Platelet Rich Plasma During Radical Prostatectomy

Not Applicable

Completed

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.

Recruitment & Eligibility

Inclusion Criteria

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

Primary Outcome Measures

Name	Time	Method
Safety of Using Platelet Rich Plasma (PRP) on the Neurovascular Bundle (NVB)	18 months	Assessed by the number of subjects experiencing serious adverse events (SAEs) after treatment with PRP following nerve-sparing radical prostatectomy

Secondary Outcome Measures

Name	Time	Method
Change in Sexual Function Using International Index of Erectile Function (IIEF-5)	Baseline; every 3 months up to 18 months.	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).
Change in Urinary Function (UF) Using the Expanded Prostate Cancer Index Composite (EPIC)	Baseline; 3 months; 6 months; 9 months; 12 months; 18 months	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.