Prostate CancerPhase 2HAMMERNCT05842057
Human Amnion Membrane Allograft and Early Return of Erectile Function After Radical Prostatectomy
A Phase 2 study testing BioDFence G3 Placental Tissue Membrane and Robot-Assisted Radical Prostatectomy in people with Prostate Cancer and Erectile Dysfunction Following Radical Prostatectomy, run by University of Miami at 1 site in United States.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 40 to 80 years, men only
- Conditions the study is for
- Prostate Cancer, Erectile Dysfunction Following Radical Prostatectomy
- What is being tested?
- BioDFence G3 Placental Tissue Membrane and Robot-Assisted Radical Prostatectomy
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 118 participants
- Where
- 1 siteUnited States
- Study dates
- 24 Aug 2023to 31 Aug 2028
- Phase
- Phase 2
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 40 to 80 years
- Men only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 1. Men aged 40 to 80 years with localized prostate cancer who are undergoing RARP at the University of Miami (UM).
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Phase 2 Randomized Trial: Human Amnion Membrane Allograft and Early Return of Erectile Function After Radical Prostatectomy (HAMMER)
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.
- Being tested
- BioDFence G3 Placental Tissue Membrane, Robot-Assisted Radical Prostatectomy
- Keywords
- Prostatectomy, Allograft Membrane
- Medical subject headings
- Prostatic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BioDFence G3 Placental Tissue MembraneBiological
Also called Dehydrated Human Amnion Chorion Membrane (dHACM), Human Amnion Membrane Allograft
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.
Robot-Assisted Radical ProstatectomyProcedure or surgery
Also called RARP
Robot-assisted surgical removal of the prostate, administered standard of care.
| Study group | Role | What they receive |
|---|---|---|
| Membrane Arm: dHACM Group | Experimental | 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. Receives: Biological: BioDFence G3 Placental Tissue Membrane; Procedure: Robot-Assisted Radical Prostatectomy |
| Control Arm: No dHACM Group | Other | 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. Receives: Procedure: Robot-Assisted Radical Prostatectomy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Erectile Function Recovery as Measured by EPIC26 Sexual Domain Score
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.
Measured: Baseline, 12 Months Post-RARP
Secondary outcomes (8)
Change in Erectile Function Recovery as Measured by SHIM Score
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.
Measured: Baseline, 12 Months Post-RARP
Change in Proportion of Men with Mild ED or Better as Defined by EPIC26 Sexual Domain Score
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.
Measured: Baseline, 3 months, 6 months, 9 months, 12 months Post-RARP
Change in Proportion of Participants with mild ED or Better as Defined by SHIM Score
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.
Measured: Baseline, 3 months, 6 months, 9 months, 12 months Post-RARP
Change in Proportion of Participants with Erections Adequate for Penetration ≥ 50% of the time
Proportion of participants with erections adequate for penetration greater than or equal to 50-percent of the time.
Measured: Baseline, 3 months, 6 months, 9 months, 12 months Post-RARP
Change in Proportion of Participants who Require the Use of More Invasive Erectile Aids
Proportion of participants who require the use of more invasive erectile aids (intra-cavernosal injection, vacuum pump, or penile prosthesis).
Measured: Baseline, 3 months, 6 months, 9 months, 12 months Post-RARP
Change in Rate of Urinary Control
Rate of urinary control as measured by EPIC26 question 3 that reports the number of participants requiring no pads per day.
Measured: Baseline, 3 months, 6 months, 9 months, 12 months Post-RARP
Change in Biochemical Failure
Biochemical failure among participants will measured as a prostate-specific antigen (PSA) level > 0.2 ng/ml on two consecutive samples.
Measured: Baseline, 3 months, 6 months, 9 months, 12 months Post-RARP
Number of Treatment-Related Adverse Events
The number of treatment-related adverse events among participants will be assessed by treating physician using the Clavien-Dindo grading scale.
Measured: Up to 12 months post-RARP
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 May 2023
- Study start24 Aug 2023
- Primary completion31 Aug 2027 (estimated)
- Study completion31 Aug 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Prostate CancerStudies of the same condition, open and under way.
- More trials run by University of MiamiThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Care provider
- Enrolment
- 118 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Miami
- Sponsor type
- University, hospital or other
- Collaborators
- Integra LifeSciences Corporation
- Responsible party
- Principal investigator, Sanoj Punnen, MD, MAS, University of Miami
- Investigators
- Sanoj Punnen, MD, MAS, Principal investigator, University of Miami
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05842057
- Sponsor's protocol ID
- 20220852
- Acronym
- HAMMER
- Status last verified
- Jul 2026
- First submitted
- 24 Apr 2023
- Last updated
- 14 Jul 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase 2 Randomized Trial: Human Amnion Membrane Allograft and Early Return of Erectile Function After Radical Prostatectomy (HAMMER)
- ClinicalTrials.gov ID
- NCT05842057
- Acronym / sponsor ID
- HAMMER / 20220852
- Keywords
- Prostatectomy, Allograft Membrane
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 118 participants (actual)
- Lead sponsor
- University of MiamiUniversity, hospital or other
- Collaborators
- Integra LifeSciences Corporation
- Study start
- 24 Aug 2023 (actual)
- Primary completion
- 31 Aug 2027 (estimated)
- Study completion
- 31 Aug 2028 (estimated)
- First posted
- 3 May 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, care provider)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Membrane Arm: dHACM Group | Experimental | Biological: BioDFence G3 Placental Tissue Membrane, Procedure: Robot-Assisted Radical ProstatectomyParticipants 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. |
| Control Arm: No dHACM Group | Other | Procedure: Robot-Assisted Radical ProstatectomyParticipants 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 may qualify
- Ages
- 40 to 80 years
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- 1. Men aged 40 to 80 years with localized prostate cancer who are undergoing RARP at the University of Miami (UM).
Key exclusion criteria (6 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| BioDFence G3 Placental Tissue MembraneAlso: Dehydrated Human Amnion Chorion Membrane (dHACM), Human Amnion Membrane AllograftThe 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. | Biological | Membrane Arm: dHACM Group |
| Robot-Assisted Radical ProstatectomyAlso: RARPRobot-assisted surgical removal of the prostate, administered standard of care. | Procedure or surgery | Control Arm: No dHACM Group, Membrane Arm: dHACM Group |
Primary outcome
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.
8 secondary outcomes
Change in Erectile Function Recovery as Measured by SHIM Score
Time frame: Baseline, 12 Months Post-RARP
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
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
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
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
Change in Rate of Urinary Control
Time frame: Baseline, 3 months, 6 months, 9 months, 12 months Post-RARP
Change in Biochemical Failure
Time frame: Baseline, 3 months, 6 months, 9 months, 12 months Post-RARP
Number of Treatment-Related Adverse Events
Time frame: Up to 12 months post-RARP
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Jul 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Sanoj Punnen, MD, MAS principal investigator
University of Miami
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing BioDFence G3 Placental Tissue Membrane and Robot-Assisted Radical Prostatectomy in people with Prostate Cancer and Erectile Dysfunction Following Radical Prostatectomy, run by University of Miami at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 14 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Erectile Function Recovery as Measured by EPIC26 Sexual Domain Score (time frame: Baseline, 12 Months Post-RARP). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Jul 2026.