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Lack of Accrual and Inadequate Funding
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| Name | Class |
|---|---|
| Vivex Biomedical | UNKNOWN |
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The use of dehydrated human amnionic membrane allograft improves erectile function recovery (as measured by (Sexual History Inventory for Men (SHIM) score) at 12 months after robotic assisted radical prostatectomy (RARP) compared to a control group with no allograft.
This is a phase 2 prospective randomized trial investigating the impact of amniotic membrane placement over the neurovascular bundles after bilateral nerve sparing robot assisted radical prostatectomy on potency. The study will have a control arm that will follow standard of care surgery, without placement of any membranes. 70 men will be allocated to each arm.
The research study will involve follow up every 3 months for the first 12 months. After this the investigators will follow patients annually with prostate-specific antigen (PSA) measurements and an assessment of any secondary therapies for 5 years post-surgery.
Randomization of study patients will be done in equal proportion to Arm I (membrane placement) and Arm II (no membrane placement, standard of care surgery) using a permuted block design stratified by baseline SHIM score (<17 vs. >=17), and use of ANY erectile aids (Yes vs. No) in the last 3 months.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Arm 1 - Amniotic Membrane Placement | Experimental | Participants who receive the human amniotic membrane placement after robotic assisted radical prostatectomy (RARP). Participants will also undergo PSA measurement and complete the EPIC 26 and Sexual History Inventory for Men (SHIM) psychosocial questionnaires at protocol-defined intervals. |
|
| Arm 2 - No Amniotic Membrane Placement | Other | Participants who do not receive human amniotic membrane placement after robotic assisted radical prostatectomy (RARP). Participants will also undergo PSA measurement and complete the EPIC 26 and Sexual History Inventory for Men (SHIM) psychosocial questionnaires at protocol-defined intervals. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Amniotic Membrane Placement | Biological | Amniotic membranes will be placed over the neurovascular bundle after extirpative RARP, and before the urethrovesical anastomosis. The membrane will cut into two longitudinal pieces and it will be placed over each neurovascular bundle separately. |
| Measure | Description | Time Frame |
|---|---|---|
| The Difference in Average Change in SHIM Score, Between Baseline and 12-Months Post-RARP, of Study Participants in Each Group | The difference in average change in Sexual History Inventory for Men (SHIM) score, between baseline and 12 months post RARP between the membrane and control arms will be assessed as the primary endpoint. The SHIM score is measured in points on a scale: The minimum score is 5 to 7 indicating severe erectile dysfunction (ED), the maximum score is 22 to 25, indicating no ED. | Baseline, 12 Months Post-RARP |
| Measure | Description | Time Frame |
|---|---|---|
| Proportion of Men in Each Group With Mild Erectile Dysfunction (ED) or Better Post-RARP | Among men with a SHIM greater than or equal to 17 at baseline, the investigators will compare the proportion of men in each group with mild ED or better, defined by a SHIM greater than or equal to 17, at 3, 6, 9 and 12 months post RARP. | Baseline, 3, 6, 9 12 Months Post-RARP |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Sanoj Punnen, MD | University of Miami | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Miami | Miami | Florida | 33136 | United States |
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| ID | Title | Description |
|---|---|---|
| FG000 | Arm 1 - Amniotic Membrane Placement | Participants who receive the human amniotic membrane placement after robotic assisted radical prostatectomy (RARP). Participants will also undergo PSA measurement and complete the EPIC 26 and Sexual History Inventory for Men (SHIM) psychosocial questionnaires at protocol-defined intervals. Amniotic Membrane Placement: Amniotic membranes will be placed over the neurovascular bundle after extirpative RARP, and before the urethrovesical anastomosis. The membrane will cut into two longitudinal pieces and it will be placed over each neurovascular bundle separately. EPIC 26: Participants will receive EPIC 26 psychosocial questionnaire at baseline, and post-RARP at protocol-defined intervals. PSA Measurement: Measurement of serum PSA levels every three months (+ 1 month) for first year post surgery, and then annually for 5 years. SHIM: Psychosocial questionnaire administered at baseline, and post-RARP at protocol-defined intervals. |
