Prostate Cancer
Conditions
Brief summary
Can platelet rich plasma applied to nerve bundles at time of surgery help the nerve bundles heal? Subjects undergoing a Radical Prostatectomy who meet study inclusion/exclusion criteria will be consented to receive an intraoperative application of platelet-rich plasma, made from their own blood at the time of surgery, for application onto their neurovascular bundles in an effort to improve the healing process. Subjects will be followed for an additional 18 months to determine the efficacy and safety of this procedure.
Interventions
Platelets that are collected from the subject during the radical prostatectomy, for prostate cancer. The platelets are concentrated in a device to 1,000,000 platelets/mL and applied topically once to the neurovascular bundle during the surgery.
DEVICEAngel Concentrated Platelet Rich Plasma System
Sponsors
Mayo Clinic
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
SUPPORTIVE_CARE
Masking
NONE
Eligibility
Sex/Gender
MALE
Age
50 Years to 60 Years
Healthy volunteers
No
Inclusion criteria
* Newly diagnosed, clinically localized prostatic adenocarcinoma * Age 50 - 60 years * Male gender * Normal preoperative sexual function * Normal urinary continence
Exclusion criteria
* Unable or unwilling to provide informed consent * Vulnerable study populations * Active systemic infection * Diabetes mellitus diagnosis * Preexisting Erectile Dysfunction or urinary incontinence * Metastatic or locally advanced prostatic adenocarcinoma on preoperative evaluation * Men found grossly or pathologically to have locally advanced or metastatic disease at the time of radical prostatectomy * An estimated blood loss of \> 750 mL at the time of radical prostatectomy * Treatment prior to surgery with any form of hormones, anti-androgens or androgen deprivation therapy * Use of an antidepressant, beta blocker or erectile dysfunction medication at the time of study screening * Men without a regular sexual partner * Use of aspirin or heparin 2 weeks before radical prostatectomy * Need for use of aspirin or heparin for 2 weeks or more after radical prostatectomy
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Safety of Using Platelet Rich Plasma (PRP) on the Neurovascular Bundle (NVB) | 18 months | Assessed by the number of subjects experiencing serious adverse events (SAEs) after treatment with PRP following nerve-sparing radical prostatectomy |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change in Sexual Function Using International Index of Erectile Function (IIEF-5) | Baseline; every 3 months up to 18 months. | The IIEF-5 (International Index of Erectile Function) is used for diagnosis of erectile dysfunction (ED). The IIEF-5, also knows as the Sexual Health Inventory for Men (SHIM), is a 5-question survey designed to assess the presence and severity of ED over the past 6 months. Questions are answered on a scale of 1-5. A score of 21 or lower is often considered indicative of ED. The IIEF-5 classifies ED into five categories based on scores: severe (5-7), moderate (8-11), mild to moderate (12-16), mild (17-21), and no ED (22-25). |
| Change in Urinary Function (UF) Using the Expanded Prostate Cancer Index Composite (EPIC) | Baseline; 3 months; 6 months; 9 months; 12 months; 18 months | The Urinary Function (UF) section of the Expanded Prostate Cancer Index composite (EPIC) questionnaire consists of 7 questions evaluating urinary habits over the past 4 weeks. To assess change in UF over time, evaluation focused on response to question 5 (number of pads or adult diapers used to control leakage), with normal urinary continence defined as a response of none per protocol. Responses are recorded on a scale of 0-3 where 0=None, 1=1 pad per day; 2=2 pads per day; and 3=3 or more pads per day. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Platelet Rich Plasma (PRP) Treatment Platelets that are collected from the subject during the radical prostatectomy, for prostate cancer. The Autologous Platelet-Rich Plasma is concentrated in a device (Angel Concentrated Platelet Rich Plasma System) to 1,000,000 platelets/mL and applied topically once to the neurovascular bundle during the surgery.
Autologous Platelet-Rich Plasma: Platelets that are collected from the subject during the radical prostatectomy, for prostate cancer. The platelets are concentrated in a device to 1,000,000 platelets/mL and applied topically once to the neurovascular bundle during the surgery.
Angel Concentrated Platelet Rich Plasma System | 19 |
| Total | 19 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Withdrawal by Subject | 5 |
Baseline characteristics
| Characteristic | Platelet Rich Plasma (PRP) Treatment | — |
|---|---|---|
| Age, Continuous | 60 years | — |
| Race and Ethnicity Not Collected | — | — Participants |
| Region of Enrollment United States | 19 participants | — |
| Sex: Female, Male Female | 0 Participants | — |
| Sex: Female, Male Male | 19 Participants | — |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 19 |
| other Total, other adverse events | 2 / 19 |
| serious Total, serious adverse events | 0 / 19 |
Outcome results
Primary
Safety of Using Platelet Rich Plasma (PRP) on the Neurovascular Bundle (NVB)
Assessed by the number of subjects experiencing serious adverse events (SAEs) after treatment with PRP following nerve-sparing radical prostatectomy
Time frame: 18 months
Population: The highest grade of adverse event (AE) is reported for each participants who experienced one or more AE.
