Platelet Rich Plasma During Radical Prostatectomy

Prostate Cancer Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02957149
• Other study ID #: 16-001320
• Secondary ID: MC2051
• Status: Completed
• Phase: N/A
• Start date: December 2016
• Est. completion date: December 21, 2022

Study information

• Verified date: May 2023
• Source: Mayo Clinic
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 24
• Est. completion date: December 21, 2022
• Est. primary completion date: December 21, 2022
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 50 Years to 60 Years

Eligibility

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

Related Conditions & MeSH terms

• Prostate Cancer
• Prostatic Neoplasms

Intervention

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.

Device:
• Angel Concentrated Platelet Rich Plasma System

Locations

Country	Name	City	State
United States	Mayo Clinic in Rochester	Rochester	Minnesota

Sponsors (1)

Lead Sponsor	Collaborator
Matthew Gettman

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in complete blood count (CBC)		baseline, day after surgery
Primary	Number of subjects experiencing adverse events through 18 months		18 months
Secondary	Change in sexual function using International Index of Erectile Function (IIEF-5)		baseline, 18 months
Secondary	Change in Urological Function using the Expanded Prostate Cancer Index composite (EPIC)		baseline, 18 months

External Links

•   Mayo Clinic Clinical Trials