| FG001 | Arm 2 - No Amniotic Membrane Placement | Participants who do not receive human amniotic membrane placement after robotic assisted radical prostatectomy (RARP). Participants will also undergo PSA measurement and complete the EPIC 26 and Sexual History Inventory for Men (SHIM) psychosocial questionnaires at protocol-defined intervals. EPIC 26: Participants will receive EPIC 26 psychosocial questionnaire at baseline, and post-RARP at protocol-defined intervals. PSA Measurement: Measurement of serum PSA levels every three months (+ 1 month) for first year post surgery, and then annually for 5 years. SHIM: Psychosocial questionnaire administered at baseline, and post-RARP at protocol-defined intervals. |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Arm 1 - Amniotic Membrane Placement | Participants who receive the human amniotic membrane placement after robotic assisted radical prostatectomy (RARP). Participants will also undergo PSA measurement and complete the EPIC 26 and Sexual History Inventory for Men (SHIM) psychosocial questionnaires at protocol-defined intervals. Amniotic Membrane Placement: Amniotic membranes will be placed over the neurovascular bundle after extirpative RARP, and before the urethrovesical anastomosis. The membrane will cut into two longitudinal pieces and it will be placed over each neurovascular bundle separately. EPIC 26: Participants will receive EPIC 26 psychosocial questionnaire at baseline, and post-RARP at protocol-defined intervals. PSA Measurement: Measurement of serum PSA levels every three months (+ 1 month) for first year post surgery, and then annually for 5 years. SHIM: Psychosocial questionnaire administered at baseline, and post-RARP at protocol-defined intervals. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | The Difference in Average Change in SHIM Score, Between Baseline and 12-Months Post-RARP, of Study Participants in Each Group | The difference in average change in Sexual History Inventory for Men (SHIM) score, between baseline and 12 months post RARP between the membrane and control arms will be assessed as the primary endpoint. The SHIM score is measured in points on a scale: The minimum score is 5 to 7 indicating severe erectile dysfunction (ED), the maximum score is 22 to 25, indicating no ED. | Due to early study termination, not all study participants completed scheduled visits. | Posted | Mean | Standard Deviation | scores on a scale | Baseline, 12 Months Post-RARP |
|
12 months
Per protocol, non-serious adverse events (AEs) were only monitored, assessed and recorded if they were attributed to the membrane placement during the RARP procedure.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Arm 1 - Amniotic Membrane Placement | Participants who receive the human amniotic membrane placement after robotic assisted radical prostatectomy (RARP). Participants will also undergo PSA measurement and complete the EPIC 26 and Sexual History Inventory for Men (SHIM) psychosocial questionnaires at protocol-defined intervals. Amniotic Membrane Placement: Amniotic membranes will be placed over the neurovascular bundle after extirpative RARP, and before the urethrovesical anastomosis. The membrane will cut into two longitudinal pieces and it will be placed over each neurovascular bundle separately. EPIC 26: Participants will receive EPIC 26 psychosocial questionnaire at baseline, and post-RARP at protocol-defined intervals. PSA Measurement: Measurement of serum PSA levels every three months (+ 1 month) for first year post surgery, and then annually for 5 years. SHIM: Psychosocial questionnaire administered at baseline, and post-RARP at protocol-defined intervals. |
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Due to early study termination, not all study participants completed scheduled visits.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Sanoj Punnen MD, MAS | University of Miami | 305-243-6596 | s.punnen@med.miami.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Nov 20, 2017 | Jul 15, 2019 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D011471 | Prostatic Neoplasms |
| ID | Term |
|---|---|
| D005834 | Genital Neoplasms, Male |
| D014565 | Urogenital Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
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| ID | Term |
|---|---|
| D017430 | Prostate-Specific Antigen |
| D017290 | Menogaril |
| ID | Term |
|---|---|
| D007610 | Kallikreins |
| D012697 | Serine Endopeptidases |
| D010450 | Endopeptidases |
| D010447 | Peptide Hydrolases |
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Participants will not know their treatment arm assignment until after robotic assisted radical prostatectomy (RARP) surgery.