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Platelet Rich Plasma (PRP) Treatment | Safety of Using Platelet Rich Plasma (PRP) on the Neurovascular Bundle (NVB) | Grade 3 or higher AE (severe or life-threatening) | 0 Participants |
| Platelet Rich Plasma (PRP) Treatment | Safety of Using Platelet Rich Plasma (PRP) on the Neurovascular Bundle (NVB) | Grade 1 or 2 AE (mild or moderate) | 2 Participants |
| Platelet Rich Plasma (PRP) Treatment | Safety of Using Platelet Rich Plasma (PRP) on the Neurovascular Bundle (NVB) | No AE | 17 Participants |
Secondary
Change in Sexual Function Using International Index of Erectile Function (IIEF-5)
The IIEF-5 (International Index of Erectile Function) is used for diagnosis of erectile dysfunction (ED). The IIEF-5, also knows as the Sexual Health Inventory for Men (SHIM), is a 5-question survey designed to assess the presence and severity of ED over the past 6 months. Questions are answered on a scale of 1-5. A score of 21 or lower is often considered indicative of ED. The IIEF-5 classifies ED into five categories based on scores: severe (5-7), moderate (8-11), mild to moderate (12-16), mild (17-21), and no ED (22-25).
Time frame: Baseline; every 3 months up to 18 months.
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| Platelet Rich Plasma (PRP) Treatment | Change in Sexual Function Using International Index of Erectile Function (IIEF-5) | Baseline | 25 score on a scale |
| Platelet Rich Plasma (PRP) Treatment | Change in Sexual Function Using International Index of Erectile Function (IIEF-5) | 3 months | 16 score on a scale |
| Platelet Rich Plasma (PRP) Treatment | Change in Sexual Function Using International Index of Erectile Function (IIEF-5) | 6 months | 19 score on a scale |
| Platelet Rich Plasma (PRP) Treatment | Change in Sexual Function Using International Index of Erectile Function (IIEF-5) | 9 months | 19 score on a scale |
| Platelet Rich Plasma (PRP) Treatment | Change in Sexual Function Using International Index of Erectile Function (IIEF-5) | 12 months | 20 score on a scale |
| Platelet Rich Plasma (PRP) Treatment | Change in Sexual Function Using International Index of Erectile Function (IIEF-5) | 18 months | 20 score on a scale |
Secondary
Change in Urinary Function (UF) Using the Expanded Prostate Cancer Index Composite (EPIC)
The Urinary Function (UF) section of the Expanded Prostate Cancer Index composite (EPIC) questionnaire consists of 7 questions evaluating urinary habits over the past 4 weeks. To assess change in UF over time, evaluation focused on response to question 5 (number of pads or adult diapers used to control leakage), with normal urinary continence defined as a response of none per protocol. Responses are recorded on a scale of 0-3 where 0=None, 1=1 pad per day; 2=2 pads per day; and 3=3 or more pads per day.
Time frame: Baseline; 3 months; 6 months; 9 months; 12 months; 18 months
Population: 4 patients were lost to follow-up for the last visit (18 months)
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Platelet Rich Plasma (PRP) Treatment | Change in Urinary Function (UF) Using the Expanded Prostate Cancer Index Composite (EPIC) | Baseline | 18 Participants |
| Platelet Rich Plasma (PRP) Treatment | Change in Urinary Function (UF) Using the Expanded Prostate Cancer Index Composite (EPIC) | 3 Months | 9 Participants |
| Platelet Rich Plasma (PRP) Treatment | Change in Urinary Function (UF) Using the Expanded Prostate Cancer Index Composite (EPIC) | 6 Months | 15 Participants |
| Platelet Rich Plasma (PRP) Treatment | Change in Urinary Function (UF) Using the Expanded Prostate Cancer Index Composite (EPIC) | 9 Months | 18 Participants |
| Platelet Rich Plasma (PRP) Treatment | Change in Urinary Function (UF) Using the Expanded Prostate Cancer Index Composite (EPIC) | 12 Months | 18 Participants |
| Platelet Rich Plasma (PRP) Treatment | Change in Urinary Function (UF) Using the Expanded Prostate Cancer Index Composite (EPIC) | 18 Months | 15 Participants |