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NCT Number: NCT05842057

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

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.

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This study is active but is not currently recruiting participants.

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Key information

Conditions

Prostate Cancer Erectile Dysfunction Following Radical Prostatectomy Genital Diseases Genital Diseases, Male Genital Neoplasms, Male Male Urogenital Diseases Neoplasms Neoplasms by Site Prostatic Diseases Prostatic Neoplasms Urogenital Diseases Urogenital Neoplasms

Age range

40 year–80 year

Sex eligibility

Male

Study type

Interventional

Phase

Phase 2

Primary location

University of Miami

Miami, Florida, 33136, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Men aged 40 to 80 years with localized prostate cancer who are undergoing RARP at the University of Miami (UM).

Exclusion criteria

  • Men requiring the use of any non-oral erectile aids for erectile dysfunction (ED).
  • Men with baseline EPIC26 scores < 50.
  • Patients with complete, bilateral nerve resection.
  • Previous treatment for prostate cancer.
  • Previous history of pelvic radiation.
  • Patients with impaired decision-making capacity.

Treatment and study plan

BioDFence G3 Placental Tissue Membrane

Biological

The BioDFence G3 Placental Tissue Membrane is a three-layer tissue allograft consisting of amnion-chorion-amnion. Amniotic membranes will be placed over the neurovascular bundle after extirpative RARP. The membrane will be cut into two longitudinal pieces and placed over each neurovascular bundle separately.

Other names: Dehydrated Human Amnion Chorion Membrane (dHACM), Human Amnion Membrane Allograft

Robot-Assisted Radical Prostatectomy

Procedure

Robot-assisted surgical removal of the prostate, administered standard of care.

Other names: RARP

Primary outcomes

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

    Time frame: Baseline, 12 Months Post-RARP

    Erectile function recovery among participants will be measured by the change in scores within the Sexual Domain of the Expanded Prostate Cancer Index Composite Short Form (EPIC26). The EPIC26 is a 26-item questionnaire used to measure health-related quality of life (HRQOL) among men with prostate cancer. The EPIC26 has five domains: Urinary Incontinence, Urinary Irritative/Obstructive, Bowel, Sexual, and Hormonal. Response options for each EPIC item form a Likert scale, and multi-item scale scores are transformed linearly to a 0-100 scale with higher scores representing better HRQOL.

Secondary outcomes

  1. Change in Erectile Function Recovery as Measured by SHIM Score

    Time frame: Baseline, 12 Months Post-RARP

    Erectile function recovery among participants will be measured as the change in Sexual History Inventory for Men (SHIM). The SHIM is a health-related quality of life (HRQOL) questionnaire whose scores measure the severity of erectile dysfunction (ED) in men using points on a scale. The minimum score of 1 to 7 points indicates severe ED; a score of 8 to 11 points indicates moderate ED; a score of 12 to 15 points indicates mild-to-moderate ED; a score of 17 to 21 points indicates mild ED; and the maximum score of 22 to 25 points indicates no significant ED.

  2. Change in Proportion of Men with Mild ED or Better as Defined by EPIC26 Sexual Domain Score

    Time frame: Baseline, 3 months, 6 months, 9 months, 12 months Post-RARP

    Proportion of men with mild ED or better as defined by an EPIC26 Sexual Domain score greater than or equal to 60. Response options for each EPIC item form a Likert scale, and multi-item scale scores are transformed linearly to a 0-100 scale with higher scores representing better sexual function.

  3. Change in Proportion of Participants with mild ED or Better as Defined by SHIM Score

    Time frame: Baseline, 3 months, 6 months, 9 months, 12 months Post-RARP

    Proportion of participants with mild ED or better as defined by a SHIM score greater than or equal to 17. The SHIM is a health-related quality of life (HRQOL) questionnaire whose scores measure the severity of erectile dysfunction (ED) in men using points on a scale. The minimum score of 1 to 7 points indicates severe ED; a score of 8 to 11 points indicates moderate ED; a score of 12 to 15 points indicates mild-to-moderate ED; a score of 17 to 21 points indicates mild ED; and the maximum score of 22 to 25 points indicates no significant ED.

  4. Change in Proportion of Participants with Erections Adequate for Penetration ≥ 50% of the time

    Time frame: Baseline, 3 months, 6 months, 9 months, 12 months Post-RARP

    Proportion of participants with erections adequate for penetration greater than or equal to 50-percent of the time.

  5. Change in Proportion of Participants who Require the Use of More Invasive Erectile Aids

    Time frame: Baseline, 3 months, 6 months, 9 months, 12 months Post-RARP

    Proportion of participants who require the use of more invasive erectile aids (intra-cavernosal injection, vacuum pump, or penile prosthesis).

  6. Change in Rate of Urinary Control

    Time frame: Baseline, 3 months, 6 months, 9 months, 12 months Post-RARP

    Rate of urinary control as measured by EPIC26 question 3 that reports the number of participants requiring no pads per day.

  7. Change in Biochemical Failure

    Time frame: Baseline, 3 months, 6 months, 9 months, 12 months Post-RARP

    Biochemical failure among participants will measured as a prostate-specific antigen (PSA) level > 0.2 ng/ml on two consecutive samples.

  8. Number of Treatment-Related Adverse Events

    Time frame: Up to 12 months post-RARP

    The number of treatment-related adverse events among participants will be assessed by treating physician using the Clavien-Dindo grading scale.

Sponsors and collaborators

Lead sponsor

University of Miami

Other

Collaborators

  • Integra LifeSciences Corporation

Registry information

Official study title

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

Acronym: HAMMER

Important dates

Study start
2023
Primary completion
2027
Study completion
2028
First posted
May 3, 2023
Registry last updated
Jul 14, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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