|
|
| EPIC 26 | Behavioral | Participants will receive EPIC 26 psychosocial questionnaire at baseline, and post-RARP at protocol-defined intervals. |
|
|
| PSA Measurement | Other | Measurement of serum PSA levels every three months (+ 1 month) for first year post surgery, and then annually for 5 years. |
|
|
| Sexual History Inventory for Men | Behavioral | SHIM psychosocial questionnaire administered at baseline, and post-RARP at protocol-defined intervals. |
|
|
| Proportion of Men in Each Group Who Are Able to Achieve An Erection Sufficient for Intercourse More the 50% of the Time Post-RARP. | Among men with a SHIM greater than or equal to 17 at baseline, the investigators will compare the proportion of men in each group who are able to achieve an erection sufficient for intercourse more than 50% of the time at 3, 6, 9 and 12 months post RARP. | Baseline, 3, 6, 9 and 12 months Post-RARP |
| Proportion of Men Who Require the Use of More Invasive Erectile Aids Post-RARP | Among men with a SHIM greater than or equal to 17 at baseline, the investigators will evaluate the proportion of men who require the use of more invasive erectile aids (intra-cavernosal injection, vacuum pump, or penile prosthesis) at 3, 6, 9, and 12 months post RARP. | 3, 6, 9 and 12 Months Post-RARP |
| Rates of Urinary Control Experienced by Study Participants | Rates of urinary control as measured by no pads per day at 3, 6, 9, and 12 months, | Baseline, 3, 6, 9, and 12 months Post-RARP |
| 5-year Rate of Prostate Cancer Recurrence Between Both Study Arms | Rate of prostate cancer recurrence in study participants in both study arms at 5 years post-radical prostatectomy. | 5 years post-RARP |
| BG001 | Arm 2 - No Amniotic Membrane Placement | Participants who do not receive human amniotic membrane placement after robotic assisted radical prostatectomy (RARP). Participants will also undergo PSA measurement and complete the EPIC 26 and Sexual History Inventory for Men (SHIM) psychosocial questionnaires at protocol-defined intervals. EPIC 26: Participants will receive EPIC 26 psychosocial questionnaire at baseline, and post-RARP at protocol-defined intervals. PSA Measurement: Measurement of serum PSA levels every three months (+ 1 month) for first year post surgery, and then annually for 5 years. SHIM: Psychosocial questionnaire administered at baseline, and post-RARP at protocol-defined intervals. |
| BG002 | Total | Total of all reporting groups |
| Participants |
|
| Age, Continuous | Mean | Standard Deviation | years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| SHIM Score | Sexual History Inventory for Men (SHIM) psychosocial questionnaire. The SHIM score measures the severity of the participant's Erectile Dysfunction (ED) in points on a scale as follows:
| Mean | Standard Deviation | points on a scale |
|
| PSA Level | A measure of the amount of prostate-specific antigen (PSA) in the blood. | Mean | Standard Deviation | ng/mL |
|
| OG001 | Arm 2 - No Amniotic Membrane Placement | Participants who do not receive human amniotic membrane placement after robotic assisted radical prostatectomy (RARP). Participants will also undergo PSA measurement and complete the EPIC 26 and Sexual History Inventory for Men (SHIM) psychosocial questionnaires at protocol-defined intervals. EPIC 26: Participants will receive EPIC 26 psychosocial questionnaire at baseline, and post-RARP at protocol-defined intervals. PSA Measurement: Measurement of serum PSA levels every three months (+ 1 month) for first year post surgery, and then annually for 5 years. SHIM: Psychosocial questionnaire administered at baseline, and post-RARP at protocol-defined intervals. |
|
|
| Secondary | Proportion of Men in Each Group With Mild Erectile Dysfunction (ED) or Better Post-RARP | Among men with a SHIM greater than or equal to 17 at baseline, the investigators will compare the proportion of men in each group with mild ED or better, defined by a SHIM greater than or equal to 17, at 3, 6, 9 and 12 months post RARP. | Participants with a SHIM score of greater than or equal to 17 at baseline. Due to early study termination, not all study participants completed scheduled visits. | Posted | Number | percentage of participants | Baseline, 3, 6, 9 12 Months Post-RARP |
|
|
|
