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Completed

NCT Number: NCT02957149

Platelet Rich Plasma During Radical Prostatectomy

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.

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Key information

Conditions

Prostate Cancer Genital Diseases Genital Diseases, Male Genital Neoplasms, Male Male Urogenital Diseases Neoplasms Neoplasms by Site Prostatic Diseases Prostatic Neoplasms Urogenital Diseases Urogenital Neoplasms

Age range

50 year–60 year

Sex eligibility

Male

Study type

Interventional

Phase

Not applicable

Primary location

Mayo Clinic in Rochester

Rochester, Minnesota, 55905, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Autologous Platelet-Rich Plasma

Other

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.

Other names: PRP

Angel Concentrated Platelet Rich Plasma System

Device

Primary outcomes

  1. 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

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

    Time frame: 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).

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

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

Mayo Clinic

Other

Registry information

Official study 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

Important dates

Study start
2016
Primary completion
2022
Study completion
2022
First posted
Nov 7, 2016
Registry last updated
Jun 5, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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