Clinical trial · Interventional
Platelet Rich Plasma During Radical Prostatectomy
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
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Prostate Cancer | Malignant Prostate Neoplasm | CURATED_EXACT | 0.92 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Angel Concentrated Platelet Rich Plasma System | Device | — | UNRESOLVED |
| Autologous Platelet-Rich Plasma | Other | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Platelet Rich Plasma (PRP) Treatment
- 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.
- interventionNames
- Other: Autologous Platelet-Rich Plasma
- Device: Angel Concentrated Platelet Rich Plasma System
Primary outcomes (1)
- measure
- Safety of Using Platelet Rich Plasma (PRP) on the Neurovascular Bundle (NVB)
- timeFrame
- 18 months
- description
- Assessed by the number of subjects experiencing serious adverse events (SAEs) after treatment with PRP following nerve-sparing radical prostatectomy
Secondary outcomes (2)
Eligibility
Eligibility (as posted)
- Sex
- Male
- Minimum age
- 50 Years
- Maximum age
- 60 Years
Show eligibility criteria text
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
References
Publications (0)
Data not yet available