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Platelet Rich Plasma During Radical Prostatectomy

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ClinicalTrials.gov Identifier: NCT02957149
Recruitment Status : Recruiting
First Posted : November 7, 2016
Last Update Posted : September 6, 2019
Sponsor:
Information provided by (Responsible Party):
Matthew Gettman, Mayo Clinic

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
Prostate Cancer Other: Autologous Platelet-Rich Plasma Device: Angel Concentrated Platelet Rich Plasma System Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 20 participants
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
Study Start Date : December 2016
Estimated Primary Completion Date : June 2021
Estimated Study Completion Date : June 2021

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Prostate Cancer

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 Name: PRP

Device: Angel Concentrated Platelet Rich Plasma System



Primary Outcome Measures :
  1. Change in complete blood count (CBC) [ Time Frame: baseline, day after surgery ]
  2. Number of subjects experiencing adverse events through 18 months [ Time Frame: 18 months ]

Secondary Outcome Measures :
  1. Change in sexual function using International Index of Erectile Function (IIEF-5) [ Time Frame: baseline, 18 months ]
  2. Change in Urological Function using the Expanded Prostate Cancer Index composite (EPIC) [ Time Frame: baseline, 18 months ]


Information from the National Library of Medicine

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Ages Eligible for Study:   50 Years to 60 Years   (Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02957149


Contacts
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Contact: Vidhu Joshi 507-538-5772 joshi.vidhu@mayo.edu

Locations
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United States, Minnesota
Mayo Clinic in Rochester Recruiting
Rochester, Minnesota, United States, 55905
Contact: Tessa Kroeninger    507-538-6107    kroeninger.tessa@mayo.edu   
Sponsors and Collaborators
Matthew Gettman
Investigators
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Principal Investigator: Matthew T Gettman, M.D. Mayo Clinic

Additional Information:
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Responsible Party: Matthew Gettman, MD, Mayo Clinic
ClinicalTrials.gov Identifier: NCT02957149     History of Changes
Other Study ID Numbers: 16-001320
First Posted: November 7, 2016    Key Record Dates
Last Update Posted: September 6, 2019
Last Verified: September 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Device Product Not Approved or Cleared by U.S. FDA: No
Additional relevant MeSH terms:
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Prostatic Neoplasms
Genital Neoplasms, Male
Urogenital Neoplasms
Neoplasms by Site
Neoplasms
Genital Diseases, Male
Prostatic Diseases