dHACM graft experienced faster recovery of potency regardless of nerve-sparing status, and there was no increased risk of biochemical recurrence after surgery, indicating the safety of this intervention.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Can dehydrated human amnion/chorion membrane accelerate the return to potency after a nerve-sparing robotic-assisted radical prostatectomy? Propensity score-matched analysis. Ogaya-Pinies, G., Palayapalam-Ganapathi, H., Rogers, T., et al.[2018]

Human placental-derived allografts, such as amniotic and chorionic membranes, significantly improve the recovery of erectile function after radical prostatectomy, as shown by a statistically significant increase in the average return to potency in intervention groups.

The use of these allografts does not negatively affect oncological outcomes, as evidenced by higher positive surgical margin rates in control groups and lower biochemical recurrence rates in those receiving the grafts.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Impact of human placental derivative allografts on functional and oncological outcomes after radical prostatectomy: a literature review. Noël, J., Ahmed, S., Mascarenhas, A., et al.[2023]

A randomized, placebo-controlled study is being conducted to evaluate the efficacy and safety of dehydrated human amniotic membrane (HAM) in improving postoperative continence and erectile function in patients undergoing radical prostatectomy for localized prostate cancer, with a target enrollment of 328 patients (164 per group).

The primary outcome will assess continence using a 24-hour pad test up to 12 months post-surgery, while secondary outcomes will include erectile function, catheter removal time, complications, and cancer recurrence, aiming to enhance recovery and reduce complications associated with prostate surgery.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Application of Dried Human Amnion Graft to Improve Post-Prostatectomy Incontinence and Potency: A Randomized Exploration Study Protocol. Barski, D., Gerullis, H., Ecke, T., et al.[2020]

Citations

1. clinicaltrials.gov clinicaltrials.gov/study/NCT05842057

Human Amnion Membrane Allograft and Early Return of ... 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 ...

2. trial.medpath.com trial.medpath.com/clinical-trial/44923de96b8f372f/nct05363644-treatment-protocol-biodefence-g3-robotic-prostatectomy

BioDFence® G3 For Full Nerve-Sparing Robotic-Assisted ... The purpose of this study is to assess functional outcomes post operatively after the use of BioDFence® G3 during robotic radical prostatectomy.

3. withpower.com withpower.com/trial/phase-2-erectile-dysfunction-5-2023-35f9b

Human Amnion Membrane Allograft for Prostate Cancer ... Trial Overview The study is testing if a special placental tissue membrane (BioDFence G3) can help men recover faster from erectile dysfunction and urinary ...

4. ctv.veeva.com ctv.veeva.com/study/biodfence-r-g3-for-full-nerve-sparing-robotic-assisted-radical-prostatectomy

BioDFence® G3 For Full Nerve-Sparing Robotic-Assisted ... The purpose of this study is to assess functional outcomes post operatively after the use of BioDFence® G3 during robotic radical prostatectomy.

5. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/38312822/

Oncologic outcomes with and without amniotic membranes ... Outcomes of cancer specific and overall survival will require follow-up study to increase our understanding of these grafts' impact on prostate cancer biology.

6. trialfinder.panfoundation.org trialfinder.panfoundation.org/en-US/trial/listing/421783

Human Amnion Membrane Allograft and Early Return of ... The BioDFence G3 Placental Tissue Membrane is a three-layer tissue allograft consisting of amnion-chorion-amnion. Amniotic membranes will be ...

7. products.integralife.com products.integralife.com/biodfence-g3-placental-tissue-membrane/product/surgical-reconstruction-surgical-amniotics-biodfence-g3-placental-tissue-membrane

BioDFence® G3 Placental Tissue Membrane BioDFence G3 Placental Tissue Membrane is a dehydrated, tri-layer amnion-chorion-amnion allograft providing enhanced handling characteristics.