Ignite Creation Date:
2025-12-24 @ 6:40 PM
Ignite Modification Date:
2026-02-17 @ 6:20 PM
Study NCT ID:
NCT05842057
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2025-07-22
First Post:
2023-04-24
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Human Amnion Membrane Allograft and Early Return of Erectile Function After Radical Prostatectomy
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D011471', 'term': 'Prostatic Neoplasms'}], 'ancestors': [{'id': 'D005834', 'term': 'Genital Neoplasms, Male'}, {'id': 'D014565', 'term': 'Urogenital Neoplasms'}, {'id': 'D009371', 'term': 'Neoplasms by Site'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D005832', 'term': 'Genital Diseases, Male'}, {'id': 'D000091662', 'term': 'Genital Diseases'}, {'id': 'D000091642', 'term': 'Urogenital Diseases'}, {'id': 'D011469', 'term': 'Prostatic Diseases'}, {'id': 'D052801', 'term': 'Male Urogenital Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER'], 'maskingDescription': 'Participants will be blinded to the treatment they receive. To minimize bias on the surgical team during the nerve sparing process, the surgical team will be blinded to arm allocation until after the prostate is removed.'}, 'primaryPurpose': 'SUPPORTIVE_CARE', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 118}}, 'statusModule': {'overallStatus': 'ACTIVE_NOT_RECRUITING', 'startDateStruct': {'date': '2023-08-24', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-07', 'completionDateStruct': {'date': '2028-08-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-07-17', 'studyFirstSubmitDate': '2023-04-24', 'studyFirstSubmitQcDate': '2023-04-24', 'lastUpdatePostDateStruct': {'date': '2025-07-22', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2023-05-03', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2027-08-31', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change in Erectile Function Recovery as Measured by EPIC26 Sexual Domain Score', 'timeFrame': 'Baseline, 12 Months Post-RARP', 'description': '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.'}], 'secondaryOutcomes': [{'measure': 'Change in Erectile Function Recovery as Measured by SHIM Score', 'timeFrame': 'Baseline, 12 Months Post-RARP', 'description': '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.'}, {'measure': 'Change in Proportion of Men with Mild ED or Better as Defined by EPIC26 Sexual Domain Score', 'timeFrame': 'Baseline, 3 months, 6 months, 9 months, 12 months Post-RARP', 'description': '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.'}, {'measure': 'Change in Proportion of Participants with mild ED or Better as Defined by SHIM Score', 'timeFrame': 'Baseline, 3 months, 6 months, 9 months, 12 months Post-RARP', 'description': '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.'}, {'measure': 'Change in Proportion of Participants with Erections Adequate for Penetration ≥ 50% of the time', 'timeFrame': 'Baseline, 3 months, 6 months, 9 months, 12 months Post-RARP', 'description': 'Proportion of participants with erections adequate for penetration greater than or equal to 50-percent of the time.'}, {'measure': 'Change in Proportion of Participants who Require the Use of More Invasive Erectile Aids', 'timeFrame': 'Baseline, 3 months, 6 months, 9 months, 12 months Post-RARP', 'description': 'Proportion of participants who require the use of more invasive erectile aids (intra-cavernosal injection, vacuum pump, or penile prosthesis).'}, {'measure': 'Change in Rate of Urinary Control', 'timeFrame': 'Baseline, 3 months, 6 months, 9 months, 12 months Post-RARP', 'description': 'Rate of urinary control as measured by EPIC26 question 3 that reports the number of participants requiring no pads per day.'}, {'measure': 'Change in Biochemical Failure', 'timeFrame': 'Baseline, 3 months, 6 months, 9 months, 12 months Post-RARP', 'description': 'Biochemical failure among participants will measured as a prostate-specific antigen (PSA) level \\> 0.2 ng/ml on two consecutive samples.'}, {'measure': 'Number of Treatment-Related Adverse Events', 'timeFrame': 'Up to 12 months post-RARP', 'description': 'The number of treatment-related adverse events among participants will be assessed by treating physician using the Clavien-Dindo grading scale.'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': True, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Prostatectomy', 'Allograft Membrane'], 'conditions': ['Prostate Cancer', 'Erectile Dysfunction Following Radical Prostatectomy']}, 'descriptionModule': {'briefSummary': '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.'}, 'eligibilityModule': {'sex': 'MALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '80 Years', 'minimumAge': '40 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1\\. Men aged 40 to 80 years with localized prostate cancer who are undergoing RARP at the University of Miami (UM).\n\nExclusion Criteria:\n\n1. Men requiring the use of any non-oral erectile aids for erectile dysfunction (ED).\n2. Men with baseline EPIC26 scores \\< 50.\n3. Patients with complete, bilateral nerve resection.\n4. Previous treatment for prostate cancer.\n5. Previous history of pelvic radiation.\n6. Patients with impaired decision-making capacity.'}, 'identificationModule': {'nctId': 'NCT05842057', 'acronym': 'HAMMER', 'briefTitle': 'Human Amnion Membrane Allograft and Early Return of Erectile Function After Radical Prostatectomy', 'organization': {'class': 'OTHER', 'fullName': 'University of Miami'}, 'officialTitle': 'Phase 2 Randomized Trial: Human Amnion Membrane Allograft and Early Return of Erectile Function After Radical Prostatectomy (HAMMER)', 'orgStudyIdInfo': {'id': '20220852'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Membrane Arm: dHACM Group', 'description': '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.', 'interventionNames': ['Biological: BioDFence G3 Placental Tissue Membrane', 'Procedure: Robot-Assisted Radical Prostatectomy']}, {'type': 'OTHER', 'label': 'Control Arm: No dHACM Group', 'description': '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.', 'interventionNames': ['Procedure: Robot-Assisted Radical Prostatectomy']}], 'interventions': [{'name': 'BioDFence G3 Placental Tissue Membrane', 'type': 'BIOLOGICAL', 'otherNames': ['Dehydrated Human Amnion Chorion Membrane (dHACM)', 'Human Amnion Membrane Allograft'], 'description': '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.', 'armGroupLabels': ['Membrane Arm: dHACM Group']}, {'name': 'Robot-Assisted Radical Prostatectomy', 'type': 'PROCEDURE', 'otherNames': ['RARP'], 'description': 'Robot-assisted surgical removal of the prostate, administered standard of care.', 'armGroupLabels': ['Control Arm: No dHACM Group', 'Membrane Arm: dHACM Group']}]}, 'contactsLocationsModule': {'locations': [{'zip': '33136', 'city': 'Miami', 'state': 'Florida', 'country': 'United States', 'facility': 'University of Miami', 'geoPoint': {'lat': 25.77427, 'lon': -80.19366}}], 'overallOfficials': [{'name': 'Sanoj Punnen, MD, MAS', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Miami'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Miami', 'class': 'OTHER'}, 'collaborators': [{'name': 'Integra LifeSciences Corporation', 'class': 'INDUSTRY'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Associate Professor of Clinical', 'investigatorFullName': 'Sanoj Punnen, MD, MAS', 'investigatorAffiliation': 'University of Miami'}}}}