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Platelet Rich Plasma During Radical Prostatectomy

Sponsor
Matthew Gettman (Other)
Overall Status
Active, not recruiting
CT.gov ID
NCT02957149
Collaborator
(none)
24
Enrollment
1
Location
1
Arm
68.8
Anticipated Duration (Months)
0.3
Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Other: Autologous Platelet-Rich Plasma
  • Device: Angel Concentrated Platelet Rich Plasma System
 N/A

Study Design

Study Type:
Interventional
Actual Enrollment :
24 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
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
Actual Study Start Date :
Dec 1, 2016
Anticipated Primary Completion Date :
Aug 26, 2022
Anticipated Study Completion Date :
Aug 26, 2022

Arms and Interventions

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

    Outcome Measures

    Primary Outcome Measures

    1. Change in complete blood count (CBC) [baseline, day after surgery]

    2. Number of subjects experiencing adverse events through 18 months [18 months]

    Secondary Outcome Measures

    1. Change in sexual function using International Index of Erectile Function (IIEF-5) [baseline, 18 months]

    2. Change in Urological Function using the Expanded Prostate Cancer Index composite (EPIC) [baseline, 18 months]

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    50 Years to 60 Years
    Sexes Eligible for Study:
    Male
    Accepts Healthy Volunteers:
    No
    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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Mayo Clinic in Rochester Rochester Minnesota United States 55905

    Sponsors and Collaborators

    • Matthew Gettman

    Investigators

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

    Study Documents (Full-Text)

    None provided.

    More Information

    Additional Information:

    Publications

    None provided.
    Responsible Party:
    Matthew Gettman, MD, Mayo Clinic
    ClinicalTrials.gov Identifier:
    NCT02957149
    Other Study ID Numbers:
    • 16-001320
    First Posted:
    Nov 6, 2016
    Last Update Posted:
    Dec 6, 2021
    Last Verified:
    Dec 1, 2021
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    Yes
    Additional relevant MeSH terms:
    Prostatic Neoplasms

    Study Results

    No Results Posted as of Dec 6, 2021