Platelet Rich Plasma During Radical Prostatectomy

Study Overview
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Brief Summary
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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.

Official Title
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A Study Evaluating Intraoperative Application of Platelet-Rich Plasma to the Neurovascular Bundles During Nerve-Sparing Radical Prostatectomy: Initial Technical Description and Prospective Early Postoperative Outcomes Analysis

Conditions
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Prostate Cancer

Intervention / Treatment
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* Other: Autologous Platelet-Rich Plasma
* Device: Angel Concentrated Platelet Rich Plasma System


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Newly diagnosed, clinically localized prostatic adenocarcinoma Age 50 - 60 years Male gender Normal preoperative sexual function Normal urinary continence Regular sexual partner 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

Ages Eligible for Study
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Minimum Age: 50 Years
Maximum Age: 60 Years

Sexes Eligible for Study
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Male

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Platelet Rich Plasma (PRP) Treatment<br>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. | Other: Autologous Platelet-Rich Plasma<br>* 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.<br>* Other names: PRP;Device: Angel Concentrated Platelet Rich Plasma System<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in complete blood count (CBC) |  | baseline, day after surgery | 
| Number of subjects experiencing adverse events through 18 months |  | 18 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in sexual function using International Index of Erectile Function (IIEF-5) |  | baseline, 18 months | 
| Change in Urological Function using the Expanded Prostate Cancer Index composite (EPIC) |  | baseline, 18 months |