Platelet Rich Plasma During Radical Prostatectomy

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

24 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-12-31

Study Completion Date

2022-12-21

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.

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Detailed Description

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Conditions

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Prostate Cancer

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

NONE

Study Groups

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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.

Group Type EXPERIMENTAL

Autologous Platelet-Rich Plasma

Intervention Type OTHER

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

Intervention Type DEVICE

Interventions

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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.

Intervention Type OTHER

Angel Concentrated Platelet Rich Plasma System

Intervention Type DEVICE

Other Intervention Names

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PRP

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

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

Minimum Eligible Age

50 Years

Maximum Eligible Age

60 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

No