Prostate Cancer
Conditions
Keywords
Prostate Cancer, Amniotic Membrane Placement, Robotic Assisted Radical Prostatectomy, RARP, Human Amniotic Membrane Allograft
Brief summary
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.
Detailed description
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.
Interventions
BIOLOGICALAmniotic 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.
BEHAVIORALEPIC 26
Participants will receive EPIC 26 psychosocial questionnaire at baseline, and post-RARP at protocol-defined intervals.
OTHERPSA Measurement
Measurement of serum PSA levels every three months (+ 1 month) for first year post surgery, and then annually for 5 years.
BEHAVIORALSexual History Inventory for Men
SHIM psychosocial questionnaire administered at baseline, and post-RARP at protocol-defined intervals.
Sponsors
Vivex Biomedical
University of Miami
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Subject)
Masking description
Participants will not know their treatment arm assignment until after robotic assisted radical prostatectomy (RARP) surgery.
Eligibility
Sex/Gender
MALE
Age
40 Years to 80 Years
Healthy volunteers
No
Inclusion criteria
* Men age 40-80 with localized prostate cancer who are undergoing bilateral nerve sparing RARP at the University of Miami
Exclusion criteria
* Men with poor urinary control at baseline requiring the use of pads for leakage * Previous treatment for prostate cancer * Previous history of pelvic radiation * Men who are using non-oral erectile aids such as vacuum pump, intra-cavernous injections, MUSE, penile prosthesis.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| The Difference in Average Change in SHIM Score, Between Baseline and 12-Months Post-RARP, of Study Participants in Each Group | Baseline, 12 Months Post-RARP | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Proportion of Men in Each Group Who Are Able to Achieve An Erection Sufficient for Intercourse More the 50% of the Time Post-RARP. | Baseline, 3, 6, 9 and 12 months 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. |
| Proportion of Men in Each Group With Mild Erectile Dysfunction (ED) or Better Post-RARP | Baseline, 3, 6, 9 12 Months 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. |
| Proportion of Men Who Require the Use of More Invasive Erectile Aids Post-RARP | 3, 6, 9 and 12 Months 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. |
| Rates of Urinary Control Experienced by Study Participants | Baseline, 3, 6, 9, and 12 months Post-RARP | Rates of urinary control as measured by no pads per day at 3, 6, 9, and 12 months, |
| 5-year Rate of Prostate Cancer Recurrence Between Both Study Arms | 5 years post-RARP | Rate of prostate cancer recurrence in study participants in both study arms at 5 years post-radical prostatectomy. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| 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. | 12 |
| 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. | 12 |
| Total | 24 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Termination of study | 9 | 9 |
Baseline characteristics
| Characteristic | Arm 1 - Amniotic Membrane Placement | Total | Arm 2 - No Amniotic Membrane Placement |
|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 5 Participants | 8 Participants | 3 Participants |
| Age, Categorical Between 18 and 65 years | 7 Participants | 16 Participants | 9 Participants |
| Age, Continuous | 60.33 years STANDARD_DEVIATION 6.95 | 60.79 years STANDARD_DEVIATION 5.49 | 61.25 years STANDARD_DEVIATION 3.76 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 6 Participants | 13 Participants | 7 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 6 Participants | 11 Participants | 5 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| PSA Level | 7.29 ng/mL STANDARD_DEVIATION 3.06 | 7.03 ng/mL STANDARD_DEVIATION 2.82 | 6.76 ng/mL STANDARD_DEVIATION 2.66 |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Black or African American | 3 Participants | 3 Participants | 0 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) White | 9 Participants | 21 Participants | 12 Participants |
| Region of Enrollment United States | 12 participants | 24 participants | 12 participants |
| Sex: Female, Male Female | 0 Participants | 0 Participants | 0 Participants |
| Sex: Female, Male Male | 12 Participants | 24 Participants | 12 Participants |
| SHIM Score | 19.25 points on a scale STANDARD_DEVIATION 7.12 | 20.25 points on a scale STANDARD_DEVIATION 5.83 | 21.25 points on a scale STANDARD_DEVIATION 4.26 |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 12 | 0 / 12 |
| other Total, other adverse events | 0 / 12 | 0 / 12 |
| serious Total, serious adverse events | 0 / 12 | 0 / 12 |
Outcome results
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.
