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

240 Participants Needed

Trial Summary

What is the purpose of this trial?

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.

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.

Is the human amnion membrane allograft safe for use in humans?

Research suggests that human amnion membrane allografts are generally safe for use in humans, as they have been used to improve recovery after prostate surgery without negatively affecting cancer control. However, there is a potential risk of tumor progression in cases with residual disease. ^{1 2 3 4 5}

How does the human amnion membrane allograft treatment differ from other prostate cancer recovery treatments?

The human amnion membrane allograft treatment is unique because it uses a natural membrane from the placenta to help speed up recovery after prostate surgery, particularly improving erectile function and reducing incontinence, without affecting cancer control. This approach leverages the membrane's growth factors and immune tolerance to aid tissue healing and nerve protection, which is different from traditional treatments that may not focus on these aspects. ^{1 2 3 4 5}

Research Team

Sanoj Punnen

Principal Investigator

University of Miami

Eligibility Criteria

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

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

Treatment Details

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.

Participant Groups

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

Findings from Research

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]

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]

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]

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 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]

References

1. England pubmed.ncbi.nlm.nih.gov

Impact of human placental derivative allografts on functional and oncological outcomes after radical prostatectomy: a literature review. [2023]

2. England 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. [2018]

3. United States pubmed.ncbi.nlm.nih.gov

Application of Dried Human Amnion Graft to Improve Post-Prostatectomy Incontinence and Potency: A Randomized Exploration Study Protocol. [2020]

4. Australia pubmed.ncbi.nlm.nih.gov

Use of human amniotic membrane repair of anterior urethral defect: First clinical report. [2021]

5. England 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. [2022]