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
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Mayo Clinic
- Enrollment
- 24
- Locations
- 1
- Primary Endpoint
- Safety of Using Platelet Rich Plasma (PRP) on the Neurovascular Bundle (NVB)
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Na
- Intervention Model
- Single Group
- Primary Purpose
- Supportive Care
- Masking
- None
Eligibility Criteria
- Ages
- 50 Years to 60 Years (Adult)
- Sex
- 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
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
Arms & Interventions
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.
Intervention: Angel Concentrated Platelet Rich Plasma System (Device)
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.
Intervention: Autologous Platelet-Rich Plasma (Other)
Outcomes
Primary Outcomes
Safety of Using Platelet Rich Plasma (PRP) on the Neurovascular Bundle (NVB)
Time Frame: 18 months
Assessed by the number of subjects experiencing serious adverse events (SAEs) after treatment with PRP following nerve-sparing radical prostatectomy
Secondary Outcomes
- Change in Sexual Function Using International Index of Erectile Function (IIEF-5)(Baseline; every 3 months up to 18 months.)
- Change in Urinary Function (UF) Using the Expanded Prostate Cancer Index Composite (EPIC)(Baseline; 3 months; 6 months; 9 months; 12 months; 18 months)