Time frame: Baseline, 12 Months Post-RARP
Population: Due to early study termination, not all study participants completed scheduled visits.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Arm 1 - Amniotic Membrane Placement | The Difference in Average Change in SHIM Score, Between Baseline and 12-Months Post-RARP, of Study Participants in Each Group | 10 scores on a scale | Standard Deviation 12.288 |
| Arm 2 - No Amniotic Membrane Placement | The Difference in Average Change in SHIM Score, Between Baseline and 12-Months Post-RARP, of Study Participants in Each Group | 13.33 scores on a scale | Standard Deviation 6.429 |
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.
Time frame: 5 years post-RARP
Population: Data were not collected due to early termination of study.
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.
Time frame: Baseline, 3, 6, 9 and 12 months Post-RARP
Population: 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.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Arm 1 - Amniotic Membrane Placement | Proportion of Men in Each Group Who Are Able to Achieve An Erection Sufficient for Intercourse More the 50% of the Time Post-RARP. | 9 months | 0 percentage of participants |
| Arm 1 - Amniotic Membrane Placement | Proportion of Men in Each Group Who Are Able to Achieve An Erection Sufficient for Intercourse More the 50% of the Time Post-RARP. | 3 months | 0 percentage of participants |
| Arm 1 - Amniotic Membrane Placement | Proportion of Men in Each Group Who Are Able to Achieve An Erection Sufficient for Intercourse More the 50% of the Time Post-RARP. | 6 months | 0 percentage of participants |
| Arm 1 - Amniotic Membrane Placement | Proportion of Men in Each Group Who Are Able to Achieve An Erection Sufficient for Intercourse More the 50% of the Time Post-RARP. | 12 months | 66.67 percentage of participants |
| Arm 2 - No Amniotic Membrane Placement | Proportion of Men in Each Group Who Are Able to Achieve An Erection Sufficient for Intercourse More the 50% of the Time Post-RARP. | 12 months | 0 percentage of participants |
| Arm 2 - No Amniotic Membrane Placement | Proportion of Men in Each Group Who Are Able to Achieve An Erection Sufficient for Intercourse More the 50% of the Time Post-RARP. | 9 months | 0 percentage of participants |
| Arm 2 - No Amniotic Membrane Placement | Proportion of Men in Each Group Who Are Able to Achieve An Erection Sufficient for Intercourse More the 50% of the Time Post-RARP. | 6 months | 0 percentage of participants |
| Arm 2 - No Amniotic Membrane Placement | Proportion of Men in Each Group Who Are Able to Achieve An Erection Sufficient for Intercourse More the 50% of the Time Post-RARP. | 3 months | 0 percentage of participants |
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.
Time frame: Baseline, 3, 6, 9 12 Months Post-RARP
Population: 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.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Arm 1 - Amniotic Membrane Placement | Proportion of Men in Each Group With Mild Erectile Dysfunction (ED) or Better Post-RARP | Mild or Better ED, 3 months | 0 percentage of participants |
| Arm 1 - Amniotic Membrane Placement | Proportion of Men in Each Group With Mild Erectile Dysfunction (ED) or Better Post-RARP | Mild or Better ED, 9 months | 0 percentage of participants |
| Arm 1 - Amniotic Membrane Placement | Proportion of Men in Each Group With Mild Erectile Dysfunction (ED) or Better Post-RARP | Mild or Better ED, 6 months | 0 percentage of participants |
| Arm 1 - Amniotic Membrane Placement | Proportion of Men in Each Group With Mild Erectile Dysfunction (ED) or Better Post-RARP | Mild or Better ED, 12 months | 66.67 percentage of participants |
| Arm 1 - Amniotic Membrane Placement | Proportion of Men in Each Group With Mild Erectile Dysfunction (ED) or Better Post-RARP | Mild or Better ED, Baseline | 100 percentage of participants |
| Arm 2 - No Amniotic Membrane Placement | Proportion of Men in Each Group With Mild Erectile Dysfunction (ED) or Better Post-RARP | Mild or Better ED, 12 months | 0 percentage of participants |
| Arm 2 - No Amniotic Membrane Placement | Proportion of Men in Each Group With Mild Erectile Dysfunction (ED) or Better Post-RARP | Mild or Better ED, Baseline | 100 percentage of participants |
| Arm 2 - No Amniotic Membrane Placement | Proportion of Men in Each Group With Mild Erectile Dysfunction (ED) or Better Post-RARP | Mild or Better ED, 3 months | 0 percentage of participants |
| Arm 2 - No Amniotic Membrane Placement | Proportion of Men in Each Group With Mild Erectile Dysfunction (ED) or Better Post-RARP | Mild or Better ED, 6 months | 0 percentage of participants |
| Arm 2 - No Amniotic Membrane Placement | Proportion of Men in Each Group With Mild Erectile Dysfunction (ED) or Better Post-RARP | Mild or Better ED, 9 months | 0 percentage of participants |
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.