| Secondary | Proportion of Men in Each Group Who Are Able to Achieve An Erection Sufficient for Intercourse More the 50% of the Time Post-RARP. | Among men with a SHIM greater than or equal to 17 at baseline, the investigators will compare the proportion of men in each group who are able to achieve an erection sufficient for intercourse more than 50% of the time at 3, 6, 9 and 12 months post RARP. | Participants with a SHIM score of greater than or equal to 17 at baseline. Due to early study termination, not all study participants completed scheduled visits. | Posted | Number | percentage of participants | Baseline, 3, 6, 9 and 12 months Post-RARP |
|
|
|
| Secondary | Proportion of Men Who Require the Use of More Invasive Erectile Aids Post-RARP | Among men with a SHIM greater than or equal to 17 at baseline, the investigators will evaluate the proportion of men who require the use of more invasive erectile aids (intra-cavernosal injection, vacuum pump, or penile prosthesis) at 3, 6, 9, and 12 months post RARP. | Participants with a SHIM score of greater than or equal to 17 at baseline. Due to early study termination, not all study participants completed scheduled visits. | Posted | Number | percentage of participants | 3, 6, 9 and 12 Months Post-RARP |
|
|
|
| Secondary | Rates of Urinary Control Experienced by Study Participants | Rates of urinary control as measured by no pads per day at 3, 6, 9, and 12 months, | Due to early study termination, not all study participants completed scheduled visits. | Posted | Number | percentage of participants | Baseline, 3, 6, 9, and 12 months Post-RARP |
|
|
|
| Secondary | 5-year Rate of Prostate Cancer Recurrence Between Both Study Arms | Rate of prostate cancer recurrence in study participants in both study arms at 5 years post-radical prostatectomy. | Data were not collected due to early termination of study. | Posted | 5 years post-RARP |
|
|
| 0 |
| 12 |
| 0 |
| 12 |
| 0 |
| 12 |
| EG001 | Arm 2 - No Amniotic Membrane Placement | Participants who do not receive human amniotic membrane placement after robotic assisted radical prostatectomy (RARP). Participants will also undergo PSA measurement and complete the EPIC 26 and Sexual History Inventory for Men (SHIM) psychosocial questionnaires at protocol-defined intervals. EPIC 26: Participants will receive EPIC 26 psychosocial questionnaire at baseline, and post-RARP at protocol-defined intervals. PSA Measurement: Measurement of serum PSA levels every three months (+ 1 month) for first year post surgery, and then annually for 5 years. SHIM: Psychosocial questionnaire administered at baseline, and post-RARP at protocol-defined intervals. | 0 | 12 | 0 | 12 | 0 | 12 |
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| D005832 |
| Genital Diseases, Male |
| D000091662 | Genital Diseases |
| D000091642 | Urogenital Diseases |
| D011469 | Prostatic Diseases |
| D052801 | Male Urogenital Diseases |
| D006867 |
| Hydrolases |
| D004798 | Enzymes |
| D045762 | Enzymes and Coenzymes |
| D057057 | Serine Proteases |
| D029584 | Prostatic Secretory Proteins |
| D029589 | Seminal Plasma Proteins |
| D000094664 | Seminal Proteins |
| D011506 | Proteins |
| D000602 | Amino Acids, Peptides, and Proteins |
| D000951 | Antigens, Neoplasm |
| D000941 | Antigens |
| D001685 | Biological Factors |
| D014408 | Biomarkers, Tumor |
| D015415 | Biomarkers |
| D009621 | Nogalamycin |
| D003630 | Daunorubicin |
| D018943 | Anthracyclines |
| D009279 | Naphthacenes |
| D011084 | Polycyclic Aromatic Hydrocarbons |
| D006841 | Hydrocarbons, Aromatic |
| D006844 | Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D009930 | Organic Chemicals |
| D011083 | Polycyclic Compounds |
| D000617 | Aminoglycosides |
| D006027 | Glycosides |
| D002241 | Carbohydrates |
| Mild or Better ED, 3 months |
|
|
| Mild or Better ED, 6 months |
|
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| Mild or Better ED, 9 months |
|
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| Mild or Better ED, 12 months |
|
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| 6 months |
|
|
| 9 months |
|
|
| 12 months |
|
|
| 6 months Post-RARP |
|
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| 9 months Post-RARP |
|
|
| 12 months Post-RARP |
|
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| No Pad Usage: 3 months post-RARP |
|
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| No Pad Usage: 6 months Post-RARP |
|
|
| No Pad Usage: 9 months Post-RARP |
|
|
| No Pad Usage: 12 months Post-RARP |
|
|