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Platelet Rich Plasma During Radical Prostatectomy

Primary Purpose

Prostate Cancer

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Autologous Platelet-Rich Plasma
Angel Concentrated Platelet Rich Plasma System
Sponsored by
Matthew Gettman
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Prostate Cancer

Eligibility Criteria

50 Years - 60 Years (Adult)MaleDoes not accept healthy volunteers

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

Sites / Locations

  • Mayo Clinic in Rochester

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Platelet Rich Plasma (PRP) Treatment

Arm Description

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.

Outcomes

Primary Outcome Measures

Change in complete blood count (CBC)
Number of subjects experiencing adverse events through 18 months

Secondary Outcome Measures

Change in sexual function using International Index of Erectile Function (IIEF-5)
Change in Urological Function using the Expanded Prostate Cancer Index composite (EPIC)

Full Information

First Posted
November 3, 2016
Last Updated
May 5, 2023
Sponsor
Matthew Gettman
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1. Study Identification

Unique Protocol Identification Number
NCT02957149
Brief Title
Platelet Rich Plasma During Radical Prostatectomy
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 Type
Interventional

2. Study Status

Record Verification Date
May 2023
Overall Recruitment Status
Completed
Study Start Date
December 2016 (Actual)
Primary Completion Date
December 21, 2022 (Actual)
Study Completion Date
December 21, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Matthew Gettman

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
Yes
Data Monitoring Committee
No

5. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Prostate Cancer

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
24 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Platelet Rich Plasma (PRP) Treatment
Arm Type
Experimental
Arm Description
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.
Intervention Type
Other
Intervention Name(s)
Autologous Platelet-Rich Plasma
Other Intervention Name(s)
PRP
Intervention Description
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
Device
Intervention Name(s)
Angel Concentrated Platelet Rich Plasma System
Primary Outcome Measure Information:
Title
Change in complete blood count (CBC)
Time Frame
baseline, day after surgery
Title
Number of subjects experiencing adverse events through 18 months
Time Frame
18 months
Secondary Outcome Measure Information:
Title
Change in sexual function using International Index of Erectile Function (IIEF-5)
Time Frame
baseline, 18 months
Title
Change in Urological Function using the Expanded Prostate Cancer Index composite (EPIC)
Time Frame
baseline, 18 months

10. Eligibility

Sex
Male
Minimum Age & Unit of Time
50 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Matthew T Gettman, M.D.
Organizational Affiliation
Mayo Clinic
Official's Role
Principal Investigator
Facility Information:
Facility Name
Mayo Clinic in Rochester
City
Rochester
State/Province
Minnesota
ZIP/Postal Code
55905
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No
Links:
URL
https://www.mayo.edu/research/clinical-trials
Description
Mayo Clinic Clinical Trials

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Platelet Rich Plasma During Radical Prostatectomy

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