Platelet Rich Plasma During Radical Prostatectomy

Mayo Clinic

Status: Completed

Conditions: Prostate Cancer

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

Study type: Interventional

Funder types: Other

Identifiers

NCT02957149

MC2051 (Other Identifier)

16-001320

NCI-2020-00836 (Registry Identifier)

Details and patient eligibility

About

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.

Enrollment: 24 patients

Sex: Male

Ages: 50 to 60 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Supportive Care

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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24 participants in 1 patient group

Platelet Rich Plasma (PRP) Treatment

Experimental group

Description:

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.

Treatment:

Other: Autologous Platelet-Rich Plasma

Device: Angel Concentrated Platelet Rich Plasma System