Platelet Rich Plasma During Radical Prostatectomy

May 5, 2023 updated by: Matthew Gettman

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

24

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Minnesota
      • Rochester, Minnesota, United States, 55905
        • Mayo Clinic in Rochester

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

50 years to 60 years (Adult)

Accepts Healthy Volunteers

No

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 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.
Other: 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.
Other Names:
  • PRP
Device: Angel Concentrated Platelet Rich Plasma System

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Matthew Gettman

Investigators

  • Principal Investigator: Matthew T Gettman, M.D., Mayo Clinic

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

December 1, 2016

Primary Completion (Actual)

December 21, 2022

Study Completion (Actual)

December 21, 2022

Study Registration Dates

First Submitted

November 3, 2016

First Submitted That Met QC Criteria

November 3, 2016

First Posted (Estimate)

November 6, 2016

Study Record Updates

Last Update Posted (Estimate)

May 8, 2023

Last Update Submitted That Met QC Criteria

May 5, 2023

Last Verified

May 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 16-001320
  • MC2051 (Other Identifier: Mayo Clinic)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

Yes

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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