Platelet Rich Plasma During Radical Prostatectomy

Mayo Clinic24 enrolled

Overview

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 Type

INTERVENTIONAL

Allocation

Purpose

SUPPORTIVE_CARE

Masking

NONE

Enrollment

Conditions

Prostate Cancer

Interventions

Autologous Platelet-Rich PlasmaOTHER

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.

Angel Concentrated Platelet Rich Plasma SystemDEVICE

Eligibility

Sex: MALEMin age: 50 YearsMax age: 60 Years

Medical Language ↔ Plain English

Inclusion Criteria: * Newly diagnosed, clinically localized prostatic adenocarcinoma * Age 50 - 60 years * Male gender * Normal preoperative sexual function * Normal urinary continence 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

Locations (1)

Mayo Clinic in Rochester

Rochester, Minnesota, United States

Outcomes

Primary Outcomes

Safety of Using Platelet Rich Plasma (PRP) on the Neurovascular Bundle (NVB)

Assessed by the number of subjects experiencing serious adverse events (SAEs) after treatment with PRP following nerve-sparing radical prostatectomy

Time frame: 18 months

Secondary Outcomes

Change in Sexual Function Using International Index of Erectile Function (IIEF-5)

The IIEF-5 (International Index of Erectile Function) is used for diagnosis of erectile dysfunction (ED). The IIEF-5, also knows as the Sexual Health Inventory for Men (SHIM), is a 5-question survey designed to assess the presence and severity of ED over the past 6 months. Questions are answered on a scale of 1-5. A score of 21 or lower is often considered indicative of ED. The IIEF-5 classifies ED into five categories based on scores: severe (5-7), moderate (8-11), mild to moderate (12-16), mild (17-21), and no ED (22-25).

Time frame: Baseline; every 3 months up to 18 months.

Change in Urinary Function (UF) Using the Expanded Prostate Cancer Index Composite (EPIC)

The Urinary Function (UF) section of the Expanded Prostate Cancer Index composite (EPIC) questionnaire consists of 7 questions evaluating urinary habits over the past 4 weeks. To assess change in UF over time, evaluation focused on response to question 5 (number of pads or adult diapers used to control leakage), with normal urinary continence defined as a response of "none" per protocol. Responses are recorded on a scale of 0-3 where 0=None, 1=1 pad per day; 2=2 pads per day; and 3=3 or more pads per day.

Time frame: Baseline; 3 months; 6 months; 9 months; 12 months; 18 months

Data from ClinicalTrials.gov

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