Platelet Rich Plasma During Radical Prostatectomy

Not Applicable

Completed

• Conditions: Prostate Cancer
• Interventions: Other: Autologous Platelet-Rich Plasma; Device: Angel Concentrated Platelet Rich Plasma System

• Registration Number: NCT02957149
• Lead Sponsor: Matthew Gettman

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2016-11-03
• Study First Submitted QC: 2016-11-03
• Study First Posted: 2016-11-06
• Study Start: 2016-12
• Primary Completion: 2022-12-21
• Study Completion: 2022-12-21
• Status Verified: 2023-05
• Last Update Submitted: 2023-05-05
• Last Update Posted: 2023-05-06

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Male
• Target Recruitment: 24

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Platelet Rich Plasma (PRP) Treatment	Autologous Platelet-Rich Plasma	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.
Platelet Rich Plasma (PRP) Treatment	Angel Concentrated Platelet Rich Plasma System	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.

Primary Outcome Measures

Name	Time	Method
Change in complete blood count (CBC)	baseline, day after surgery
Number of subjects experiencing adverse events through 18 months	18 months

Secondary Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (1)

Mayo Clinic in Rochester; 🇺🇸 Rochester, Minnesota, United States