Platelet Rich Plasma During Radical Prostatectomy

NCT02957149 | Completed Results FDA Device

• 3 other identifiers: MC2051NCI-2020-0083616-001320
• Study Type: interventional
• Target: 24
• Locations: 1 country
• Sites: 1

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.

Conditions

Prostate Cancer

Outcome Measures

Primary Outcomes (1)

• 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

  18 months

Secondary Outcomes (2)

• 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

Study Arms (1)

Platelet Rich Plasma (PRP) Treatment

EXPERIMENTAL

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.

Other: Autologous Platelet-Rich Plasma; Device: Angel Concentrated Platelet Rich Plasma System

Interventions

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.

Also known as: PRP

Platelet Rich Plasma (PRP) Treatment

Angel Concentrated Platelet Rich Plasma System DEVICE

Platelet Rich Plasma (PRP) Treatment

Eligibility Criteria

• Age: 50 Years - 60 Years
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Mayo Clinic: lead

Study Sites (1)

Mayo Clinic in Rochester

Rochester, Minnesota, 55905, United States

Location

MeSH Terms

Conditions

Prostatic Neoplasms

Condition Hierarchy (Ancestors)

Genital Neoplasms, Male; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Prostatic Diseases; Male Urogenital Diseases

Results Point of Contact

• Title: Matthew Gettman, MD
• Organization: Mayo Clinic

Gettman.Matthew@mayo.edu

507-284-3249

Study Officials

• Matthew T. Gettman, M.D.

  Mayo Clinic

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 3, 2016
• First Posted: November 7, 2016
• Study Start: December 1, 2016
• Primary Completion: December 21, 2022
• Study Completion: December 21, 2022
• Last Updated: June 5, 2025
• Results First Posted: June 5, 2025

Record last verified: 2025-06

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)