Time frame: 3, 6, 9 and 12 Months Post-RARP
Population: 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.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Arm 1 - Amniotic Membrane Placement | Proportion of Men Who Require the Use of More Invasive Erectile Aids Post-RARP | 3 months Post-RARP | 0 percentage of participants |
| Arm 1 - Amniotic Membrane Placement | Proportion of Men Who Require the Use of More Invasive Erectile Aids Post-RARP | 6 months Post-RARP | 0 percentage of participants |
| Arm 1 - Amniotic Membrane Placement | Proportion of Men Who Require the Use of More Invasive Erectile Aids Post-RARP | 9 months Post-RARP | 0 percentage of participants |
| Arm 1 - Amniotic Membrane Placement | Proportion of Men Who Require the Use of More Invasive Erectile Aids Post-RARP | 12 months Post-RARP | 66.67 percentage of participants |
| Arm 2 - No Amniotic Membrane Placement | Proportion of Men Who Require the Use of More Invasive Erectile Aids Post-RARP | 12 months Post-RARP | 100 percentage of participants |
| Arm 2 - No Amniotic Membrane Placement | Proportion of Men Who Require the Use of More Invasive Erectile Aids Post-RARP | 3 months Post-RARP | 0 percentage of participants |
| Arm 2 - No Amniotic Membrane Placement | Proportion of Men Who Require the Use of More Invasive Erectile Aids Post-RARP | 9 months Post-RARP | 33.33 percentage of participants |
| Arm 2 - No Amniotic Membrane Placement | Proportion of Men Who Require the Use of More Invasive Erectile Aids Post-RARP | 6 months Post-RARP | 0 percentage of participants |
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,
Time frame: Baseline, 3, 6, 9, and 12 months Post-RARP
Population: Due to early study termination, not all study participants completed scheduled visits.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Arm 1 - Amniotic Membrane Placement | Rates of Urinary Control Experienced by Study Participants | No Pad Usage: 3 months post-RARP | 22.22 percentage of participants |
| Arm 1 - Amniotic Membrane Placement | Rates of Urinary Control Experienced by Study Participants | No Pad Usage: 9 months Post-RARP | 60 percentage of participants |
| Arm 1 - Amniotic Membrane Placement | Rates of Urinary Control Experienced by Study Participants | No Pad Usage: 6 months Post-RARP | 42.86 percentage of participants |
| Arm 1 - Amniotic Membrane Placement | Rates of Urinary Control Experienced by Study Participants | No Pad Usage: 12 months Post-RARP | 100 percentage of participants |
| Arm 1 - Amniotic Membrane Placement | Rates of Urinary Control Experienced by Study Participants | No Pad Usage: Baseline | 100 percentage of participants |
| Arm 2 - No Amniotic Membrane Placement | Rates of Urinary Control Experienced by Study Participants | No Pad Usage: 12 months Post-RARP | 33.33 percentage of participants |
| Arm 2 - No Amniotic Membrane Placement | Rates of Urinary Control Experienced by Study Participants | No Pad Usage: Baseline | 100 percentage of participants |
| Arm 2 - No Amniotic Membrane Placement | Rates of Urinary Control Experienced by Study Participants | No Pad Usage: 3 months post-RARP | 27.27 percentage of participants |
| Arm 2 - No Amniotic Membrane Placement | Rates of Urinary Control Experienced by Study Participants | No Pad Usage: 6 months Post-RARP | 50 percentage of participants |
| Arm 2 - No Amniotic Membrane Placement | Rates of Urinary Control Experienced by Study Participants | No Pad Usage: 9 months Post-RARP | 60 percentage of participants |