N/A
N=24
Platelet Rich Plasma During Radical Prostatectomy
Prostate Cancer
Bottom Line
View on ClinicalTrials.gov: NCT02957149 ↗Enrolled (actual)
24
Serious AEs
0.0%
Results posted
Jun 2025
Primary outcome: Primary: Safety of Using Platelet Rich Plasma (PRP) on the Neurovascular Bundle (NVB) — 0; 2; 17 Participants
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Autologous Platelet-Rich Plasma (Other); Angel Concentrated Platelet Rich Plasma System (Device)
- Age
- Adult · 50+ yrs
- Sex
- Male
- Sponsor
- Mayo Clinic
- Primary completion
- Dec 2022
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Safety of Using Platelet Rich Plasma (PRP) on the Neurovascular Bundle (NVB) |
0; 2; 17 | — |
| SECONDARY Change in Sexual Function Using International Index of Erectile Function (IIEF-5) |
25; 16; 19; 19; 20; 20 | — |
| SECONDARY Change in Urinary Function (UF) Using the Expanded Prostate Cancer Index Composite (EPIC) |
18; 9; 15; 18; 18; 15 | — |
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.
Eligibility Criteria
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
Data sourced from ClinicalTrials.gov (NCT02957149). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.